Proactiveinvestors Australia OncoSil Medical Ltd https://www.proactiveinvestors.com.au Proactiveinvestors Australia OncoSil Medical Ltd RSS feed en Mon, 27 May 2019 01:12:56 +1000 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - OncoSil Medical attracts $16.7 million for breakthrough pancreatic cancer radiation treatment ]]> https://www.proactiveinvestors.com.au/companies/news/195320/oncosil-medical-attracts-167-million-for-breakthrough-pancreatic-cancer-radiation-treatment-195320.html OncoSil Medical Ltd (ASX:OSL) has received strong shareholder support for its share purchase plan, with applications materially exceeding the aggregate capped amount of $4 million at 12 cents per share.

This amount is in addition to the A$12.7 million raised through the recent share placement to institutional and sophisticated investors at the same issue price.

Commercialisation of OncoSil™ for pancreatic cancer treatment

Funds raised from the institutional placement and share purchase plan are expected to see the company through to the commercialisation of its OncoSil device in the European Union.

OncoSil is a targeted radioactive isotope implanted directly into a patient’s pancreatic tumours via an endoscopic ultrasound.

Treatment with the OncoSil is intended to deliver more concentrated and localised beta radiation compared to external beam radiation.

READ: OncoSil Medical seen as undervalued by broker following success with pancreatic cancer treatment trials

Analysts at Bell Potter considers OncoSil substantially undervalued and has a buy recommendation with a 12-month price target of 39 cents (current price: 14 cents).

John Hester from Bell Potter highlighted the fact that the company has just received further encouraging news regarding the progress of its global pancreatic clinical study program.

He noted that 40 patients have now been recruited with 31 successful implants completed to date.

$44.8 million revenue forecasted for fiscal 2019

Hester is forecasting revenues to increase from $3.5 million in fiscal 2018 to $44.8 million in fiscal 2019.

His projections point to a net profit of $27 million in 2019, representing underlying earnings per share of 4.4 cents.

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Thu, 19 Apr 2018 14:42:00 +1000 https://www.proactiveinvestors.com.au/companies/news/195320/oncosil-medical-attracts-167-million-for-breakthrough-pancreatic-cancer-radiation-treatment-195320.html
<![CDATA[News - OncoSil Medical seen as undervalued by broker following success with pancreatic cancer treatment trials ]]> https://www.proactiveinvestors.com.au/companies/news/194682/oncosil-medical-seen-as-undervalued-by-broker-following-success-with-pancreatic-cancer-treatment-trials-194682.html OncoSil Medical Ltd (ASX:OSL) is viewed by analysts at Bell Potter as substantially undervalued based on Tuesday’s closing price of 13 cents.

The broker has a buy recommendation on the stock with a 12-month price target of 39 cents.

OncoSil is a medical device company focused on localised treatments for patients with pancreatic and liver cancer.

The global target market for pancreatic and liver cancer is estimated to be about US$3.5 billion.

Clinical study delivering promising results

John Hester from Bell Potter highlighted the fact that the company has just received further encouraging news regarding the progress of global pancreatic clinical study program.

He noted that 40 patients have now been recruited with 31 successful implants completed to date.

Of the 20 who have reached the first evaluation point, the response rate is 20%.

Previously inoperable patients undergoing curative surgery

Providing further justification for confidence was the fact that three of the 20 have undergone potentially curative surgery.

It is believed that another three patients are likely surgical candidates following down-staging in their disease.

OncoSil chief executive officer Daniel Kenny said: “The surgical resection findings to date represent an important milestone, as they demonstrate an improved outcome in a patient study group who were deemed inoperable when enrolled.

“Additional patients continue to be assessed by their clinical teams for surgical resection, and we look forward to providing further updates.”

Funded through to European Union commercialisation

In March, OncoSil completed an institutional placement raising $12.7 million.

This was accompanied by a share purchase plan capped at $4 million.

Funds raised from the institutional placement and share purchase plan are expected to see the company through to European Union commercialisation of the OncoSil™ device.

This includes achieving the key milestone of CE Mark certification.

Jump in revenues in fiscal 2019

Hester is forecasting revenues to increase from $3.5 million in fiscal 2018 to $44.8 million in fiscal 2019.

His projections point to a net profit of $27 million in 2019, representing underlying earnings per share of 4.4 cents.

Hence, his target price which implies share price upside of 200% to the company’s current trading range, implies a PE multiple of less than 10.

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Wed, 11 Apr 2018 08:38:00 +1000 https://www.proactiveinvestors.com.au/companies/news/194682/oncosil-medical-seen-as-undervalued-by-broker-following-success-with-pancreatic-cancer-treatment-trials-194682.html
<![CDATA[News - OncoSil Medical reveals positive data from pancreatic cancer clinical study ]]> https://www.proactiveinvestors.com.au/companies/news/185980/oncosil-medical-reveals-positive-data-from-pancreatic-cancer-clinical-study-185980.html OncoSil Medical Ltd’s (ASX:OSL) pancreatic cancer clinical study has demonstrated significant local disease control with up to 73% reduction in tumour volume observed 4 weeks post implant.

The company’s lead product, OncoSil™, is a targeted radioactive isotope, implanted directly into a patient’s pancreatic tumour via an endoscopic ultrasound.

Treatment with OncoSil is intended to deliver more concentrated and localised beta radiation compared to external beam radiation.

OncoSil has provided an overview of early study results at the European Association of Nuclear Medicine (EANM) Congress, which took place in Vienna on 21 October 2017.

Positive data from the first group of patients who completed CT imaging in the 8, 16 and 24-week study follow-up periods was presented by OncoSil.

This early study data is consistent with previously completed studies that validated the safety, efficacy and delivery of the OncoSil™ device.

OncoSil continues to progress patient recruitment of its global pancreatic cancer clinical study program, with 28 subjects now enrolled into the study group.

The company will continue to recruit subjects beyond the initial 20 subject target to gather additional valuable clinical experience and to account for subject loss due to factors such as withdrawal.

It is worth noting that the prognosis for patients diagnosed with pancreatic cancer, regardless of stage, is generally poor; the relative five-year survival rate for all stages combined is circa 5%.

The estimated worldwide market opportunity for OncoSil in pancreatic cancer exceeds $1 billion.

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Mon, 23 Oct 2017 11:08:00 +1100 https://www.proactiveinvestors.com.au/companies/news/185980/oncosil-medical-reveals-positive-data-from-pancreatic-cancer-clinical-study-185980.html
<![CDATA[News - OncoSil Medical gets ready to present pancreatic cancer clinical study data ]]> https://www.proactiveinvestors.com.au/companies/news/185602/oncosil-medical-gets-ready-to-present-pancreatic-cancer-clinical-study-data-185602.html OncoSil Medical Ltd (ASX:OSL) continues to make progress, having recruited 28 subjects into the study group of its Global Pancreatic Cancer Clinical Study Program, up from 23 patients on 22 September.

The company’s lead product, OncoSil™, is a targeted radioactive isotope, implanted directly into a patient’s pancreatic tumours via an endoscopic ultrasound.

Treatment with OncoSil is intended to deliver more concentrated and localised beta radiation compared to external beam radiation.

14 subjects in the study group have now been successfully implanted with the OncoSil device.

The company had earlier reported positive interim data relating to tumour response and disease control from the subjects implanted during the current phase of the program.

Importantly, study investigators have been encouraged by the clinical data that have emerged so far from the study.

Oncosil will share a study progress update at the European Association of Nuclear Medicine in Vienna on 21 October.

The European Association of Nuclear Medicine is the largest organisation dedicated to Nuclear Medicine in Europe.

It is worth noting that the prognosis for patients diagnosed with pancreatic cancer, regardless of stage, is generally poor; the relative five-year survival rate for all stages combined is circa 5%.

The estimated world-wide market opportunity for OncoSil in pancreatic cancer exceeds $1 billion.

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Mon, 16 Oct 2017 11:10:00 +1100 https://www.proactiveinvestors.com.au/companies/news/185602/oncosil-medical-gets-ready-to-present-pancreatic-cancer-clinical-study-data-185602.html
<![CDATA[News - OncoSil Medical continues to advance its pancreatic cancer study ]]> https://www.proactiveinvestors.com.au/companies/news/184401/oncosil-medical-continues-to-advance-its-pancreatic-cancer-study-184401.html OncoSil Medical Ltd (ASX:OSL) continues to make steady progress, having recruited 23 subjects into the study group of its Global Pancreatic Cancer Clinical Study Programme.

The company’s lead product, OncoSil™, is a targeted radioactive isotope, implanted directly into a patient’s pancreatic tumours via an endoscopic ultrasound.

Treatment with OncoSil is intended to deliver more concentrated and localised beta radiation compared to external beam radiation.

Importantly, 10 subjects in the study group have now been successfully implanted with the OncoSil device across four study sites.

Positive interim data relating to tumour response and disease control has been received from subjects implanted during the current phase of the programme.

Study investigators have been encouraged by the clinical data that have emerged so far from the study.

Oncosil intends to share a study progress update at the European Association of Nuclear Medicine in Vienna on 21 October.

The company will continue to recruit subjects beyond the initial 20 subject target to gather additional valuable clinical experience.

Recruitment efforts for the global study continue to accelerate across all 10 activated centres in Australia, the UK and the U.S.

Significantly, the data gathered to date will contribute to the 20-subject Supplemental Data Request to secure CE Marking, Oncosil’s immediate focus.

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Fri, 22 Sep 2017 10:35:00 +1000 https://www.proactiveinvestors.com.au/companies/news/184401/oncosil-medical-continues-to-advance-its-pancreatic-cancer-study-184401.html
<![CDATA[News - OncoSil Medical achieves steady progress in pancreatic cancer study ]]> https://www.proactiveinvestors.com.au/companies/news/182767/oncosil-medical-achieves-steady-progress-in-pancreatic-cancer-study-182767.html OncoSil Medical (ASX:OSL) has recruited the first subject outside Australia for its Global Pancreatic Cancer Clinical Study Programme, at The University of Leicester in the UK.

The company’s lead product, OncoSil™ is a targeted radioactive isotope, implanted directly into a patient’s pancreatic tumours via an endoscopic ultrasound.

Treatment with OncoSil™ is intended to deliver more concentrated and localised beta radiation compared to external beam radiation.

The company has already conducted four clinical studies with encouraging results on tolerability, safety and efficacy.

A CE Mark application to commercially sell OncoSil™ in the European Union (EU) is under review.

18 patients have now been recruited for the company’s global pancreatic cancer clinical study program, up from 13 patients on 31 July.

Importantly, the data from all 18 patients is eligible to contribute to the 20-subject Supplemental Data Request to secure the CE Marking.

Pancreatic cancer is typically diagnosed at a late stage, when there is a poor prognosis for long-term survival.

The World Cancer Research Fund estimated that in 2012, 338,000 people globally were diagnosed with pancreatic cancer.

Hepatocellular carcinoma (HCC) or liver cancer, is the 6th most common cancer in the world with 782,000 new cases diagnosed in 2012.

The value of the hepatocellular cancer market is expected to triple in size to $1.4 billion by 2019.

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Tue, 22 Aug 2017 12:05:00 +1000 https://www.proactiveinvestors.com.au/companies/news/182767/oncosil-medical-achieves-steady-progress-in-pancreatic-cancer-study-182767.html
<![CDATA[News - OncoSil Medical wins key approval ]]> https://www.proactiveinvestors.com.au/companies/news/176553/oncosil-medical-wins-key-approval-176553.html OncoSil Medical (ASX:OSL) has received approval from the Institutional Review Board (IRB) of the MD Anderson Cancer Center at the University of Texas for its global clinical study program in pancreatic cancer.

The approval is the final step for US hospitals to agree to participate in a clinical study and recruit and treat patients under the agreed study protocols.

MD Anderson will now finalise site initiation and complete final training before first patient recruitment which is anticipated to occur in May.

Daniel Kenny, CEO, commented:

"We are pleased to make continued progress with our clinic operations in the US, and are encouraged by the engagement of our study center partners in working toward the treatment of patients as part of this important global study in pancreatic cancer."


What is OncoSil™

OncoSil's lead product, OncoSil™, is a targeted radioactive isotope (Phosphorous-32), implanted directly into a patient’s pancreatic tumours via an endoscopic ultrasound.

Treatment with OncoSil™ is intended to deliver more concentrated and localised beta radiation compared to external beam radiation.


Share price re-rating

OncoSil has recently started ticking off milestones, and the market has re-rated the stock on the back of these.

Shares in the company have hit $0.13 this week, which is 63% higher than one-month ago.

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Wed, 19 Apr 2017 09:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/176553/oncosil-medical-wins-key-approval-176553.html
<![CDATA[News - Oncosil Medical attracts broker attention ]]> https://www.proactiveinvestors.com.au/companies/news/175871/oncosil-medical-attracts-broker-attention-175871.html Oncosil Medical (ASX:OSL) has received a Buy Recommendation and a price target of $0.38 per share from broker Wilsons.

Oncosil last traded circa $0.10 per share. The following is an extract from the report.


First patient enrolled in the OncoPac-1 trial

We maintain our BUY rating with a revised price target of 38cps ($2.00 un-risked on a three-year view).

Oncosil Medical has enrolled the first subject in its OncoPac-1 clinical trial.

This clinical trial seeks to establish OncoSilTM as a first-line therapy for patients diagnosed with locally advanced pancreatic cancer (LAPC).

LAPC is a swiftly lethal disease in which conventional radiotherapy struggles for significance, taking too long to administer and adding too much toxicity over chemotherapy.

OncoSilTM is an old idea in some ways but the chance of being able to deliver a tumour-killing dose of radiation in one procedure with good safety has seen major oncology centres join the queue to get their LAPC patients into OncoPac-1.

Once the trial’s “pilot” phase is over and it launches nationally in the USA, we think the stock will capture some much deserved investor attention.

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Tue, 04 Apr 2017 08:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/175871/oncosil-medical-attracts-broker-attention-175871.html
<![CDATA[News - OncoSil Medical crosses a milestone in global pancreatic cancer study ]]> https://www.proactiveinvestors.com.au/companies/news/175485/oncosil-medical-crosses-a-milestone-in-global-pancreatic-cancer-study-175485.html OncoSil Medical (ASX:OSL) and Monash Health has recruited the first subject for a global clinical study program of OncoSil™ device in pancreatic cancer.

OncoSil™ device is a targeted radioactive isotope implanted directly into a patient’s pancreatic tumours via an endoscopic ultrasound.

Treatment with OncoSil™ is intended to deliver more concentrated and localised beta radiation compared to external beam radiation.

The recruitment of the first subject represents a significant milestone in the clinical study process to date.

The first subject has completed all baseline assessments and will now commence one month of chemotherapy prior to implantation with the OncoSil™ device.

This patient is the first in a total of 20 subjects required to meet the supplemental data request from BSI, the company’s notified body to secure CE Marking for the OncoSil™ device.

Monash Health is the largest public health service in Melbourne, and has agreed to be the lead Australian study centre.

To date, OncoSil Medical has confirmed the participation of 16 centres for the global pancreatic clinical study program.

One of these centres, St Vincent’s Hospital, Sydney received Ethics approval on 16 March and is expected to commence recruiting subjects for the study program in the coming weeks.

OncoSil Medical is working with large recruitment centres, and many of the sites included in the study are top-tier cancer centres, including MD Anderson and John Hopkins in the U.S.

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Tue, 28 Mar 2017 11:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/175485/oncosil-medical-crosses-a-milestone-in-global-pancreatic-cancer-study-175485.html
<![CDATA[News - OncoSil Medical outlines timeline for CE Mark ]]> https://www.proactiveinvestors.com.au/companies/news/172884/oncosil-medical-outlines-timeline-for-ce-mark-172884.html OncoSil Medical (ASX:OSL) has provided an update on its CE Mark application for OncoSil™.

OncoSil™ is a targeted radioactive isotope (Phosphorous-32), implanted directly into a patient’s pancreatic tumours via an endoscopic ultrasound.

Treatment with OncoSil™ is intended to deliver more concentrated and localised beta radiation compared to external beam radiation.


Update

OncoSil said that based on information received from BSI, the company has advised that CE Certification for the pancreatic cancer indication will now be granted subject to the following conditions:

- Provision of supplemental data from 20 locally advanced pancreatic cancer patients supporting the existing safety and clinical performance data already reviewed; and

- OncoSil Medical agrees to undertake a Post Marketing Clinical Follow-up program.

The 20 patient supplemental data request from BSI is consistent with the request received from the US FDA prior to granting an Investigational Device Exemption (IDE) in July 2016.

The company is well positioned to provide the supplemental data from its Global Pancreatic Clinical Study program.

Daniel Kenny, chief executive officer, commented:

"After a lengthy and complex review it is clear that the company is now well on its way to obtaining the CE Mark this year.

"I am pleased with the progress that the OncoSil team has made over the past 12 months in securing the IDE from the FDA, and the on-boarding of top tier recruitment sites in Australia, UK and the US.

"OncoSil is well positioned to collect the supplemental data quickly and to finalise our post marketing follow up program to secure the CE Mark in 2017."

The CE Mark review for the Primary Liver indication (HCC) is ongoing.

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Thu, 09 Feb 2017 08:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/172884/oncosil-medical-outlines-timeline-for-ce-mark-172884.html
<![CDATA[News - OncoSil Medical Ltd updates on Pancreatic Cancer Clinical Study ]]> https://www.proactiveinvestors.com.au/companies/news/169562/oncosil-medical-ltd-updates-on-pancreatic-cancer-clinical-study-169562.html OncoSil Medical Ltd (ASX:OSL) has provided an update on its global OncoPaC clinical study program.

Highlights:

- Johns Hopkins Hospital and MD Anderson Cancer Centre are the leading U.S. centres;
- Investigational Review Board (IRB) process has commenced and is on-going for these two U.S. centres;
- Guy’s and St Thomas’ Hospitals, London are the leading UK centres; and
- Monash Health has agreed to be the lead Australian centre – ethics submission filed and under review.


Daniel Kenny, chief executive officer, commented:

"I am are delighted with the participation of these four prestigious centres in our global clinical program.

"These centres bring tremendous credibility as well as the benefit of being potential high volume recruitment sites.

"Our team looks forward to working with these centres and their state of the art facilities.

"I am pleased to report that we have another 11 centres in the U.S., UK and Australia currently evaluating the feasibility of participating in our study."

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Mon, 28 Nov 2016 10:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/169562/oncosil-medical-ltd-updates-on-pancreatic-cancer-clinical-study-169562.html
<![CDATA[News - OncoSil Medical Ltd: Broker boosts price target ]]> https://www.proactiveinvestors.com.au/companies/news/168718/oncosil-medical-ltd-broker-boosts-price-target-168718.html OncoSil Medical Ltd (ASX:OSL) has been receiving a lot of broker attention recently, and Bell Potter has maintained its Buy, while boosting its Valuation by 18% to $0.39 per share. The following is an extract from the report.

 

OncoPac-1 Commencing Recruitment in 1QCY17


The company conducted its regular quarterly update this week.

Key points were:

The OncoPac-1 study is set to commence recruitment in 1Q CY17 at 10 prestigious oncology centres around the world, headlined by MD Anderson (Texas) and Johns Hopkins (Baltimore).

These two hospitals are ranked #1 and #9 respectively in the treatment of adult cancers in the US.

The involvement of these two institutions comes as no surprise given the breakthrough nature of the study and the absence of any recent innovation in the treatment for advanced pancreatic cancer.

Other hospital in active preparation (i.e. working through ethics approval) include five NHS hospitals in the UK and three in Australia.

The first 20 patients in the “run in” are expected to commence recruitment in early calendar 2017 and report in the second half of the year – we expect as soon as July or August 2016.

In Europe, OSL has now closed out all remaining points with the British Standards Institute following a meeting with this body earlier in November.

The BSI is responsible for recommending CE Mark Approval which will be an important step towards progressing the first commercial sale which we now expect will occur in calendar 2017.

OSL had $13.8m in cash as at 30 September 2016 which is more than sufficient to complete the first 20 patients in OncoPac-1.

The cash burn through to 30 June 2017 is expected to run at approximately $2m/qtr including the cost of the clinical trial.


Retain Buy Recommendation

The next 8 months will be a frenetic period. Even though the OncoPac-1 trial is about to commence, the risks remain high as this is a first in class device, never previously administered in the US.

The FDA and the hospitals involved will be watching carefully.

We remind investors that earlier trials of this therapy achieved a stunning 82% disease control rate.

The CEO and his team have progressed this therapy an extraordinary distance in the last 18 months and the company is now at the cusp of being into the clinic.

We retain the Buy rating.

Valuation is raised to $0.39 (from $0.33).

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Wed, 09 Nov 2016 11:10:00 +1100 https://www.proactiveinvestors.com.au/companies/news/168718/oncosil-medical-ltd-broker-boosts-price-target-168718.html
<![CDATA[News - OncoSil Medical Ltd's well-funded and delivering milestones ]]> https://www.proactiveinvestors.com.au/companies/news/168179/oncosil-medical-ltd-s-well-funded-and-delivering-milestones-168179.html OncoSil is a late stage medical devices company focused on localised treatments for patients with pancreatic and liver cancer.

Recent highlights include the Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (the FDA).


Next steps

Following the approval, the company has initiated its planned global clinical study of OncoSilTM for the treatment of pancreatic cancer, OncoPac-1.

The company is moving quickly to operationalise its clinical program.

Currently ten centres have commenced the Institutional Review Board (IRB) or Ethics Committee approval process in the US, UK and Australia.

In preparation for the commencement of OncoPac-1, the company successfully performed a full hot calibration run of OncoSilTM in August with the Department of Nuclear Medicine, Royal North Shore Hospital, Sydney, which included initial training and calibration of their equipment to ensure dose accuracy of OncoSilTM.

Daniel Kenny, chief executive officer, commented: “This quarter has been a quarter of significant milestones with the receipt of the FDA IDE approval and initiation of OncoPac-1.

"Our success this Quarter is a testament to the hard work and dedication by the whole team.

"We remain dedicated and focussed to achieving our CE Mark and successful enrolment for OncoPac-1 for our shareholders and stakeholders."

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Fri, 28 Oct 2016 11:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/168179/oncosil-medical-ltd-s-well-funded-and-delivering-milestones-168179.html
<![CDATA[News - OncoSil Medical Ltd receives a Buy recommendation ]]> https://www.proactiveinvestors.com.au/companies/news/167598/oncosil-medical-ltd-receives-a-buy-recommendation-167598.html OncoSil Medical Ltd (ASX:OSL) has received a Buy rating and $0.42 per share price target from Wilsons Research.

OncoSil shares last traded at $0.12. The following is an extract from the report.


Our valuation of the OncoSilTM product supports our valuation and investment view. We maintain our BUY rating with a revised price target of 42cps.


OncoSil Redux

OncoSil is working to initiate US clinical trial sites ahead of launching its OncoPac-1 study early next year.

We see that clinical trial as the major set piece that can underwrite valuation development over the next few years. OncoPac-1 comprises a short ‘run-in’ phase to assess safety in the first 20 patients.

The European regulators may also seek to review that data, in which case OncoSil’s wait for ‘CE Mark’ may extend to mid-2017.

Execution of the OncoPac-1 project and obtaining marketing authorisation in Europe next year can get the stock back on track after a tough but successful year pushing hard for the US trial approval.


Key points

OncoPac-1 trial. OncoSil is moving towards initiating its first clinical sites in the USA and Australia.

This clinical trial is designed to demonstrate that adding OncoSilTM treatment to chemotherapy can delay pancreatic tumour progression, compared with chemotherapy alone.

We see OncoSilTM as potentially practice changing if it can deliver an ablative radiation dose to the tumour in one procedure, with good safety.

OncoPac-1 data may resolve CE Mark impasse. OncoSil has been working with the European regulator for more than a year, seeking marketing authorisation.

Although approval could be granted at any time, the EU regulator may elect to wait for initial safety data from OncoPac-1.

In that trial, a short, 20-patient safety component is planned, with results due H1, 2017.

Balance sheet remains in reasonably good shape with ~$14m in cash and equivalents (Oct, 16).


Valuation

Our risked DCF model implies a 42cps target price on a fully diluted basis.

Key variables in the valuation are the terms on which OncoSil can partner the asset for major market access (upfront fees, milestone payments, royalties, territories).

Equity value is ‘due’ a re-rating as company moves into US pivotal trial. Our un-risked valuation for OncoSil is $2.20 per share on a 2-3 year view.

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Wed, 19 Oct 2016 09:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/167598/oncosil-medical-ltd-receives-a-buy-recommendation-167598.html
<![CDATA[News - OncoSil Medical Ltd swells cash position after tax refund ]]> https://www.proactiveinvestors.com.au/companies/news/166417/oncosil-medical-ltd-swells-cash-position-after-tax-refund-71209.html OncoSil Medical Ltd (ASX:OSL) has bagged a $2.3 million R & D Tax Incentive Refund, swelling the company cash (and cash equivalents) to circa $14 million.

The company said it anticipates its ongoing research and development activities including components of the global OncoPac-1 clinical study, will also be eligible for the research and development tax incentive scheme.

OncoSil is a clinical-stage medical device company seeking to provide a new medical radiation treatment for cancer subjects.

The company's lead product, OncoSil™ is silicon and phosphorus (p32) beta emitter, able to be implanted by an endoscopically placed catheter in localised solid tumours of subjects with pancreatic cancer.

Treatment with the OncoSil™ device, known as brachytherapy, is intended to deliver more concentrated and localised beta radiation compared to external beam radiation.


Commercialisation plan

OncoSil recently delivered a significant milestone on the pathway to commercialisation, as it received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA).

The IDE Approval is beneficial in supporting OncoSil's ongoing CE mark application, with the company remaining confident of obtaining the CE Mark in the near term.


Broker spotlight

OncoSil has been receiving some strong broker attention, as the company moves closer to commercial revenue.

OncoSil last traded at $0.125.

- Wilsons Research $0.48 per share.
- Bell Potter $0.33 per share.
- WilsonHTM $0.48 per share.
- Van Leeuwenhoek (earlier in year) $0.80 per share.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 26 Sep 2016 12:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/166417/oncosil-medical-ltd-swells-cash-position-after-tax-refund-71209.html
<![CDATA[News - OncoSil Medical Ltd outlines pending board departure of Martin Rogers ]]> https://www.proactiveinvestors.com.au/companies/news/165799/oncosil-medical-ltd-outlines-pending-board-departure-of-martin-rogers-70970.html OncoSil Medical Ltd (ASX:OSL) has outlined today in its 2016 Annual General Meeting (AGM) Notice of Meeting, that Martin Rogers has confirmed to the board that he is not standing for re-election at this year's AGM.

Accordingly, Rogers resignation as a director will be effective on conclusion of the meeting, set for 11am (AEDT) on Tuesday 18 October 2016 in Sydney.

Dr. Roger Aston, chairman, noted in his letter to shareholders that the company continues to progress towards its goals for the OncoSil™ radiation treatment of pancreatic cancer.

OncoSil recently delivered a significant milestone on the pathway to commercialisation, as it received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA).

The IDE Approval is beneficial in supporting OncoSil's ongoing CE mark application, with the company remaining confident of obtaining the CE Mark in the near term.


Key appointments

In today's Annual Report for 2016, OncoSil highlighted that several key appointments were completed to support the continued growth and development of the company.

These appointments include David James, Michael Warrener, and Charles Rowland as the President of U.S. Operations.

Rowland is a highly credentialed healthcare executive including four years’ service as President of Sirtex Medical U.S.


Broker spotlight

OncoSil has been receiving some strong broker attention recently, as the company moves closer to commercial revenue.

OncoSil last traded at $0.125.

- Wilsons Research $0.48 per share.
- Bell Potter $0.33 per share.
- WilsonHTM $0.48 per share.
- Van Leeuwenhoek (earlier in year) $0.80 per share.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 12 Sep 2016 13:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/165799/oncosil-medical-ltd-outlines-pending-board-departure-of-martin-rogers-70970.html
<![CDATA[News - OncoSil Medical Ltd completes key step towards commercial sales ]]> https://www.proactiveinvestors.com.au/companies/news/165527/oncosil-medical-ltd-completes-key-step-towards-commercial-sales-70532.html OncoSil Medical Ltd (ASX:OSL) has completed a key step towards commercial sales of OncoSilTM, a treatment for pancreatic cancer.

This involved the successful completion of a supply chain validation process including the first radioactive calibration delivery of OncosilTM to a Sydney hospital.

The company plans to undertake a global clinical study of OncoSilTM, known as the OncoPac-1 study.

David James, head of manufacturing, commented: “We are delighted with the safe and successful validation shipment of the dose to a typical clinical site as it demonstrates that we are prepared for the commencement of OncoPac-1 and commercialisation.

“It further shows that the staff, procedures, and commercial partners that the company have assembled are accomplished at manufacturing and distributing the OncoSil product.”


U.S. market entry

The U.S. Food and Drug Administration has granted OncoSil the clearance it needs to start testing its medical device for the treatment of pancreatic cancer in U.S. patients.

The OncoPac-1 study is a major set piece for OncoSil, designed to secure U.S. market access and drive clinical adoption elsewhere.

The study will start with a 20 patient safety run-in phase, before opening up to a randomised, open-label, pivotal trial targeting 300 patients.
CE Mark

A CE Mark application for regulatory approval to commercially sell the OncoSilTM device in the European Union and other non-US markets is under review with commercial launch planned for 2H16, subject to approval.

OncoSil remains confident of near-term approval to start selling OncoSil™ in Europe. The CE Mark, if attained, will provide both further technology validation and modest revenues.

European centres have been invited to participate in OncoPac-1, enabling practitioners to try the product under the guidance of a controlled protocol and be participants in the academic exercise.

If successful, OncoPac-1 could be a landmark study for both OncoSil and patients globally.


Analysis

The manufacturing, supply chain validation and delivery to clinical and commercial centres of the OncoSil product is a key step to commercial sales and the treatment of patients in the OncoPac-1 study.

As OncoSil continues to complete such milestones, it gets closer to commercial revenues.

The company had $13.3 million in cash at 30 June 2016 which will likely allow the company to fund the commencement of the trial.

OncoSil has been receiving strong broker attention recently, as the company moves closer to commercial revenue.

OncoSil last traded at $0.14 with broker price targets ranging from $0.33 to $0.80.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Thu, 18 Aug 2016 10:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/165527/oncosil-medical-ltd-completes-key-step-towards-commercial-sales-70532.html
<![CDATA[News - OncoSil Medical Ltd shines under broker spotlight ]]> https://www.proactiveinvestors.com.au/companies/news/165526/oncosil-medical-ltd-shines-under-broker-spotlight-70473.html OncoSil Medical Ltd (ASX:OSL) has been receiving some strong broker attention recently, as the company moves closer to commercial revenue.

OncoSil last traded at $0.14. The following are extracts and valuations from the broker reports.


Quick wrap of targets:

- Wilsons Research $0.48 per share.
- Bell Potter $0.33 per share.
- WilsonHTM $0.48 per share.
- Van Leeuwenhoek (earlier in year) $0.80 per share.


Latest report from Wilsons Research

IDE trial approval sets the scene for evidence development and commercialisation

The US Food and Drug Administration has granted OncoSil Medical the clearance it needs to start testing its medical device for the treatment of pancreatic cancer in US patients.

The OncoPac-1 Study is a major set piece for OncoSil, designed to secure US market access and drive clinical adoption elsewhere.

An Investigational Device Exemption (IDE) approval is a profoundly validating event for the company, in terms of proving that it can work well with major regulators to progress the development of medical device assets.

The study itself is first rate from the design perspective – it’s a tough study, it asks the correct clinical questions and it has a good chance of detecting any clinically meaningful signals.

We maintain our price target at 48cps. We rate OncoSil a SPECULATIVE BUY.


Key points

FDA approval to commence US clinical trial.

Months of collaborative work with the FDA has been rewarded with OncoSil Medical’s clearance to start testing OncoSil™ in human subjects with locally advanced, unresectable pancreatic cancer.

The OncoPac-1 study is the company’s major clinical set piece over the next 3-4 years, designed to secure US market access and drive adoption elsewhere.

The study design is as we expected: starting with a 20 patient safety “run-in” phase, before opening up to a randomised, open-label, pivotal trial targeting 300 patients, which on our calculations is enough to assess the level of anticipated efficacy in a statistically meaningful way.

The trial has chosen a clinically relevant comparator, too, in the gemcitabine/abraxane regimen, which is the US standard of care.

The primary endpoint of local progression free survival (PFS) is a registrable outcome with supportive secondary measures including PFS, overall survival (OS) and pain relief.


Project costs and timing.

The FDA has added a lot of value in informing OncoSil’s approach to OncoPac-1 in terms of patient safety, physician/endoscopist training, tumour stratification, procedural contingencies and the objective measurement of endpoints.

We are expecting good recruitment rates as a result and view a two-year estimated enrolment period as achievable.

Primary and secondary endpoints may be assessable by 2019, supporting a US approval in 2021, which is consistent with our forecasts and valuation basis.


CE Mark next.

OncoSil remains confident of near-term approval to start selling OncoSil™ in Europe. CE Mark, if attained, will provide both further technology validation and modest revenues.

The decision to invite European centres to participate in OncoPac-1 is smart, enabling practitioners to try the product under the guidance of a controlled protocol and be participants in the academic exercise.

If successful, OncoPac-1 could be a landmark study in interventional radiology for pancreatic adenocarcinoma.


Valuation.

We use a risk-adjusted discounted cash flow model to value OncoSil. Our price target is set with reference to our DCF valuation.

OncoSil remains a Speculative stock with a high risk/return profile.

Un-risked valuation (three-year view, clinically de-risked) is $2.75 per share.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Tue, 16 Aug 2016 11:20:00 +1000 https://www.proactiveinvestors.com.au/companies/news/165526/oncosil-medical-ltd-shines-under-broker-spotlight-70473.html
<![CDATA[News - Oncosil Medical Ltd: Commercial Revenues Closer ]]> https://www.proactiveinvestors.com.au/companies/news/165525/oncosil-medical-ltd-commercial-revenues-closer-70408.html Oncosil Medical Ltd (ASX:OSL) has received a Buy recommendation from broker Bell Potter, and a valuation of $0.33, more than double the current price.

The following is an extract from the report.


Commercial Revenues Closer

Earlier today OncoSil announced that it had received an Investigational Device Exemption (IDE) from the US FDA. The company will now initiate a pivotal clinical trial for OncoSil for the treatment of inoperable pancreatic cancer.

The first patient in this 300 patient study is expected to be enrolled in early 2017. The primary endpoint is localised progression free survival. The secondary endpoints include progression free survival and overall survival.

As per our previous research on the likely trial design, the FDA’s acceptance of the localised progression free survival primary endpoint is a significant boost to the prospects of success in this trial.

The randomised study will compare OncoSil+Chemotherapy to chemotherapy alone.

In earlier studies (conducted nearly a decade ago) the vast majority of patients (83%) showed a response to the treatment, hence the decision by the FDA to approve the study in this first in class treatment for the disease is exciting news.

This open label study will report regularly beginning with the first cohort of 20 patients where the FDA will focus primarily on safety. Following this, we expect a significant acceleration in recruitment due to the absence of competing clinical trials.

OSL had $13.3m in cash at 30 June 2016 which we believe is ample to commence the trial. We expect the cost of the pivotal clinical trial to be in the range of US$24m – US$26m over the next two to three years.


Maintain Buy Recommendation, Valuation raised to $0.33

The awarding of the IDE is a major step forward for this first in class therapy, consequently the valuation is raised by 10% to $0.33.

Overall changes to earnings in the forecast period are not material in absolute terms. We maintain our Buy recommendation.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Fri, 12 Aug 2016 12:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/165525/oncosil-medical-ltd-commercial-revenues-closer-70408.html
<![CDATA[News - OncoSil Medical Ltd: IDE Approval from the U.S. Food and Drug Administration ]]> https://www.proactiveinvestors.com.au/companies/news/160327/oncosil-medical-ltd-ide-approval-from-the-us-food-and-drug-administration-70189.html OncoSil Medical Ltd (ASX:OSL) has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA).

The company will now initiate a pivotal clinical investigation for OncoSil™ for the treatment of eligible subjects with pancreatic cancer.

OncoSil is a late stage medical devices company focused on localised treatments for subjects with pancreatic and liver cancer.


Daniel Kenny, CEO for OncoSil, commented:

“We are delighted to receive FDA approval for the IDE which is a significant milestone in our regulatory pathway and a validation of our product and supporting processes to commence this important clinical study.

"This achievement in only eight months from submission is a testament to the quality of the work that our dedicated and highly experienced team has undertaken and I would like to acknowledge and thank them.

“We have also been active in a number of preparatory steps to support the initiation of the OncoPac-1 Study.

"We have been working to secure leading Principal Investigators, key hospitals and centres in the United States, Europe and Australia.

“The IDE Approval is beneficial in supporting our ongoing CE mark application and we remain confident of obtaining our CE Mark in the near term.

"Our clinical team continues to advance the engagement with leading clinicians and centres in Europe, with the aim of treating both Study subjects and commercial cases, once we achieve our CE mark.”


OncoPac-1 U.S and International Clinical Study

As previously advised, the company had filed an IDE Amendment with the FDA for its planned global clinical study of OncoSil™ for the treatment of pancreatic cancer (OncoPac-1).

This followed an intensive eight month process of submissions and interactions with the FDA.

The company has received notification from the FDA that the IDE Amendment submission has been approved thereby clearing the way for the company to initiate its planned global clinical study, OncoPac-1.

The key details of OncoPac-1 study are as follows:

- OncoPac-1 is a global, multi-centre, randomised, open label, pivotal efficacy and safety study of OncoSil™. The Study is intended to include up to 30 centres in the United States and other international markets including the United Kingdom, Europe and Australia;

- In this pivotal study, a total of 300 subjects will be recruited with locally advanced unresectable adenocarcinoma of the pancreas. Stage 1 of the Study consists of 20 subjects across a maximum of 5 centres in the United States. These patient data will be subject to an FDA review focused on the safety profile;

- Following the successful completion of Stage 1, eligible subjects will be randomised to either OncoSil™ plus standard chemotherapy treatment or standard chemotherapy treatment of gemcitabine or gemcitabine + nab-paclitaxel alone. In the investigational arm, OncoSil™ microparticles will be implanted intra-tumourally via endoscopic ultrasonography;

- Primary Efficacy Endpoint is Local Progression Free Survival (LPFS). Secondary Endpoints include Progression Free Survival (PFS), Overall Survival (OS), Pain Scores, Body Weight, Safety & Tolerability, and Performance Status. Quality of life measures will be studied;

- OncoPac-1 Study is expected to enrol the first subject in early 2017 and recruitment is anticipated to take approximately 2 years, with each patient to be followed until disease progression. Subjects are then followed for overall survival until death, or until the last enrolled study patient has completed 52 weeks of overall survival follow-up.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 02 Aug 2016 10:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/160327/oncosil-medical-ltd-ide-approval-from-the-us-food-and-drug-administration-70189.html
<![CDATA[News - OncoSil Medical Ltd confident of a successful outcome with the FDA ]]> https://www.proactiveinvestors.com.au/companies/news/160326/oncosil-medical-ltd-confident-of-a-successful-outcome-with-the-fda-70078.html OncoSil Medical Ltd (ASX:OSL) has continued to make progress with its two key regulatory filings during the June quarter 2016, which remain the primary focus and value enablers for the OncoSil™ technology.

OncoSil's lead product is OncoSil™ with the first target indication being pancreatic cancer.

There is also potential use for OncoSil™ in other solid tumours outside of pancreatic cancer.

Daniel Kenny, CEO, commented:

“This second quarter has been another period of steady progress towards our immediate regulatory goals.

"The whole team including our VP of Regulatory, Nicole Wilson, has again put in a huge amount of work with both BSI on the CE mark and the FDA for our IDE, which we expect will result in successful determinations the near term.

"We remain highly focussed and driven to achieving both of these regulatory outcomes for our shareholders and stakeholders.”


Details for the June quarter

The company has continued to make progress with its two key regulatory filings during the June quarter, which remain the primary focus and value enablers for the OncoSil™ technology.

In May 2016, additional material was submitted to BSI, the company’s Notified Body, in support of its CE Mark application for the OncoSil™ product.

This submission addressed all questions requested from BSI to date and no additional follow up questions have been received since.

The company is seeking to expedite a response from BSI and remains confident of a successful outcome in its CE Mark, thus enabling commercial sales of OncoSil™ in the European Union and other non U.S. markets.

During the period, the company and its advisers also had ongoing interactions with the United States Food and Drug Administration (the FDA) following the Q-Submissions meeting in March.

Following on from this, the company lodged an Investigational Device Exemption (IDE) Amendment with the FDA on 30 June 2016, for the planned global clinical study of the OncoSil™ for the treatment of pancreatic cancer.

The company said that it remains confident of a successful outcome with the FDA which it believes could be in the near term.

The collection of data from the IDE study will be used to support a Premarket Approval application to the FDA and enable OncoSil™ to be commercialised in the United States, one of the world’s largest healthcare markets.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 28 Jul 2016 07:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/160326/oncosil-medical-ltd-confident-of-a-successful-outcome-with-the-fda-70078.html
<![CDATA[News - OncoSil Medical Ltd remains confident on CE Mark and IDE submissions ]]> https://www.proactiveinvestors.com.au/companies/news/160325/oncosil-medical-ltd-remains-confident-on-ce-mark-and-ide-submissions-69531.html OncoSil Medical Ltd (ASX:OSL), a late stage medical device company focused on localised treatments for patients with pancreatic and liver cancer, has provided an update on its regulatory submissions.

OncoSil's lead product is OncoSil™ with the first target indication being pancreatic cancer.

There is also potential use for OncoSil™ in other solid tumours outside of pancreatic cancer.


Daniel Kenny, CEO, commented:

“We are delighted with the progress we have been making to prosecute and progress both our CE mark and IDE submissions.

"In particular, the filing today with the FDA is the culmination of an intense period of work by our team and advisers to prepare additional information in response to matters that have been raised in our Q-Submissions meeting and other interactions with the agency in recent months.

"While we had initially hoped this IDE process would be completed in the first half of 2016, we believe a positive outcome is still achievable in the near term.

"Our progress is also consistent with the FDA’s published data that for 2015 72% of IDE submissions were approved within two Q&A cycles.

"OncoSil is now concluding the first Q&A cycle.

"We understand that many of our shareholders and investors are eagerly awaiting both the CE mark and IDE and appreciate their ongoing patience as we progress through these two regulatory processes.”


ADDITIONAL DETAILS

European Union – CE Mark

The company advises that in May 2016, it submitted further material in support of its CE Mark application for the OncoSil™ product in response to all requested questions received from the Notified Body, BSI, which is assessing the submission.

Since then, no additional follow up questions have been received from BSI.

The company remains confident of a successful outcome in its CE Mark which it believes could be in the near term, thus enabling to commencement of commercial sales of OncoSil™ in the European Union and application for commercialisation in Asia Pacific markets.


United States – Investigational Device Exemption

Today, the company filed an Investigational Device Exemption (IDE) Amendment with the U.S Food and Drug Administration (the FDA) for its planned global clinical study of the OncoSil™ for the treatment of pancreatic cancer.

This detailed submission followed ongoing and recent interactions with the FDA, the company and its advisers.

While there can be no guarantees, the company remains confident of a successful outcome with the FDA which it believes could be in the near term.

The IDE approval and the collection of the study data will be used to support a Premarket Approval (PMA) application and enable the company to commercialise OncoSil™ in the United States, one of the world’s largest healthcare markets.


Analysis

OncoSil is well-funded with $14 million in cash at the end of March 2016.

Broker WilsonHTM has placed a Speculative Buy with a 12 month price target $0.48 per share.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 30 Jun 2016 09:40:00 +1000 https://www.proactiveinvestors.com.au/companies/news/160325/oncosil-medical-ltd-remains-confident-on-ce-mark-and-ide-submissions-69531.html
<![CDATA[News - OncoSil Medical Ltd: Thoughts on OncoSil's regulatory situation ]]> https://www.proactiveinvestors.com.au/companies/news/160324/oncosil-medical-ltd-thoughts-on-oncosils-regulatory-situation-69285.html OncoSil Medical Ltd (ASX:OSL) has received a WilsonHTM Research Update, with the broker maintaining a Speculative Buy with a 12 month price target $0.48 per share.

OncoSil last traded at $0.14. The following is an extract from the report.


Thoughts on OncoSil's regulatory situation

The Report says:

We maintain a SPECULATIVE BUY rating with a 12 month price target $0.48


Regulatory Status:

American and European regulatory agencies are still working with Oncosil Medical to map out the safest means of bringing the OncoSilTM medical device to market.

While the program is delayed, both regulators have likely added much value to the asset.

Improvements to study design and the clinical protocol may mean faster patient recruitment and higher quality evidence development at the back end of the trial.

Trial approval by US FDA remains the most important near-term catalyst for the stock.


Key Points:

IDE approval remains the most important near-term catalyst; The US FDA is reviewing Oncosil’s Investigational Device Exemption (IDE) proposal to conduct a large clinical trial of OncoSilTM for the treatment of pancreatic cancer.

In Europe, regulators have spent almost a year assessing Oncosil’s application to market its product for treating pancreatic and liver cancers.

The IDE approval from the FDA significantly outweighs European approval from a valuation perspective, in our view.

Oncosil’s US trial sets out a pathway to obtaining higher level evidence for the device, which ultimately is the only basis for clinical adoption and reimbursement expectations in the major markets.


What does not kill development programs, makes them stronger:

Both regulators appear to be making significant intellectual investments in assessing the safest means of testing OncoSilTM and making it available to patients.

The review phase has taken longer than we expected, devoting much time to understanding and controlling the risks associated with the intended endoscopic delivery system, defining how best to stratify potential patients and tumour types, managing potential procedural complications and satisfying the regulators on other “what if” scenarios.


Balance sheet:

Oncosil reported ~$14m cash as 31 March. The regulatory delay will defer first revenues, but also delay the upfront R&D expenses associated with the US trial.

We remain comfortable that Oncosil has sufficient capital to obtain its respective approvals, commence European sales and support its US trial, as we have modelled, from the first half of calendar 2017.


Valuation:

Our revised target price of 48cps reflects the delay impact.
 

Catalyst profile post-FDA approval:

If the FDA allows Oncosil’s IDE study in the coming months, then that should correspond to more regular positive new flow over the balance of 2016.

We understand that the target trial sites comprise high impact cancer centres, whose association may further validate the OncoSilTM technology.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 17 Jun 2016 11:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/160324/oncosil-medical-ltd-thoughts-on-oncosils-regulatory-situation-69285.html
<![CDATA[News - OncoSil Medical Ltd makes key appointment to drive commercialisation strategy ]]> https://www.proactiveinvestors.com.au/companies/news/160323/oncosil-medical-ltd-makes-key-appointment-to-drive-commercialisation-strategy-68677.html OncoSil Medical Ltd (ASX:OSL) has appointed Michael Warrener as Global Sales and Marketing Director.

Warrener will be responsible for implementing the company’s commercialisation strategy and infrastructure.

He will be based in Sydney and will oversee the initial market launch in Europe, Australia and key Asian markets.

Warrener spent eight years with Sirtex Medical Ltd (ASX:SRX).

Daniel Kenny, managing director, commented:

“As we progress though the regulatory process, we are working in parallel to advance our sales and marketing infrastructure, and Michael’s appointment is a key part of this strategy.

"His relevant and senior level experience in the medical device sector in introducing a new brachytherapy device for cancer and building adoption and reimbursement makes him a key addition to our leadership team.

"I look forward to working with Michael as we pursue our goal to commercialise OncoSil™ as a viable new treatment for pancreatic cancer and other solid tumours."

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 18 May 2016 12:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/160323/oncosil-medical-ltd-makes-key-appointment-to-drive-commercialisation-strategy-68677.html
<![CDATA[News - OncoSil Medical Ltd confident CE Mark will be granted in near-term ]]> https://www.proactiveinvestors.com.au/companies/news/160322/oncosil-medical-ltd-confident-ce-mark-will-be-granted-in-near-term-68348.html OncoSil Medical Ltd (ASX:OSL) is a late stage medical devices company focused on localised treatments for patients with pancreatic and liver cancer.

OncoSil said in its March 2016 quarterly update, that the company finalised detailed responses on all outstanding questions received by the Notified Body, for the CE Mark application for OncoSilTM in the European Union.

In follow up communications, the Notified Body has committed to holding a face to face meeting following review of OncoSil's latest data package.

OncoSil added that as a result of the recent interactions, the company remains confident in its submission for the CE Mark being granted and expects a final decision in the near-term.

A granting of the CE Mark would enable commercial sales to commence in the European Union and an application for TGA approval in Australia in 3Q 2016.


Daniel Kenny, CEO, commented:

“This last quarter has been an extraordinarily busy and productive time for the company.

"Our key focus in the shorter term is to achieve the CE Mark and enable commercial launch and first sales.

"We believe that the ongoing review process remains productive and collaborative.

"We remain optimistic about a favourable decision shortly on the CE Mark.

"The plans we have been putting in place internally, including the key management hires, should help us to be in a position to launch promptly, upon a favourable CE Mark decision.

"In addition, we view the IDE filing as a key step towards our longer term vision to be able to treat cancer patients with OncoSil in the world’s largest market, the United States.”


March quarter highlights:

- Finalised detailed responses for CE Mark to outstanding questions received from Notified Body;
- Dr Chris Roberts appointed non-executive director;
- Submitted detailed responses to US FDA Investigation Device Exemption (IDE) questions;
- Held productive face to face (Q Sub) meeting with US FDA regarding IDE submission;
- Completed $10.0m placement to Regal Funds Management; and
- Net Cash inflow of $8.6m for the Quarter and closing cash balance of $14.4m.


Preparations for commercial launch

OncoSil has also undertaken further activities in preparation for a commercial launch.

The company said: "During the quarter a great deal was achieved in Manufacturing Operations with the consolidation of alloying, atomisation & classification into a single dedicated facility in the UK.

"In addition de-novo production runs were also completed at this facility in January.

"We therefore believe that our Manufacturing Operations are all in readiness for commercial launch with inventory sufficient for several years of clinical trials and commercial sales.

"The company has also progressed its Investigation Device Exemption (IDE) with the FDA.

"During the quarter, the company submitted an additional data package of approximately 1,700 pages in response to FDA questions.

"In March, senior management and regulatory advisers met with the relevant Medical, Branch and Divisional Directors from the FDA.

"The company is also working to expand its investor relations activities and is pleased to report that Bell Potter Securities initiated research coverage during the quarter, in addition to continuing coverage from Wilson HTM and Van Leeuwenhoeck Institute."

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Fri, 29 Apr 2016 10:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/160322/oncosil-medical-ltd-confident-ce-mark-will-be-granted-in-near-term-68348.html
<![CDATA[News - OncoSil Medical Ltd: Van Leeuwenhoek applies $0.80 per share valuation ]]> https://www.proactiveinvestors.com.au/companies/news/160321/oncosil-medical-ltd-van-leeuwenhoek-applies-080-per-share-valuation-67287.html OncoSil Medical Ltd (ASX:OSL) has received a valuation of $0.80 per share from Van Leeuwenhoek.

OncoSil last traded at $0.16 per share. The following is an extract from the report.


Path towards Commercialisation - valuation 80 cents per share

Based on our NPV valuation, we believe that OncoSil Medical is substantially undervalued at the current share price of AUD 0.16.

Considering the upcoming CE Mark, OncoSil™’s much higher potential commercial success compared to Sirtex’ SIR-Spheres (with total annual sales of more than AUD 176 million) and the high unmet medical need in pancreatic and primary liver cancer, induces us to increase our valuation.

The previous estimate was AUD 170-210 million and to calculate a more justified valuation of OncoSil™ of AUD 275-325 million or AUD 0.65-0.80 per share.

This represents a substantial upside from the current share price.


Executive Summary:

- OncoSil Medical (ASX:OSL) is an Australia based Life Sciences company that provides an innovative technology for safer and more effective radiation therapies for difficult to treat cancers like pancreatic cancer and hepatocellular carcinoma (HCC).

Its lead product is OncoSil™ for pancreatic cancer.

A second indication is HCC. For both indications the company filed for a CE Mark in the EU, which is expected to be granted early 2016.


- In July 2015 the company filed the CE Mark Design Dossier for both pancreatic and HCC liver cancer to the Notified Body.

In September 2015 it was announced that the Notified Body has scheduled a Fast Track review for OncoSil™, which took place on October 6th over a period four days.

We expect that the CE Mark will be awarded end of 2016Q1. A CE Mark will facilitate commercialization and sales in large markets other than the EU including Australia, Canada and Singapore.

The company also filed for an IDE with the FDA, for which we expect approval towards the end of 2016Q1 as well.


- Both the market for pancreatic cancer and HCC liver cancer are estimated to be USD 1-1.5 billion.

The lack of effective treatments that offers significantly improved survival rates provides ample opportunity to be a game changer for the treatment of these cancers.

We feel that OncoSil™ therefore has the potential to be a blockbuster (sales > 1 billion) within a few years since the therapy would be useful in other cancers as well.


- Beginning of 2016 the company successfully raised AUD 10 million in an Institutional Placement to finance the commercialization of its lead product candidate OncoSil™.

We feel that the company may raise additional capital at a higher price in early 2017 following regulatory success with the CE Mark and FDA IDE filings in Q1 2016.

The current cash position after this raise is AUD 15 million.


- There are a number of key milestones to focus on in the next 6-12 months which include: approval of the CE Mark in the EU, start of sales in both the EU and other regions as well (Australia, Canada, Singapore), and the approval of the IDE by the FDA.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 02 Mar 2016 09:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/160321/oncosil-medical-ltd-van-leeuwenhoek-applies-080-per-share-valuation-67287.html
<![CDATA[News - OncoSil Medical updates on CE Mark, Regal Funds joins share register ]]> https://www.proactiveinvestors.com.au/companies/news/160320/oncosil-medical-updates-on-ce-mark-regal-funds-joins-share-register-67273.html OncoSil Medical (ASX:OSL) said that it continues to be in active engagement with the Notified Body for the CE Mark submission.

Granting of the CE Mark would enable commercial sales to commence in the European Union, and application for TGA approval in Australia.

OncoSil's lead product is OncoSil™ with the first target indication being pancreatic cancer.

There is also potential use for OncoSil™ in other solid tumours outside of pancreatic cancer.

The core focus of the company now is United States Food and Drug Administration (FDA) and CE Mark approval.


OncoSil update

- During January and February 2016, the company prepared detailed responses to outstanding questions received from the Notified Body. The company has been advised that the issues raised in three memoranda from the Notified Body have now been closed out;

- The company is currently finalising a response with material it expects to be completed for submission to the Notified Body within the next two to three weeks; and

- The Notified Body plans to schedule a face to face meeting with the company as a means of addressing the material and any questions, as soon as practicable.


Timing

The time that the Notified Body may take to complete its final review and provide a recommendation is expected to be in the near term.

Filing of the CE Mark is complex.

OncoSil said that the process has been complicated and taken longer than anticipated, partly because the pancreatic and liver cancer indications sought are part of a single CE Mark submission.

OncoSil added that it remains confident in its submission for CE Mark being granted, thereby enabling commercial sales to commence in the European Union and application for TGA approval in Australia.


Clinical

OncoSil is also actively pursuing its Investigation Device Exemption (IDE) with the FDA.


Corporate

Regal Funds Management recently became a substantial shareholder in the company, following the $10 million placement completed on 10 February 2016.


Analysis

The recent pull-back in the OncoSil share price to $0.145 provides investors with a lower entry point into the stock as it progresses towards the landmark CE Mark decision.

Research released today from Van Leeuwenhoek said: "We believe that OncoSil Medical is substantially undervalued at the current share price.

"Considering the upcoming CE Mark, OncoSil™’s much higher potential commercial success compared to Sirtex’ SIR-Spheres (with total annual sales of more than AUD 176 million) and the high unmet medical need in pancreatic and primary liver cancer, induces us to increase our valuation from our previous estimate of AUD 170-210 million and to calculate a more justified valuation of OncoSil™ of AUD 275-325 million or AUD 0.65-0.80 per share.

"This represents a substantial upside from the current share price."

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

]]>
Tue, 01 Mar 2016 10:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/160320/oncosil-medical-updates-on-ce-mark-regal-funds-joins-share-register-67273.html
<![CDATA[News - OncoSil Medical: Speculative Buy and $0.50 target from broker ]]> https://www.proactiveinvestors.com.au/companies/news/160319/oncosil-medical-speculative-buy-and-050-target-from-broker-67069.html OncoSil Medical (ASX:OSL) has received a Speculative Buy recommendation from WilsonHTM.

The broker has maintained its $0.50 target price, and said that was pre-emptively diluted for anticipated capital raising event(s) in FY16-17.

OncoSil last traded at $0.20. The following is an extract from the report.


"OncoSil takes the money ahead of key milestones"

We maintain a SPECULATIVE BUY rating. No change to target price of 50 cps which was pre-emptively diluted for anticipated capital raising event(s) in FY16-17.


OncoSil takes the money ahead of key milestones

OncoSil Medical has announced an opportunistic funding top-up of $10m while waiting for two key milestones.

It expects to start selling its brachytherapy device for the treatment of pancreatic cancer this year, once approved by the European regulator.

A well-designed, large clinical trial is also anticipated in the USA in 2016, should the FDA grant approval.

Additional capital is required to support the company through to profitability, although non-dilutive alternatives could present themselves over the next few years, if its asset attracts interest from commercial partners. 


Key points

1) A surprise $10m private placement priced at 22cps. Attractively priced, small offering to institutional market, ahead of two short-term price catalysts for the stock: pending European marketing approval (CE Mark) for OncoSil™ and FDA’s potential approval of OncoSil’s plans to commence a registration-directed clinical trial.

2) Additional capital required to fully prosecute the global trial and initial commercialisation. OncoSil reported $5.8m cash at end of Dec-15. Although a first product launch should follow immediately after CE Marking, we expect sales will be modest initially.

OncoSil’s clinical trial is the company’s major set piece over the next three years – likely to recruit around 250 patients with top-line data potentially available in 2018. The trial has been designed to form the basis for a Premarket Authorisation (PMA) submission to the FDA.

3) Trial execution a catalyst for attracting commercial interest, possibly funding.

OncoSil™ is most likely to be commercialised in the USA via collaboration with a larger partner. We understand several high profile clinical sites are being targeted, which may help attract partner interest.

An early partnering transaction could obviate the need for additional equity capital – providing upside to our forecast and valuation (development risk reduction, non-dilutive R&D capital).


Valuation

The most important valuation milestones in the near term are IDE trial approval and a positive CE Marking decision, which support valuations of up to $1.00 per share, on a 12-month view.

If we completely de-risk the OncoSil valuation model (all clinical and development success probabilities set to 100%, discount rate set closer to 8-9% reflecting a more established medical device business), we can see potential valuations of $2.75 per share emerging over the next 3-5 years.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

]]>
Wed, 17 Feb 2016 13:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/160319/oncosil-medical-speculative-buy-and-050-target-from-broker-67069.html
<![CDATA[News - OncoSil Medical receives substantial holder notice from Regal Funds Management ]]> https://www.proactiveinvestors.com.au/companies/news/160318/oncosil-medical-receives-substantial-holder-notice-from-regal-funds-management-66949.html Clinical-stage Australian Lifesciences company OncoSil Medical (ASX:OSL), has received an initial substantial holder notice from Regal Funds Management, with a 10.98% stake.

Regal now holds circa 45.5 million shares, purchased at $0.22.

The OncoSil treatment is an implantable nuclear medicine (radiotherapy) device that has been successfully piloted in pancreatic and liver cancer.

The device is inserted directly into the centre of the tumour using well established technology.

It has clinically demonstrated target tumour regression (tumour shrinkage) in both solid tumour indications of pancreatic and liver cancer.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

]]>
Wed, 10 Feb 2016 12:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/160318/oncosil-medical-receives-substantial-holder-notice-from-regal-funds-management-66949.html
<![CDATA[News - OncoSil Medical bags $10M to commercialise cancer treatment ]]> https://www.proactiveinvestors.com.au/companies/news/160317/oncosil-medical-bags-10m-to-commercialise-cancer-treatment-66839.html OncoSil Medical (ASX:OSL) has taken a major step in driving global commercialisation of its OncoSil localised radiation cancer treatment by securing a A$10 million institutional investment.

The placement by way of a subscription agreement for some 45.4 million shares was priced at A$0.22 a share.

Shares in the company were last trading at A$0.24, representing a 40% improvement over the past month and a 243% gain year on year.

The funds will be used to aggressively drive the company's commercialisation plans to position OncoSil as an innovative, new medical radiation treatment for pancreatic cancer and other solid tumours – which have major un-met medical needs.

The OncoSil treatment is an implantable nuclear medicine (radiotherapy) device that has been successfully piloted in pancreatic and liver cancer.

The device is inserted directly into the centre of the tumour using well established technology.

It has clinically demonstrated target tumour regression (tumour shrinkage) in both solid tumour indications of pancreatic and liver cancer.


Regulatory momentum

OncoSil Medical currently has an Investigational Device Exemption (IDE) filing in progress with the U.S. Food and Drug Administration (FDA) and concurrently is pursuing Conformité Européenne (CE) Mark certification with the European regulatory body for the product.

A clinical trial is required to support a future application to market the product in the U.S. and may represent another potential price catalyst for the company.

The outcome of the FDA process is expected to help characterise the costs, timing and likelihood of its first U.S. approval.

Meanwhile, a CE Mark is the mandatory regulatory designation required to commercially market and sell OncoSil in the European Union, and would also facilitate regulatory approvals, commercialisation and sales of OncoSil in other major markets, including Australia, Canada, and Singapore.

The company was granted a Fast Track review by the European regulator to assess its CE Mark application for OncoSil in pancreatic and primary liver cancer (HCC).


Analysis

This level of investment and financial backing is highly encouraging at this point in time, and represents a strong validation for OncoSil brachytherapy technology and its global commercialisation potential.

This vote of confidence reflects positively on market sentiment regarding the outcome of the FDA submission, which is OncoSil’s next catalyst.

A positive outcome could see OncoSil’s trial recruiting patients by the second quarter, which could in turn generate further price catalysts for the company on the road to product commercialisation.

The CE Mark, European marketing approval and first sales also represent potential drivers in the foreseeable future for this well performing stock.

OncoSil shares have gained 243% in value year on year and were last trading at A$0.24.


Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

]]>
Wed, 03 Feb 2016 10:50:00 +1100 https://www.proactiveinvestors.com.au/companies/news/160317/oncosil-medical-bags-10m-to-commercialise-cancer-treatment-66839.html
<![CDATA[News - OncoSil Medical share price target upgraded by broker ]]> https://www.proactiveinvestors.com.au/companies/news/160316/oncosil-medical-share-price-target-upgraded-by-broker-66809.html OncoSil Medical (ASX:OSL) is the subject of a research report by WilsonHTM. Here is a summary of the report:

IDE submission for OncoSil

OncoSil Medical made its first submission to the FDA, seeking approval to trial its brachytherapy device for the treatment of pancreatic cancer. A well-designed, pivotal clinical trial is required to support a future application to market the product in the US.

Later this quarter, the FDA’s response letter and further trial design detail should come to light, clarifying the pathway towards US licensure. Meanwhile, the European approval process has encountered a longer review period than expected, but we remain confident.

We maintain a SPECULATIVE BUY rating. Target price upgraded to 50 cps (risked) with potential, milestone-dependent upside to $1/share over the next 12 months. Current share price is $0.23.


Key points

OncoSil has filed an application with the FDA to conduct a new clinical trial of OncoSil™ in the treatment of pancreatic cancer – this IDE filing sets out OncoSil’s investigational plan to test the safety and efficacy of OncoSil™ in a study which may ultimately support marketing approval in the US.

FDA response letter is the next catalyst – FDA review times can be as short as 30 days for IDE applications, so a positive outcome could see OncoSil’s trial recruiting patients by the second quarter. IDE approvals give no assurances with respect to the future approval of products, but they do confirm that the agency sees a reasonable case that the product’s putative benefits outweigh the safety risks faced by patients participating in the trial.

The FDA’s response letter and the release of OncoSil’s proposed trial design are the next catalysts which will help characterise the costs, timing and likelihood of its first US approval. We are anticipating a 225-275 patient study to examine surrogate endpoints such as local progression free survival and tumour regression (overall response rates).

CE Mark process ongoing – the European approval process has taken longer than the company anticipated. The value of the CE Marking process, from our perspective, is independent validation of OncoSil’s systems/technologies.

Valuation – our risked DCF lifts to 50 cps in anticipation of FDA clearance and increased confidence in development plans. Un-risked valuation for OncoSil suggests further potential of up to $2.75 per share over a 3-5 year period (upside case) on a fully diluted basis.

Risks and catalysts
Catalysts: a) CE Mark; b) FDA trial guidance; c) EU marketing approval and first sales. Risks: a) access to capital; b) clinical trial design risk; c) regulatory risks; d) product safety/quality/logistics risks; e) sector sentiment.


BUSINESS DESCRIPTION

OncoSil Medical Limited (OSL) is developing a novel form of brachytherapy for the treatment of pancreatic and liver cancers. OncoSil™ provides a means of irradiating tumours from the inside, using microparticles impregnated with the radioactive isotope Phosphorus-32. OncoSil™ is expected to be granted CE Mark this year and be the subject of a large clinical trial in the US next year. We estimate a US$250m sales opportunity in the major pancreatic cancer markets.

INVESTMENT THESIS

OncoSil™ is an attractive product concept on account of its “single treatment” nature and dose intensity. We think the product deserves “accelerated review” status with the FDA and will find good adoption by interventional radiologists, if approved.

REVENUE DRIVERS

- Pricing and reimbursement
- Market penetration (new clinical centres/hospitals, physician acceptance)
- New markets (geographical, clinical indications)

BALANCE SHEET

As at the 1HFY15 result, OncoSil had ~$7m in cash and no debt.


Valuation

Our price target is lifted to 50 cps, which is based on a risked, discounted cash flow (DCF) methodology. The upgrade is mainly in anticipation of the FDA clearing OncoSil’s IDE study in the manner we have described here, and our increased confidence about the development program, given what we have gathered from our clinical conversations with the company and other sources.

We have developed an explicit forecast for OncoSil™ sales across three segments of the global cancer market: the US, five EU (UK, France, Germany, Italy and Spain) and APAC (principally Australia and New Zealand). We assess peak sales potential of ~US$350-400m for OncoSil™, with 75% of that relating to the treatment of locally advanced and/or metastatic pancreatic cancer in the US.

The most important valuation milestones in the near term are the IDE trial approval and a positive CE Marking decision, which might support valuations of up to $1.00 per share, on a 12-month view. If we completely de-risk the OncoSil valuation model (all clinical and development success probabilities set to 100%, discount rate set closer to 8-9% reflecting a more established medical device business), we can see potential valuations of $2.75 per share emerging over the next 3-5 years.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

]]>
Tue, 02 Feb 2016 08:43:00 +1100 https://www.proactiveinvestors.com.au/companies/news/160316/oncosil-medical-share-price-target-upgraded-by-broker-66809.html
<![CDATA[News - OncoSil Medical appoints Dr Chris Roberts a non-executive director ]]> https://www.proactiveinvestors.com.au/companies/news/160315/oncosil-medical-appoints-dr-chris-roberts-a-non-executive-director-66661.html Clinical-stage Australian Lifesciences company OncoSil Medical (ASX:OSL) has appointed Dr Chris Roberts as an independent non-executive director of the company, with immediate effect.

Dr Roberts is a highly experienced director and senior executive with 40 years’ experience in the medical innovation space, and was the chief executive officer / president of Cochlear Limited (ASX:COH) from February 2004 to August 2015.

He was primarily responsible for the significant increase in Cochlear Limited’s sales from $348 million in 2005 to $926 million in 2015.

Dr Roberts was also chairman of Sirtex Medical (ASX:SRX), from March 2000 to December 2002, and was executive vice-president of global sleep disorder treatment company ResMed Inc (NYSE:RMD, ASX:RMD) from 1992 to 2004.

Daniel Kenny, CEO, commented: “We are delighted to welcome someone of the calibre of Dr Roberts to our board of directors.

"Dr Roberts’ outstanding track record of achievement across multiple disciplines in the commercialisation of medical innovation will be a valuable addition to the board, as the company continues to advance the commercialisation of OncoSil™ as a medical radiation treatment for pancreatic cancer and other solid tumours.”

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

]]>
Thu, 21 Jan 2016 11:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/160315/oncosil-medical-appoints-dr-chris-roberts-a-non-executive-director-66661.html
<![CDATA[News - OncoSil Medical is a stock on the move ]]> https://www.proactiveinvestors.com.au/companies/news/160314/oncosil-medical-is-a-stock-on-the-move-66373.html Clinical-stage Australian Lifesciences company OncoSil Medical (ASX:OSL) has been a strong performer on the Australian Securities Exchange in recent weeks.

Intra-day today the company is 6.4% firmer at $0.25 on strong volume of circa 700,000 shares traded.

A month ago the company was trading in the $0.15 to $0.17 range.

Go back almost a year when Daniel Kenny was first appointed CEO, and the shares could have been snapped up for under $0.07.

That makes the company a 3.5 bagger since Kenny came on board.

Earlier in the month the company filed an Investigational Device Exemption (IDE) with the US Food and Drug Administration (FDA) for its lead product candidate, the OncoSil™ localised radiation treatment for cancer.

This is a significant milestone in the development pathway for OncoSil™ in pancreatic cancer and is the first step towards securing FDA commercial approval for OncoSil™ under a Pre-market Approval (PMA).

At the time, Kenny, commented:

“I am delighted to report that we have filed our Investigational Device Exemption submission with the US FDA.

"This represents a key milestone in the development timeline for OncoSil™ in the USA.

"In conjunction with our ongoing CE Mark process with the European regulator, the company now has an active global regulatory licensing pathway.”


How OncoSil™ works

OncoSil™ is an implantable nuclear medicine (radiotherapy) device that has been successfully piloted in pancreatic and liver cancer.

The device is inserted directly into the centre of the tumour using well established technology.

OncoSil™ has clinically demonstrated target tumour regression (tumour shrinkage) in both solid tumour indications of pancreatic and liver cancer.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

]]>
Tue, 29 Dec 2015 15:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/160314/oncosil-medical-is-a-stock-on-the-move-66373.html
<![CDATA[News - OncoSil Medical appoints Charles Rowland as president of U.S. operations ]]> https://www.proactiveinvestors.com.au/companies/news/160313/oncosil-medical-appoints-charles-rowland-as-president-of-us-operations-66173.html Clinical-stage Australian Lifesciences company OncoSil Medical (ASX:OSL) has now appointed Charles Rowland as president, OncoSil Medical USA.

Rowland was previously President of Sirtex Medical US from 2002 to 2006.

His role with Oncosil will include being responsible for developing and executing the company’s U.S. Business plan.

Rowland will be the company’s official representative with the U.S. FDA as it works towards U.S. licensure for its lead product candidate, the OncoSil™ localised radiation treatment for cancer.

Daniel Kenny, CEO, commented:

“We are delighted to announce the appointment of Mr Charles Rowland as President of our USA operations.

"His is a key appointment as we move into a highly significant phase in the licensing & commercialisation of OncoSil™, in the US market."


How OncoSil™ works

OncoSil™ is an implantable nuclear medicine (radiotherapy) device that has been successfully piloted in pancreatic and liver cancer.

The device is inserted directly into the centre of the tumour using well established technology.

OncoSil™ has clinically demonstrated target tumour regression (tumour shrinkage) in both solid tumour indications of pancreatic and liver cancer.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

]]>
Tue, 15 Dec 2015 13:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/160313/oncosil-medical-appoints-charles-rowland-as-president-of-us-operations-66173.html
<![CDATA[News - OncoSil Medical files Investigational Device Exemption submission with FDA ]]> https://www.proactiveinvestors.com.au/companies/news/160312/oncosil-medical-files-investigational-device-exemption-submission-with-fda-66144.html OncoSil Medical (ASX:OSL) has now filed an Investigational Device Exemption (IDE) with the US Food and Drug Administration (FDA) for its lead product candidate, the OncoSil™ localised radiation treatment for cancer.

This is a significant milestone in the development pathway for OncoSil™ in pancreatic cancer and is the first step towards securing FDA commercial approval for OncoSil™ under a Pre-market Approval (PMA).

Daniel Kenny, CEO, OncoSil Medical, commented:

“I am delighted to report that we have filed our Investigational Device Exemption submission with the US FDA.

"This represents a key milestone in the development timeline for OncoSil™ in the USA.

"In conjunction with our ongoing CE Mark process with the European regulator, the company now has an active global regulatory licensing pathway.”


Additional submission details

OncoSil formally filed its IDE submission on 10th December 2015 after successfully completing a lengthy pre-IDE process.

The pre-IDE process involved an FDA review of the proposed Clinical Investigational plan including the endorsement of clinical endpoints and outcomes measures.

The IDE submission is the culmination of a detailed body of preparatory work conducted by OncoSil’s medical and regulatory team over a six month period, which was undertaken in parallel with its Conformité Européenne (CE) Mark application process and ongoing review with the European regulatory body.

OncoSil said that it is pleased to report significant, positive progress with its CE Mark application, and the process remains ongoing.

The formal review continues with the Notified Body and the company anticipates a decision in the New Year.


US Pancreatic cancer market opportunity

According to the most recent American Cancer Society statistics, the number of new cases of pancreatic cancer in the United States in 2015 is expected to be 48,960.

Pancreatic cancer has a poor prognosis and is responsible for a relatively high percentage of cancer-related mortality.

The number of deaths in 2015 is expected to be 40,560. Pancreatic cancer is the 4th leading cause of cancer mortality in the US, after lung cancer (158,000), colon cancer (49,700) and breast cancer (40,730).

The relative five-year survival rate for all stages of pancreatic cancer combined is approximately 5%.

There currently exists a large un-met medical need for viable, new treatment options for pancreatic cancer which OncoSil Medical aims to meet with OncoSil™.

The estimated world-wide market opportunity for OncoSil™ in pancreatic cancer exceeds $1 billion.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 14 Dec 2015 09:40:00 +1100 https://www.proactiveinvestors.com.au/companies/news/160312/oncosil-medical-files-investigational-device-exemption-submission-with-fda-66144.html
<![CDATA[News - OncoSil Medical banks $1.5M tax refund ]]> https://www.proactiveinvestors.com.au/companies/news/160311/oncosil-medical-banks-15m-tax-refund-65857.html OncoSil Medical (ASX:OSL) has received a boost to its cash balance after it received a refund from the Australian Taxation Office of $1,535,444.

This follows the lodgement of the 2014/15 financial year tax return.

The cash rebate is related to expenditure on eligible Australian and international R & D activities conducted during the period.

OncoSil recently attracted a new substantial shareholder with the Fremantle-based JK Nominees Pty Ltd now holding a 5.56% stake.

OncoSil has around $5 million in cash at the end of September 2015.


CE Mark application for OncoSil™

Recently, OncoSil was granted a Fast Track review by the European regulator to assess its CE Mark application for OncoSil™ in pancreatic and primary liver cancer (HCC).

A CE Mark is the mandatory regulatory designation required to commercially market and sell OncoSil™ in the European Union, and would also facilitate regulatory approvals, commercialisation and sales of OncoSil™ in other major markets, including Australia, Canada, and Singapore.

The company said it was pleased with the Fast Track review meeting and now anticipates that the Notified Body will make a decision in respect of the CE Mark for OncoSil™ by end of year.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

]]>
Fri, 27 Nov 2015 12:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/160311/oncosil-medical-banks-15m-tax-refund-65857.html
<![CDATA[News - OncoSil Medical has a new substantial shareholder in JK Nominees ]]> https://www.proactiveinvestors.com.au/companies/news/160310/oncosil-medical-has-a-new-substantial-shareholder-in-jk-nominees-65764.html Australian Lifesciences company OncoSil Medical (ASX:OSL) has a new substantial shareholder with the Fremantle-based JK Nominees Pty Ltd.

JK Nominees now holds 20 million shares for a 5.56% stake.

Recently OncoSil was granted a Fast Track review by the European regulator to assess its CE Mark application for OncoSil™ in pancreatic and primary liver cancer (HCC).

A CE Mark is the mandatory regulatory designation required to commercially market and sell OncoSil™ in the European Union, and would also facilitate regulatory approvals, commercialisation and sales of OncoSil™ in other major markets, including Australia, Canada, and Singapore.

The company said it was pleased with the Fast Track review meeting and now anticipates that the Notified Body will make a decision in respect of the CE Mark for OncoSil™ by end of year.


How OncoSil™ works

OncoSil™ is an implantable nuclear medicine (radiotherapy) device that has been successfully piloted in pancreatic and liver cancer.

The device is inserted directly into the centre of the tumour using well established technology.

OncoSil™ has clinically demonstrated target tumour regression (tumour shrinkage) in both solid tumour indications of pancreatic and liver cancer.


Broker valuation

Wilson HTM recently initiated coverage on OncoSil with a Speculative Buy rating and a price target of A$0.35.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

]]>
Tue, 24 Nov 2015 09:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/160310/oncosil-medical-has-a-new-substantial-shareholder-in-jk-nominees-65764.html
<![CDATA[News - Oncosil Medical makes pivotal hire on path to commercialisation ]]> https://www.proactiveinvestors.com.au/companies/news/160309/oncosil-medical-makes-pivotal-hire-on-path-to-commercialisation-65219.html Oncosil Medical (ASX:OSL) has appointed Tom Milicevic as chief financial officer and company secretary, effective immediately.

Milicevic brings specific financial expertise in medical device and biotech companies.

The hire is a pivotal one as the company transitions from a development focus to the commercialisation of its OncoSilTM localised radiation treatment for cancer.

Oncosil is progressing towards a Conformité Européenne (CE) Mark application for its OncoSil™ localised radiation treatment for cancer.

A decision in respect in respect to the CE Mark is expected in November.

OncoSil™ is an implantable nuclear medicine (radiotherapy) device that has been successfully piloted in pancreatic and liver cancer.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong.

]]>
Thu, 22 Oct 2015 16:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/160309/oncosil-medical-makes-pivotal-hire-on-path-to-commercialisation-65219.html
<![CDATA[News - OncoSil Medical completes Fast Track Face-to-Face for CE Mark ]]> https://www.proactiveinvestors.com.au/companies/news/160308/oncosil-medical-completes-fast-track-face-to-face-for-ce-mark-65040.html Australian Lifesciences company OncoSil Medical (ASX:OSL) has provided an update on its Conformité Européenne (CE) Mark application for its OncoSilTM localised radiation treatment for cancer.

Last month the company was granted a Fast Track review by the European regulator to assess its CE Mark application for OncoSil™ in pancreatic and primary liver cancer (HCC).

OncoSil has advised that the Fast Track Face-to-Face review phase has been completed, and it now awaits the final outcome of the review as the Notified Body continues its assessment over the coming weeks.

The company was pleased with the review meeting and anticipates that the Notified Body will make a decision in respect of the CE Mark for OncoSil™ in November.

A CE Mark is the mandatory regulatory designation required to commercially market and sell OncoSil™ in the European Union, and would also facilitate regulatory approvals, commercialisation and sales of OncoSil™ in other major markets, including Australia, Canada, and Singapore.


How OncoSil™ works

OncoSil™ is an implantable nuclear medicine (radiotherapy) device that has been successfully piloted in pancreatic and liver cancer.

The device is inserted directly into the centre of the tumour using well established technology.

OncoSil™ has clinically demonstrated target tumour regression (tumour shrinkage) in both solid tumour indications of pancreatic and liver cancer.


Buyers and users of OncoSil™

The devices would be purchased by governments, national health services, or individual hospitals.

The next step is that the surgeons involved need to be trained and certified to use OncoSil's device.

Every physician or surgeon involved in using the device would have to be certified or trained by OncoSil, which would be part of its license requirements.

OncoSil would therefore require clinical adoption from both medical and radiation oncologists, along with GI surgeons and liver surgeons to cover the two indications.


OncoSil makes key appointments

Last week OncoSil made two new key appointments in preparation for the commercialisation of its OncoSil™.

The appointments include David James as global head of manufacturing operations, and Greg Rogers as manufacturing engineering manager.

James brings more than 20 years’ experience, including six years with leading cancer treatment company Sirtex Medical (ASX:SRX) as global operations manager.

Rogers has more than 27 years experience in leadership, operations, quality control and change management roles in the medical device and diagnostics sectors.


Broker valuation

Wilson HTM recently initiated coverage on OncoSil with a Speculative Buy rating and a price target of A$0.35.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 12 Oct 2015 10:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/160308/oncosil-medical-completes-fast-track-face-to-face-for-ce-mark-65040.html
<![CDATA[News - OncoSil Medical strengthens team in preparation for commercialisation ]]> https://www.proactiveinvestors.com.au/companies/news/160307/oncosil-medical-strengthens-team-in-preparation-for-commercialisation-64985.html Clinical-stage Australian Lifesciences company OncoSil Medical (ASX:OSL) has made two new key appointments in preparation for the commercialisation of its OncoSilTM localised radiation treatment for cancer.


Daniel Kenny, CEO, featured in an interview recently heading up to the CE Mark, which can be accessed here.


The appointments include David James as global head of manufacturing operations, and Greg Rogers as manufacturing engineering manager.

James brings more than 20 years’ experience, including six years with leading cancer treatment company Sirtex Medical (ASX:SRX) as global operations manager.

Rogers has more than 27 years experience in leadership, operations, quality control and change management roles in the medical device and diagnostics sectors.

Daniel Kenny, CEO, commented:

“Both these appointments are pivotal additions to OncoSil Medical’s senior management team and will be integral to the company as it transitions it focus from the development phase to the commercialisation of OncoSilTM for the treatment of pancreatic and primary liver cancer (HCC).

"On behalf of the OncoSil team I would like to welcome David and Greg and we look forward to their strong, positive contributions as we continue to progress our commercialisation plans.”


Broker valuation

Wilson HTM has initiated coverage on OncoSil Medical with a Speculative Buy rating and a price target of A$0.35. The target is more than double the company's last traded price.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 09 Oct 2015 07:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/160307/oncosil-medical-strengthens-team-in-preparation-for-commercialisation-64985.html
<![CDATA[News - OncoSil Medical valued at A$0.35 price target: broker ]]> https://www.proactiveinvestors.com.au/companies/news/160306/oncosil-medical-valued-at-a035-price-target-broker-64965.html OncoSil Medical (ASX:OSL) has been the recipient of research coverage from broker Wilson HTM. The price target is more than double the company's last trading price of $0.15.

The broker said: We initiate coverage on OncoSil Medical with a Speculative Buy rating and a risked price target of 35 cps (un-risked 100 cps).


The following is an extract from the report.

A great time to be developing new brachytherapy devices

We initiate coverage on OncoSil Medical with a SPECULATIVE BUY rating and a risked price target of 35 cps (un-risked 100 cps). A new initiative at the US Food and Drug Administration could potentially ease the path to initial approvals for medical devices in areas as desperate as pancreatic cancer. Oncosil’s medical device fits the profile: a radioactive implant designed to ablate aggressive, primary pancreatic tumours, in a single procedure with good safety. 

Nothing on the market does that well enough and the prognosis for people diagnosed with this disease is poor. We assess early clinical interest in Oncosil, which is designing a pivotal trial in the US. A modest launch in Europe is planned for 2016, but the explosive catalyst for this stock will be the FDA’s review and potential approval of Oncosil’s proposed pivotal US trial plan, later this year.


Key points

Introducing OncoSil Medical – this Australian medical device company is responding to one of the most pressing problems in solid tumour oncology today – how to rapidly “de-escalate” aggressive pancreatic cancers. Current radiological methods are inadequate, which is why they have been relegated, over the past decade or so, to a largely palliative role. Oncosil has developed an implantable, radioactive device which can deliver a large, potentially decisive dose of radiation in one sitting, to shrink tumours with good safety.

The company is readying a modest European launch and a pivotal Phase III trial in the US next year. We assess peak sales in the order of A$350-400m for the treatment of locally advanced and metastatic pancreatic cancer.

The drive towards Level 1 clinical evidence – Oncosil’s current data comprises four Phase II trials conducted in small numbers of patients. Its development plan is adequate to generate higher level evidence, on which marketing approvals and widespread reimbursement will ultimately depend.

Valuation – our risked DCF model implies a 35 cps target price on a fully diluted basis. The key variables in the valuation are the choice of commercial pathway in major markets (direct sales versus distribution). Equity value could re-rate as the company passes quality and evidence gates: CE Mark in Q4; US pivotal trial design approval by the FDA in Q4; first commercial sales to EMEA in 2016. Our de-risked valuation for Oncosil is approximately 100 cps (upside case).

 

Risks and catalysts

Catalysts: a) CE Mark; b) FDA trial guidance; c) EU marketing approval and first sales. Risks: a) access to capital; b) clinical trial design risk; c) regulatory risks; d) product safety/quality/logistics risks; e) sector sentiment.


Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 08 Oct 2015 10:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/160306/oncosil-medical-valued-at-a035-price-target-broker-64965.html
<![CDATA[Media files - OncoSil Medical's MD Daniel Kenny spells out the pathway to CE Mark with Proactive Investors ]]> https://www.proactiveinvestors.com.au/companies/stocktube/5842/oncosil-medicals-md-daniel-kenny-spells-out-the-pathway-to-ce-mark-with-proactive-investors-547.html Sun, 04 Oct 2015 08:26:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/5842/oncosil-medicals-md-daniel-kenny-spells-out-the-pathway-to-ce-mark-with-proactive-investors-547.html <![CDATA[News - OncoSil Medical receives hefty valuation from research firm ]]> https://www.proactiveinvestors.com.au/companies/news/160305/oncosil-medical-receives-hefty-valuation-from-research-firm-64867.html OncoSil Medical (ASX:OSL) has received a valuation of A$175-210 million, or A$0.50-0.60 per share, from international life sciences research group, Van Leeuwenhoeck Institute.

OncoSil's shares last traded at A$0.175.

The following is an extract from the report.


The Report says:

Based on our NPV valuation, we believe that OncoSil Medical is substantially undervalued at the current share price of AUD 0.16.

Considering the upcoming CE Mark, OncoSil™ much higher potential commercial success compared to Sirtex’ SIR-Spheres (with total annual sales of more than USD 110 million) and the high unmet medical need in pancreatic and primary liver cancer, induces us to calculate a more justified valuation of Oncosil of AUD 175-210 million or AUD 0.50-0.60 per share.

This represents a substantial upside from the current share price.


Executive Summary:

- OncoSil Medical is a Life Sciences company that provides an innovative technology for safer and more effective radiation therapies for difficult to treat cancers. Its lead product is OncoSil™ for pancreatic cancer. A second indication is HCC. For both indications the company filed for a CE Mark in the EU.

- OncoSil™ is an implantable device that emits radiation directly into the targeted tumour. Four clinical trials were conducted with positive results on safety and efficacy. Due to the high unmet medical need and very poor survival rates of pancreatic and liver cancer, there is a large demand for new therapies to treat these cancer types.

- In July the company filed for CE Mark for pancreatic and HCC liver cancer. On September 6th it announced that the Notified Body had scheduled a Fast Track review for OncoSil™, which will take place on October 6th over four days. A CE Mark will facilitate commercialisation and sales in the EU plus Australia, Canada and Singapore. The company also expects to file for an IDE with the FDA in 2016Q4.

- Both the market for pancreatic cancer and HCC liver cancer are estimated to be USD1-1.5b. The lack of effective treatments provides ample opportunity for a game changer for the treatment of these cancers. We feel that OncoSil™ therefore has the potential to be a blockbuster (sales > 1 billion) within a few years.

- There are a number of key milestones to focus on in the next 6-12 months.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 02 Oct 2015 09:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/160305/oncosil-medical-receives-hefty-valuation-from-research-firm-64867.html
<![CDATA[News - OncoSil Medical's Daniel Kenny talks path to CE Mark with Proactive Investors ]]> https://www.proactiveinvestors.com.au/companies/news/160304/oncosil-medicals-daniel-kenny-talks-path-to-ce-mark-with-proactive-investors-64859.html OncoSil Medical's (ASX:OSL) managing director Daniel Kenny talks pathway to CE Mark approval with Proactive Investors.


VIEW FULL INTERVIEW HERE


OncoSil's lead product candidate is the OncoSil™ medical device, which is focussed on localised radiation treatment for cancer.

OncoSil™ is a silicon and P32 (phosphorus) pure beta emitter with the potential to be used medically as a brachytherapy treatment.

The OncoSil™ device delivers more concentrated and localised beta radiation compared to external beam radiation.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 01 Oct 2015 11:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/160304/oncosil-medicals-daniel-kenny-talks-path-to-ce-mark-with-proactive-investors-64859.html
<![CDATA[News - OncoSil Medical's device scheduled for CE Mark Fast Track review ]]> https://www.proactiveinvestors.com.au/companies/news/160303/oncosil-medicals-device-scheduled-for-ce-mark-fast-track-review-64464.html Clinical-stage Australian Lifesciences company OncoSil Medical (ASX:OSL) has been scheduled for a Conformité Européenne (CE) Mark Fast Track review for OncoSil™.

OncoSil™ is a localised radiation treatment for cancer, and is the company's lead product candidate.

There is also potential use for OncoSil™ in other solid tumours outside of pancreatic cancer.

A CE Mark is the mandatory regulatory designation required to commercially market and sell OncoSil™ in the European Union, and would be a company-making milestone.

Once received, this will open up a potentially sales pipeline allowing OncoSil to target the top five European markets of the UK, Germany, France, Italy and Spain.

In addition to these markets, OncoSil under the CE Mark licensing will also be able to target Australia, New Zealand, Singapore and Canada.

The company can then file for licensure in those countries.

The estimated world-wide market opportunity for OncoSil™ in pancreatic cancer exceeds US$1 billion.

Daniel Kenny, CEO for OncoSil, brings previous experience delivering the CE Mark process for other companies when he was based in Europe.

Kenny told Proactive Investors, "On two previous occasions I have worked through the CE Mark process for medical devices, and am very familiar with the process.

"And I am pleased to say that OncoSil is progressing in a way that I would have hoped for."

Kenny added, "Once you are in a fast-track review you would expect the full administrative process to take four to six weeks.

"Following the four days there is still an administrative review period to accept the recommendation to issue the CE Mark, then actually issue the certification.

"The review was initially forecast for September, but considering the long term opportunity of OncoSil™ and the fact we are now moving towards certification, the delay was disappointing but not material."

OncoSil's submission to U.S. FDA for Investigational Device Exemption (IDE) for OncoSil™ remains on schedule to be granted later in 2015.


CE Mark details

The Fast Track review will assess OncoSil Medical’s design dossier and make a recommendation in respect of the CE Mark for OncoSil™.

The review will take place in the UK commencing October 6th 2015, and will be conducted over four days.

Upon completion of this review the Notified Body will make a determination to either recommend the granting of CE Mark certification for OncoSil™, or ask OncoSil to provide additional information in order to obtain certification.

Kenny added, "We are now on schedule for our final review.

"We filed the CE Mark to the Notified Body in July, and now they have scheduled the final review.

"This process will take to around the end of October, so therefore we are getting very close to getting regulated and approved.

"Following approval, the next step is going to market."

Kenny brings almost 30 years’ experience in the global pharmaceutical industry, including senior roles with Roche, Allergan and Baxter.


Pathway to market

Post CE Mark certification, OncoSil will then be able to provide what are currently confidential details of its go-to-market strategy for each target market, region and country.

This would include market share targets and potential forecasts on revenue streams.


How OncoSil™ works

OncoSil™ is an implantable nuclear medicine (radiotherapy) device that has been successfully piloted in pancreatic and liver cancer.

The device is inserted directly into the centre of the tumour using well established technology.

OncoSil™ has clinically demonstrated target tumour regression (tumour shrinkage) in both solid tumour indications of pancreatic and liver cancer.


Buyers and users of OncoSil™

The devices would be purchased by governments, national health services, or individual hospitals.

The next step is that the surgeons involved need to be trained and certified to use OncoSil's device.

Every physician or surgeon involved in using the device would have to be certified or trained by OncoSil, which would be part of its license requirements.

OncoSil would therefore require clinical adoption from both medical and radiation oncologists, along with GI surgeons and liver surgeons to cover the two indications.


Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 10 Sep 2015 12:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/160303/oncosil-medicals-device-scheduled-for-ce-mark-fast-track-review-64464.html
<![CDATA[News - OncoSil Medical appoints Dr Ashish Soman as chief medical officer ]]> https://www.proactiveinvestors.com.au/companies/news/160302/oncosil-medical-appoints-dr-ashish-soman-as-chief-medical-officer-62741.html OncoSil Medical (ASX:OSL) has appointed Dr Ashish Soman as its chief medical officer in the lead-up to commercialisation of its OncoSil™ localised radiation treatment for pancreatic and primary liver cancer.
   
He has over 24 years of experience and will play a key role in the upcoming regulatory approvals process, including European CE Mark and US FDA Investigational Device Exemption.

Dr Soman will be responsible for the development of a full Clinical Development program in support of OncoSil™, a key part of which will be the commercialisation of the OncoSil™, later in 2015.

His previous roles include country medical director, Australia for major bio-pharmaceutical company AstraZeneca from 2012-2014, where he managed a team of 30 employees spanning medical affairs, medical information and publications, compliance and patient safety.

Prior to that he was medical director - cardiovascular & diabetes for AstraZeneca Australia, from 2009-2012.

Dr Soman has also previously held roles with Sanofi-aventis Australia-New Zealand, from 2006-2009, and Roche Products Ltd in the UK, from 2004-2006.

“We are delighted to welcome Dr Soman to the OncoSil Medical team, and his is a key appointment as the company moves into the advanced stages of our regulatory approvals and commercialisation process for OncoSil™,” chief executive officer Daniel Kenny said.

“He is an experienced pharmaceutical physician and former country medical director with AstraZeneca and has broad therapy area knowledge including oncology.

“Dr Soman also has strong technical expertise in medical affairs, R&D, patient safety and medical compliance, and his diverse skill sets make him the ideal candidate to fulfil the role as chief medical officer.”

The company is on schedule for the Conformité Européenne (CE) Mark approval of OncoSil™ in the third quarter of 2015.

Commercialisation in the European Union would also facilitate sales in other major markets, with the global market for Pancreatic Cancer being US$1 billion, and for HCC Liver Cancer an additional US$1.4 billion.


OncoSil™

OncoSil™ is an implantable nuclear medicine (radiotherapy) device for the treatment of cancer, and is the company's lead product candidate.

It has been successfully piloted in pancreatic and liver cancer. It has clinically demonstrated target tumour regression (tumour shrinkage) in both solid tumour indications of pancreatic and liver cancer.



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 04 Jun 2015 10:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/160302/oncosil-medical-appoints-dr-ashish-soman-as-chief-medical-officer-62741.html
<![CDATA[News - OncoSil Medical appoints Professor Pierce Chow to head liver cancer board ]]> https://www.proactiveinvestors.com.au/companies/news/107279/oncosil-medical-appoints-professor-pierce-chow-to-head-liver-cancer-board-107279.html Clinical-stage Australian Lifesciences company OncoSil Medical (ASX:OSL) has appointed Professor Pierce Chow as chairman of the company’s primary liver cancer - hepatocellular carcinoma (HCC) - Scientific Advisory Board.

The company also plans to file for CE Mark in both pancreatic and liver cancer indications in Q3, 2015.

The OncoSil™ device has clinically demonstrated target tumour shrinkage in both solid tumour indications of pancreatic and liver cancer, with the primary liver cancer market representing a major new market opportunity estimated to be worth $1.4b by 2019.

The appointment of Professor Chow represents a major endorsement of OncoSil’s plans to actively pursue the HCC indication with the company’s OncoSil™ localised radiation treatment, in addition to the pancreatic cancer indication.

Professor Chow is acknowledged as a global leader in oncology, with particular emphasis on HCC, and the development of medical devices.

He is Professor at the Duke-NUS Graduate Medical School and Senior Consultant Surgeon at the National Cancer Centre Singapore and the Singapore General Hospital.

He is also concurrently NMRC Senior Clinician Scientist.

During his career, Professor Chow has utilised his clinical experience and reputation in the Asia-Pacific region to successfully lead multi-disciplinary teams in translational research projects and multi-national investigator-initiated clinical trials.

Professor Chow commented: “I am delighted to be working again with the Team at OncoSil, and look forward to my role as chairman of the HCC Scientific Advisory Board in developing the HCC program.

"Every now and again you come across a new and exciting approach in medicine that really stands out.

"OncoSil is exactly that for primary liver cancer I look forward to utilising my skills and expertise in this area to help realise this potential.”


The OncoSil™ opportunity in Primary Liver cancer

Hepatocellular Carcinoma is the sixth most common cancer in the world with 782,000 new cases diagnosed in 2012.

Its very poor prognosis makes it the third leading cause of cancer-related mortality, responsible for approximately 600,000 deaths annually. The value of the hepatocellular cancer (HCC) market is expected to triple in size to $1.4b by 2019, which more than doubles the market potential of Oncosil.

Surgery offers patients the most consistent and significant survival advantage, yet less than 20% of HCC patients are suitable for surgery at time of diagnosis.

Even in patients who have surgery, long term survival remains low because of recurrent carcinoma and progressive liver disease.

Approximately 30% of inoperable HCC patients may benefit from existing therapies that prolong life but outcomes and survival of the remaining inoperable patients is extremely poor.

Radiation therapy may be used, but has systemic side effects in an already sick patient population. Localised radiation therapy, such as that supplied by OncoSil™, may offer a potential treatment option without systemic side effects.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 21 May 2015 14:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/107279/oncosil-medical-appoints-professor-pierce-chow-to-head-liver-cancer-board-107279.html
<![CDATA[Media files - OncoSil Medical CEO Daniel Kenny talks to Proactive Investors about the company's fight against cancer ]]> https://www.proactiveinvestors.com.au/companies/stocktube/5841/oncosil-medical-ceo-daniel-kenny-talks-to-proactive-investors-about-the-companys-fight-against-cancer-516.html Thu, 21 May 2015 11:00:00 +1000 https://www.proactiveinvestors.com.au/companies/stocktube/5841/oncosil-medical-ceo-daniel-kenny-talks-to-proactive-investors-about-the-companys-fight-against-cancer-516.html <![CDATA[News - OncoSil Medical's device on track for commercialisation in Europe ]]> https://www.proactiveinvestors.com.au/companies/news/106983/oncosil-medical-s-device-on-track-for-commercialisation-in-europe-106983.html Clinical-stage Australian Lifesciences company OncoSil Medical (ASX:OSL) is on-track to commercialise OncoSil™ in the European Union.

Following the recent granted of ISO certification for OncoSil™, filing remains on schedule for the Conformité Européenne (CE) Mark approval in Q3, 2015.

OncoSil™ is a localised radiation treatment for cancer, and is the company's lead product candidate.

It is an implantable nuclear medicine (radiotherapy) device that has been successfully piloted in pancreatic and liver cancer.

The localised radiation therapy is inherently safe, effective and well tolerated.

Commercialisation in the European Union would also facilitate sales in other major markets, with the global market for Pancreatic Cancer being US$1 billion, and for HCC Liver Cancer an additional US$1.4 billion.

OncoSil™ has clinically demonstrated target tumour regression (tumour shrinkage) in both solid tumour indications of pancreatic and liver cancer.

Daniel Kenny, CEO, commented: “I am delighted with the efforts of the regulatory and medical affairs team in securing ISO Certification in April.
 
"This certification is a key requirement for CE mark Approval.

"In my career I have been involved with numerous commercially successful ‘blockbuster’ products in Europe and I am very excited to now be in the forefront of potentially a new radiation treatment for the dreaded disease of pancreatic and liver cancer.”

Kenny brings almost 30 years’ experience in the global pharmaceutical industry, including senior roles with Roche, Allergan and Baxter.


CE Mark

OncoSil Medical will file for CE Mark in both pancreatic and primary liver cancer – hepatocellular carcinoma (HCC).

HCC Liver cancer was added to the CE Mark filing after regulatory advice as it serves to considerably strengthen the filing position, and carries no additional regulatory risk.

It comes after clinical studies conducted confirmed OncoSil™’s ability to demonstrate tumour shrinkage in both solid tumour indications of pancreatic and liver cancer.


How OncoSil™ works

The OncoSil™ device is inserted directly into the centre of the tumour using well established technology.

Radiation therapy, such as that supplied by OncoSil™, is known to kill tumour cells.

OncoSil™ is classed by regulators as a class III medical device, not a drug.

In drug development human studies are typically undertaken as phase I, phase II and phase III studies. In medical device development studies, are undertaken as pilot and pivotal/registration studies.

Therefore medical devices typically require less clinical trial work for approval, less funding and have a faster time to approval when compared to drug development.


ISO certification

OncoSil Medical recently announced it had been granted ISO 13485:2012 and ISO 13485:2003 certification for OncoSil™ for the design, development and control of manufacture of the device in the area of oncology.

This is a pivotal and key requirement for CE Marking of medical devices in the European Union.


Analysis

OncoSil Medical is on-track to commercialise OncoSil™ in the European Union, with filing on schedule for the Conformité Européenne (CE) Mark approval in Q3, 2015.

Commercialisation in the European Union would be a milestone for the company, and would also facilitate sales in other major markets.

The global market for Pancreatic Cancer is US$1 billion, and for HCC Liver Cancer an additional US$1.4 billion.

The company has total cash and credits of over $9 million.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 19 May 2015 12:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/106983/oncosil-medical-s-device-on-track-for-commercialisation-in-europe-106983.html
<![CDATA[News - OncoSil Medical restructures board, management to advance Pivotal Clinical Trial ]]> https://www.proactiveinvestors.com.au/companies/news/160301/oncosil-medical-restructures-board-management-to-advance-pivotal-clinical-trial-57460.html OncoSil Medical (ASX:OSL) has restructured its board and senior management as part of its growth plans as it advances the Pivotal Clinical Trial for its OncoSil™ localised radiation therapy treatment for pancreatic cancer.

It is also designed to ensure the appropriate level of focus on both the commercialisation and regulatory goals of the business.

Current non-executive director Dr Roger Aston has been appointed the executive chairman and has intimate knowledge and understanding of the OncoSil™ nuclear medicine domain space, having cofounded pSivida Ltd, the original owner of the OncoSil™ technology, in 2001.

He was also the inventor of the patent for the OncoSil™ product.  Aston is a scientist and biotechnology entrepreneur with a successful track record in both fields, and has been closely involved in both start-ups and major pharmaceutical companies.

Significantly, Aston has critical experience with the US Food and Drug Administration (FDA) and European Union (EU) in product registration, clinical trials, global licensing agreements, plus capital raising and other corporate activity.

He will relinquish two of his other current board positions in order take on the increased responsibilities of the Executive Chairmanship with OncoSil Medical.

The current non-executive chairman Martin Rogers will continue to help drive the company’s goals and objectives as a non-executive director.

Current chief executive officer Dr Neil Frazer will take on the newly created key role of chief medical officer and will remain an executive director of the company.

Dr Frazer will take on the newly created role of chief medical officer and will be responsible for building and managing the Doctor-to-Doctor relationships required to successfully implement and deliver the Pivotal Clinical Trial.

He will also be responsible for doctor interactions as part of the CE Mark in Europe expected next year and associated commercialisation.

Dr Frazer will transfer two million loan funded shares to Dr Aston in recognition of increased responsibilities.

The company is actively engaged in a formal search process for a new chief executive officer.

“The changes provide for a broader scope of management focus specifically designed to meet the growing needs of the business as we continue to expand our operations with the roll-out of the OncoSil™ Pivotal Clinical Trial with the US FDA and also upcoming commercialisation with the CE Mark in EU,” Rogers said.

Further, "that we are in a position to have two outstanding industry professionals, in Dr Roger Aston and Dr Neil Frazer, lead the business, as Executive Chairman and Chief Medical Officer respectively, is a testament to the potential of our clinical programs and the strong work to date of the OncoSil Medical team.

"I personally welcome the changes and look forward to continuing to work to help drive the commercialisation of OncoSil™ as a new treatment option for pancreatic cancer patients globally.”

 


Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 09 Sep 2014 17:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/160301/oncosil-medical-restructures-board-management-to-advance-pivotal-clinical-trial-57460.html