Listed Biotechnology Companies I-O

This Page Last Updated On 4/1/19

IDT - Institute of Drug Technology Australia Ltd.

The company had a pretty average 2003 and early 2004 with consolidation being the theme. Share prices were lack lustre until July when they increased around 30% as a result of the announcement of deals with US companies, but gradually declined about 30% to the end of 2005 and a decline and recovery in 2006 associated with reduced revenue and profitability but with significant recovery in the last 6 months due to improved financials (up 14% in 2006). The company had a market value of $26 million at the end of 2010 which was low given that it is one of the few biotech companies that until recently had been consistently profitable. Financials had indicated that revenues were growing slowly and profitability was up considerably. This together with the announcement of improved collaboration with Pfizer had resulted in a recovery in prices (up 21% in 2007 but down 31% in 2008 - below the average market decline for the sector) with the potential for improvement when current market malaise has passed. However there has been a sharp drop in 2009 with announcement of reduced revenues and profit (down 18%). Evidence of sharply reduced revenues and profit for FY2010 led to a sharp drop in 2010 with recovery at the end of the year on expectation of return to profit in the current financial year (down 57%). There was a 35% decline in 2011 to $17 million with company reporting difficult economic conditions but there has been some recovery due to government funding to support drug research and improved financials although not as much as expected. There was a further 44% fall in 2012 to $10 million due to poor financials and expectations of increased losses in the current financial year due to project delays. An explanation to the market of the opportunities for the company recovered the share price temporarily but the resignation of the CEO at the end of the year has left some uncertainty. There was an 18% recovery in 2013 to $11 million a new Japanese strategic investor and a new CEO appointed (eventually up 70% at $28 million following signature of manufacturing agreement with Imugene and improving financial outlook with fund raising completed). There was a 60% decline in 2014 to $29 million with fund raising then acquisition of a portfolio of generic drugs and fund raising to support this in process. There was a 147% increase in 2015 to $81 million with manufacture of new generics well advanced, distributors in North America found and new funds raised to speed up commercialisation. There was a 51% decline in 2016 to $45 million with offshore manufacturing gearing up, FDA approval and US launch for first of the new generic drug portfolio, new funds raised to assist commercialisation of new drug portfolio and staged divestment of CMAX to a Japanese company for $14 million (61% divested in first stage for $10 million). There was a further 50% decline in 2017 to $23 million but sales of generics are higher than projected, new product launched in the US market and new development agreement with Victorian Government. However departure of Managing Director had a negative effect. There has been a decrease and recovery in 2018 to $20 million (down 10%) with a substantial write off of intangibles and sale of some of its generic products portfolio. A strategic review of the company concluded that the company should stay in the generics market but be more selective as there has been a significant deterioration in generics pricing in the US market. The situation is not helped by a warning letter from the FDA about in-house procedures. Announcement in August 2018 of an agreement to develop cannabis medicinal products resulted in a 20% jump assisted by improved year end financials, now up 61% to $34 million with some reduction in shares. (31/12/18)

(IIL - Innate Immunotherapeutics Ltd.)

New Zealand company developing treatments for secondary progressive multiple sclerosis listed on the ASX in December 2013. Shares down 3% in 2014 at $34 million and down 13% in 2015 to $32 million. There was a decline and recovery in 2016 to $243 million (up 476%) following fund raising and publicity about trial underway with value highly speculation driven. There was a temporary speculative increase in early 2017 to $315 million possibly associated with indications by a Trump official of investment in the company but this rapidly subsided with application that a major shareholder may have gained effective control of the company in contravention of the Corporations Act (mid June 2017 down 52% at $120 million). In late June 2017, the share price collapsed when a Phase 2b clinical trial of a lead compound showed no clear clinical or statistical benefit (eventually down 97% at $6 million). Company looked for a new key technology and closed its New Zealand operations. There had been an 11% recovery in 2018 to $7 million but the announcement in March of proposed acquisition of Melbourne company Amplia Therapeutics and its cancer program for $3.9 million in shares resulted in a 220% share price jump (now up 20% at $14 million). Company has proceeded with the acquisition of Amplia and a 10:1 consolidation with significant changeover of board in line with Amplia shareholders holding 45% share of the company. Company changed its name to Amplia Therapeutics (ASX:ATX) at beginning of September. (10/9/18)

IMC - Immuron Ltd.

Name changed from Anadis Ltd in December 2008. Shares bottomed in March 2003 and quadrupled following that, although they fell 19% in 2005 (partly as a result of a capital raising) and 27% in 2006. This continued through into 2007 with a further 66% decline to a market cap of $10 million. This lack of momentum led to the exit of the CEO. Uncertainty remained about the viability of the company but speculation over laboratory results led to a brief 50% jump in prices in early 2008 but prices fell 70% in 2008 to a market cap of $4 million. Manufacturing business was sold in 2008 and name changed to Immuron (ASX:IMC) in December 2008. Expectations of trial of immunotherapy product, new potential product licensed in from Israel and fund raising has led to some fluctuations in 2009 (up 173% at $23 million with further funds raised and new shareholding from Israeli licensee). US-based executives have been let go and there are discussions with leading pharma company on influenza treatment. Prices down 12% in 2010 with a market cap of $21 million following fund raising and positive clinical trial results. There has been an increase and decline in 2011 (down 24% at $17 million with appointment of new CEO but sales were still low although a recent deal with Paladin Labs offered promise). There was a further 80% decline in 2012 to $4 million with changeover of board members and a new funding round. There was a 50% recovery in 2013 before a 50% drop with resignation of CEO and a new round of fund raising which brought in new investors (eventually down 10% at $9 million). There was an unexplained recovery early in 2014 then a fall with the announcement of further fund raising to support clinical trials and pay off debt (eventually down 51% at $13 million with new funds raised). Company has completed 40:1 share consolidation but recent resignation of CEO is of concern. There has been a 180% increase in 2015 to $37 million with new COO appointed and new orders for Travelan from the US. No clear explanation for the increase is apparent other than an increased profile (an overly optimistic analyst report) in the US market feeding some speculation. There was a 45% decline in 2016 to $28 million with new fund raising completed. There was a 160% recovery in 2017 with promotion on developments in the NASH treatment market and progress towards listing in the US which was held up until clinical result analysis has been completed (eventually down 30% at $25 million with some last minute declines indicating eventual IPO price was not optimal). Recent resignation has resulted in planning for orderly transfer of management. There was a 5% increase in 2018 to $29 million with US DoD research providing positive reference for Travelan, a new trial commencing, a substantial improvement in Travelan revenues and positive clinical trial results as well as raising substantial funds in the US. (2/1/19)

IMM - Immutep Ltd.

Prior to 2009, Prima Biomed (renamed as Immutep in November 2017) had never excited the market, possibly because it set up a number of subsidiary companies originating from the same research institute and all of the technologies would take some time to reach market. Over the initial years, share prices trended steadily downwards and fell 60% in 2004. There was a 30% increase in October/November 2004 associated with Board changes, but this was wiped out at the end of the year when prices fell. Prices fell 29% in 2005 and 46% in 2006 but there was a rise in early 2007 due to favourable results from an early clinical trial on CVAC technology (down 58% in 2007 due to speculation over director associated share sell off). The market cap of $3 million in 2007 followed fund raising and the company was repositioning itself for a new business or change of direction with departure of Executive Chairman. Prices down 76% in 2008. There was an unexpectedly large recovery of 2900% in 2009 to a market cap of $92 million with some refinancing, access to a line of credit, commencement of clinical trials, FDA approval for clinical trials and unrealistic speculation associated with an unrelated vaccine development overseas. There was fund raising in 2010 but some share price decline which resulted in a market cap of $127 million (up 13%) and an announcement of intention to list on NASDAQ led to a temporary price rise. There was a 59% increase to $271 million in 2011 with clinical trial progressing, an agreement on approach for European Phase III trial, a new round of fund raising and potential commercialisation in the Middle East in 2011. However there was a marked and unexplained decline in late July 2011 (eventually down 6% at $168 million). There was a temporary 50% increase early in 2012 but shares were eventually down 31% at $117 million with NASDAQ listing, TGA approval for manufacturing of CVAC in Australia, significant changes in the Board and senior management and termination of programs in Dubai and Holland. There was a 21% decline in 2013 to $107 million with new funds raised and new clinical trials proposed and there was a further fall when initial analysis of Phase 2 clinical trial indicated no significant effect (eventually down 65% to $48 million). There was an 8% decline in 2014 to $44 million but FDA granting of Fast Track Designation to CVac and positive clinical results caused a noticeable improvement. Company acquired French pharma Immutep SA with assistance from US fund Bergen to increase focus on immuno-oncology sector (eventually down 15% at $45 million). Shares down 27% in 2015 to $33 million with Immutep earning milestone payment from GSK for commencing clinical trial. The company has made a sensible decision now supported by shareholders to cease costly clinical development of CVac and concentrate its resources on the LAG-3 immunotherapy products it acquired through Immuntep. There was a 55% rise in share price to market cap of $105 million in 2015 with announcement of new collaborations in Japan, positive trial results with CVAC, entry of new investors and commencement of milestone payments by Novartis. There was a 29% decline in 2016 to $75 million with company registering in the US to trade in American Depository Shares and receiving notification that it is not meeting NASDAQ requirements with steps being taken to rectify this. There was a further 39% decline in 2017 to $53 million with new collaborations announced and indications that NASDAQ listing will be retained as well as progress in clinical trials and new fund raising completed in the US market. Company changed name to Immutep (ASX:IMM) at the end of November 2017 with departure of chairman and director. There has been a 27% increase in 2018 with company value at $94 million following announcement of clinical trial collaboration with Merck & Co., raising of more funds and encouraging results from combination trial with Keytruda as well as new IND application. A recent significant fall in price was attributed to new fund raising in the US market. (22/12/18)

IMU - Imugene Ltd.

Imugene tripled in price during 2003 and prices more or less remained at this level until early 2005. This was based on optimistic expectations which could not be met in the short term. There was a fall and partial recovery in prices during 2005 (down 30% overall) and a recovery in 2006 (up 38% overall) with stabilisation in early 2007 associated with positive results in avian influenza trials (down 41% in 2007). There was a further 45% fall in early 2008 with a subsequent jump associated with positive trial results and a further jump with announcement of a strategic alliance with Merial and initial payments (down 43% in 2008). The market cap of $5 million for the company in 2009 was reasonable and prices in FY2009 were expected to climb further (temporary rise following speculation associated with outbreak of swine influenza and eventually up 4% with a year in profit) but there was a 60% decline in 2010 with ending of agreement with Merial. Announcement of negotiations with a new potential licensee resulted in a bounce and shares are down 38% in 2010 with a market cap of $8 million following announcement of positive vaccine trial. Announcement of deal with Novartis appeared to have little new effect and company is in dormant mode. However licence income has provided profitability in the last year. Down 78% to $2 million in 2011 with announcement of termination of development agreement with Novartis due to trial results not meeting expectations. A review concluded that activities needed to be cut back with concentration on vaccine delivery and pig vaccines rather than poultry as well as development of new partnerships. Laboratory has been closed. Shares were down 33% in 2012 until the announcement of acquisition of a drug delivery platform for $1 million more than doubled share price. Down 8% at $4 million in 2012 with acquisition of drug delivery platform complete, renewal of Board, introduction of new strategic direction in drug delivery and new funds raised. There had been a 9% increase in 2013 to $5 million with changeover of Board, new fund raising completed and discontinuation of main drug development with exit of leading shareholder. However there was a jump in October with the announcement of acquisition of Biolife Science Qld Ltd for around $3 million in shares and new funds to be raised. Eventually up 55% to $11 million in 2013 with acquisition of Biolife complete. There was a 41% decrease in 2014 to $13 million with NDA process commenced for new vaccine and more fund raising in process and decision to unload interests in Linguet drug delivery platform. There was a 20% increase in 2015 to market cap at $21 million and CRO appointed for clinical trial with more funds raised. Shares up 58% in 2016 to $41 million following substantial fund raising and engagement of new CEO. There was a 21% decrease in 2017 with company value at $43 million and substantial new funds raised and a 27% recovery in 2018 to $69 million with release of positive data on development of cancer vaccines, the signing of an exclusive licence to important IP and the raising of substantial funds for clinical research and trials in the US and Europe as well as Australia. (21/12/18)

IPD - Impedimed Ltd.

Eight year old Queensland company listed in October 2007 before substantial revenue had been generated. Following listing, prices increased then declined and on basis of fundamentals, it was hard to see prices being maintained until there were realistic projections for a substantial increase in revenue and profitability. Market cap of $128 million was high as revenues had been stable. Down 5% in 2008 compared to market sector decline of 39% which indicated strong support for company and up 4% in 2009 associated with possibility that insurers in the US may accept the Impedimed product as the gold standard. Prices rose 4% in 2010 with announcement of special reimbursement code for Impedimed use, contracts with US managed care organisations, raising of funds to expand operations in the US and strengthening of US team. This had been balanced by levelling off in revenues. Prices down 35% in 2011 to $82 million with progress in FDA approval. There was an unexplained 19% jump to $98 million in early 2012 and then an 85% decline to $15 million associated with a new round of funding completed and a change of CEO. Value of company in early 2013 was more in line with fundamentals than value four years before and continuing high losses with no growth in revenues resulted in strategic realignment and cost cutting. There was a 206% increase in 2013 to $44 million with a subsequent 241% increase in 2014 to $245 million with new funds raised and further raising in process, a new clinical trail commencing ahead of schedule and official reimbursement status for L-Dex in US. There was a 41% increase in 2015 to $347 million with L-Dex launched commercially in the US market. The company was then looking at the application of its technology to diagnosis of chronic heart failure. There was a 13% decrease in 2016 to $386 million after substantial fund raising and new agreement for clinical trials with Mayo Clinic as well as improved reimbursement in US fuelling confidence and launch of next generation device. However there was a 1% decline in 2017 to $384 million with an increase associated with commencement of sales of new SOZO device and application for 510(k) status with FDA but there has been a fall associated with positive clinical support not being converted into increased sales and reduced losses. There was a further 81% decline in 2018 to $72 million with signing of long term commercial service agreements and positive results coming from trials indicating that the company should have passed its nadir (recent recovery with 80% jump). The company has also sold the assets of XiTRON Technologies which it acquired in 2007. (3/1/19)

IVQ - InvitroCue Ltd.

Singaporean-based company listed on ASX in January 2016 through reverse takeover of of Bunuru Corp. Provides products and services based on cell based analytics in laboratories for pharma and cosmetics companies. Number of collaborations in Singapore, China and Europe with main focus on China market in digital pathology, liver and drug assaying services. 11% decline in 2016 since listing with company value at $41 million. There was a 14% decrease in 2017 to $39 million with new funds raised and a temporary recovery in 2018 to $40 million (even) following raising of new funds. (2/1/19)

IVX - Invion Ltd.

Company formed from the merger of CBio (ASX:CBZ) and US company Inverseon Inc. at end of August 2012. CBio was a ten year-old company developing a product for the treatment of autoimmune diseases and listed in February 2010 after 5 years of clinical trials. On listing shares fell 79% and company was valued at $31 million by the end of 2010 following additional fund raising. The company received a payment from Novo Nordisk after meeting a clinical milestone and then raised further funds to support clinical trials. There was a 216% increase in 2011 to $107 million due mainly to speculation, company promotions and new capital injections. The announcement in August 2011 that a clinical trial did not meet required endpoints resulted in a 50% price loss and shareholder dissatisfaction resulted in almost total board and upper management turnover (eventually down 71% at $15 million following decision by Novo Nordisk not to take up an option to extend collaboration and further departure from Board of international scientific directors). There was no significant price move in 2012 with option payment from Novo Nordisk and institution of legal proceedings against former directors as well as a strategic review which resulted in a proposal for acquisition of the US company Inverseon Inc, a proposed name change to Invion. There was a 29% drop in share prices to company value of $11 million prior to merger. Prices down 10% in 2012 with merged company value of $22 million following positive meeting with FDA and a new strategic alliance for clinical trials. There was an initial increase to $25 million in 2013 associated with initiation of a trial in the US on asthma patients but shares fell back due to a new round of fund raising and appointment of new managing director (eventually up 47% at $39 million with a recent price jump due to new licence in agreement for new drug). There was a decline and recovery in 2014 (down 44% at $26 million) with further funds raised but less than 50% take up of rights issue. There was a further 87% decline in 2015 to $7 million with new funds raised, successful phase 2 trial completed and more funds raised. There was a 67% decrease in 2016 to $2 million with progress towards Phase 3 trial but there are questions about financial viability. There was a 200% speculative increase with company value at $25 million in 2017 with significant new non-dilutive investment by Hong Kong company and a new deal with this company for an anticancer treatment. A proposal by the Board for a 100:1 consolidation has been deferred due to shareholder reaction. There was an additional 200% increase (based mainly on speculation) in 2018 to $99 million with new fund raising completed and promising results from laboratory studies. Company is proposing to spin off respiratory assets to a separate company, Chronic Airway Therapeutics Ltd, which will develop these assets in China. (2/1/19)

KZA - Kazia Therapeutics Ltd.

Name changed from Novogen to Kazia Therapeutics in November 2017. Novogen showed a steady rise in share price from $1.25 in September 2002 to over $8 in December 2003. The company achieved significant sales and a successful entry into the US market. However, the value of the company has fallen by over 70% to around $49 million since then. In our view, this market cap is fair. Some levelling or fall in share prices was expected during 2006 unless the company could reduce its losses. This occurred (down 48% in 2006) and was accentuated by a downturn in the market and delays in milestone licence payments. However there was a temporary lift in 2007 associated with resolution of a patent infringement and an associated new licensing agreement. Pricing held up initially in 2008 despite the market fall but then fell although there was a temporary recovery associated with fund raising to support Marshall Edwards in the US (down 52% in 2007 and down 44% in 2008). There was some initial recovery in 2009 supported by speculation apparently based on a blog in the US which caused a spike in May and new research on possible applications of phenoxodiol but since then there was a gradual decline resulting in departure of Managing Director. Prices down 14% in 2009 and a further 36% in 2010 to market cap of $39 million. Announcement of lack of significant effect in clinical trials in June 2010 resulted in halving of prices (down 80% to $12 million) with a substantial reorganisation of management and advisory from NASDAQ on low share price and sale of IP to subsidiary for US$4 million in stock as well as NASDAQ questioning of listing of subsidiary Marshall Edwards. There was a temporary recovery in 2011 associated with move of IP to Marshall Edwards subsidiary, sale of consumer products division and further indications of NASDAQ listing problems which appear to have been resolved (down 17% to $10 million). Prices declined 34% in 2012 to $7 million with sale of business providing profitability and proposal (subsequently terminated) to merge with Kai Medical, a sleep apnoea device company, with consolidation of shares and distribution of shares in MEI Pharma (previously Marshall Edwards). However, there was a 100% jump in November with the announcement of a large placement in MEI Pharma (eventually up 65% at $17 million) and acquisition of Australian company Triaxial Pharmaceuticals. There was a 56% decline in 2013 to $8 million until announcement of positive laboratory results resulted in a 425% speculative jump and a further unexplained speculative jump in October affected prices (eventually up 21% in 2013 at $32 million) with more funds raised and new collaborations commenced. There was a 58% decline to $16 million in 2014 with promising results for child anticancer treatments, a new round of fund raising and problems in meeting NASDAQ compliance. The announcement that a lead compound may be effective against melanoma doubled the share price in December (eventually down 45% at $26 million). There has been an 45% recovery in 2015 to $68 million with NASDAQ extending time to achieve compliance, promising laboratory results released, development and elucidation of a new chemotherapy product, new fund raising and new research partners but sudden resignation of CEO who has been replaced (eventually up 5% at $49 million). There was a 27% decrease in 2016 with company value at $41 million with engagement of new executive staff and licensing in of technology for clinical trials on brain cancer treatment. There has been a further 55% decrease in 2017 to $18 million with structural changes occurring in the company as it gears up for clinical trials and termination of Anisina clinical development program as well as streamlining of board and reduction in costs. Company changed name to Kazia Therapeutics (ASX:KZA) as well as consolidation of stock and a move to the China market and licensing out of technology to company run by former employees. Following consolidation, stock was down 46% to $22 million in 2017 with planning underway for a Phase II clinical trial. There was a 19% decline in 2018 with company value at $23 million with receipt of stock in Noxopharm and significant speculation based on improving financials as well as commencement of phase II clinical trial which is providing inconclusive results and divestment of technology for 12% of new company Trobio Therapeutics. New fund raising has temporarily depressed prices. (2/1/18)

LBT - LBT Innovations Ltd.

This company was originally called LabTech Systems and listed in July 2006 following a period on the Newcastle Stock Exchange. It gained an early break in 2007 with an agreement with bioMerieux for significant licence fees and milestone payments for its first product. This favoured profitability of the company in the four years after listing However, when the product was eventually commercialised, royalty income appeared to be less than expected. The company’s next product did not go the BioMerieux route but was folded into a joint venture with the Swiss laboratory instrumentation company Hettich AG in an attempt to control returns from commercialisation. This was finalised in June 2013 and it will depend on the effectiveness of the joint venture to ensure optimum return to LBT. Company value up 39% to $8 million in 2013 with $2 million gained from signing new joint venture and up 28% to $11 million in 2014 with further income from milestone payments, new fund raising, introductions of new and future products and continuing profitability. There was a 30% decline to $8 million in 2015 with the announcement that bioMérieux intends to terminate its licensing agreement for LBT's first product with likely loss of profitability in the short term but some recovery due to improving circumstances with substantial licensing fee paid and better than expected results in US clinical trials (even at $11 million). There was excessive speculation in a 700% jump to $93 million in 2016 with FDA approval and clearance of new APAS device, a new CEO appointed and new funds raised to support commercialisation ( eventually up 250% to $45 million). There was a 47% decrease in 2017 to $28 million with financials better than expected, new funds raised and new prototype product in testing. There was a 52% decline in 2018 to $18 million with new funds raised, positive trial results for new equipment and first commercial sales of new equipment in Australia and the US. (4/1/19)

LCT - Living Cell Technologies Ltd.

This company listed in September 2004 having previously been listed without note on the Newcastle Stock Exchange. In our view, the company was listing too soon and promising much. The company did well following listing with share prices up 100% and positive scientific reports were released. But it was hard to see this being maintained in 2005 and prices fell 53% in 2005 to par and remained at this level in 2006 with a small temporary rise in mid 2006 (down 10% in 2006). Preliminary favourable results from Phase II trials in Russia resulted in a 200% increase in September/October 2007 and prices rose 92% overall in 2007. There was a fall and recovery in 2008 associated with new investment, increased expectations for commercialisation and approval for a clinical trial in New Zealand (down 73% in 2008, up 120% in 2009 and down 39% in 2010). The market cap of $39 million at the end of 2010 following fund raising was reasonable if a little high as a result of speculation on positive clinical trials which are under way in Russia and in New Zealand. Establishment of subsidiary in Russia offered opportunity for early commercialisation with registration of the encapsulation device gained. Recent grant to support clinical trials is also promoting share price as well as early positive results from NZ trials which are being expanded. Appointment of new Managing Director appeared to have had little effect although a rise was associated with continuing positive trial results. Lack of positive price movement in 2010 appears to have led to shareholder dissatisfaction causing ditching of Chairman and one director at AGM. Some recovery in late 2010 with announcement of sale of Diabecell treatments in Russia. There was a further fall in share price in 2011 to $16 million (down 66%) with new substantial investors and funding support for clinical trials which have been expanded to Argentina. Lack of market support has indicated uncertainty about eventual commercialisation not helped by recent departure of another CEO and termination of agreement with Centocor. There was a 144% jump in October 2011 with announcement of joint venture with Otsuka Pharmaceuticals which was contributing $25 million (eventually down 66% at $16 million). There was a 2% increase in 2012 to $18 million associated with establishment of joint venture and associated increase in value of company from sale of IP as well as new fund raising and promising clinical trial results. There has been an increase of 12% to $20 million in 2013 with publication of successful trial for treatment of Parkinson’s disease and a further jump to $35 million (up 96%) with first transplant of NTCELL therapy capsules into a human. Announcement in December that NTCELL clinical study results would be withdrawn following an audit resulted in sharp price fall (eventually up 56% at $28 million). There was a 19% decrease in 2014 to $27 million with a strategic reorganisation of the company, Otsuka’s withdrawal from NTCELL development to concentrate on DIABECELL in US and Japan, more funds raised and exploration of new opportunities. There was a 37% decrease in 2015 to $17 million and a 76% rebound with announcement of successful clinical trial for treatment of Parkinson's (eventually down 21% at $21 million). There was a speculative 78% increase in 2016 to $51 million with commencement of Phase IIb trial of NTCell and new funds raised. There was a speculative 125% increase in 2017 to $114 million but announcement that clinical trial results showed no significant statistical difference between treated and sham treated groups which resulted in an 82% fall (eventually down 70% at $15 million. There was some recovery when it was announced that the previous assessment was premature so the results will be reviewed in May 2017. There was a decline and recovery in the first nine months of 2018 to $17 million (up 11%) with company looking for new opportunities and reducing costs and clinical trial starting to show significant results. An unexplained 100% jump in prices occurred in October (now up 48% at $23 million. (29/12/18)

LER - Leaf Resources Ltd.

This company was formed from the merger in early 2010 of listed company Aquacarotene Ltd and Farmacule Bioindustries with an associated share consolidation. Name of the merged company was changed to Leaf Energy in November 2010 and then to Leaf Resources in August 2014. Company value was $4 million and prices fell 43% in 2010 following the merger but was even in early 2011 with first milestone for Vitronectin production successfully achieved. However, shares fell 20% following announcement of departure of CEO but recovered (eventually down 40% to $2 million), a new CEO was appointed and initial test shipments of product have begun. New funds raised via 1 for 1 rights issue to explore potential of marine yeast, shares fell 29% in 2012 to $2 million without explanation and a new chairman has been appointed. There was a further 17% decrease to $3 million in 2013 with half year results indicating improving financials and new direction of bioethanol production from bio-waste and new collaboration with Actinogen on bioethanol. There was a 161% increase in 2014 to $13 million with technical advancements announced, new collaboration with ZeaChem in the US, the reception of a Greentech Award and the raising of further funds. The company changed its name to Leaf Resources in August 2014 in line with changed business. There was a 35% increase in 2015 to $20 million with technical advances announced which make the process more economically viable, new research agreements signed and new funds raised. There was a 3% decrease in 2016 at $25 million with progress through to scale up of pilot plant, new international collaborations and funds raised to support this. There was a 26% decrease in 2017 to $27 million with new funds raised, expansion of the board, new agreements signed and new site selected in Malaysia. There has been a further 52% decrease in 2018 to $17 million with feasibility study well received by potential supporters and feedstock supply contracts signed as well as successful fund raising for next commercialisation stage. (29/12/18)

MDC - Medlab Clinical Ltd.

Company listed in July 2015 and is focussing on biologics targeting illness Share prices remained around listing price in 2015 and revenues and aims of company are modest. Share prices increased 325% in 2016 to company value of $152 million and company is operating proactively by gaining a research licence to use medical cannabis which possibly contributed to the speculative increase. Company has raised further funds through rights issue and is about to start clinical trials using cannabis. There has been an 8% decrease in 2017 to $141 million with government attitudes to cannabis medication changing and ethics approvals for Phase 2 trial on treatment of depression and for two trials on cannabis being obtained. A recent short lived 23% fall in share price is as yet unexplained but a more recent increase has been in anticipation of clinical trials with a cannabis product expected to start shortly. The granting of a licence to sell or supply cannabis products in early 2018 resulted in a 50% price jump to $212 million with a placement oversubscribed. There has since been a substantial correction (eventually down 53% at $76 million). (3/2/19)

MEB - Medibio Ltd.

Name changed from BioProspect in November 2014 following acquisition of new technology and preparations for new consumer product with substantial reorganisation of company and consolidation in process. Company has developed a diagnostic heart rate variability technology for mental health diagnosis and is about to conduct first validation trial. Company value in 2015 was even at $29 million with announcement of agreement with Johns Hopkins for US-based validation trial, 100:1 share consolidation complete, acquisition of diagnostic technology complete with new stress diagnosis technology being patented, positive feedback from recent presentations in North America, early adoption by two companies in Australia and new fund raising completed. There was a 18% decline in 2016 to $26 million but with announcement of results of positive trial, the shares recovered significantly (eventually up 28% at $57 million). There was a 10% decrease in 2017 to $69 million and appointment of new CEO/Managing Director, new agreements with Mayo Clinic, Japan and an Australian provider, appointment of high profile Board members and positive clinical trial results with the aim of gaining FDA clearance in 2018. There was been a further 33% decrease in 2018 to $47 million with acquisition of Vital Conversations, a complementary company in the Corporate Wellness market, and signing of corporate contracts for the mental health check. The sudden unexplained departure of the MD/CEO in August resulted in a 31% fall in share price (now down 94% at $4 million and aggravated by current fund raising). Shareholders representing 6% of the company unsuccessfully tried to replace two directors with three new ones due to dissatisfaction with fall in share price but there have been changes at the Board level and reduction of costs in the US. (25/12/18)

MEM - Memphasys Ltd.

Previous company (NuSep) created to specialise in the sales and distribution of bioseparations products originally sold through Life Therapeutics. This company had undertaken extensive developmental work but commercialisation was still at an early stage. Prices had fallen 86% since listing in May 2007 (down 65% in 2007, down 74% in 2008 and down 67% in 2009). Company value at $2 million was precarious until the reverse takeover of NxGen Pharmaceuticals was announced. NuSep business was to be spun out into another vehicle: Prime BioSeparations. Independent expert report indicated proposed acquisition not fair nor reasonable and acquisition did not proceed. Shares were relisted after 20:1 consolidation in early July and fell 71% in 2009 with company value at $6 million following successful capital raising. Shares down 13% in 2010 with fund raisings and acquisition as well as new venture in Asian market increasing value to $16 million and reporting of a profitable year. There was a 70% decline in 2011 to $8 million associated with declining revenues and profitability due to delays in commercialisation and the need to inject funds into longer term investments including the Singapore project which has received local blessing and investment. Advent of new major investor appeared to have temporarily halted price slide in 2011. Nevertheless there was a 54% decline in 2012 to $3 million with questions raised about the carrying value of the company’s intangible assets, short term loans incurred to expand consumables business and outstanding payments on options in both half yearly and annual reports. There was a slight recovery with the announcement of a Singapore joint venture on plasma processing and this led to a 55% jump when external investment in the venture commenced and company was restructured accordingly. There has also been a proposal to spin out the PrIME business to enable this business to gain appropriate value and this is to occur in 2013. A new Singaporean investor is also taking up 15% of the company with an associated fall in price and a substantial change over of the board. By the end of the year, shares were up 7% at company value of $10 million. In early 2013, the company divested non-core assets with little effect on share prices although there has been a recent rise with promotion of the company in the market and new funds raised (down 1% at $12 million). There was a decrease of 33% to $9 million in 2014 with departure of CEO, new financing for Singapore project in place and possibly speculation over revaluation of NuSep although loans are still propping up the company. Company is pressing ahead with commercialisation of Sperm Sep technology with new agreement with German company in animal reproduction. In association with presentation at AGM shares jumped 60% for a number of possible reasons (eventually up 3% at $13 million). There has been a steep drop in share price in 2015 with some recovery due to proposal to sell company's gel business and share in plasma separation business in Singapore (down 44% at $11 million with substantial equity change.). There was an 88% drop to $3 million in 2016 with resignation of Board member and resignation from Prime Biologics Board of key supporter of NuSep and share issue doubling capital at a low price. The company has sold its US gels business to China and is about to announce disposal of its interest in Singapore-based Prime Biologics. This was not helped by NuSep litigation against Prime in Singapore over research equipment which further eroded the share price. One fears this story will end in tears. Name changed to Memphasys (ASX:MEM) in July 2016 with some temporary recovery in share price (eventually down 88% at $3 million). Company was looking for funds for survival. There was a decline and recovery in 2017 (eventually down 60% at $9 million) with litigation resolved and a decision to continue with the next step of the SpermSep development with agreement with device partner and associated substantial fund raising has been depressing the price further. There was a 50% decline in 2018 with company value at $5 million with announcement of settlement of litigation with former financiers, progress on sperm separation device, a new substantial investment from the horse breeding industry and a 15:1 share consolidation. There was an unexplained 300% share price jump in mid October just prior to announcement of appointment of Key Opinion Leader to review a new device (now down 7% to $10 million). (28/12/18)

MGZ - Medigard Ltd.

This company, specialising in retractable syringes and giving sets, listed in February 2004. Since then the share price has fallen 80% and the company is valued at $1 million with small cash reserves. The award of funds (twice) by the Queensland Government has been useful, but significant developments will need to occur for survival of this company. Prices stabilised in 2006, even in 2007 and down 55% in 2008 but there have been wide price oscillations in 2009 due to FDA approval for equipment and unrealistic speculation about potential of company and agreement for manufacture of equipment in North America (up 122% in 2009). Prices fell 45% in 2010 following announcement of rights issue to fund expansion in US but with still no sales recorded and little market reaction to signing of manufacturing agreement. There was a 71% decline to $1 million in 2011 and with departure of the CEO and a director, company appeared to be suffering a slow death. There was a further 50% fall in 2012 but prices doubled with the announcement of a Heads of Agreement for commercialisation of Medigard’s product portfolio through Shanghai Sol-Millenium Products (eventually even). There was a 75% increase in 2013 to $3 million with signing of licensing agreement with Shanghai Sol-Millenium but income remains minimal. There was an 18% increase in 2014 without any signs of commercialisation and company is relying on borrowed funds. There was a further 82% increase in 2015 to $5 million without any satisfactory explanation by the company but the price dropped with the market downturn and revenues are still to appear (eventually down 64% at $1 million) with loan funding from partner still unresolved. There was a 75% increase in 2016 to $2 million with expectation of further royalty payments in the future but convertible notes are propping up the company’s cash position and there was a 48% decrease in 2017 to $1 million. However, without explanation, there was a short term 250% recovery in share prices in July 2017 (eventually up 43% at $4 million) with board members providing a cash injection. There has been a 33% decrease in 2018 to $3 million with engagement of advisers to explore new opportunities and a new licensing agreement signed which will require fund raising which is depressing prices. (30/12/18)

MSB - Mesoblast Ltd.

This company, drawing on stem cell technology from Adelaide and overseas, launched in mid December 2004 at a premium of 60% and although prices dropped to par, they have again risen, up 89% in 2005, up 55% in 2006 but down 30% in 2007 associated with market correction and further oscillations in 2008 (down 22%). There was a further increase in 2009 with release of trial results (up 36%) and another 243% increase in 2010 based on inflated analyst reports, speculation and strategic alliance with Cephalon. It is still too early to assess the substance of this company but some questions have been asked about issues of ownership of associated companies. The company is also being strongly promoted even though commercialisation is some time away and current income until recently has been reliant on grants and interest income. In our view, the company is overvalued for this stage of the commercialisation cycle and significant work is required to achieve commercialisation to justify the value of $2.0 billion in 2011 following absorption of Angioblast Systems and investment by Cephalon. However the US$100 million licence fee payment by Cephalon provided support for the value from the larger companies and this together with subsequent income supported the 48% increase in value in 2011 to $1.9 billion. There was an overall downward movement from 2012 with some speculation relating to a diabetes trial and international promotion initially pushing prices but a recent steep fall is as yet unexplained but may relate to Teva’s lack of interest in Mesoblast since its takeover of Cephalon (denied by Mesoblast) (down 23% to $1.5 billion). There was a 10% increase in 2013 to $1.88 billion associated with positive clinical trial results and FDA approvals and a further $170 million fund raising as well as acquisition of Osiris Therapeutics cultured stem cell business and new collaborations formed and new developments in Japan on acceptance of stem cell therapy. There was a 20% decline in 2014 to $1.5 billion with announcement that the company is bringing forward plans for commercialisation with proposed operations in Singapore and new agreement with NIH on end stage heart failure clinical trial. However in August there was a recovery (eventually down 25% at $1.4 billion). There have been price oscillations in 2015 with market cap at $1.15 billion (down 22%) with promising results from clinical trials on stem cell use to treat chronic lower back pain and graft versus host disease in children, positive developments for incentives in Japan and a new deal with Celgene. The company succeeded in a Nasdaq listing in the US to raise US$68 million but there is some bite back from observers who have noted that clinical trial results have not been as good as the company would have us believe. This resulted in a 33% price fall (eventually down 58% to $703 million). Shares fell a further 36% in 2016 to $452 million but announcement of clinical trial results and less negative half yearly financials resulted in an 80% recovery. Licensing of technology re homing of stem cells from Harvard has also led to some speculation but the selling by Credit Suisse and JP Morgan of their substantial shares in the company is also significant and there was a further 40% fall with indications that Teva Pharma is pulling out of its strategic alliance with Mesoblast after a year but this was countered by positive trial results announced (down 23% at $546 million in 2016). As a result of deal with Malinkrodt and promising clinical results, there was a 2% increase in 2017 to $687 million with raising of further funds and a 45% increase in 2018 to $1.054 billion with announcement of positive phase 3 trial results and new collaborations in China which have been completed with injection of funds. However, the market responded negatively with release of clinical trial results (down up to 35%) and current value is $597 million (down 18% in 2018). (30/12/18)

NEU - Neuren Pharmaceuticals Ltd.

Merger of two New Zealand companies listed at beginning of February 2005. Collaborations in the US and Australia. Following listing, prices fell about 15% but recovered with the announcement that progress through clinical trials for first product has been facilitated with considerable cost savings. There was also an unexplained 50% jump in prices in late 2005 which held up into 2006 and a temporary improvement in 2006 associated with collaboration with Metabolic Pharmaceuticals but prices fell 25% overall in 2006 with a temporary rise in early 2007 associated with expectations about a glypromate Phase 3 trial which had commenced and a 50% fall followed by a temporary jump in November 07. The company had a market cap of $1 million in early 2009 following several fund raisings but prices had fallen 55% in 2007, 94% in 2008 and a further 50% in early 2009 following announcement of glypromate clinical trial showing no effect. There was a massive turnaround in prices in April 2009 possibly due to speculation over new funding and new move into cancer research as well as announcement that US Army will fund next clinical trial. Prices rose 270% in 2009 but fell 57% in 2010 to a market cap of $7 million. There was a fall and a recovery in 2011 due to speculation over recommencement of clinical trials (up 69%) which together with fund raising increased market cap to $31 million. Up 30% at $41 million in 2012 with good publicity and speculation pushing up prices and a 229% increase in 2013 to $174 million with FDA fast track status provided to fragile X treatment. There was a 30% decline in 2014 to $129 million with a total recovery following announcement of successful Phase II trial of NNZ-2566 in treatment of Rett syndrome (eventually up 4% at $191 million). Shares increased 13% to company value of $215 million with orphan drug and breakthrough therapy designation sought from FDA. There was a 38% increase in 2015 to $267 million with speculation on new FDA applications but when Breakthrough Therapy designation was not granted, prices fell sharply (eventually down 4% at $197 million with more funds raised). There was a further 16% decline in 2016 to $167 million with some subsequent recovery. Announcement that a phase 2 clinical trial did not meet efficacy endpoints resulted in a 35% fall in late April (eventually down 51% at $100 million). There was a 186% recovery in 2017 to $318 million with promising clinical trials and new funds raised. There was a considerable lift in price prior to 20:1 consolidation in late November. There had been a 15% decrease in 2018 to $275 million but the announcement of a licensing deal in August with Acadia Pharma resulted in a further 43% fall to $118 million (down 56% following recent recovery to $141 million). (1/1/19)

NHL - Novita Healthcare Ltd.

Previous company Avexa Ltd. had barely snipped its umbilical with AMRAD in September 2004 and was already raising extra funds for clinical trials. Initially share prices fell 30% and were kept at this level by the su8bsequent fund raising. However there was a 45% fall in 2005 with subsequent recovery associated with high expectations for its anti HIV/AIDS drug licensed from Shire and actually rose 30% overall in 2005 and remained steady in 2006 with a drop associated with the related merger between CSL and Zenyth Therapeutics and a recovery associated with a development deal with a Chinese company and progress in clinical trials with elevated expectations for commercialisation of apricitabine. The recovery continued into 2007 with an 80% increase in 2007 and an associated $89 million capital raising. The company was bolstering its position with collaborations with a number of groups in Australia and overseas and fund raising. The company had raised funds and market cap was $106 million of which $33 million was cash (prices down 84% in 2008 but up 109% in 2009 following extension of assessment by Tibotec). Announcement of merger with Progen Pharmaceuticals at end of 2008 was countered by proposal from Cytopia and shareholder revolt. Eventually merger did not proceed. Perceived value of AVX bolstered by favourable expert's report valuing Apricitabine at around $200 million which was somewhat at variance with non-cash value of company. There was an initial 19% decline in 2010 following decision of Tibotec not to continue with assessment and withdrawal from government program with CSIRO. This was followed by a steep drop in May with announcement of closure of Apricitabine program due to lack of international interest and resignation of CEO. Down 75% in 2010 to $33 million with cash holding of $22 million. There have been questions about responsibility of directors and appropriate disclosure. There has been a wholesale change over of the Board with the injection of experience from the pharmaceutical industry but further appointments and sparring with Calzada suggests a certain amount of disarray in perspective. Intellectual property previously valued at over $200 million has been written off and advisory assistance has been sought to evaluate remaining portfolio. Attempts by Calzada to roll the Board were unsuccessful and Calzada sold its holding. Avexa is pressing ahead with means of commercialising its intellectual property and value has risen and fallen in 2011 associated with its handling of a share in Allied Healthcare. In April, a filip was given to the price with agreement with FDA on how to proceed with Apricitabine and there was another attempt to outlicence ATC (eventually down 21% at $26 million in 2011). Shares down 39% at $16 million in 2012 with agreement with EMA on how to proceed with Apricitabine and promising results with HIV Integrase Inhibitors and antibiotics. There was a further 16% decline in 2013 and sale of its share in Allied Healthcare but a recent unexplained jump corrected this slide possibly associated with new plans with Link to develop and commercialise ATC and proceeding with coal mine investment (down 37% in 2013 at $10 million). Up 33% at $15 million in 2014 with new fund raising, new grant won and ATC produced for new program with Link which has been mentioned in a US Aids magazine. There was a 50% decline in 2015 to $7 million with some recovery on announcement of intention to acquire TALI Health and associated 20:1 share consolidation (eventually down 78% at $3 million). There was a further 52% decline in 2016 to $2 million with new funds raised and TALI acquisition completed. Conclusion of this acquisition resulted in some recovery as well as improved publicity and substantial new fund raising (eventually down 61% at $6 million).Name changed to Novita Healthcare Ltd (AX:NHL) in December 2016. There was a 63% increase in 2017 to $16 million with sale or dissolution of legacy businesses, raising of new funds, acquisition of Newly, an online marketplace connecting healthcare professionals with organisations in need and appointment of new CEO. There was a 34% decrease in 2018 to $13 million with launch of first commercial product and changeover of Board with new fund raising and sale of Newly subsidiary. (1/1/19)

NOX - Noxopharm Ltd.

Company formed to test ability of candidate drug to reduce cancer resistance to chemotherapy. Led by CEO who had controversial stint with Novogen (now Kazia Therapeutics) in US. Listed at a value of $15 million in August 2016 and shares doubled in value by end of 2016 to around $30 million. Optimism continued into 2017 but this has moderated since May with a price fall associated with fund raising and a subsequent highly speculative price jump associated with moving technology into another company and favourable preclinical results (eventually up 169% at $117 million.) There was a 12% decline in 2018 to $109 million and a recovery to $163 million (up 32%) with speculation over clinical results then a fall to $54 million (down 61%) following announcement of results. (30/12/18)


NTI - Neurotech International Ltd.

Maltese Australian company developing neurostimulation and neurodiagnostic solutions for use in home-based therapies for children with Autism Spectrum Disorder (ASD). Listed on ASX early November 2016. Main initial focus on Italian then European market with clinical trials in the US to follow. Second device Mente 2 listed with FDA and receiving CE marking. In 2016 shares increased 93% to company value of $34 million with commencement of shipment of devices. There had been a decrease of 56% in 2017 to $15 million but announcement of a positive outcome from a US clinical study resulted in a 70% recovery (now down 48% at $22 million with new funds raised). There was a 45% decrease in 2018 with company value at $12 million with clinical trial results due and EU approval for next version of the Mente device. Announcement of publication of trial results resulted in a temporary recovery of value (now down 78% to $5 million) and new CEO/MD appointed. (3/1/19)

OBJ - OBJ Ltd.

Backdoor listing through a software company, OBJ acquired transdermal permeability enhancement technology in 2004. Several announcements of the experimental features of the technology have been made, but commercialisation of the technology would take time and so some speculation was likely. Shares increased 108% in 2005, declined 30% in 2006, declined 38% in 2007 and fell 86% in 2008: the company had a market cap of $5 million following fund raising which was vulnerable at that time in our view. However there has been speculation associated with laboratory results, further fund raising and a commercial deal which lifted the share price 480% in 2009 to a market cap of $32 million. Technology appears some distance from commercialisation. There has been recent shareholder disaffection but impact on prices uncertain although there has been reorganisation of the company with departure of the Chief Operating Officer. There was a large increase in 2010 associated with speculation on collaboration on product development with GSK and a consumer product company but was down 21% at $27 million by the end of 2010 which was high in our view. There was a temporary increase in 2011 in association with a collaborative agreement with GSK (eventually down 22% to $21 million). There had been a 17% decline to $17 million in 2012 but there was a jump with announcement of development agreement with Procter & Gamble going into clinical trials (eventually up 6% at $22 million). There was a decline and recovery in 2013 to $47 million (up 74%) with announcement of new fund raising which was partially successful and new clinical arrangement with GSK Oral Healthcare. There was a further 191% increase to $157 million in 2014 with signing of licensing agreements with Proctor & Gamble and Coty Inc. and launch of new product in Asia incorporating OBJ’s magnetic microarray technology. There was a decrease of 45% in 2015 to $94 million with little sign of income from collaborations but more funds raised. Shares up 30% in 2016 to $123 million with positive trial of knee protector and new licensing agreement with Proctor & Gamble. There was a 42% decrease in 2017 with company value at $72 million despite a new licensing agreement with Proctor & Gamble and launch of new products in China, Japan and Taiwan. There has been a further 55% decline in 2018 to $33 million with collaboration with Proctor & Gamble expanding. (3/1/19)

OCC - Orthocell Ltd.

Regenerative medicine company focussing on regeneration of cartilage and tendon and repair of soft tissue industries. Formed in 2006 and listed in 2014 with a good trials and licensing of process in China as well as link ups with stem cell companies overseas. Has been able to grow tendon in laboratory which demonstrates progress over other stem cell companies. Shares down 13% in 2015 to company value of $33 million with presentation of positive data at international conference and new funds raised. There were price oscillations in 2016 with company value at $39 million (down 1% following new round of fund raising). Announcement of agreement with Johnson and Johnson company and regulatory advance with CelGro in the US led to a temporary rise, eventually down 11% at $36 million following speculation about developments and new funds being raised. There has been a 56% decrease in 2018 with company value at $18 million and strengthening of its scientific advisory board and new studies demonstrating effectiveness of therapies as well as sales into Poland, Italy, UK and Ireland and new funds raised. (30/12/18)

OIL - Optiscan Imaging Ltd.

Since the announcement of its licensing deal with Pentax in 2000, share prices have languished and despite some rise associated with the overall market lift in August 2003, prices have not been strongly supported except for rises associated with regulatory approval in the US, the release of a new research product and the deal with Carl Zeiss. The company is currently valued at $10 million, which is vulnerable with stability in 2005, a 28% increase in 2006, a 33% decrease in 2007, a further decline of 82% in 2008 but up 46% in 2009 and down 11% in 2010, following departure of CEO after only two years. To maintain value, the company will need to become profitable and will need to increase revenues. Recent declines have been due to soft forward sales projections by Pentax as well as broader issues in the market and this is being reflected in decreasing revenues. There was a rapid drop in price in October 2008 with need for fund raising. Company has been downsized in difficult climate with a recent contract with Carl Zeiss offering some hope as well as the new agreement with Hoya and new fund raising. Agreement on expanded cooperation with Carl Zeiss has provided some lift in prices at end of 2010. There has been a fall and recovery in value in 2011 (eventually up 69% to $16 million) with a strategic review underway and further speculation in December 2011. Prices more than doubled after October 2011 apparently due to speculation but were down 30% in 2012 to $14 million with new funding and sale of new product to Carl Zeiss. There was a 39% decrease in 2013 to $9 million and a further 26% decrease in 2014 to $7 million. This was reversed temporarily when company announced a global OEM supply agreement and opportunities for new markets in the neurosciences as well as milestone payment from Carl Zeiss(down 2% with company value at $10 million). There was a temporary recovery in 2015 (eventually down 47% to $6 million) with fund raising completed, changeover of Board, launch of new product and extension of agreement with Zeiss. There was a 31% decline in 2016 to $4 million with shares suspended as company has been unsuccessful in raising critical funds so far and this situation was not improved by resignation of Chairman and majority of Board. All have now been replaced together with the appointment of a new CEO. Following period of suspension, company has raised more funds (60% shortfall made up by underwriter), further funds and launch of new product (up 107% at $22 million). In 2017 there was a 67% increase to $43 million due to market developments with raising of new funds and new Zeiss product launched as well as new sales into China and new reference sites in China and the US. There has been a 55% decrease in 2018 to $19 million with resignation of Chairman and significant changeover of the Board as a result of shareholder dissatisfaction. Latest product sold through Carl Zeiss has received FDA clearance. (28/12/18)

OPT - Opthea Ltd.

As a management and investment company, Opthea (previously Circadian) had been relatively strong in the past as some of its investments have provided a commercial return or at least some value in the stock market. Until recently, the market cap was supported more by net asset backing rather than economic revenue or returns. The outlook for share prices remains uncertain. There was a clear 45% decline in prices in 2005, an increase of 35% in 2006 and a 22% decrease in 2007 associated with gains from sale of Zenyth shareholding to CSL, announcements of investments and funding in new areas and collapse of Metabolic share price. The sale of Axon and Zenyth provided income and profitability but now the company will have to work on the next growth area to maintain value. This is Vegenics (recently fully acquired), although this could be some time from commercialisation. Shares declined 52% in 2008, in line with the overall fall in the market but there was a 21% recovery in 2009. Company market cap of $27 million in 2009 was little more than cash holdings of $22 million. Problem with licensing arrangements of VEGX technology to Ark Therapeutics has been resolved. There was a decline and recovery in prices in 2010 (down 19%) which continued into 2011 (down 18% to $22 million). There was a recovery in 2012 associated with commencement of clinical trials and positive diagnostic tests leading to a fund raising which again depressed prices (down 26% at $17 million) and launch of new diagnostic product. There was a 41% decline in 2013 to $10 million with signing of new contract indicating new direction and sudden departure of CEO. A new Managing Director was appointed in February 2014. There was little movement in 2014 (down 20% to $24 million) with some speculation over a proposed trial of treatment for wet AMD and substantial new fund raising which doubled company value. Prices up 142% in 2015 with company value at $59 million with positive results from licensing partner and FDA approval for clinical trial on AMD treatment which has commenced. Company changed name to Opthea in December 2015. There was a further 15% increase in early 2016 to $68 million which was increased when Phase 1 results were positive (eventually up 111% at $127 million). There was a 17% decline in 2017 to $141 million with the raising of new funds to support next round of clinical trials after successful results so far. There has been a 17% decrease in 2018 to $145 million with a latest trial results promising and exercising of options raising further funds. (22/12/18)

OSL - Oncosil Medical Ltd.

Company arising from acquisition by Neurodiscovery Ltd of Enigma Therapeutics in April 2013. Enigma had exclusive global licence to BrachySil, a technology for using radioactive isotopes for treating solid tumours, from PSIMedica Ltd, a subsidiary of pSivida (ASX:PVA). Name changed to Oncosil in June 2013 and product to be manufactured in Germany for pivotal trials to be completed in 2014/15, CE and FDA approval to be obtained in 2015. Funds raised to fund global registration study in September 2013. Shares down 34% in 2014 to company value of $31 million and up 191% in 2015 at $90 million. A new CEO was appointed as well as a Chief Medical Officer and manufacturing managers to push forward with commercialisation. As company had not matched its projections and these were stretching out further, questions were being asked about its trials and regulatory process as well as the viability of its treatment but despite this further funds raised for commercialisation and apparent regulatory developments (down 66% to $40 million in 2016). There was some temporary recovery with announcement that FDA had provided IDE approval leading to clinical trials for treatment of pancreatic cancer. Shares up 80% in 2017 with company value at $76 million and recruitment for clinical trial was advanced. There has been a decline and recovery (up 16%) in 2018 to $114 million with substantial new funds raised and clinical results promising. (23/12/18)