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ALGORAE PHARMACEUTICALS LIMITED Earnings Release 2017

Nov 9, 2017

64249_rns_2017-11-09_bcc94f8f-de0f-4f96-89b7-7f1a84f556d6.pdf

Earnings Release

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Living Cell Technologies Limited

ACN: 104 028 042 ASX: LCT OTCQX: LVCLY

ASX ANNOUNCEMENT

Top-line results of LCT Parkinson’s trial require further analysis

10 November 2017 – Sydney, Australia & Auckland, New Zealand – The results of Living Cell Technologies Limited’s Phase IIb clinical study of NTCELL[®] for Parkinson’s disease have been unblinded. Three of the four primary endpoints were met. No product or procedure adverse events occurred and there is no evidence of xenogeneic infection in patients and their partners. However, at 26 weeks post implant, there is not a statistically significant difference between the groups who received NTCELL and the patients who had sham surgery, as measured by the change in the Unified Parkinson’s Disease Rating Scale (UPDRS Part III in the off state).

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NTCELL is a regenerative cell therapy that had shown potential in early trials as a disease-modifying agent in Parkinson’s disease.

The study was designed to confirm the most effective dose of NTCELL, define any placebo component of the response and further identify the initial target Parkinson’s disease patient sub group.

The study consisted of three groups of six patients. Two patients from each group had sham surgery with no NTCELL implanted, to act as a control. Group 1 received 40, group 2 80 and group 3 120 microcapsules of NTCELL on each side of the brain.

The patients who did not receive NTCELL will receive treatment determined by the Data Safety Monitoring Board (DSMB). At this stage, the DSMB has recommended that no treatment be given to the placebo patients.

The Principal Investigator, Dr Barry Snow, Auckland City Hospital, says “The next step is to analyse the data in depth and continue to monitor patients in accord with the study extension protocol, particularly for the efficacy movements at longer time points.”

Dr Ken Taylor, CEO of LCT, says, “While this was a very good study from a safety viewpoint, we are disappointed that the efficacy primary endpoint has not been met. It is encouraging that some efficacy data is positive and that the treatment was well tolerated and safe. More data analysis and input from our advisors is required but at this time we cannot proceed with a regulatory application.”

Investor call

LCT CEO Ken Taylor and Principal Investigator Dr Barry Snow will host an investor call to discuss the results of the Phase IIb clinical study of NTCELL in Parkinson's disease on the day of the announcement.

Date : Friday 10 November 2017 Time : NZT 4:00pm, AEST 2:00pm

Conference ID : 3389168

Toll-free dial-in numbers for participants: Australia - 1800 123 296 New Zealand - 0800 452 782 Canada - 1855 5616 766 China - 4001 203 085 Hong - Kong 800 908 865 India - 1800 3010 6141 Japan - 0120 985 190 Singapore - 800 616 2288 United Kingdom - 0808 234 0757 United States - 1855 293 1544 or toll +61 2 8038 5221

– Ends –

For further information: www.lctglobal.com

At the Company: Media Contact: Ken Taylor Rachael Joel Chief Executive Botica Butler Raudon Partners Mobile: +64 21 796 000 Tel: +64 9 303 3862 [email protected] Mobile: +64 21 403 504 [email protected]

About NTCELL[®]

NTCELL is an alginate coated capsule containing clusters of neonatal porcine choroid plexus cells that are sourced from a unique herd of designated pathogen-free pigs bred from stock originally discovered in the remote sub-Antarctic Auckland Islands. Choroid plexus cells are naturally occurring “support” cells for the brain and secrete cerebrospinal fluid (CSF), which contains a range of factors that support nerve cell functions and protective enzymes that are crucial for nerve growth and healthy functioning. In NTCELL, the porcine choroid plexus cells are coated with LCT’s propriety technology IMMUPEL™ to protect them from attack by the immune system. Therefore, no immunosuppressive regimen is required for treatment.

Following implantation into a damaged site within the brain, NTCELL functions as a neurochemical factory producing CSF and secreting multiple nerve growth factors that promote new central nervous system (CNS) growth and repair disease-induced nerve degeneration while potentially removing waste products such as amyloids and proteins.

LCT has filed PCT application No. PCT/US2016/032543 entitled “Treatment of CNS disease with encapsulated inducible choroid plexus cells” and US application No. 15/154,709 was published 15 December 2016. LCT also has gene chip analysis of NTCELL identifying multiple growth and trophic factors, antioxidants, chaperone molecules and other bioactive components.

NTCELL has the potential to treat neurodegenerative diseases because choroid plexus cells help produce CSF as well as a range of neurotrophins (nerve growth factors) that have been shown to protect against neuron (nerve) cell death in animal models of disease. NTCELL has been shown in preclinical studies to regenerate damaged tissue and restore function in animal models of Parkinson’s disease, stroke, Huntington’s disease, hearing loss and other non-neurological conditions, such as wound healing. In addition to Parkinson’s disease, NTCELL has the potential to be used in a number of other CNS indications, including Huntington’s, Alzheimer’s and motor neurone diseases including amyotrophic lateral sclerosis (ALS).

About Parkinson’s disease

Parkinson’s disease is a progressive neurological condition characterised by a loss of brain cells that produce dopamine (a neurotransmitter that conveys messages between brain cells to ensure effective movement and planning of movement) and many other types of neurons. People with Parkinson’s disease experience reduced and slow movement (hypokinesia and bradykinesia), rigidity and tremors.

Parkinson’s disease is the second most common neurodegenerative disorder after Alzheimer’s disease, affecting approximately 7 million people worldwide. The average age of onset is 60 years, and the incidence increases with age. Men are one and a half times more likely to have Parkinson's disease than women.

Current treatments for Parkinson’s disease are symptomatic and do not reverse or slow the degeneration of neurons in the brain. Most existing pharmaceutical treatment options focus on restoring the balance of dopamine and other neurotransmitters. The effectiveness of dopamine replacement therapy declines as the disease progresses. When dopamine treatments are no longer useful, some patients are treated with Deep Brain Stimulation (DBS), in which a medical device is surgically implanted in the brain in order to send electrical impulses to regions of the brain involved in the control of movement. While DBS leads to short-term symptomatic improvement, it does not impact disease progression and is not curative or neuroprotective.

About Living Cell Technologies

Living Cell Technologies Limited (LCT) is an Australasian biotechnology company improving the wellbeing of people with serious diseases worldwide by discovering, developing and commercialising regenerative treatments which restore function using naturally occurring cells.

LCT’s lead product, NTCELL[®] , is an alginate coated capsule containing clusters of neonatal porcine choroid plexus cells. After implantation NTCELL functions as a biological factory, producing factors to promote new central nervous system growth and repair disease-induced nerve degeneration.

The Phase I/IIa clinical trial of NTCELL for the treatment of Parkinson’s disease, in New Zealand, met the primary endpoint of safety and halted the progression of the disease two and a half years after implant. Results from this trial were used to design a larger Phase IIb trial to confirm the most effective dose of NTCELL, define any placebo component of the response and further identify the initial target Parkinson’s disease patient sub group. This trial commenced in March 2016. The 26 week results of this trial require further analysis and patients will continue to be monitored in accordance with the study extension protocol.

In addition to Parkinson’s disease, NTCELL has the potential to be used in a number of other central nervous system indications, including Huntington’s, Alzheimer’s and motor neurone diseases including amyotrophic lateral sclerosis (ALS).

LCT’s proprietary encapsulation technology, IMMUPEL™, allows cell therapies to be used without the need for co-treatment with drugs that suppress the immune system.

LCT is listed on the Australian (ASX: LCT) and US (OTCQX: LVCLY) stock exchanges. The company is incorporated in Australia, with its operations based in New Zealand.

For more information visit www.lctglobal.com or follow @lctglobal on Twitter.

Forward-looking statements

This document may contain certain forward-looking statements, relating to LCT’s business, which can be identified by the use of forward-looking terminology such as “promising,” “plans,” “anticipated,” “will,” “project,” “believe,” “forecast,” “expected,” “estimated,” “targeting,” “aiming,” “set to,” “potential,” “seeking to,” “goal,” “could provide,” “intends,” “is being developed,” “could be,” “on track,” or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other health authorities’ requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any health authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding the approval and commercialisation of the product candidates could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data, and new clinical data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. LCT is providing this information and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise.