What the Brokers Say

WHAT THE BROKERS SAY: Interesting news and views from across the Resource Analyst universe.



Website: www.breakawayresearch.com

TNG Limited (ASX: TNG)

TNG Limited (ASX: TNG) has made considerable progress over its portfolio of development and exploration projects, and has developed a two-pronged strategy, with the focus on its ferrous and strategic metals projects, with value adding options being explored for the non-core assets.

A review of the 2012 Mount Peake PFS and comminution optimisation results has generated improvements to the already robust project economics, and exploration results point to the potential for additional resources.

The addition of the Roper River licences has strengthened the ferrous metals side of the portfolio.

TNG continues to work towards development of its Mount Peake Vanadium-titanium-iron project, and commercialisation of the TIVAN® hydrometallurgical process.

It is expected that the DFS will be completed by late 2014 – timing will be dependent upon results of the pilot scale TIVAN® testwork and obtaining funding.

The company is now exploring DFS and development funding options, with the preferred option being introduction of a project equity or offtake partner.

Exploration work has also continued over the Mount Hardy and McArthur base metals projects, with very encouraging results from these high quality assets.

Achieving funding, further exploration success and positive TIVAN® pilot plant results should be key price drivers over the short to medium term.

The 100 per cent-owned Mount Peake Vanadium-titanium-iron project is located 235 kilometres north of Alice Springs in the Northern Territory.

The project has resources of 160 million tonnes grading 0.28 per cent vanadium, 5.3 per cent titanium and 23 per cent iron.

Recent exploration success at Mount Peake has enhanced the possibility of significant resource expansions.

Website: www.breakawayresearch.com

White Rock Minerals (ASX: WRM)

White Rock has a 100 per cent interest in the highly prospective Mt Carrington project area, located in northern NSW.

A recent resource category upgrade provides further confidence that Mt Carrington can host a medium scale gold-silver operation, buoyed by existing infrastructure which supports a low CAPEX development model.

White Rock Minerals (ASX: WRM) continues to make steady progress at the Mt Carrington gold-silver project.

The Mt Carrington project incorporates eight nearby deposits which combine to form a global resource base of 700,000 ounces at 1.4 grams per tonne gold equivalent (AuEq).

Following an infill drill program at the flagship White Rock deposit (4.4 million tonnes (Mt) at 58g/t silver for 8.2 million ounces (Moz) of silver), the company announced a resource category upgrade, shifting 1.7Mt at 77g/t silver for 4.2Moz silver into the higher ‘Indicated’ category.

The upgrade in the resource now completes the major geological component of its assessment plans and puts the company firmly on the path to development.

White Rock also recently announced that the ‘Conceptual Project Development Plan’ for the Mt Carrington project had been submitted to the NSW Department of Trade and Investment and was approved, and referred to the Department of Planning and Infrastructure.

Encouragingly, the White Rock deposit is already located within a ‘Mining Lease’ and is well supported by historical infrastructure (such as a tailings dam), providing confidence development consent can be gained in a timely manner.

Pre-feasibility studies are well advanced, centred on permitting, metallurgical test work and baseline studies.

In July 2012, White Rock completed a Scoping Study on the Mt Carrington gold-silver project.

The Study outlined the parameters for a medium-scale operation targeting production of approx. 40,000 ounces AuEq per annum.

Although the current global resource contains eight separate deposits, the Scoping Study only assessed mining five of the deposits (based on open pit shells).

The key outcomes of the Scoping Study are:

800,000 tonnes per annum, six year operation, producing 107,000 ounces of gold, 6.9Moz silver;

40,000 ounces per annum AuEq production;

Capital cost of $24 million;

Cash operating costs of $46/tonne milled ($869/oz AuEq);

NPV10 of $40 million, IRR of 62 per cent post tax; and

Gold price of $1,500/oz, silver price of $30/oz.

White Rock envisage an 800,000 tonnes per annum processing plant with a CIL circuit (to recover gold) and a floatation circuit (to recover the silver).

Significant infrastructure is still in place from the historical ‘Mount Carrington Mines’ mining operations, contributing to a low CAPEX estimate of $24 million.

These items include:

1.5Mt tailings dam (with room for expansion);

750 million litres freshwater dam;

Administration and exploration offices;

Water treatment plant;

Connection to the power grid; and

Sealed highway access.

Following the positive outcomes of the 2012 Scoping Study, White Rock commenced with infill drill programs, metallurgical studies and permitting.


Disclaimer: The above is intended as a guide only. The Roadhouse accepts no responsibility for investments made from this advice, successful or otherwise.

The views, opinions or recommendations of this article do not in any way reflect the views, opinions, recommendations, of The Resources Roadhouse.

The Roadhouse makes no representation or warranty with respect to the accuracy, completeness or currency of the content. The content is for educational purposes only and does not constitute financial advice. Independent advice should be obtained from an Australian financial services licensee before making investment decisions.

Bionomics receives BNC105 Phase II trial results

THE PHARMACY: Bionomics Limited (ASX: BNO) has announced the results of the DISRUPTOR-1 trial of BNC105 in patients with metastatic renal cancer.

“The DISRUPTOR-1 trial has been the first of its kind in testing the combination of an mTOR inhibitor with a vascular disrupting agent in renal cancer, with the prospect of adding a new dimension to the renal cancer treatment armamentarium,” Bionomics CEO and managing director Dr Deborah Rathjen said in the company’s announcement to the Australian Securities Exchange.
 
“Significant progress has been made in validating BNC105 as an anti-cancer agent.

“Through patient subgroup analysis and association of biomarkers to treatment benefit, the data from this trial shows us the best way forward to maximising the utility of BNC105 for renal cancer patients, as well as how to best employ the drug in other cancer types.”

Bionomics conducted this randomised Phase II clinical trial in patients with metastatic renal cell cancer with 139 patients enrolled at sites across the US, Singapore and Australia.

The trial design targeted patients who had previously failed up to two tyrosine kinase inhibitor therapies, randomising them to either of two treatment arms: one receiving the standard of care renal cancer drug Afinitor and the other receiving both Afinitor and BNC105.

Patients who were progressing or who were intolerant to Afinitor monotherapy, were allowed to receive BNC105 single agent treatment.

Patients were treated until disease progression or until adverse effects prohibited further therapy.

Data from a total of 136 patients (69 in the BNC105 + Afinitor arm and 67 in the Afinitor-only arm) treated in this study were able to be analysed.

The combination of BNC105 and Afinitor was safe and tolerable.

The adverse event profile of the combination arm did not significantly differ from that of the Afinitor-only arm, and mirrored the known and expected toxicities of Afinitor.

“DISRUPTOR-1 has produced a ground-breaking discovery of potential biomarkers that may allow pre-treatment selection of patients most likely to benefit from BNC105,” Dr Rathjen said.

“We are exploring partnership opportunities for BNC105 and expect to attract a depth of interest given the compelling data generated from this trial and the recent ovarian cancer trial data.”

OncoSil Medical commences Pivotal Clinical Trial

THE PHARMACY: OncoSil Medical (ASX: OSL) has commenced its Pivotal
Clinical Trial for its OncoSil™ localised radiation therapy for the
treatment of pancreatic cancer.

The commencement of the trial involves a submission to its lead
Australian site’s Ethics Committee for review/approval to commence
recruitment.
 
The company said the trial has the potential to be a Global Registration Study.

OncoSil Medical considers the trial to be a major milestone and
achievement in the company’s development pathway to commercialise
OncoSil™ as a viable treatment option for pancreatic cancer patients in
global markets.

The clinical trial for OncoSil™ will enrol 150 patients across 20 trial
sites and will compare patients receiving standard-of-care (for
inoperable pancreatic cancer, this is chemotherapy treatment) with
patients receiving standard-of-care plus OncoSil™ treatment, in a
randomized and controlled fashion.

150 patients will be randomized, of which 100 subjects will receive
OncoSil™ plus chemotherapy and 50 patients will receive chemotherapy
alone.

If positive, data generated by the trial may facilitate the
commercialisation of OncoSil™, including in the US, the world’s largest
health care market.

OncoSil Medical explained OncoSil™ is classified by regulators as a class III medical device and is not a drug.

“In drug development the human studies are undertaken as phase I, phase
II and phase III studies,” the company said in it ASX announcement.

“In medical device development they are undertaken as pilot and pivotal/registration studies.

“Thus medical devices require less clinical trial work for approval,
less funding required and faster time to approval when compared to drug
development.”

The company indicated it plans to roll-out the trial in Australia, in
parallel with trial sites in the UK, Belgium, Singapore and then the US.

Its initial focus will be to engage hospitals as trial sites, followed
by patient recruitment and then the commencement of dosing patients
under the trial.

OncoSil Medical is also finalising preparations for an Investigational
Device Exemption (IDE) submission for OncoSil™ with the US Food and Drug
Administration (FDA).

The company said the submission of an IDE is a key step forward along
its regulatory pathway for OncoSil™ claiming a successful study under an
IDE will allow OncoSil™ to also be commercialised in the US.

Antisense Therapeutics commences stem Cell mobilisation trial

THE PHARMACY: Antisense Therapeutics (ASX: ANP) has commenced dosing in its Phase I Stem Cell Mobilisation (SCM) Human Proof of Concept trial of ATL1102, the company’s second generation antisense drug targeting the VLA-4 receptor.

Antisense said the trial will assess the safety, tolerability and effect of ATL1102 on the release of hematopoietic stem cells (CD34+) into the blood when dosed alone and in combination with an existing therapy (Granulocyte Colony Stimulating Factor (G-CSF)).

The randomised, open label study of ATL1102 dosed over 5 days (given on day 1, 3 and 5) in 10 healthy volunteers is being conducted by clinical research organisation, Nucleus Network at its clinical trial unit at the Alfred Hospital in Melbourne, Victoria.

With the necessary screening, dosing and follow up of patients, Antisense anticipates results from the trial will be available to be reported mid-2014.

“The stem cell mobilisation opportunity for ATL1102 while commercially attractive with, by our estimation, a market potential of several hundred million dollars per annum, also presents as an excellent return on investment proposition given costs are expected to be relatively low for developing the drug in this indication,” Antisense Therapeutics CEO and managing director Mark Diamond said in the company’s announcement to the Australian Securities Exchange.

“We believe that positive outcomes from this trial will strongly enhance our drug’s potential for this application and naturally we relish the opportunity to further develop a drug that can potentially provide better outcomes for cancer patients.

“We look forward to successfully conducting the study and to reporting results from this SCM trial which are anticipated mid-year.”

Antisense explained the mobilisation (release) of these stem cells from the bone marrow into the blood is part of an important medical procedure used to improve outcomes for patients undergoing chemotherapy to treat certain cancers.

The stem cells released into the blood are then collected and stored before high dose chemotherapy and then re-infused to replace those lost during chemotherapy in order to re-establish the immune system.

The basis for using ATL1102 in the SCM indication is related to the role of VLA-4 in regulating the release of CD34+ stem cells from the bone marrow, with another drug that also targets VLA-4 having been shown to increase CD34+ stem cell release in humans.

The company said in a previous study involving Multiple Sclerosis patients, ATL1102 demonstrated similar activity to that drug by increasing CD34+ levels in the blood.

“This human Phase I trial of ATL1102 is designed to evaluate whether ATL1102 can improve mobilisation of CD34+ stem cells when used in combination with standard mobilisation therapy to levels that would make it clinically beneficial for use in the collection of stem cells for transplantation,” Nucleus Network medical director and principal investigator for the trial Dr Jason Lickliter said in Antisense’s ASX announcement.

“There is an acknowledged clinical need for increasing mobilisation levels beyond those achieved by the current therapeutic approach, and so I am very pleased to be working with Antisense Therapeutics to assess the merits of ATL1102 in this important clinical setting.”

Website: www.antisense.com.au

OncoSil Medical commences Pivotal Clinical Trial

THE PHARMACY: OncoSil Medical (ASX: OSL) has commenced its Pivotal Clinical Trial for its OncoSil™ localised radiation therapy for the treatment of pancreatic cancer.

The commencement of the trial involves a submission to its lead Australian site’s Ethics Committee for review/approval to commence recruitment.
 
The company said the trial has the potential to be a Global Registration Study.

OncoSil Medical considers the trial to be a major milestone and achievement in the company’s development pathway to commercialise OncoSil™ as a viable treatment option for pancreatic cancer patients in global markets.

The clinical trial for OncoSil™ will enrol 150 patients across 20 trial sites and will compare patients receiving standard-of-care (for inoperable pancreatic cancer, this is chemotherapy treatment) with patients receiving standard-of-care plus OncoSil™ treatment, in a randomized and controlled fashion.

150 patients will be randomized, of which 100 subjects will receive OncoSil™ plus chemotherapy and 50 patients will receive chemotherapy alone.

If positive, data generated by the trial may facilitate the commercialisation of OncoSil™, including in the US, the world’s largest health care market.

OncoSil Medical explained OncoSil™ is classified by regulators as a class III medical device and is not a drug.

“In drug development the human studies are undertaken as phase I, phase II and phase III studies,” the company said in it ASX announcement.

“In medical device development they are undertaken as pilot and pivotal/registration studies.

“Thus medical devices require less clinical trial work for approval, less funding required and faster time to approval when compared to drug development.”

The company indicated it plans to roll-out the trial in Australia, in parallel with trial sites in the UK, Belgium, Singapore and then the US.

Its initial focus will be to engage hospitals as trial sites, followed by patient recruitment and then the commencement of dosing patients under the trial.

OncoSil Medical is also finalising preparations for an Investigational Device Exemption (IDE) submission for OncoSil™ with the US Food and Drug Administration (FDA).

The company said the submission of an IDE is a key step forward along its regulatory pathway for OncoSil™ claiming a successful study under an IDE will allow OncoSil™ to also be commercialised in the US.

Website: www.oncosil.com.au

Oil Basins strikes new Institutional Funding Agreement

THE BOWSER: Oil Basins (ASX: OBL) has entered into a funding agreement with The Australian Special Opportunity Fund LP, a New York-based institutional investor managed by The Lind Partners, LLC for a total funding commitment of up to $7.25 million.

Under the agreement with Lind, OBL will receive $350,000 funds upon execution in the form of $275,000 convertible security and $75,000 as first equity tranche prepayment.

The agreement has a term of up to 2 years, made up of:

A six per cent coupon convertible security in the face amount of $300,000, and

Monthly equity purchases in the amount of $100,000 which can be increased up to $300,000 per month by mutual consent (up to an aggregate of $6.975 million).

Funds will provide working capital and can be utilised for development of the company’s projects and exploration permits in both onshore and offshore
Australia.

The company will be required to satisfy each monthly equity purchase by issuing ordinary fully paid shares to Lind with the issue price to be determined by reference to the volume weighted average price of the company’s shares during a predetermined pricing period.

“The Agreement with Lind will give the company certainty to access to equity market funding especially during the planning and six month build-up phase of the Derby Block field and support operations and allow OBL to advance its exploration program with the hopes of unlocking significant value at both its Derby Block and Backreef Area USG / USO projects,” Oil Basins director and chief executive officer Neil Doyle said in the company’s announcement to the Australian Securities Exchange.

“Importantly, the Agreement ensures that the company’s ongoing efforts are adequately funded as we advance our Canning Basin operated projects over the coming months.”

Viralytics announces International Institutional ownership

THE PHARMACY: Viralytics Limited (ASX: VLA) has completed a $27.1 million equity offering that included a number of new institutional investors who specialize in healthcare.

The offering was finalised after approval by shareholders at the company’s general meeting on 6 March 2014.

The major participants in the placement were United States-based Cormorant Asset Management, which now holds an 8.9 per cent stake in Viralytics;

BVF Partners L.P., also located in the United States (6.7 per cent);

Abingworth, headquartered in the United Kingdom (6.1 per cent);

Sabby Capital, headquartered in the United States (5.8 per cent); and

Hunter Hall, located in Australia (4.9 per cent).

The capital raised will fully fund the company through 2016, including its expanding clinical trial program.

Viralytics currently has a Phase 2 study and a Phase 1/2 trial ongoing with an additional randomised Phase 2 melanoma clinical trial in the planning stage.

The studies are evaluating the company’s lead product CAVATAK™ in late-stage cancer patients and will provide important data to guide its further development.

Website: www.viralytics.com

VivaGel®‐coated condom approved for marketing in Japan.

THE ROADHOUSE PHARMACIST: Starpharma (ASX: SPL) has been granted regulatory certification for marketing of the company’s VivaGel®‐coated condom in Japan.

Starphama explained VivaGel® is licensed to Okamoto Industries as a condom coating for the Japanese market.

Japan is the world’s second largest condom market and Okamoto is the market leader for condoms sold in the country with an approximate 60 per cent share of the Japanese market.

Under Starpharma’s commercial licence agreement with Okamoto, Okamoto has exclusive Japanese marketing rights for the VivaGel®‐coated condom.

VivaGel®‐coated condoms sold in Japan are to carry the VivaGel® brand and Starpharma will receive royalties based on sales of these condoms.

“This receipt of the world’s first marketing approval for a VivaGel®‐coated condom in Japan marks a major milestone for this product and for our strategically important partnership with Okamoto,” Starpharma chief executive officer Dr Jackie Fairley said in the company’s announcement to the Australian Securities Exchange.

“We greatly appreciate Okamoto’s support and assistance in achieving this certification and we look forward to a long and mutually profitable commercial relationship.

“Following this certification Starpharma looks forward to the introduction of its innovative, patented VivaGel®‐coated condom to this key market in partnership with Okamoto, one of the world’s leading condom companies,”

Starpharma said the value of the Japanese condom market has been estimated to be in the order of US$500 million.

In addition to its dominant position in the Japanese condom market, Okamoto also holds strong market positions in several other Asian markets, including Korea, Taiwan, Malaysia, Singapore and China.

Earlier this year Okamoto’s senior managing director Seiji Takeuchi said condoms with functional coatings and gels represent the next wave of innovation in the Japanese condom market following on from a decades‐long focus on condom thinness.

“We are very pleased to be in a partnership with Starpharma for this product,” Takeuchi said.

Unilife Secures $60M debt financing

THE ROADHOUSE PHARMACIST: Unilife Corporation (ASX: UNS) has entered into a $60 million debt financing agreement with an affiliate of healthcare sector investment firm OrbiMed.

Unilife said $40 million was funded to Unilife at the closing of the deal. Under the terms of the agreement, provided Unilife is in compliance, two additional tranches of $10 million each will be provided to the company in December 2014 and June 2015.

“OrbiMed is one of the premier healthcare investors in the world,” Unilife chairman and CEO Alan Shortall said in the company’s announcement to the Australian Securities Exchange.

“With OrbiMed and their independent advisors having conducted extensive due diligence into all aspects of our business, including our products, IP and commercial pipeline, we believe this agreement represents a significant endorsement of Unilife.

“In particular, I believe OrbiMed’s decision to accept a small share of our future net sales highlights their confidence in our business model and future growth.

“This $60 million commitment provides us with the necessary capital to drive business growth as we bring several large contracts with existing customers through to commercial rollout.

“Our decision to take only $40 million of the $60 million upfront will ensure we have the cash to support our operations while minimizing interest payments.

“I believe Unilife’s growing base of customers will view our long-term partnership with OrbiMed as a positive development, as it further strengthens our business position and capacity to meet their future needs.”

During the six year term of the agreement, Unilife will make interest-only payments to OrbiMed currently calculated at a rate of 10.25 per cent per annum, with the principal to be repaid by 12 March 2020.
 
OrbiMed will also receive a tiered royalty payment based on net sales generated by Unilife during each fiscal year of the agreement. The maximum royalty rate is 2.75 per cent of annual net sales.

The royalty rate decreases as annual net sales increases. Total royalties paid to OrbiMed under the agreement are capped as Unilife has the option to buy out the royalty payment, which is at a reduced amount at any time on or before the fourth anniversary of the agreement.
 

Venturex Resources gets Mining Approval for Pilbara project

THE DRILL SERGEANT: A Mining Proposal by Venturex Resources (ASX: VXR) has received approval from the Western Australia Department of Mines and Petroleum for the development of the company’s Pilbara copper-zinc project at the Sulphur Springs site, located in the western Pilbara region.

 

Project location. Source: Company announcement

 

Venturex said the granting of the Mining Proposal represents the final core government approval for the project, having already secured Clearing Permit approval, and struck a Mining Agreement with the traditional owners.

“The successful securing of these key approvals for the Sulphur Springs site is a significant milestone for both the development of the project and the future of the company,” Venturex Resources managing director Michael Mulroney said in the company’s announcement to the Australian Securities Exchange.

“It’s a credit to the efforts of our project group and the relevant Government authorities that the permitting process has occurred in a timely fashion.

“We have long identified permitting as one of the key determinants to the successful, and timely, development of the project which is why the company has, and will continue to, invest considerable time and resources in our relationships with all stakeholders involved with the project.

“Our focus is now on advancing the project’s development options as part of the company’s drive to commercialise our extensive copper-zinc assets in the Pilbara region through 2014.”

Email: admin@venturexresources.com

Website: www.venturexresources.com