Complete Listing of Gerald's Response to Questions
Post# of 30028
Posted On: 07/10/2014 5:12:53 PM
Complete Listing of Gerald's Response to Questions
Gerald's responses are in bold .
Welcome to #AskAMBS, thank you MDM Worldwide for organizing the event.
WCoastGuynCA: What 3 milestones will occur to allow AMBS to up-list?
LymPro partnership, Eltoprazine first patient in, MANF orphan drug designation.
Neal S: Are you still planning on projecting Lympro revenue during the 2Q Call and when will that call occur?
That is our plan, yes.
Iker: What's a realistic timeframe for uplisting? Q3 2014? Q4? or Q1 2015?
Our projected timeline is Q4/15. (I'm sure he meant 2014)
topher plow: When do you expect to issue revenue guidance for Lympro?
In our 2nd quarter conference call.
topher plow: Any updates on the lesser known products, Nuropro, BC Sera Pro, or Phenoguard?
We will not be publicly commenting on these at the current time.
topher plow: Will there be PRs regarding info presented at AAIC?
Yes.
Leonardo Casini: Is there already a marketing plan for the Lympro commercialization?
Our strategy parameters are in place, however we cannot disclose at this time.
Biotrader2014: With commercialization planned under CLIA, what seen or unforeseen events could delay commercialization?
Completion of the partnership terms could delay, however we are confident we will get this done in a timely fashion.
Don Lausch: Any updates on CED?
Studies are currently ongoing.
Biotrader2014: Possibility of uplisting WITHOUT requiring a reverse split? What specific chain of catalyst events would be needed?
It is possible. I cannot discuss the background at the current time.
Michael Bliss: Whatever happened to the proposed collaboration with Generex Biotech?
Amarantus terminated it. We want to maintain all rights to our diabetes programs in the immediate future.
Iker: What would be an acceptable reverse stock split for uplisting? 1-for-5? 1-for-10? and to which National Exchange? NYSE, NASDAQ? NSX?
We are in discussions w/ both exchanges and have not made any decisions regarding a reverse split or its necessity in Q4.
The Gr8Life: Not having to do a R/S to uplist is ideal, however is there a PPS that $AMBS would have to reach 1st before a R/S is considered?
We are not currently focused on stock price, but fundamental science. Will reevaluate once we achieve the milestones.
fibonacci: suggestions: Publish data in letters/journals, not blogs. Where is BC-SeraPro? Don't pal w/ #fraudsters thestreet+feuerstein.
We are in process of submitting several manuscripts to top-tier journals & expect publications to start in the fall.
topher plow: Can AMBS say anything about a partner in Diabetes? If not, when can you?
I cannot discuss at the current time.
Robert Hipps: is the identified partner for LymPro aware they are the front runners from AMBS' perspective?
Yes.
marcus jackson: GC when will we learn who our target partner is that BD is handing LymPro off to? Ty
We expect to complete the agreement by the end of the summer.
topher plow: Does AMBS expect to have a big pharma partner for one or more MANF indications before uplisting?
We expect to complete the agreement by the end of the summer.
Buy and Hold: Other than the obvious benefits of up-listing, aren't you concerned with short houses and hedge funds?
We’ve subjected to naked shorting, unauthorized Berlin listing & other tactics. I think we can handle legal shorting.
Zoomboom: how are Grant applications going, can you say how many apps are filed, when can expect to hear about news on this Front.
We have submitted 6 applications to date, and are working on more for the August deadline.
topher plow: When does AMBS expect to finish negotiations with the target Lympro partner?
In the summer.
Erik Pike: Have you directed Lincoln Park Capital to purchase any shares as of yet? If so, how much of the line has AMBS used thus far?
One purchase w/ LPC for 1.5M shares as a test to make sure process works properly. We do not need to draw at this time.
Jason Napodano, CFA: Sorry for the upcoming barrage - but I'm about to tweet out a ton of questions
giddy up
Jason Napodano, CFA: How many patients of the original 44 are included in the longitudinal clinical performance analysis?
We have 42 of the 44 charts available.
Jason Napodano, CFA: Was the bridging study something that the FDA or CMS required, or what that conducted just to better understand Version 2?
Conducted to better understand V2.
Jason Napodano, CFA: Does the Analytical Performance package put together from studies conducted at Becton Dickinson include both Version 1 and 2?
Yes, it supports both versions.
Jason Napodano, CFA: What is the timeline for obtaining a commercial lab partner for LymPro?
This summer.
Paolo Giannerini: do you plan to split the therapeutic and the diagnostic division? Do you think it could be a positive operation?
It's a possibility we are considering once LymPro is commercial-stage. We believe there is significant benefit.
Jason Napodano, CFA: How quickly can you and a commercial partner be ready to file for CLIA?
We remain on the timeline for 2014.
Dave Drennan: Will you partner for future development of MANF? How much partner interest on MANF to date? Best of luck over next few weeks.
At some point we will partner the program, yes. We have interest. We are exploring options.
Jason Napodano, CFA: How soon after CLIA can we expect partnership discussions for use of LymPro as a companion diagnostic?
Those discussions have started. It will first be used as a surrogate marker in Tx trials, then entry criteria.
Jason Napodano, CFA: Everything still on track to begin a Phase 2 LID study with eltoprazine before the end of the year?
Yes. David Lowe, Charlotte Keywood and Mark Wakefield are working extremely hard on this.
Greg
With the extensive amount of growth at AMBS I'm curious as to how many employees are currently at each location?
We have 13 team members in the US and 7 in Geneva Switzerland.
Jason Napodano, CFA: Any thoughts you can share on the design of the P2 #eltoprazine study? Size? Location? Endpoints?
Phase 2b trial, 200 patients, Europe & US, Unified Dyskinesia Rating Scale.
Jerry Gundersheimer: Estimate of range of where you'd like see share price before reverse split/up-list? Glad it's in 2015.
We do not know a reverse is needed.
Jason Napodano, CFA: Is there grant funding available for the P2 eltoprazine study, for example from organization such as MJFF?
It is possible. I cannot discuss further details.
Jason Napodano, CFA: You’ve already released the interim toxicology data. When can we expect functional data on MANF in RP?
We expect functional data in the very near future.
Jason Napodano, CFA: Does it make sense to pursue to separate Orphan designations on MANF in both RP and Wolframs?
Yes.
Marc Rokoff: wondering how much more dilution expected before uplist. Are shares currently being added to the market? At what rate?
We don't foresee significant dilution, only warrants. We don't plan to do a raise to fund our current operations.
Jason Napodano, CFA: What is the timeline for the first Orphan Drug application with MANF?
2H-2014
Zak Asmelash: with current valuation very low, is hostile take-over a concern?
We have already created infrastructure to defend against this. I would welcome someone to try.
DMan: Any grant update with MJFF regarding Eltoprazine and MANF for PD?
I cannot comment at the current time.
fazo: is the GENEVA office up and running? whats the purpose and cost of this? wheres $$$ coming from?
It is up and running. It costs $3/month. The purpose is Dr. Lowe and Dr. Keywood having an office to work in. (I believe he meant $3K/month)
Jason Napodano, CFA: Has Orphan Drug designation ever been granted on a preclinical drug? Will the FDA want to see human studies under first?
Yes. The FDA does not need human data to grant ODD.
Matt Ascone: Will there be any forthcoming publications from the Bascom Palmer Institute re: Retinitis Pigmentosa and MANF?
Yes.
Matt Ascone: Can you comment on the expected timeframe for the release of that publication?
we were told later this year
Perry Matice: (no question listed)
to improve our shareholder's equity in prep for the uplist.
Jason Napodano, CFA: What is the timeline for the first MANF IND application?
2H-15
rjs_alpha: Gerald, in 2013 you hoped for one or more Investigational New Drug filings in 2014 for MANF studies. What's the current timetable?
We were delayed due to inability to raise funds with DTCC Chill. We have pushed the timetable to 2015.
Jason Napodano, CFA: Congrats on the warrant conversion! I estimate cash at Sept 30th will be around $2.6 million. What is the current cash run-rate?
It remains in the $500k-$700k range, with fluctuations based upon program needs.
Solantey: Is there a defined plan in place to promote LymPro to the global media?
When the time is right, yes. Get KOLs behind it first. We don't want our data getting slammed as has happened to others.
Jason Napodano, CFA: Can you discuss potential for non-dilutive cash in the near-term?
There is significant potential for near-term non-dilutive financing.
Robin Schwartz: Would you please update developments with Banyan Biomarkers and the work with the DOD on TBI
We have deprioritized that for now to focus on retinitis pigmentosa. When funds become available we will refocus there.
topher plow: Has AMBS been approached for a buyout?
I cannot comment.
Jason Napodano, CFA: Ok, I'm done. I've thoroughly dominated the #AskAMBS hashtag!
I expected nothing less...
rjs_alpha: has the company begun pharmacology studies in traumatic brain injury, ischemic heart disease, or diabetes?
We are focusing on RP, however are planning studies in IHD and diabetes.
Paolo Giannerini: I would like an update regarding eltoprazine: next steps phase 2 or 3? Ongoing partnership negotiation? Time to market?
A 200 patient Phase 2b that will complete end of 2015. Expect 2 parallel Phase 3s 2016-2018, submission in 2019.
Due to the overwhelming response, I will try to answer questions I couldn't get to in a forthcoming blog post. Thank you everyone for your questions and thanks again to MDM Worldwide.
With respect to MDM - they have been nothing but professional and disclosure driven. I think that author is very short. (not sure what author he refers to, but there has been some negative assertions on the boards lately regarding the company's involvement with MDM)
Tweets copied and pasted from https://twitter.com/G_Commish
Gerald's responses are in bold .
Welcome to #AskAMBS, thank you MDM Worldwide for organizing the event.
WCoastGuynCA: What 3 milestones will occur to allow AMBS to up-list?
LymPro partnership, Eltoprazine first patient in, MANF orphan drug designation.
Neal S: Are you still planning on projecting Lympro revenue during the 2Q Call and when will that call occur?
That is our plan, yes.
Iker: What's a realistic timeframe for uplisting? Q3 2014? Q4? or Q1 2015?
Our projected timeline is Q4/15. (I'm sure he meant 2014)
topher plow: When do you expect to issue revenue guidance for Lympro?
In our 2nd quarter conference call.
topher plow: Any updates on the lesser known products, Nuropro, BC Sera Pro, or Phenoguard?
We will not be publicly commenting on these at the current time.
topher plow: Will there be PRs regarding info presented at AAIC?
Yes.
Leonardo Casini: Is there already a marketing plan for the Lympro commercialization?
Our strategy parameters are in place, however we cannot disclose at this time.
Biotrader2014: With commercialization planned under CLIA, what seen or unforeseen events could delay commercialization?
Completion of the partnership terms could delay, however we are confident we will get this done in a timely fashion.
Don Lausch: Any updates on CED?
Studies are currently ongoing.
Biotrader2014: Possibility of uplisting WITHOUT requiring a reverse split? What specific chain of catalyst events would be needed?
It is possible. I cannot discuss the background at the current time.
Michael Bliss: Whatever happened to the proposed collaboration with Generex Biotech?
Amarantus terminated it. We want to maintain all rights to our diabetes programs in the immediate future.
Iker: What would be an acceptable reverse stock split for uplisting? 1-for-5? 1-for-10? and to which National Exchange? NYSE, NASDAQ? NSX?
We are in discussions w/ both exchanges and have not made any decisions regarding a reverse split or its necessity in Q4.
The Gr8Life: Not having to do a R/S to uplist is ideal, however is there a PPS that $AMBS would have to reach 1st before a R/S is considered?
We are not currently focused on stock price, but fundamental science. Will reevaluate once we achieve the milestones.
fibonacci: suggestions: Publish data in letters/journals, not blogs. Where is BC-SeraPro? Don't pal w/ #fraudsters thestreet+feuerstein.
We are in process of submitting several manuscripts to top-tier journals & expect publications to start in the fall.
topher plow: Can AMBS say anything about a partner in Diabetes? If not, when can you?
I cannot discuss at the current time.
Robert Hipps: is the identified partner for LymPro aware they are the front runners from AMBS' perspective?
Yes.
marcus jackson: GC when will we learn who our target partner is that BD is handing LymPro off to? Ty
We expect to complete the agreement by the end of the summer.
topher plow: Does AMBS expect to have a big pharma partner for one or more MANF indications before uplisting?
We expect to complete the agreement by the end of the summer.
Buy and Hold: Other than the obvious benefits of up-listing, aren't you concerned with short houses and hedge funds?
We’ve subjected to naked shorting, unauthorized Berlin listing & other tactics. I think we can handle legal shorting.
Zoomboom: how are Grant applications going, can you say how many apps are filed, when can expect to hear about news on this Front.
We have submitted 6 applications to date, and are working on more for the August deadline.
topher plow: When does AMBS expect to finish negotiations with the target Lympro partner?
In the summer.
Erik Pike: Have you directed Lincoln Park Capital to purchase any shares as of yet? If so, how much of the line has AMBS used thus far?
One purchase w/ LPC for 1.5M shares as a test to make sure process works properly. We do not need to draw at this time.
Jason Napodano, CFA: Sorry for the upcoming barrage - but I'm about to tweet out a ton of questions
giddy up
Jason Napodano, CFA: How many patients of the original 44 are included in the longitudinal clinical performance analysis?
We have 42 of the 44 charts available.
Jason Napodano, CFA: Was the bridging study something that the FDA or CMS required, or what that conducted just to better understand Version 2?
Conducted to better understand V2.
Jason Napodano, CFA: Does the Analytical Performance package put together from studies conducted at Becton Dickinson include both Version 1 and 2?
Yes, it supports both versions.
Jason Napodano, CFA: What is the timeline for obtaining a commercial lab partner for LymPro?
This summer.
Paolo Giannerini: do you plan to split the therapeutic and the diagnostic division? Do you think it could be a positive operation?
It's a possibility we are considering once LymPro is commercial-stage. We believe there is significant benefit.
Jason Napodano, CFA: How quickly can you and a commercial partner be ready to file for CLIA?
We remain on the timeline for 2014.
Dave Drennan: Will you partner for future development of MANF? How much partner interest on MANF to date? Best of luck over next few weeks.
At some point we will partner the program, yes. We have interest. We are exploring options.
Jason Napodano, CFA: How soon after CLIA can we expect partnership discussions for use of LymPro as a companion diagnostic?
Those discussions have started. It will first be used as a surrogate marker in Tx trials, then entry criteria.
Jason Napodano, CFA: Everything still on track to begin a Phase 2 LID study with eltoprazine before the end of the year?
Yes. David Lowe, Charlotte Keywood and Mark Wakefield are working extremely hard on this.
Greg
With the extensive amount of growth at AMBS I'm curious as to how many employees are currently at each location? We have 13 team members in the US and 7 in Geneva Switzerland.
Jason Napodano, CFA: Any thoughts you can share on the design of the P2 #eltoprazine study? Size? Location? Endpoints?
Phase 2b trial, 200 patients, Europe & US, Unified Dyskinesia Rating Scale.
Jerry Gundersheimer: Estimate of range of where you'd like see share price before reverse split/up-list? Glad it's in 2015.
We do not know a reverse is needed.
Jason Napodano, CFA: Is there grant funding available for the P2 eltoprazine study, for example from organization such as MJFF?
It is possible. I cannot discuss further details.
Jason Napodano, CFA: You’ve already released the interim toxicology data. When can we expect functional data on MANF in RP?
We expect functional data in the very near future.
Jason Napodano, CFA: Does it make sense to pursue to separate Orphan designations on MANF in both RP and Wolframs?
Yes.
Marc Rokoff: wondering how much more dilution expected before uplist. Are shares currently being added to the market? At what rate?
We don't foresee significant dilution, only warrants. We don't plan to do a raise to fund our current operations.
Jason Napodano, CFA: What is the timeline for the first Orphan Drug application with MANF?
2H-2014
Zak Asmelash: with current valuation very low, is hostile take-over a concern?
We have already created infrastructure to defend against this. I would welcome someone to try.
DMan: Any grant update with MJFF regarding Eltoprazine and MANF for PD?
I cannot comment at the current time.
fazo: is the GENEVA office up and running? whats the purpose and cost of this? wheres $$$ coming from?
It is up and running. It costs $3/month. The purpose is Dr. Lowe and Dr. Keywood having an office to work in. (I believe he meant $3K/month)
Jason Napodano, CFA: Has Orphan Drug designation ever been granted on a preclinical drug? Will the FDA want to see human studies under first?
Yes. The FDA does not need human data to grant ODD.
Matt Ascone: Will there be any forthcoming publications from the Bascom Palmer Institute re: Retinitis Pigmentosa and MANF?
Yes.
Matt Ascone: Can you comment on the expected timeframe for the release of that publication?
we were told later this year
Perry Matice: (no question listed)
to improve our shareholder's equity in prep for the uplist.
Jason Napodano, CFA: What is the timeline for the first MANF IND application?
2H-15
rjs_alpha: Gerald, in 2013 you hoped for one or more Investigational New Drug filings in 2014 for MANF studies. What's the current timetable?
We were delayed due to inability to raise funds with DTCC Chill. We have pushed the timetable to 2015.
Jason Napodano, CFA: Congrats on the warrant conversion! I estimate cash at Sept 30th will be around $2.6 million. What is the current cash run-rate?
It remains in the $500k-$700k range, with fluctuations based upon program needs.
Solantey: Is there a defined plan in place to promote LymPro to the global media?
When the time is right, yes. Get KOLs behind it first. We don't want our data getting slammed as has happened to others.
Jason Napodano, CFA: Can you discuss potential for non-dilutive cash in the near-term?
There is significant potential for near-term non-dilutive financing.
Robin Schwartz: Would you please update developments with Banyan Biomarkers and the work with the DOD on TBI
We have deprioritized that for now to focus on retinitis pigmentosa. When funds become available we will refocus there.
topher plow: Has AMBS been approached for a buyout?
I cannot comment.
Jason Napodano, CFA: Ok, I'm done. I've thoroughly dominated the #AskAMBS hashtag!
I expected nothing less...
rjs_alpha: has the company begun pharmacology studies in traumatic brain injury, ischemic heart disease, or diabetes?
We are focusing on RP, however are planning studies in IHD and diabetes.
Paolo Giannerini: I would like an update regarding eltoprazine: next steps phase 2 or 3? Ongoing partnership negotiation? Time to market?
A 200 patient Phase 2b that will complete end of 2015. Expect 2 parallel Phase 3s 2016-2018, submission in 2019.
Due to the overwhelming response, I will try to answer questions I couldn't get to in a forthcoming blog post. Thank you everyone for your questions and thanks again to MDM Worldwide.
With respect to MDM - they have been nothing but professional and disclosure driven. I think that author is very short. (not sure what author he refers to, but there has been some negative assertions on the boards lately regarding the company's involvement with MDM)
Tweets copied and pasted from https://twitter.com/G_Commish
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