Saturday, 1 January 2011

Healthlinx Limited (HTX.AX) key developments

Latest Key Developments

Healthlinx Ltd Announces Issue Of Shares
Thursday, 30 Dec 2010 12:49am EST 

Healthlinx Ltd announced that it issued 1,347,709 ordinary shares for a total consideration of AUD100,00 and 202,156 unquoted options at an exercise price of AUD0.1018. Ordinary shares and unlisted options issued pursuant to a Convertible Note Agreement for up to $7.23 million between the Company and SpringTree Special Opportunities Fund, LP, a New York based investment fund, and originally approved by shareholders on November 26, 2009 and further approved on October 11, 2010. 

Healthlinx Ltd Announces Part 1 Of Second Study Confirms Superior Efficacy Of OvPlex Ovarian Cancer Diagnostic
Tuesday, 14 Dec 2010 05:23pm EST 

Healthlinx Ltd announced that reports initial analysis of part 1 of its multinational ovarian cancer biomarker study confirms a statistically significant increase in diagnostic performance of OvPlex over CA125 alone. Enhanced performance of OvPlex was also established specifically for early stage (Stage I-II) disease. These data represent preliminary statistical comparisons of area under the curve (AUC) of receiver operator curves (ROC) generated from Part 1 of the second larger multi-national, multi-centre biomarker study. Biomarker measurements in over 500 samples have been completed to date, which represents a subset of the full OvPlex study that will include a total of 1150 samples which will be collected in Australia, Singapore and the United Kingdom. Measurement of all OvPlex biomarkers was performed in over 500 samples as part 1 of the current biomarker study and the epithelial ovarian cancer patients and normal subjects (case / control) have undergone independent preliminary analysis (Emphron Informatics Pty Ltd) in order to draw comparisons with our previous OvPlex trial. The primary end point for the study is to undertake a ROC analysis of control subjects versus all epithelial ovarian cancer patients. Part 1 of the study demonstrated that OvPlex significantly outperformed the diagnostic capability of CA125 alone. 

Healthlinx Ltd Announces Early Results In OvPlex Ovarian Cancer Biomarker Study
Thursday, 11 Nov 2010 05:23pm EST 

Healthlinx Ltd announced that stage 1 of the multi-centre, multi-site second study for OvPlex has returned excellent initial data for the two new biomarkers AGR2 and HTX010 being evaluated for accuracy in diagnosing ovarian cancer. To date, AGR2 and HTX010 data have been analysed in over 400 case and control samples. Both AGR2 and HTX010 demonstrated statistically significant elevations in circulating plasma concentrations in both early stage (Stages I-II) and late stage (Stages III-IV) ovarian cancer patients. These data are significant as they confirm and reinforce previous findings from several smaller pilot studies and now pave the way for HealthLinx to use these markers in its OvPlex multimarker panel. Previous modelling with these biomarkers demonstrated improved diagnostic efficiency of the OvPlex panel. In combination with the other OvPlex biomarkers the Company expects a marked. Based on these data, HealthLinx will now move forward with plans to further develop and partner the AGR2 immunoassay as a clinical diagnostic tool with a range of potential applications related to cancer diagnosis and monitoring. 

Healthlinx Ltd Executes Commercial Agreement With Millipore
Tuesday, 28 Sep 2010 07:06pm EDT 

Healthlinx Ltd announced that it has signed a commercial agreement with Millipore Corporation, one of the research reagent companies to license HealthLinx’s AGR2 monoclonal antibody. The worldwide non-exclusive licence agreement allows Millipore to market and sell the monoclonal antibody for research purposes only, with upfront fees and royalties to flow back to HealthLinx. 

Healthlinx Ltd Signs Exclusive OvPlex License Agreement With Medison Pharma Limited
Monday, 6 Sep 2010 07:51pm EDT 

Healthlinx Ltd announced that it has signed an exclusive OvPlex license agreement with Medison Pharma Limited, an Israeli marketing company. Under the terms of the agreement Medison Pharma will endeavour to register and commercialise OvPlex in Israel. Israel is now the fourth jurisdiction to secure an OvPlex licence following Australia, United Kingdom and Singapore. Under the agreement Medison is granted exclusive rights for 10 years to market, distribute and sell the OvPlex panel in Israel. 

Healthlinx Ltd Announces Issue Of Shares Pursuant To Conversion Of Convertible Note
Wednesday, 1 Sep 2010 06:32pm EDT 

Healthlinx Ltd announced the issue of 1,584,786 fully paid ordinary shares. The total consideration for the issue is $100,000. The shares on conversion of Tranche 11 of $100,000 made in accordance with the Convertible Note Agreement between the Company and SpringTree Special Opportunities Fund, LP as announced on October 5, 2009 and approved by shareholders on November 26, 2009. 

Healthlinx Ltd Commences South Korea OvPlex Study For KFDA Regulatory Approvals
Tuesday, 31 Aug 2010 07:47pm EDT 

Healthlinx Ltd announced that it has finalised research agreements with its collaborators in South Korea to begin the 220 patient study required for South Korea Food and Drug Administration (KFDA) approval for the distribution of OvPlex. The trial will be conducted by Principal Investigator Professor Byoung-Gie Kim of Samsung Medical Center and Sungkyunkwan (SKK) University School of Medicine. Professor Kim assisted HealthLinx in securing further key institutions to participate in the trial including the highly reputable Asan Medical Centre and Seoul National University Hospital. Collectively the three hospitals have over 12,000 beds and support the three gynaecological cancer research centres in the country. It is anticipated that the study will take approximately 12–14 months to complete and then submissions to the KFDA will commence. The company is also in final negotiations with one of the largest privately owned, centralised laboratories in South Korea to partner the technology for commercial distribution. When the terms sheets are finalised, the market will be informed accordingly. 

Healthlinx Ltd Progress On Prostate Cancer Diagnostic
Monday, 21 Jun 2010 08:23pm EDT 

Healthlinx Ltd announced new data that may be the basis for the Company’s development of a new and more accurate prostate cancer diagnostic compared to what is currently used. PSA is the most commonly used biomarker for diagnosis of prostate cancer and is the most widespread form of prostate cancer screening tool with a specificity of 63.1 per cent and low sensitivity of 34.9 per cent. This poor performance highlights the need for a statistically improved more effective method to detect prostate cancer. Prostate cancer is the ninth most common cancer and is often associated with over-diagnosis and unnecessary surgery. The market opportunity for a diagnostic for prostate cancer is greater than USD350 million per annum based on the PSA test. Globally there were 679,000 new cases of prostate cancer identified in 2002 with 221,000 men losing their lives. Although some data suggest modest survival benefit from PSA screening, there is a strong un-met clinical and market need for a product that can increase specificity. Early data suggest that one of HealthLinx’s biomarkers shows significant potential for fulfilling this un-met market need and justifies priority development. 

Healthlinx Ltd Announces Launch Of International Study On OvPlex Cancer Test
Monday, 14 Jun 2010 06:30pm EDT 

Healthlinx Ltd announced that it will launch a major international trial on the OvPlex test, that will see 1150 samples screened using the current five biomarker panel and an additional two biomarkers including the recently described biomarker AGR2. The multi-site, multi-centre trial that is partially funded with $750,000 from the Victorian Government Victoria’s Science Agenda Investment Fund, aims to test whether the two new biomarkers can increase the sensitivity and specificity of OvPlex to greater than 97 per cent. The study has been powered to allow direct determination of sensitivity and specificity and will include collaborators from Australia, Singapore and the United Kingdom. The current OvPlex test relies on measurement of five biomarkers found in human blood and delivers 92% sensitivity and 94% specificity for the diagnosis of early stage (stage I & II) ovarian cancer. The trial will involve 1150 women and begins on June 15, 2010. The first stage of the study will use 450 samples secured through collaborators that include the Victorian Cancer Bio Bank, West Australian Research Tissue Network/SJOG Pathology and University Hospital Singapore. 

StoneBridge Securities Completes Private Placement Of $0.750 Million In Healthlinx Ltd
Monday, 7 Jun 2010 06:41pm EDT 

Healthlinx Ltd announced that Stonebridge Securities Limited has successfully completed the placement of 7,500,000 ordinary fully paid shares at 10 cents each plus free attaching options, as announced on June 1, 2010. The placement includes 300,000 new shares. The purpose of the issue is to further support the commercial roll out of the OvPlex cancer test over the next 12 months. 

 

Positive Criteria for Property Prices in 2011

 

For 2011, there will be a number of criteria that will pull property prices one way or the other, which we outline below:

 

Positive Criteria for Property Prices in 2011

1.  More competitive and more abundant mortgages after credit squeeze affects die away

2.  UK coming out of recession

3.  Increased employment by mid 2010

4.  Increase in private sector bonuses

5.  Lack of house building

6.  Increasing population

7.  Pent up demand from three years of low market activity – please needing to move

8.  Likely change of government

9.  2012 Olympics London

10. Javelin trains and East London Rail service-orbital London

 

Negative Criteria for Property Prices in 2010

1.  Higher VAT, national insurance, petrol duty and tax on bonuses

2.  Increase in inflation feeding through to higher interest rates and higher costs

3.  Increase in unemployment likely peaking around March 2011 

4.  High oil prices and energy prices - feeding through to inflation and higher interest rates

5. Public sector jobs losses continuing through 2011 and lower or freezes on public sector wages

6.  Possibility the UK Coalition may break-up

7.  High levels of deposit required

8.  Low lending to salary multiples

9.  Heat oil, petrol, diesel adversely affects rural areas and house prices in remoter parts 

 

Overall, we believe the positive factor more or less cancel out the negative factors and prices will remain fairly subdued and fluctuating around current levels through 2010 on an overall UK national level. However, we predict property prices in the more wealthy southern and London areas will be stronger than in northern areas that are more exposed to public sector and manufacturing sector jobs losses and spending cuts.

 

Property Price Predictions

 

1    London  +2%

2    SE England +1.5%

3    East Anglia +1%

4    Scotland +1%

5    SW England 0%

6    NW England -1.5%

7    Midlands -2%

8    Wales -3%

9    NE England  -3.5%

10  Northern Ireland -5%

Other criteria

US Dollar to the UK£    $1.65 / £1

UK£ to the Euro    £1 / 1.17 Euro

Oil price  $93/bbl early 2011 rising to $112 by June 2010 then dropping back to $90

UK Gas price 45p/therm

UK Interest Rates – rising from 0.5% in Mar 2011 to 1.75% by end 2011

FT rising to 6050 by early May 2011 then dropping in June to 5000 then closing same end 2011

UK Inflation CPI staying at 3.2% or thereabouts all year 

UK GDP staying at 2% through 2011 (on quarterly annualized basis) 

Security outlook – Iran and North Korea key hot-spots (Pakistan remains a concern).

Euro interest rate – staying at 2% through 2011

US Interest rates rising from 0.25% early 2010 to 1% end 2011

UK unemployment – rising slightly through 2011

Wage inflation – staying at ~2.3% through 2011

GDP growth London 2.7%, North 1.2%, Midland 0.8%, Scotland 1.3%. Wales 0%

GDP China 9%, GDP India 7%, GDP Africa 3.5%, Global GDP 3.0%, UK 2%, USA 2%, Euroland 2% - as a whole over 2010

Iran and North Korea developing nuclear weapons capability will be a key issue – lack of global leadership not helping resolve. Terrorism threats reduce as oil prices rise and economic situation in most of the Middle East improves. Security situation in Iraq improves considerably as government representation and political will wins over as expanding oil exports improve economic picture for the population as a whole.   

USA debt situation is likely to deteriorate further. Dollar declines as the Obama administration continues to print money devalues the currency and causes bond rates to rise sharply. Chinese and other international investor become increasingly frustrated with declining dollar value. Further talk of valuing oil in a basket of global currencies causes dollar to drop further and forces US loan interest rates to rise.

Inflation starts to become a serious issue by March 2011 and interest rates in western nations rise. All commodities prices rise. Oil, gas, copper, sugar, wood prices all rise. Oil production continues on a bumpy plateau – oil shortages start showing by mid 2011.

Greece, Portugal, Ireland, Spain and Italy continue economic stagnation exacerbated by high oil prices (oil import costs). Further Euro debt contagion and potential bail-outs for Italy, Portugal and Spain if oil prices rise >$120/bbl.  These countries need to leave the Euro to devalue their currencies and regain competitiveness. France and Germany continue to drive the European economies through manufacturing and commerce expertise – peripheral Euro-zone countries suffer as the Euro stays strong. Norway and Sweden will continue to excel. Norway with its huge budget surplus, high performing sovereign wealth fund and high transparency and environmental standards.

As oil prices continue to rise, Dubai/UAE and Middle Eastern economies continue to grow strongly.   China continues it’s boom with GDP 9%. Brazil and India also boom with GDP at 7% and 9% respectively. 

Property Commentary

 

Prime West London will see the largest UK price increases of about 4% driven by higher city bonuses, foreign investors taking advantage of the low sterling values and relative cost in Euro, Middle East and Far East currency terms.

 

The Tory–Lib/Dem Coalition will be further strained by a concerted effort by some newspapers to target Lib-Dem politicians in an attempt to destabilize the Coalition and cause a snap election. As the Tories gains political momentum, the following general policies are enacted:

 

1.  Higher rate taxes are lowered after a few years

2.  Private sector and financial services are encouraged

3.  Public sector cuts through pay freezes, jobs cuts, efficiency improvements and project cancellations

4.  Manufacturing and remaining heavy industry will not necessarily benefit

5.  Market economy stronger, competition more intense

6.  Social and housing benefits costs reduced

7.  Large infra-structure projects rationalized

 

Such measures tend to benefit London and SE England and increase the north-south divide. Rural areas will be particularly badly affected by public sector jobs cuts along with northern and western areas. Manufacturing will continue its long term stagnation – with a decline in Sterling in value in 2009-2010 not having the desired positive export impact.  Massive global wealth will continue to feed into London – boosting financial services and positively impacting West End prime property demand and prices along with property in surrounding central areas.

 

We expect the property market to pick up by mid January until end May then rapidly cool and stagnate for the rest of the year. Any increase in property prices in the first five months of the year in most areas will be wiped out by a slide in the second half of 2011 as interest rates rise, inflation takes hold and oil prices continue to escalate.

 

If oil prices rise above $120/bbl then a recession in western developed nations six months later is highly likely in view of debt levels and fragile banking systems. Hence if oil increases to $120/bbl by mid 2011, a “western developed nation” recession will occur by Dec 2011.

 

London will start to feel the positive impact of the upcoming Olympics in 2012 in 2011.  800,000 additional people swelling London’s population in the next ten years and lack of building will support prices. The positive impact of the East London Rail, Javelin High Speed Rail links from Kent and other rail/tube upgrades will benefit the city and property prices close to new stations (e.g. New Cross Gate, Brockley, Gravesend) will continue to rise.

 

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Look-back on 2010 Predictions

For good order we now look-back on our predictions for 2010. Overall we were close on most of the predictions.

Property prices in 2010 (in order of decrease):

London  +3%

East Anglia +3%

SE England +1.5%

SW England +1%

Scotland +1%

Midlands -2%

NW England -1%

Wales -1%

Northern Ireland -3%

10 NE England  -3%

Very close - general regional trend correct – London saw prices rise about 5% year-on-year whilst the north saw a slight drop (as close as one can realistically get looking at all indexes)

Other criteria

US Dollar to the UK£    $1.5 / £1    Very close, ended year at $1.55 / £1

UK£ to the Euro    £1 / 0.88 Euro   Not close – ended year at 1.173 (Euro was far stronger – debt contagion was averted or deferred for some months )

Oil price  $75 early 2010 rising to $102 by end 2010  Rose to $94/bbl by end 2010 - close

UK Gas price 48p/therm  Very accurate – averaged about 48p/therm

UK Interest Rates – rising from 0.5% in Feb 2010 to 3.25% by end 2010  Stayed at 0.25% - missed by a long margin – despite inflation rising to 3.2% the BoE kept rates at record lows!

FT rising from 5350 Jan 2010 to 5550 by end 2010   FT closed 2010 at 5850 - higher than expected

UK Inflation CPI rising from 1.6% early 2010 to 2.9% end 2010  Very close, inflation rose to 3.2% by end 2010

UK GDP rising from 0% early 2010 to 2.2% by end 2010 (on quarterly annualized basis) Accurate –more or less  spot on

Security outlook – worsening – far more tensions in Middle East and increase in tensions South Asia - with Iran in key role.   Indeed, Iran was a key security concern though North Korea also joined the list

Euro interest rate – 2% rising to 2.75% by end 2010   Rates stayed at 2%

US Interest rates rising from 0.25% early 2010 to 1.25% end 2010   Rates remained at 0.25% 

UK unemployment – dropping from March 2010 slowly - Unemployment actually rose slightly through 2010

Wage inflation – rising from 2.8% end 2009 to 3.7% end 2010  Wages inflation was somewhat more subdued at ~2.8% throughout 2010

GDP growth London 2.2%, North 1%, Midland 1%, Scotland 1.5%   Yes, London had higher growth than Midlands and Scotland

GDP China 10%, GDP India 6.5%, GDP Africa 2%, Global GDP 2.5%, UK 1.7%, USA 2%, Euroland 2% - as a whole over 2009 – Very accurate, almost spot on

Continued economic hardship in Middle East and South Asia along with lack of global leadership will lead to increased tensions and further degradation of security in the Middle East and South Asia – disenfranchised radical groups. Iraq security and economic well-being will improve further. Overall global terrorism will increase. The Iran nuclear issue will be the key security point in 2010 – with significant risk of being a trigger event.  Iran was a key issue but overall security levels did not deteriorate significantly.

USA and UK will both come out of recession, but debt overhang will stifle any strong recovery because of increasing tax and massive public spending programmes making these economies less competitive and efficient. Interest rates will rise sharply mid 2010 as inflation starts to get out of control. All commodities prices will rise. Oil, gas, copper, sugar, wood prices will all rise. Oil production is on a bumpy plateau – oil shortages may start showing end 2010.  Generally fairly accurate.

Greece, Portugal, Ireland, Spain and Italy will suffer long recessionary or periods of stagnation – there will be national calls for some of these countries to leave the Euro – so as to de-value their currencies and gain competitively. France and Germany will continue to drive the European economies through manufacturing and commerce expertise – peripheral Euro-zone countries will suffer as the Euro stays strong. Norway and Sweden will continue to excel. Norway with its huge budget surplus. 

As oil prices rise, stability of Dubai will improve – growth will resume end 2010 and by end 2011 the current financial turmoil will be a distant memory. China will continue to boom at GDP 10%+. Brazil and India will also boom. 

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For Reference Commentary made end 2009 – for Property Prediction 2010

 

Prime West London will see the largest price increases of about 5% driven by higher city bonuses, foreign investors taking advantage of the low sterling value and relative cost in Euro, Middle East and Far East currency terms.

 

One point to consider is the expectation that there will be a new government of Tories by mid 2010. We’d give this a 50% chance of a Tory majority, 25% change of a hung parliament and 25% Labour stay in power. Based on a Tory victory, what normally happens when Tories get into power is:

 

1.  Higher rate taxes are lowered after a few years

2.  Private sector and financial services are encouraged

3. Public sector will be cut through pay freeze, jobs cuts, efficiency improvements and project cancellations

4.  Manufacturing and remaining heavy industry will not necessarily benefit

5.  Market economy stronger, competition more intense

6.  Social costs reduced

7.  Large infra-structure projects rationalized

 

If such measures did not benefit London and SE England we would be surprised – these are also the traditional Tory strongholds. So we would expect to see mid to upper end southern property perform rather better than they would under Labour. Meanwhile lower end northern property – with proximity to public sector jobs and manufacturing jobs would expect to perform worse under Tory than Labour. So the period of stimulating northern prices by public sector jobs growth has likely come to an end. But the positive affects on prime London property could be significant. Okay, these are only trends – but they are based on previous actions implemented over many decades by both parties.

 

We expect the property market at the start of the year to be fairly active from mid January to early May with first time buyers re-entering the market after many years of very low activity. Interest rates will start rising likely March in response to increasing inflation – this will be the big story of 2010 – inflation. Record low interest rates and billions of printed money will feed through – if oil prices rise to $100/bbl as we expect – then inflation will start loosing control. And interest rates will need to be jacked up very quickly. This would then stall out any housing recovery fairly rapidly by end 2010. We see this scenario as about 50% chance by end 2010. If oil prices stay between $50/bbl and $80/bbl – then inflationary pressures will be far more subdued. And we would be far more confident that house prices in London and southern England would continue to rise in a sustainable manner.

 

London: There are some areas of the UK that look particularly attractive at present. London is of course one of these – with the Olympics in 2012, financial services industry that should stablize and then prosper after the Tories get into power mid 2010 and the 800,000 extra people expected in the next ten years, with very low levels of building. Crossrail, new High Speed Rail links, East London Rail Line and large redevelopments in various suburbs all point to higher prices. Talk of a mass movement of banking staff to overseas areas is, we believe, a little premature – if you were the head of a big bank, would you not first of all wait five months to see if the Tories get into power? Remember most banking staff have kids in public schools – it takes a year to properly implement an overseas move. Plans may be being formulated, but we believe the trigger would be a Labour victory – and this is unlikely.

 

Cornwall: This county is an interesting study. One tends to think of such counties as full of local agricultural workers and fishermen – with a few rich Londoner buying holiday homes. But the demographic make-up is far more varied. Many Midlanders, northerners and London-southern people migrate to Cornwall to start small businesses, retire, telecommute, or start work in the public sector. The population has the largest growth of any county in the last 35 years – about 25%. This is forecast to continue to rise – it’s hardly surprising because:

 

1.  It’s a very beautiful place

2.  Five hours by car or direct train to London – not so far

3.  Improved airport links (Newquay)

4.  Continuous stream of wealthy Londoners buying holiday homes

5.  IT improvements – more consultants living in Cornwall and working in London

6.  Lots of interesting people, arts, culture, scenery, beaches, sand, seas, sun, surf

7.  Warmest UK place by far in the winter – longest winter days in UK with brightest sun

 

Add to this that there is almost zero building in Cornwall because of strict planning and you have a recipe for increasing property prices. Yes, despite property prices being about 10 times the average indigenous worker wage, we believe prices will continue to rise above trend to the average UK prices. For inland hotspots, Truro ranks highest with the best schools in the county, a Cathedral city, Cornwall’s capital and beautiful shops. Good rail and road links help. For coast destinations, the riches areas will probably rise as fast as the poorer areas. So the very most select areas are Manaccan, Mylor, Rock, Padstow, Mousehole, St Ives, Helford, Mawman Smith, Fowey, Helford, Looe. For more down-at-heal value, Newlyn, Newquay, Perranporth, Portreath, Penzance, Bude are good examples. Be careful with Newquay though – keep an eye to make sure there is no threat to flights being cancelled since this would adversely affect property prices in the immediate area. The same is true of direct trains to London – it’s a low chance these will be stopped, but always possible – this would be rather catastrophic for property prices through Cornwall. One would hope rail times would instead improve – but higher oil prices are not good news since long distance travel by car becomes far more expensive. Hence Cornwall is fairly exposed to the effects of Peak Oil.