Oct 1, 2015 Virtual Investor Conference Notes:
Post# of 30067
Posted On: 10/05/2015 8:34:41 PM
Oct 1, 2015 Virtual Investor Conference Notes:
ESS
- Preparing to initiative a Phase 2 clinical study with the Army in Texas later Q4 or early Q1
- Applying for 2nd ESS orphan for Congenital Giant Hairy Nevus that effects 1 in 20,000 births/yr
- Severe Burns pediatrics is a rare pediatric disease that they are looking at as a orphan
- Received ODD for the treatment of burns > 50%
- ESS operating under non-diluted funding from AFRIM.
- Of the 15 pediatric patients (average age of 6) that received ESS, 100% survived. Included a 2 year old with a 95% burn which has almost 100% mortality rate.
- Patients don't have to come back for reconstructive surgery
- Now have an active IND for severe burns. Relatively simple to get additional IND, including Congenital Hairy Nevus, now that manufacturing problems have been resolved.
- GMP process is getting re-certified by Lonza expected to be complete in Q4
- Product has the support of some of the industry's top KOL
- Potential for continued support. $130M awarded by US Gov. for wound care very recently.
- ESS was presented to a special panel in May. Some of this data will available in Q4. Currently completing a review.
- Opportunity for PRV which are selling at a average of $300M
- First gen ESS likely an immediate benefit for patients, but other things can be added to make it truly revolutionary and expand into a number of other areas
- Some data has been presented by Dr. Steven Boyce, the original inventor, regarding the addition of melanocytes as well as hair and sweat glands. There is significant potential to have a revolutionary series of products beyond wound care including cosmetics.
Eltoprazine
- Phase 2b launched in June 2015 and currently treating patients
- INDs in both US & Europe
- Focus on ODD for PD LID which may reduce the burden of bring the product to market
- Recent data published in the Summer on the mechanism of action of Eltoprazine which shows it's hitting right at the heart of the condition
- Successful Adult ADHD Phase 3 Study - Preparing and putting in publication format
- Used in 30 trials with over 600 patients in up to 6x dosage. Safty issue is off the table.
- Restart 2b enrollment late this year or 2016. Data in 2H of 2016 or 1H of 2017.
- Eltoprazine could be a potential value inflection for the company in the mid-term
MANF
- Two Orphans - RP & RAO
- Blue sky potential in a lot of areas including a disease modify treatment for Parkinson's
- Intent to make additional data available shortly
- Expand development program into additional high-value indications
- Golden child. Potential to generate multiple billions of dollars
- MANF entering the clinic will be a significant value inflection for the company
Lympro
- Completed enrollment and currently evaluating data to use Lympro to identify CTE with Boston University
- Evaluating strategic transactions now and we expect one will be accomplished in the 4th quarter
- Immediate value inflection for the company could be strategic transactions Dx division and uplisting
- Next: comparing LymPro results against PET
ESS
- Preparing to initiative a Phase 2 clinical study with the Army in Texas later Q4 or early Q1
- Applying for 2nd ESS orphan for Congenital Giant Hairy Nevus that effects 1 in 20,000 births/yr
- Severe Burns pediatrics is a rare pediatric disease that they are looking at as a orphan
- Received ODD for the treatment of burns > 50%
- ESS operating under non-diluted funding from AFRIM.
- Of the 15 pediatric patients (average age of 6) that received ESS, 100% survived. Included a 2 year old with a 95% burn which has almost 100% mortality rate.
- Patients don't have to come back for reconstructive surgery
- Now have an active IND for severe burns. Relatively simple to get additional IND, including Congenital Hairy Nevus, now that manufacturing problems have been resolved.
- GMP process is getting re-certified by Lonza expected to be complete in Q4
- Product has the support of some of the industry's top KOL
- Potential for continued support. $130M awarded by US Gov. for wound care very recently.
- ESS was presented to a special panel in May. Some of this data will available in Q4. Currently completing a review.
- Opportunity for PRV which are selling at a average of $300M
- First gen ESS likely an immediate benefit for patients, but other things can be added to make it truly revolutionary and expand into a number of other areas
- Some data has been presented by Dr. Steven Boyce, the original inventor, regarding the addition of melanocytes as well as hair and sweat glands. There is significant potential to have a revolutionary series of products beyond wound care including cosmetics.
Eltoprazine
- Phase 2b launched in June 2015 and currently treating patients
- INDs in both US & Europe
- Focus on ODD for PD LID which may reduce the burden of bring the product to market
- Recent data published in the Summer on the mechanism of action of Eltoprazine which shows it's hitting right at the heart of the condition
- Successful Adult ADHD Phase 3 Study - Preparing and putting in publication format
- Used in 30 trials with over 600 patients in up to 6x dosage. Safty issue is off the table.
- Restart 2b enrollment late this year or 2016. Data in 2H of 2016 or 1H of 2017.
- Eltoprazine could be a potential value inflection for the company in the mid-term
MANF
- Two Orphans - RP & RAO
- Blue sky potential in a lot of areas including a disease modify treatment for Parkinson's
- Intent to make additional data available shortly
- Expand development program into additional high-value indications
- Golden child. Potential to generate multiple billions of dollars
- MANF entering the clinic will be a significant value inflection for the company
Lympro
- Completed enrollment and currently evaluating data to use Lympro to identify CTE with Boston University
- Evaluating strategic transactions now and we expect one will be accomplished in the 4th quarter
- Immediate value inflection for the company could be strategic transactions Dx division and uplisting
- Next: comparing LymPro results against PET
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