Here's my email to info@generex.com for the call Thursday:
_______________________
Hi, Joe and Team,
As requested, here are my questions for the conference call on Thursday. Hopefully the call is an open enough means of communication that you can do justice to most of these topics, despite quiet periods.
1) NGIO IPO - Please give us the full info dump on this topic, since it is seen by many of us as the key to funding both companies and unlocking the value of all the parts of "the machine".
- What barriers remain for getting the IPO to market?
- Is there a Road Show planned? When? What can you tell us about the attendees?
- When will IPO share pricing be released?
- When will a share count for the IPO be released?
- What is a realistic time frame for the IPO/first day of trading?
- This IPO will presumably fund GNBT. Will NGIO issue additional common shares to fund its needs for working capital/going concern, or will the NGIOP preferred shares be the approach?
Forgive us, but with the dates that have been mentioned on calls and on the Big Biz Show that have come and gone, the info from conversations various shareholders have had with Dawson James that has not panned out, Joe's statements that he would not defer the IPO for scientific milestones despite the stretching time frame, etc., a reasonable person can't help but wonder if one or more of the following isn't blocking our path for this mission-critical IPO:
- Share price being sought isn't attracting market interest.
- There isn't any interest until further events (IND submission and/or approval, Phase I/II submission/start and/or completion, etc.) occur.
- There is some sort of regulatory delay.
Please do your best to dispel fears that this keystone event is not being held up and confirm that we are indeed VERY close to this milestone.
2) Covid-19 Vaccine - Hopefully, the opening info on the call will answer some of the many Qs we all have, but here are some of the details we would love to flesh out:
- IND submission timeline?
- China Phase I/II testing start date estimate relative to IND approval (2 weeks after IND approval? 2 months after approval?)?
- US Phase I/II testing start date estimate relative to IND approval?
- Joe stated on the last call that the Pre-IND and its response "solved some of the issues with the application" to BARDA. What can you tell us about your continued pursuit of funding from BARDA?
- Are you still pursuing money from any other countries or organizations (Health Canada, etc.) that you can give us updates on?
- What is the status, best guess timeline, and need for the peer review on the "Complete Vaccine", and is that a holdup for any further steps?
- Are any Covid vaccine deals with additional countries (Singapore, S Africa, Canada, etc.) still in the works that might lead to up-front payments (before vaccine approval) that might help with working capital issues?
3) Revenues -
- Regarding the NuGen Health CCM/RPM efforts, on the 8/26 call Sanjay told me in the Q&A that the device delays for the CCM/RPM were expected to be cleared in ~6 weeks, paving the way for the first Medicare reimbursements for these projects to be received around Thanksgiving. Yet on the last 10K, covering thru 1/31/21, we had $0 in revenues. What caused the delay in this program (which I was very excited to hear about, since it seemed very promising for providing a recurring and growing revenue stream)? What can you tell us about the revenue stream that has been established here since 1/31/21 (Still dead in the water? Slowly ramping now? Really taking off?)? Where do we stand on patient count enrolled in these programs now, and what are some realistic ramp-up estimates for patient enrollment (or revs if you can speak to that) in these initiatives?
- Excellagen - Tony Dolesi said last summer that the VA was going to 25% capacity in August and that may help get Excellagen rolling again. Where do we stand on VA opportunities, and do we have the funding to move on that whenever the opportunity presents itself? On the non-VA front, it has been circulated that McKesson needs $millions to stock Excellagen, and we also need to re-hire the Sales staff to get Excellagen off the ground outside the VA... where do we stand on this commercial (non-VA) rollout? What is the timeline for the payment on the initial 500 doses for the recently-announced deal with Nexgen Medical in Malaysia, and will these proceeds be used to further the commercial rollout of Excellagen mentioned above?
- Presuming there are other initiatives in AZ that are now active (3/31 PR stated: "This facility will be complete and fully operational by May 1 and will include all of our previously announced partnerships, in addition, our new business of CCM/RPM."
, how quickly can we expect revenues to start to come in from these efforts and in what sort of magnitude?
- Do you expect enough revenues in a short-term period that you will be able to cease putting GNBT shares to the market for funding?
Less-pressing topics that would be great to get updates on:
4) Regentys - Joe mentioned that China might be interested in their ExtraCellular Matrix Hydrogel. Is there any update on that angle, and could it help get clinical testing started? I believe there was a trial pending in Australia for that... any progress there?
5) Any AltuCell update? Is Gary still hanging with us? How are things proceeding with the Italy trials?
6) $6MM for Employee benefits to be raised thru share issues - Have shares been issued for that, or has the $1MM in cash it appears went toward that worthy cause granted us a delay in issuing shares for that purpose until a better share price/time?
7) An NGIO acquisition target was mentioned. Is that still in the works? What can you tell us about that?
Any progress on a deal with Swine Flu, Influenza, or any other initiatives with China?
9) Jason gave a decent amount of info on an LOI for a Texas-based diagnostics firm (Aima Bio?) on the August call. Still an open item? Updates?
Thanks in advance for as much information as you can provide and thank you all for your hard work on all of the many GNBT/NGIO initiatives. We sincerely look forward to good news and significant updates on the call.
____________________________
I hope you all are submitting Qs as well so we can make the most of the call!
_______________________
Hi, Joe and Team,
As requested, here are my questions for the conference call on Thursday. Hopefully the call is an open enough means of communication that you can do justice to most of these topics, despite quiet periods.
1) NGIO IPO - Please give us the full info dump on this topic, since it is seen by many of us as the key to funding both companies and unlocking the value of all the parts of "the machine".
- What barriers remain for getting the IPO to market?
- Is there a Road Show planned? When? What can you tell us about the attendees?
- When will IPO share pricing be released?
- When will a share count for the IPO be released?
- What is a realistic time frame for the IPO/first day of trading?
- This IPO will presumably fund GNBT. Will NGIO issue additional common shares to fund its needs for working capital/going concern, or will the NGIOP preferred shares be the approach?
Forgive us, but with the dates that have been mentioned on calls and on the Big Biz Show that have come and gone, the info from conversations various shareholders have had with Dawson James that has not panned out, Joe's statements that he would not defer the IPO for scientific milestones despite the stretching time frame, etc., a reasonable person can't help but wonder if one or more of the following isn't blocking our path for this mission-critical IPO:
- Share price being sought isn't attracting market interest.
- There isn't any interest until further events (IND submission and/or approval, Phase I/II submission/start and/or completion, etc.) occur.
- There is some sort of regulatory delay.
Please do your best to dispel fears that this keystone event is not being held up and confirm that we are indeed VERY close to this milestone.
2) Covid-19 Vaccine - Hopefully, the opening info on the call will answer some of the many Qs we all have, but here are some of the details we would love to flesh out:
- IND submission timeline?
- China Phase I/II testing start date estimate relative to IND approval (2 weeks after IND approval? 2 months after approval?)?
- US Phase I/II testing start date estimate relative to IND approval?
- Joe stated on the last call that the Pre-IND and its response "solved some of the issues with the application" to BARDA. What can you tell us about your continued pursuit of funding from BARDA?
- Are you still pursuing money from any other countries or organizations (Health Canada, etc.) that you can give us updates on?
- What is the status, best guess timeline, and need for the peer review on the "Complete Vaccine", and is that a holdup for any further steps?
- Are any Covid vaccine deals with additional countries (Singapore, S Africa, Canada, etc.) still in the works that might lead to up-front payments (before vaccine approval) that might help with working capital issues?
3) Revenues -
- Regarding the NuGen Health CCM/RPM efforts, on the 8/26 call Sanjay told me in the Q&A that the device delays for the CCM/RPM were expected to be cleared in ~6 weeks, paving the way for the first Medicare reimbursements for these projects to be received around Thanksgiving. Yet on the last 10K, covering thru 1/31/21, we had $0 in revenues. What caused the delay in this program (which I was very excited to hear about, since it seemed very promising for providing a recurring and growing revenue stream)? What can you tell us about the revenue stream that has been established here since 1/31/21 (Still dead in the water? Slowly ramping now? Really taking off?)? Where do we stand on patient count enrolled in these programs now, and what are some realistic ramp-up estimates for patient enrollment (or revs if you can speak to that) in these initiatives?
- Excellagen - Tony Dolesi said last summer that the VA was going to 25% capacity in August and that may help get Excellagen rolling again. Where do we stand on VA opportunities, and do we have the funding to move on that whenever the opportunity presents itself? On the non-VA front, it has been circulated that McKesson needs $millions to stock Excellagen, and we also need to re-hire the Sales staff to get Excellagen off the ground outside the VA... where do we stand on this commercial (non-VA) rollout? What is the timeline for the payment on the initial 500 doses for the recently-announced deal with Nexgen Medical in Malaysia, and will these proceeds be used to further the commercial rollout of Excellagen mentioned above?
- Presuming there are other initiatives in AZ that are now active (3/31 PR stated: "This facility will be complete and fully operational by May 1 and will include all of our previously announced partnerships, in addition, our new business of CCM/RPM."
, how quickly can we expect revenues to start to come in from these efforts and in what sort of magnitude? - Do you expect enough revenues in a short-term period that you will be able to cease putting GNBT shares to the market for funding?
Less-pressing topics that would be great to get updates on:
4) Regentys - Joe mentioned that China might be interested in their ExtraCellular Matrix Hydrogel. Is there any update on that angle, and could it help get clinical testing started? I believe there was a trial pending in Australia for that... any progress there?
5) Any AltuCell update? Is Gary still hanging with us? How are things proceeding with the Italy trials?
6) $6MM for Employee benefits to be raised thru share issues - Have shares been issued for that, or has the $1MM in cash it appears went toward that worthy cause granted us a delay in issuing shares for that purpose until a better share price/time?
7) An NGIO acquisition target was mentioned. Is that still in the works? What can you tell us about that?
Any progress on a deal with Swine Flu, Influenza, or any other initiatives with China? 9) Jason gave a decent amount of info on an LOI for a Texas-based diagnostics firm (Aima Bio?) on the August call. Still an open item? Updates?
Thanks in advance for as much information as you can provide and thank you all for your hard work on all of the many GNBT/NGIO initiatives. We sincerely look forward to good news and significant updates on the call.
____________________________
I hope you all are submitting Qs as well so we can make the most of the call!
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