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On-wards and Up-wards..., page-2

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    Hawk

    Sunday was cold & rainy day in Sydney so I found myself re-reading the news also. Specifically the website & recent newsletter.

    To read reports I copy the content to MSword, highlight relevant info & delete the noise.
    In case it saves others the hastle here's the result (of what I read as important at least):

    Hair Products (Revenue Generating)
    The global hair care market is around $80 billion annually and growing rapidly
    Entity
    $ Relevance
    Product
    Purpose
    Competitive Advantage
    Upside Risks
    1 Advangen
    FULLY OWNED SUBSIDUARY OF CDY (All revenues retained)
    LEXELIS, EVOLIS, JO-JU…

    Hair Growth/Volumizing Tonic

    Hair Growth/Volumizing Shampoo
    • Hair Loss Prevention
    • Hair Volumizing
    • Natural plant based formulae
    • Works on women (unlike competitor products)
    • Main competitor products linked to cancer, increased hair growing elsewhere on the body, residues
    • TGA approved - évolis® is the first TGA listed topical hair growth product in 24 years
    • the segment is awash with polymer based products that essentially “stick‟ to the hair to make it look thicker…there is a distinct lack of active shampoos and lotions on the market that address the actual biology of the hair. With a range of safe and efficacious FGF5 inhibitors Advangen stands alone in this market
     
    • Organic Revenue Increases
    • Move into new market
    • Partnering
    • New Products
    • Mainstream Advertising
    • Sales results from recent move into China / Japanese marketing

    Hair Products (New Global Brand & Product Strategy)
    • Assessing opportunities in established markets through brand partnerships (USA, Europe)
    • launching Advangen branded antiaging hair care products in fast growing markets
    Hair Products (New Product Development)
    • new discoveries and intellectual property
    • Advangen‟s Chief Scientist, Dr Masakuni Yamamoto, the team …have developed new formulations
    • As a precursor to efficacy testing, these novel lotions have recently undergone safety testing in 50 healthy human subjects
    • The results indicate that our lotions have not caused any adverse reaction in any of the subjects.
    • In Japan we have opened new channels and developed new products for some of our existing distributors like Natural Garden…..we will start seeing the results through increased revenues from late 2014.
    ANTI-AGING HAIR CARE
    • the fastest growing segment is the antiaging hair care, which includes products for hair loss, volume or quality concerns…..we stand out in this crowd as the only natural product that has scientifically validated and biologically active ingredients. Our products actually make the hair grow better, faster, stronger and thicker.
    • are developing new products that specifically target the antiaging hair care segment, both for men and women.
    PREVENTION OF HAIR GREYING
    • An exciting new application is prevention of greying of the hair…..by slowing the rate of hair fall and keeping the hair follicle in the growing phase longer, the process of greying is also slowed.
    Eyelash Growth
    • the market is dominated by prostaglandin based products with a drug like side effect profile. In contrast, naturally derived FGF5 inhibitors are expected to be safe, with similar efficacy.
    • Treatments that promote eyelash growth represent an exciting new market with high demand for scientifically validated products and little competition. The current market leader, Allergan, has the only approved treatment for eye lash growth (Latisse) which sold $74 million in its first year of launch. Latisse has experienced $10-15 million in annual growth since its inception and in 2013 reached over $124 million in global sales.

    Cancer Detection
    Bladder Cancer Detection
    Entity
    $ Relevance
    Product
    Purpose
    Competitive Advantage
    Upside Risks
    1 Pacific Edge
    Milestone Fee (Paid)
    +
    Royalties Will Also Be Paid To Cellmid On Cxbladder® Revenues

    First Payment Due Sept.2014
    CxBladder
    Bladder Cancer Detection

    • Organic Revenue Increases (Product is new to market, huge upside, Generating Early Revenues In Australia, New Zealand And The USA)
    • Move into new market
    • Partnering
    • New Products using CDY IP
    • US Medicare news

    • in the process of commercial development in Spain and has singled out Japan and South East Asia as potential new market opportunities.
    • In the past twelve months Pacific Edge has built a solid footprint for Cxbladder in the US market with a certified laboratory, the rollout of its US sales and marketing force, and through its education programs which have built the reputation and awareness of the Cxbladder test among clinicians.
    • In their recently released Annual Report Pacific Edge Chairman Chris Swann said “evaluating haematuria (blood in the urine) in American patients for bladder cancer is a significant market of scale”.
    • “our goal of attaining a business with a gross revenue of $100 million after five full years of trading remains our target and continues to be steadily attainable”.

    Lung Cancer Detection
    Entity
    $ Relevance
    Product
    Purpose
    Competitive Advantage
    Upside Risks
    1 CeleraQuest
    Licence Fee (Future) Upon Commercialization
    +
    On-Going Royalties

    LungDx
    Lung Cancer Diagnostic Test Incorporating Cellmid’s Midkine Biomarker.
    (Currently in Clinical Validation Phase)

    • Positive Clinical Validation Results
    • Contract Signing
    Note: After 31st Oct, CDY has the option to dual license the IP for similar purpose
    • achieved major advances during the last twelve months…in the process of testing of the samples on the Luminex platform with results expected to be submitted to the NCI‟s data review committee later this year.
    • Quest has exclusive rights to use midkine in a lung cancer test until 31 October 2014, unless they launch a product before that date. Given that they are successful in a product launch, they retain exclusivity. Otherwise they retain the right to continue to use midkine on a nonexclusive basis according to the terms of the license agreement.
    Latex Bead Midkine Test
    Entity
    $ Relevance
    Product
    Purpose
    Competitive Advantage
    Upside Risks
    1 Fujikura Kasei
    License Fee (Future)
    +
    Ongoing Material Supply Contract

    Latex Bead Midkine Test
    (Currently in Clinical Validation Phase)

    • Positive Clinical Validation Results
    • Contract Signing
    Note: After 31st Oct, CDY has the option to dual license the IP for similar purpose
    • we expect that the agreement will be signed as soon as costs and quantities can be reliably determined by both parties.

    Cancer Treatment
    MK antibody program is on track…we have advanced our “first in man‟ anti-midkine antibody (MK Ab or CAB 102) program with the completion of humanisation, lead selection and the commencement of GMP manufacturing.
    Cancer Medicine – Tumours
    Entity
    $ Relevance
    Product
    Purpose
    Competitive Advantage
    Upside Risks
    1 Cellmid
    NPD

    Oncology Program CAB102
    Cancer - Oncology is a Branch Of Medicine That Deals With Tumours
    • Breakthrough therapy
    • IND-enabling study completion (expected to be completed during 4Q 2014)
    • Entering the clinic (phase I/IIa clinical testing in early 2015)
    • Positive manufacturing results
     
    CAB102 is a humanised monoclonal antibody targeting MK for use in solid tumours. In vivo pre-clinical studies have shown that anti-MK antibodies inhibit tumour growth, tumour spread (metastasis) and tumour blood vessel growth (angiogenesis) in a variety of xenograft models.
    • achieved a major milestone with the successful humanising of its most promising oncology antibody.
    • early manufacturing testing suggests that it can be made in sufficient quantities to make it a feasible drug product.
    • In preparation for clinical testing two aspects fundamental to the program‟s success need to be properly executed. These are the preclinical safety testing and the manufacture of the drug product.
    • Cellmid has recently appointed its manufacturing partner, Rodon Biologics (Portugal), and commenced this manufacturing process. We have progressed through some of the technically most challenging parts without adverse events and expect that we will be able to produce CAB102 as planned.

    Treatment of Inflammatory and Autoimmune diseases
    Cellmid holds has the most comprehensive global patent portfolio around the use of anti-MK agents for treating inflammatory and autoimmune diseases.
    Treatment Of Inflammatory & Autoimmune Diseases (Kidney Disease And Multiple Sclerosis)
    Entity
    $ Relevance
    Product
    Purpose
    Competitive Advantage
    Upside Risks
    1 Cellmid
    NPD

    CAB101 Inflamatory Antibody
    Treatment Of Inflammatory & Autoimmune Diseases (Kidney Disease And Multiple Sclerosis)

     
    In vivo pre-clinical studies in various animal models of inflammation and autoimmunity have shown that the murine version of the antibody ameliorates disease by reducing inflammatory cell infiltration and increasing regulatory T cell numbers. No off target toxicities have been observed. Pre-clinical studies of CAB101 are ongoing.

    Treatment of heart disease
    Heart Attack
    Entity
    $ Relevance
    Product
    Purpose
    Competitive Advantage
    Upside Risks
    1 Cellmid
    NPD

    CMK103 Cardiac Ischemia Treatment
    Heart Attack - Prevent Heart Failure By Reducing The Damage To Tissues Inflicted By Heart Attack

    • Pos. pre-clinical results
    • Pos. manufacturing studies
    pre-clinical and manufacturing studies of CMK103 are currently underway.


    Imminent Upside Risks
    - market realization of SP discount on peers
    - newsflows accompanying the annual report


    Financials
    Link: 2014 Prelim Financials
    Valuations
    http://www.cellmid.com.au/SiteMedia/w3svc921/Uploads/Documents/Cellmid_30 May 2014.pdf
    http://www.cellmid.com.au/SiteMedia/w3svc921/Uploads/Documents/RM Research Report 3 Feb 2014.pdf





    Scientific/Medical Terms:
    Column 1 Column 2
    1 In vivo
    studies are those conducted in animals including humans
    2 Cardiac Ischemia
    Heart attack
    3 Antibody
    An antibody (Ab), also known as an immunoglobulin (Ig), is a large Y-shape protein produced by plasma cells that is used by the immune system to identify and neutralize foreign objects such as bacteria and viruses
    4 autoimmune diseases
    Autoimmunity is the failure of an organism in recognizing its own constituent parts as self, thus leading to an immune response against its own cells and tissues.
    5 infarct
    Tissue death
    6 IND
    Investigational New Drug
    7 Ameliorate
    make (something bad or unsatisfactory) better.
    8 Apoptosis
    programmed cell death
    Last edited by Trae: 10/09/14
 
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