from tsuguy on iFlub
Quote:Here are my shorthand notes...
ICON has converted over 40 times from BD to ICON
Cost less than $150k
No revenue until 2015 on LymPro and will be from research in AD
RUO segmented market - $150 mill annually
Position - Aid in a diagnosis to AD
Pre-Screening patients before going into AD treatments
On average 50% patients screened with PET fail - large cost $10k per patient screen
30-40% savings per PET screen means we are looking at about 6-7k per test total
Contracted research company - 200 ongoing AD Trials - 143 Phase 2 trial (focus) estimate 100 subjects per trial 14,300 potential subjects.
Sales via clia will be modest in 2015, but 2016 will be growth with pharma partners
44 subjects tested to date
Expanding study to include early stage AD - can identify all stage. Currently in late to mid stage.
RD increased over 700k to 1.2 million due to clinical work
Anticipate increased an increase due to key product programs.
Has cash and cash equivalents 2.4 million
Additional 18million equity financing through LPC
List AMBS on exchange on later in the year
Eltroprazine - No drugs approved for Lid
Charlotte Keywood - clinical
drug project manufacturing
clinical study protocol
clinical research organization
Open IND in Europe
To open IND with neurology with FDA
Start trial at end of this year
MANF
Want to get into clinical trials ASAP
Moved aggressively to take IP and Licenses
Will continue this strategy on Licensing and IP
Develop in orphan indications and retain ability to advance for curative application
Done private toxicology in the eye and was great success
Potential diabetes application
Protein therapy is focus at the time
Preparing MANF to FDA for one or more orphan optomal indications.
Q&A
Jason Napodano - Zachs
Data from AAIC and C4CT Summit - accuracy of those results and adding biomarkers. What biomarkers are we looking at and what is the return of those biomarkers.
Answer: CD69 subsurface marker - All other markers are all cell types and express CD69
Pharma's think 80% is really good especially from a single marker, because additional markers can be reviewed. Each marker added on complicated the analysis to a certain extent. Have to add another antibody to identify cell type and another to identify CD69. So each additional marker required additional antibody. Each antibody added increases cost and does change reimbursement. Exploring different combinations of the markers to come up with a matrix with efficiency, effectiveness, and cost control with maximum profit margin.
Could be several 1000 of these tests processed a day. Could cut a 4000 person trial group to 2500 to identify 2000 accurate AD patients for PET. $15 million on enrollment alone on this example.
LymPro - "stage independent" demonstration that score will not be different for each stage of disease.
Commissioning of first of several work orders only $150k or less. This will get LymPro ready for presentation to pharma companies doing clinical trials.
CLIA requires only 1 lab for use. This is going to be a long-term relationship with ICON. Part of the sales price will go to ICON for doing the work because they will be processing test.
CLIA to validate the assay. Put ourself into other business arrangements but will not discuss on this call.
ELTROPRAZINE in discussions with an individual Dr. XXX who has worked on this. Discussed him being the principle investigator. First POC trial was 50% funded by MJFF. There has been some additional discussion on this forthcoming trial. Will occur with or without MJFF. They are interested in more quantitative data. Looking at true connecting monitor devices, stream of high density data. Concern of accuracy of patient diaries. Want to get better or true quantitative measures of this data. Looking into potential grant applications.
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Quarter by quarter view of next quarters
Enrollment of EL2 - expect to see full data
Requesting meeting with FDA on ELTROPRAZINE
MANF - see additional data on toxicology work
4th quarter
efficacy of MANF
file one or more apps with FDA
LymPro - receive completion of study
Expect to see completion of fit for purpose and clia
pre-ind meeting and filing and initian of phase 2b
2015
Initial commercial sales on LymPro
trials LymPro will be used in
FDA response on MANF apps
Commercial manufacturer of MANF - target list done now and doing due diligence on now
Toxicology data on MANF
ELTROPRAZINE - end of phase 2b
LymPro continued use in clinical trials
Marketing effort initiated
Not sure of spinoff
Looking at a number of strategic transactions - asset acquisition, offsetting expenses from various transactions
Tiered approach to LymPro sales
Want to be involved in as many trial as possible but theraputic successfully trials. If they become successful by use in their treatment they would have to use LymPro in identifying test. Want to be a companion diagnostic.
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J. Petro, JWP Inc.
Need shares available to protect negative market forces in hostile takeover. Key focus.
As we look to expand the company into strategic acquisition for opening new lines of business and fortify current lines of business. Investors want to know they are not investing in dead horse.
There is a potential to raise additional capital and want to have the ability to do that in the least dilutive method as possible. Where/who you raise money is important.
Have seen other companies on OTC survive by diluting out shareholders, don't want to follow that trend. Want to see true value by increased for him and his family, and shows his true intent.
Not many billion or 5 billion $ companies on OTC marketplace.
Want to allow larger institutions to take large value accredit positions into the company.
AMBS does not have the intent to go it alone, want to maximize every dollar in to AMBS to max amount to shareholders. Big pharma has invested 10's of billions into AD research without any credence into verifying trials.
Want to follow Amivid footsteps. LymPro is leverage point in negotiation to acquire exclusive asset. Groups in big pharma want to see more data and are very interested in ICON data.
Phenogard - prohibited discussing partnership activity, but can say they are active. Astrocytes have taken on importance in scientific community. Have 87 Cell lines in freezer. Trying to expand on different cell lines and high degree of confidence that we are going into other proteins. Can't go any further on those results.
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Have met all milestones - CRO has been terminated for lack of enrollment measures and was reason for delay in the data.
Expect to grab a large number of the $150 million potential revenue. Need to determine how many markers will be part of assay.
I apologize if there are any inaccuracies as this was quick shorthand as I heard it.
