Good news and bad news about the transcription. Go
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Posted On: 09/03/2020 2:45:02 PM
Good news and bad news about the transcription. Good news is I have the first 40 minutes, bad news is I only have the first 40 minutes. The free version only allows 40 minutes of transcription. Maybe there is another one out there, but here is the first 40 minutes.
Unknown Speaker 0:00
day everyone and welcome today's generics biotechnology Corporation shareholder conference call. At this time all participants are in a listen only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing the start and one on your touch tone phone.
Unknown Speaker 0:22
Please note this call may be recorded and it is now my pleasure to turn the call over to Anthony crushy. Please go ahead.
Unknown Speaker 0:35
Oh looking statements included in this presentation are made pursuant to the Safe Harbor provisions of the private securities litigation Reform Act of 1995. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results levels of activity, performance or achievements to be materially different from any future results. levels of it.
Unknown Speaker 1:00
activity, performance or achievements expressed or implied by these forward looking statements. In some cases, you can identify forward looking statements by the use of words such as may could expect, intend, plan, seek, anticipate, believe, estimate predict potential or continue within the negative of these terms or other comparable terminology. You should not place undue reliance on forward looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases beyond our control and that could materially affect actual results, levels of activity, performance or achievements. A more detailed description of the other risks and uncertainties may be found in our annual report on form 10 K, and other public filings with the Securities and Exchange Commission. If any of these results or uncertainties materialize, or if our underlying assumptions prove to be incorrect, actual results may vary significantly from what we've projected in any forward looking statement. You
Unknown Speaker 2:00
Read this presentation reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to obligations, operations, results of operations, growth strategy and liquidity. We assume no obligation to publicly update or revise these forward looking statements for any reason, whether as a result of new information, future events or otherwise. Now, I'd like to turn over the call to Jonah Scott Oh, President and Chief Executive Officer of Gen X biotechnology Corporation.
Unknown Speaker 2:32
Thank you, Anthony. Good morning, myself, generics management team, and board of directors would like to thank you for parties for for participating today. On generously share all the conference call. We have announced the agenda which includes our new venture new Gen health, which is a 5050 partnership
Unknown Speaker 2:52
with a healthcare technology company in the remote monitoring for diagnostic home use this transaction closed
Unknown Speaker 3:00
Yesterday, we are quite excited about it.
Unknown Speaker 3:03
It will give more details later in the program.
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We also signed in MLU with Malaysia, Malaysian partners for up to 100 50 million in potential revenues for vaccine development and manufacturing for the country of Malaysia. In addition, we signed a letter of intent with potential Chinese partners for up to 400 million guaranteed in our vaccine
Unknown Speaker 3:26
development program and revenue streams
Unknown Speaker 3:31
once we get approved, also, we were contacted by the Canadian or NRC last week for morphew with help Canada last six months, and they informed us they want to move forward. Move ahead and moving our vaccine forward for Canada. We now look forward to those discussions in the coming days. Also, we signed a strategic investment and acquisition Li investment is $20 million
Unknown Speaker 4:00
It'll be an upmarket deal. It's a strategic investment. And we are acquiring a diagnostic business with, with that $20 million for 10 million for a 51% stake in that company.
Unknown Speaker 4:14
This call
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also includes an update on the autosol acquisition. It will give a brief summary and answer all questions at the end of the briefing on all of the areas about businesses and subsidiaries. Now, I like to inform you that generations in quiet period, because of our newly fall, that's one, four financing of up to $14 million that we
Unknown Speaker 4:40
ate Cade two weeks ago. So I'm limited to what I can say as it pertains to forecasting values, financing initiatives, appraisals, or revenue assumptions. Thank you for understanding this when the question and answer format starts at the end of this briefing,
Unknown Speaker 4:58
but like to go to off
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area of the agenda, which is our FDA response to AI and pre AI the package for our ii keystores Cobra two vaccine that we submitted
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about a month ago. We got our response.
Unknown Speaker 5:17
I believe it was two days ago. And I'd like to turn it over to rich Purcell, head of research and development will give a synopsis of that package response from the FDA. Rich, please.
Unknown Speaker 5:33
So
Unknown Speaker 5:36
we received this response from the FDA. When we put our pre ind briefing packages last month. They gave us a very detailed response as to the truth. We're very happy with the response. they've agreed to our
Unknown Speaker 5:56
specific detailed recommendations to
Unknown Speaker 6:00
Including the protocol but then change the protocol, minor elements of diagnostic evaluations in the immune system that will include them. And also a couple of inclusion exclusion language. But overall the protocol design has been approved by the FDA. And we're quite pleased with that.
Unknown Speaker 6:22
We do not have to do any toxicology work. And that is a major step that they've declared that no additional toxicology work is necessary. The Agilent that we're working with this is three M's 052 Agilent is in clinical trials and we're able to reference that clinical trial to allow that edge event to go into any clinical trials with us.
Unknown Speaker 6:52
So that's a very good positive results as well.
Unknown Speaker 6:56
Overall, we have immunogenicity trials.
Unknown Speaker 7:00
inclusion criteria use in our evaluation of the clinical trials of participants. In healthy subjects, we have to define the immunogenicity of the vaccine when we get our final formulation. So overall a very clear direction from the FDA dashboard.
Unknown Speaker 7:22
Forever. Great, thanks. And I just like to reiterate, it was a great response from the FDA. We've been involved in many, many responses to the FDA and this one, I have to tell is one of the better ones that I've seen. So it's a great job by the whole team. Very proud of the work they put forth to the FDA, without partners PPD worldwide as well as some of our research center. So it's fantastic news and now we have a clear path to getting into clinics without vaccine once. Once that is complete develop.
Unknown Speaker 7:58
I'd like to move on to
Unknown Speaker 8:00
The news that we announced today, which is our 5050 partnership with worldwide Digi tax,
Unknown Speaker 8:07
which we form new Gen health, which is now a subsidiary of generous. I like to, you know, introduce everybody to Dr. The vehicle, who is now our 5050 partner and is the owner of worldwide Digi deck. That's an again, please I would love to comment on, obviously partnership.
Unknown Speaker 8:30
Thanks, Joe.
Unknown Speaker 8:32
I'm very glad to be part of this new organization and help transform health care for the benefit of patients. As you know, patient engagement, remote patient monitoring and management have become the cornerstones of exciting new approaches to preventative accountable health care. With the launch of new Gen health we will be will be able to enable provider organizations to put to put this exciting model of innovation into practice
Unknown Speaker 9:00
So I'm very, very excited and privileged to be part of this organization. And looking forward to it. Thank you.
Unknown Speaker 9:06
Thank you very, very much stuff and have been. So this partnership here for us, you know, since COVID, started back in late January, and became such a, you know, monster to have
Unknown Speaker 9:23
returned to pretty much all business in the United States. We've had to rethink some of the areas
Unknown Speaker 9:31
of business that we're in, and how to, you know, be like a chameleon. So pretty much at adopt to putting our infrastructures in place that are in place to good use. So, here we're going to introduce this program throughout different distribution channels, Arizona, our partners clinics in Arizona, utilizing their
Unknown Speaker 9:57
doctors and patient populations for this program.
Unknown Speaker 10:00
Like to get a comment from Sanjay Kumar, who was running our Arizona operations, and one of the general management team members. So if you would love to have you to give a little bit of color on what you've been able to set up in Arizona,
Unknown Speaker 10:16
the breadth of the partnerships that we have there, and the patient populations where this program
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can immediately start giving real results not only for the doctors, not only for the patients, but for Gen X's
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income streams. So please, thank you. Thank you. So as you are aware that Arizona is the third third largest Medicare market in the country, we've been working in setting up
Unknown Speaker 10:48
our provider network for the past four years, have had tremendous experience in this area of work with Dr. Patel at wealthcare and as other subsequent HMOs. And as the
Unknown Speaker 11:00
everybody's aware of Dr. Patel is is the leader in the industry when it comes to Medicare HMOs.
Unknown Speaker 11:09
Currently, we are partnered with four large primary care clinics, actually three primary care clinics and one
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endocrinology, probably one of the largest in the country with the 14 endocrinologist under one roof.
Unknown Speaker 11:27
With these four providers they have close to 50,000 Medicare recipients active the key word is active in their practices. And and they are willing,
Unknown Speaker 11:39
excited and ready to go. And I believe just for these four clinics, which are our initial beta site and then we will spread out to Florida and California. But we will first beta these clinics in Arizona and then take it to our MSL also with ginger
Unknown Speaker 12:00
Alexa has in Oklahoma, Texas and other and four other states. I believe just these four clinics should make us, one of the market leaders in the country. And I think I'm very confident that we will be one of the top four or five
Unknown Speaker 12:17
remote patient monitoring companies in the country. I'm pretty confident about that. And with that, I wouldn't take much more of your time. And I thank you very nice.
Unknown Speaker 12:29
Thank you, Sanjay. So this program that we're about ready to watch, you know, we had initially looked at many, many remote monitoring companies and why would we do that? Well, you know, right now, it's all about telemedicine. It's all about remote monitoring the costs of pandemic situation and because the federal government as well as states now have put in big dollars to be able to take care of patients.
Unknown Speaker 13:01
From a home setting, so we jumped into this business Why? Because we have the patient populations. We have the doctor partners, and we have the networks to get these, these this program up and running. And it's probably one of the best programs we've seen. Dr. Levine and his team have put together an excellent program.
Unknown Speaker 13:23
Probably one of the most sophisticated systems we've seen one of the more few friendly, user friendly gooeys and applications for the patient, as well as
Unknown Speaker 13:35
the diagnostic equipment that's given by the doctor to the patient after education to use at home so the doctor can monitor the patient and provide
Unknown Speaker 13:48
the necessary care and benefits to those patients. So we're pretty excited about this program. Our infrastructure is set up.
Unknown Speaker 13:58
Dr. devina team is
Unknown Speaker 14:00
fantastic job and building out his whole infrastructure. And it's a perfect partnership that we believe we can get up and running very quickly, as well as really Scott revenue with this whole program quite quickly. So let's move on now to some of the vaccine deals that we've put together. And that we are working on,
Unknown Speaker 14:23
which will substantially change Gen X, for the better moving forward, give us the necessary credibility in one of our platforms, that $50 million has gone into plus over the years, and we're finally starting to get recognized for our vaccine work infectious disease, primarily with
Unknown Speaker 14:48
our development work in source code. So we
Unknown Speaker 14:55
last week, we find a Li for a guaranteed 400 million
Unknown Speaker 15:00
dollars if our vaccine is approved in China, with Chinese partners,
Unknown Speaker 15:07
once we're working on the contract now with the lawyers and our lawyers, and we believe that we will have this contract sign with a $5 million upfront payment,
Unknown Speaker 15:21
they will pay all of the work in China, everything.
Unknown Speaker 15:26
The clinical trial works, the manufacturing
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and then getting it through the approval process with the Chinese FDA, which then we would receive a $20 million
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success fee, and then a 20% or a minimum of $2 per dose, which gets us gets us to that guaranteed 400 million
Unknown Speaker 15:51
initially, so it could be much higher, but as of right now they're guaranteeing if success, at least $400 million in revenues to generate
Unknown Speaker 16:00
On a royalty stream, so we're very excited about that. We believe that we're working hard to get those contracts done. The big thing there is to get that upfront payment of $5 million, make it real, which we believe will occur. Did they have the signing, that's what
Unknown Speaker 16:18
we've negotiated and
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our Chinese plant potential partners are right now.
Unknown Speaker 16:27
eager to get to work, so quite excited about that program.
Unknown Speaker 16:32
The next program that we announced was our partnership with Ben Thai Kenda. Malaysian company, and the infrastructure and engineering space that will build out manufacturing facilities for us in our partnership, to
Unknown Speaker 16:53
manufacture the vaccine for the people of Malaysia. That deal calls for
Unknown Speaker 17:00
on contract signing, which is my fact that I have a final call to go over the final details of the contract.
Unknown Speaker 17:08
That's 100 $50 million deal up to 100 $50 million.
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We get two and a half million dollars on contract signing,
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which will be used to further develop the vaccine.
Unknown Speaker 17:22
And then they pay for all the costs in Malaysia to throw the, the vaccine through their Malaysian FDA, get that approval.
Unknown Speaker 17:34
We get a licensing fee of 17 and a half million dollars and then
Unknown Speaker 17:40
vaccine royalties of three and $4 per dose for them with distributed simulation people. So we're very, very excited about that program.
Unknown Speaker 17:53
And that partnership, we believe that that will be sign
Unknown Speaker 17:58
within the next coming in the company.
Unknown Speaker 18:00
coming days, and we'll get our first two and a half million dollars on that signing. So we'll be able to further along our vaccine, which is,
Unknown Speaker 18:09
you know, been been difficult for us because we're a small company, and we need that assistance and most of these partnerships to make, make this work. And we're just very happy that decided to get that recognition. And we're able to move forward with what we believe will be one of the better solutions for COVID.
Unknown Speaker 18:30
So our next agenda item
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is we were notified last week from were notified last week from Canada, that after an extensive Canadian review, and over 60 submissions from companies
Unknown Speaker 18:51
and we've been working with Canada now for the last six months. With the whole Canada. We were turned over to the Canadian and our
Unknown Speaker 19:00
See branch of government,
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which we were notified, they want to move our vaccine forward
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for helping Canadians
Unknown Speaker 19:12
in the early stages of discussions, and we're confident of a successful positive outcome. So, you know, we've put extensive work in with Canadian authorities over the last six months, we've worked with their FDA, we've worked with their
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Health Canada, to make them understand what the opportunity is and
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what our solution fully can be expected to do is successful. We believe we will be successful, and we're very proud to be working with the Canadians, as well as providing a real solution to the Canadian people.
Unknown Speaker 19:50
That deal was consummated by Gen X pharmaceuticals Canada, our wholly owned subsidiary, and that's where that
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work will be done, as well as our our Chinese partners contract that will also will be done through
Unknown Speaker 20:09
Gen X pharmaceuticals Canada. So we're very excited about the new developments in the countries and the partners in those countries believing in our pathway and us providing a real potential solution for this pandemic.
Unknown Speaker 20:27
So, that's, those are the big items that were on the agenda, obviously, like to give you a quick update on all to sell. We're excited about moving that forward. We're quite thankful to Gary and his team at all to cell for hanging in there with us.
Unknown Speaker 20:47
But our big goal is to get that acquisition done. And I'd love to turn it over to Gary to give an update on what ultracell is because they've been moving solid beautifully with their programs and
Unknown Speaker 21:01
I'd even love to hear all the great things that Gary's been doing, Gary, if you would love to hear an update on all your developments and
Unknown Speaker 21:10
be sure tech. Good morning, everyone.
Unknown Speaker 21:14
Yeah, so basically, everybody has gotten a little bit of pushback or big pushback from the pandemic. And all eyes and ears are on the vaccination as we can all appreciate. However, we still were following our process of getting all of our, you know, regulatory stuff in place. We are in the process of execution of Lauren's study in South America. So we're just waiting for the ethics committee to sign off and give us final approval. We have all the insurance and all the all the material necessary that are required in in place.
Unknown Speaker 21:53
We have a human study in Italy that was pushed back obviously because of transplants put on hold
Unknown Speaker 22:00
So our team in Italy has gotten all the approvals with the government over there. So we're actually on right now we're being informed that we're given a date where we can execute the human trial. This will be the first in the world to demonstrate in
Unknown Speaker 22:18
the encapsulation technology uses these human islet cells to reverse type one diabetes. So we're very excited about that. And having the fact that we spent two years getting the approvals was a big stepping stone monumental stepping stone for the company.
Unknown Speaker 22:38
We're also working in house with scaling up our encapsulation technology, because we have been pinged by many companies out there, whether it be academic institutions, or commercialized companies to utilize our encapsulation technology.
Unknown Speaker 22:55
Simply for the from the standpoint we feel it's the probably the best in the world and
Unknown Speaker 23:00
The fact that we have five years of human data to support it.
Unknown Speaker 23:04
So we're really in good shape with that. And that's one of our goals to create a revenue stream also, with our encapsulation technology. So we pretty much got a lot on my plate right now. And we think that we're making some nice progress in spite of what's going on, you know, across the globe. But we think we're in pretty good shape and we're looking forward to continue to move the studies along coordinate.
Unknown Speaker 23:33
Thanks, Gary, I really appreciate the update and can't can't wait to consummate and finally close all to sell. Now, we believe we'll get into that a little bit. You know, how we're going to close it and
Unknown Speaker 23:48
add all the new developments in financing space, which we'll get to. So I'd like to move on to one of our other agenda items we have strategically
Unknown Speaker 24:00
Partnered and sent find an LSI
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with a Texas based diagnostic company.
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That company has its emergency use application and right now for COVID testing,
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which we believe they will get. The technology is probably one of the best out there that we've seen.
Unknown Speaker 24:26
That's also another business that we can move through our doctor networks as well as
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utilize this with their patient populations for testing. The company also synergistic, not only in infectious disease, but in cancer diagnostics that they're working on. And she strategic li li Stein with them and they have fun. That's been funding them. That fund will fund the Gen X $20 million in an up market deal.
Unknown Speaker 25:00
that we're working on.
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And $10 million will be utilized to acquire 51% of this diagnostic company.
Unknown Speaker 25:11
It's, it's something that really just synergistically fits perfectly with both of our main platforms,
Unknown Speaker 25:20
cancer and infectious disease. And we're quite confident that both all three entities ourselves Gen X
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diagnostic company, as well as the font wants this to happen, and we're working right now on contracts to make that happen. So we believe in the coming
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weeks,
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all of these agenda items will have a positive outcome is no guarantee is that obviously,
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still negotiations to be doing and they're ongoing until final contracts are signed. But we're quite confident that
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all parties involved in any of these transactions are highly motivated to get these things done with Gen X. So
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very proud of the developments that we've been able to put together
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as well as
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you know,
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how to change our business a little bit based upon what's going on today,
Unknown Speaker 26:25
you know, in the world with this pandemic, so we're quite excited about it all. And now I'd like to give some updates on where we stand with our existing businesses like to turn it on the call over now to Tony de Lisi. Tony is CEO, Ola region, and as everybody knows, that company's been somewhat devastated in regard to
Unknown Speaker 26:51
you know, the effects of what's been going on throughout the United States with the pandemic. As you know, good luck will win.
Unknown Speaker 27:00
Wouldn't there we, we got our federal
Unknown Speaker 27:04
federal contracts on the VA hospital system, as I'm sure everybody's aware of back in late March. And unfortunately, the VA hospitals
Unknown Speaker 27:14
believe except 20 of them are all still closed down for any of these types of services that excelligence could provide benefit with. So Tony, I'd love for you to get an update and what you got you and the team has been doing during these very tough times that we will face.
Unknown Speaker 27:34
Absolutely. And thank you, Joe, for the introduction. as Joe put it, the we were awarded by the SAS the sack is the strategic acquisition center of the VA. were awarded a BPA contract in late March, biologics Blanket Purchase Agreement contract, which gives us the ability to conduct business in all hundred and 65
Unknown Speaker 28:00
of the hospital that are associated with the VA. In addition, the clinics that are out in the communities there's over 1000 clinics that we have potential access to now, this contracts is a really coveted and awarded very few organizations prior to get back on track, and we're working within this VA and select hospitals to run the pilot clinical studies that were needed, as well as get ready for a presentation that could be submitted along with the BPA contracts
Unknown Speaker 28:34
to the committee, the value analysis committees for this analysis with that COVID hit and the VA is shut down. All elective surgeries were shot. They are beginning to reopen very slowly. One of the issues the VA has with reopening is that these clinics for elective surgeries this small and the waiting room
Unknown Speaker 29:00
have small, and many of these patients are handicapped and cannot walk. And they're brought in, in wheelchairs for the most part. So several people, you know, a loved one, a caretaker, have to bring these patients to the clinic. And with the spacing that's required, they're only going to begin opening at 25% capacity, and what is to be able to accommodate the patients. So we've not been able to fully take advantage of the contracts as of this point. But we've been doing in the in the meantime, is we've been working with rep solutions, which is an organization that supplies representatives. It's the recruiting organization, and we've been getting ready. So the Giro, we've interviewed well over 80 individuals who have probably going to move forward into the VA initially with 12. But simultaneously we'd like to launch into those clinics within the VA those thousand claims
Unknown Speaker 30:00
As well as some of the podiatry offices that do surgical procedures at the office, because we did get our Medicare coverage as well. So with those things said, we've been diligent in recruiting, hiring, screening, interviewing some top sales representatives, including representatives that have called on the VA system for one pharmaceutical company or another, many of them in the wound care space, but they're now currently with hired and looking for 1099 contracts. So the relationships are in place and they know the, their way around the VA systems how to navigate and they have relationships that are strong with many of the surgeons. So that's what then we look forward to the sort of launch as this COVID scenario dissipates. And we're very excited about the potential opportunity within the VA hospital and some of the clinics that we're going to launch into
Unknown Speaker 31:01
Great, thank you very much. Thanks very much for the update. Tony.
Unknown Speaker 31:07
like to also get a comment, if I would.
Unknown Speaker 31:11
Jason terell, Chief Medical and Chief Scientific Officer on the acquisition that we will be making on the diagnostic space and how that kind of fits nicely with our own diagnostic business we own today.
Unknown Speaker 31:26
I think here it's adopted, adopted Jor el, and his synopsis on what we'll be acquiring as well as how that fits nicely into our business model. People be great. So Jason, if you would.
Unknown Speaker 31:42
Yeah, absolutely. Thank you Joe.
Unknown Speaker 31:44
We are very excited to have this opportunity to partner with Amer bio. They truly have a fantastic team of lab professionals there and are setting up an amazing operations and laboratory facility and importantly, they're leaving
Unknown Speaker 32:00
product is the aim of gene COVID-19 diagnostic test, which I consider will become the best most preferred diagnostic test on the market. And this is perfect timing, as Joe said, because it entirely complements and supports our COVID-19 vaccine development program and the large clinical trials that will soon be conducting. And this this test is so unique. I'd like to take just a minute to kind of explain the test and the opportunity that it will provide to us
Unknown Speaker 32:35
that it's it's called the imaging 2019 novel coronavirus detection kit. And it's a nucleic acid based real time polymerase chain reaction or RT PCR test, and it detects nucleic acids of the SARS
Unknown Speaker 32:53
COBie two genome.
Unknown Speaker 32:55
It's unique in that it has a wide variety of different specimens that it can be
Unknown Speaker 33:00
On these in these oropharyngeal swabs nasal pharyngeal swabs,
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nasal interpreted swabs, also nasal pharyngeal washes and aspirants
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as well as Bravo elvio or novasure specimens, which is more than the typical standard tests can be used on.
Unknown Speaker 33:23
And in addition to the standard collection processes that are currently being performed in hospitals, physician offices, satellite clinics and drive thru facilities that we see popping up,
Unknown Speaker 33:36
Amy will be providing FDA approved home based sample collection kits. And this is mine the fastest and most important feature sources of COVID-19 testing. So with their with the broad range of specimens they can test with the broad access to the different means and methods of collections. I feel that Ava is perfectly positioned position to capture the magic
Unknown Speaker 34:00
A number of tests across the full spectrum of collection methods. And what makes their lab unique is that they're using cutting edge top of the line devices for nucleic acid extraction, and automated PCR testing.
Unknown Speaker 34:19
In this provides really three things, improved accuracy, improved turnaround time, and a very high test capacity. When we talk about accuracy, all nucleic acid PCR tests that are FDA approved are highly accurate. And most of these by who and CDC standards require detection of two genes that are expressed by the virus.
Unknown Speaker 34:44
The imaging actually chose for for and as expected, and the clinical studies that we've seen today, it has outperformed all the other similar tests. And this is important obviously, because higher accuracy means fewer false positives.
Unknown Speaker 35:00
Fewer false negatives and ultimately better care better outcome from patients. They also have an advantage in speed testing turnaround time.
Unknown Speaker 35:10
With their new reagents and advanced lab systems, they can turn this test around with under just a few hours of analysis time.
Unknown Speaker 35:20
This is a big improvement. And it's important because, you know, faster reporting means faster diagnosis, it means earlier initiation of treatment, and again, better care and outcome for patients. And lastly is their testing capacity. This, this facility in Texas will be able to perform 1.4 million tests per month. And that's astounding and for context, the entire entire US is performing, you know, slightly over 20 million tests per month. Texas alone is performing more than 2 million per month. And we know that the current testing could
Unknown Speaker 36:00
acity overall in the healthcare system cannot meet the current demand for tests. And importantly, in the future, as students return to school when employees return to work, and restrictions are eased, will undoubtedly see a major increase in the demand for tests. So aima is here position to absorb a very significant portion of all these tests that will be faced with in the future. And as Joe said, they've applied for FDA, emergency use authorization, their submission back it is as strong as it could possibly be. And I expect to see approval in the coming days, two weeks. So with that, Joe, I'll turn it back to you.
Unknown Speaker 36:48
Thanks, Jason. I really appreciate that. So I'd like to now get an update from regenesis.
Unknown Speaker 36:55
Ricky you want
Unknown Speaker 36:57
even update please?
Unknown Speaker 36:59
Yep,
Unknown Speaker 37:00
regenda Corporation is alive and strong.
Unknown Speaker 37:03
Our company is regenerative medicine company focused on the development of a novel hydro gel to treat different forms of irritable bowel syndrome. And we have found that
Unknown Speaker 37:15
our focus mark is going to be in ulcerative colitis with a view toward krones.
Unknown Speaker 37:21
We continue to continue development and drug we're hopefully finalizing a formulation very shortly. With help from the University of Pittsburgh and Steven battleaxe and his team at McGowan Institute.
Unknown Speaker 37:31
We have a view toward the clinical trial starting into one in Australia, under the direction of
Unknown Speaker 37:41
Tom speroni, who's a well recognized global leader, the AI space and
Unknown Speaker 37:46
we have Steven Wexner, who is our chief medical officer and has provided some great direction on the development of clinical trial applications in alternate locations including Israel. So our
Unknown Speaker 38:00
Short term play is to continue our development, get ourselves in a position to initiate clinical trials. Obviously, the COVID thing is slowed things down. But to the extent we're able to move that forward, we're doing that as quickly as possible. And we're just optimistic. Thanks.
Unknown Speaker 38:20
Thanks for I appreciate the update. So
Unknown Speaker 38:24
I'd like to make a further comment. So, you know, with our vaccine work that now it's like to catch fire with, with partners and countries, and we are in discussions with other countries, as we've announced before, we believe that more and more, we'll see the benefit and
Unknown Speaker 38:47
the real potential solutions with our vaccine work.
Unknown Speaker 38:53
And we believe that in the company Moz is the reason why we couldn't get a couple more big partnerships.
Unknown Speaker 39:00
On the table, we are in discussions with a few other countries. And we'll hope hopeful that occur. Now also like to just update anyway we, we just recently heard from bata and BARDA.
Unknown Speaker 39:16
We were deficient in a couple of areas, which we knew about, which is our protocol for FDA, which now we've put that package in the pre package ind package in, we've gotten our responses from the FDA would have been nice to have that in there. So that was an area that we were deficient in, as well as the cost for using the three m as your agent. At the time. We didn't have any safety data on that, or any of the
Unknown Speaker 39:47
testing,
Unknown Speaker 39:49
preclinical data, so we were able to get that from the NIH and a reference letter for that Agilent
Unknown Speaker 40:00
Prior to our submission or application submission, we're now we have that that approval to use the reference,
Transcribed by https://otter.ai
Unknown Speaker 0:00
day everyone and welcome today's generics biotechnology Corporation shareholder conference call. At this time all participants are in a listen only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing the start and one on your touch tone phone.
Unknown Speaker 0:22
Please note this call may be recorded and it is now my pleasure to turn the call over to Anthony crushy. Please go ahead.
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Oh looking statements included in this presentation are made pursuant to the Safe Harbor provisions of the private securities litigation Reform Act of 1995. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results levels of activity, performance or achievements to be materially different from any future results. levels of it.
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activity, performance or achievements expressed or implied by these forward looking statements. In some cases, you can identify forward looking statements by the use of words such as may could expect, intend, plan, seek, anticipate, believe, estimate predict potential or continue within the negative of these terms or other comparable terminology. You should not place undue reliance on forward looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases beyond our control and that could materially affect actual results, levels of activity, performance or achievements. A more detailed description of the other risks and uncertainties may be found in our annual report on form 10 K, and other public filings with the Securities and Exchange Commission. If any of these results or uncertainties materialize, or if our underlying assumptions prove to be incorrect, actual results may vary significantly from what we've projected in any forward looking statement. You
Unknown Speaker 2:00
Read this presentation reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to obligations, operations, results of operations, growth strategy and liquidity. We assume no obligation to publicly update or revise these forward looking statements for any reason, whether as a result of new information, future events or otherwise. Now, I'd like to turn over the call to Jonah Scott Oh, President and Chief Executive Officer of Gen X biotechnology Corporation.
Unknown Speaker 2:32
Thank you, Anthony. Good morning, myself, generics management team, and board of directors would like to thank you for parties for for participating today. On generously share all the conference call. We have announced the agenda which includes our new venture new Gen health, which is a 5050 partnership
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with a healthcare technology company in the remote monitoring for diagnostic home use this transaction closed
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Yesterday, we are quite excited about it.
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It will give more details later in the program.
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We also signed in MLU with Malaysia, Malaysian partners for up to 100 50 million in potential revenues for vaccine development and manufacturing for the country of Malaysia. In addition, we signed a letter of intent with potential Chinese partners for up to 400 million guaranteed in our vaccine
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development program and revenue streams
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once we get approved, also, we were contacted by the Canadian or NRC last week for morphew with help Canada last six months, and they informed us they want to move forward. Move ahead and moving our vaccine forward for Canada. We now look forward to those discussions in the coming days. Also, we signed a strategic investment and acquisition Li investment is $20 million
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It'll be an upmarket deal. It's a strategic investment. And we are acquiring a diagnostic business with, with that $20 million for 10 million for a 51% stake in that company.
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This call
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also includes an update on the autosol acquisition. It will give a brief summary and answer all questions at the end of the briefing on all of the areas about businesses and subsidiaries. Now, I like to inform you that generations in quiet period, because of our newly fall, that's one, four financing of up to $14 million that we
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ate Cade two weeks ago. So I'm limited to what I can say as it pertains to forecasting values, financing initiatives, appraisals, or revenue assumptions. Thank you for understanding this when the question and answer format starts at the end of this briefing,
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but like to go to off
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area of the agenda, which is our FDA response to AI and pre AI the package for our ii keystores Cobra two vaccine that we submitted
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about a month ago. We got our response.
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I believe it was two days ago. And I'd like to turn it over to rich Purcell, head of research and development will give a synopsis of that package response from the FDA. Rich, please.
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So
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we received this response from the FDA. When we put our pre ind briefing packages last month. They gave us a very detailed response as to the truth. We're very happy with the response. they've agreed to our
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specific detailed recommendations to
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Including the protocol but then change the protocol, minor elements of diagnostic evaluations in the immune system that will include them. And also a couple of inclusion exclusion language. But overall the protocol design has been approved by the FDA. And we're quite pleased with that.
Unknown Speaker 6:22
We do not have to do any toxicology work. And that is a major step that they've declared that no additional toxicology work is necessary. The Agilent that we're working with this is three M's 052 Agilent is in clinical trials and we're able to reference that clinical trial to allow that edge event to go into any clinical trials with us.
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So that's a very good positive results as well.
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Overall, we have immunogenicity trials.
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inclusion criteria use in our evaluation of the clinical trials of participants. In healthy subjects, we have to define the immunogenicity of the vaccine when we get our final formulation. So overall a very clear direction from the FDA dashboard.
Unknown Speaker 7:22
Forever. Great, thanks. And I just like to reiterate, it was a great response from the FDA. We've been involved in many, many responses to the FDA and this one, I have to tell is one of the better ones that I've seen. So it's a great job by the whole team. Very proud of the work they put forth to the FDA, without partners PPD worldwide as well as some of our research center. So it's fantastic news and now we have a clear path to getting into clinics without vaccine once. Once that is complete develop.
Unknown Speaker 7:58
I'd like to move on to
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The news that we announced today, which is our 5050 partnership with worldwide Digi tax,
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which we form new Gen health, which is now a subsidiary of generous. I like to, you know, introduce everybody to Dr. The vehicle, who is now our 5050 partner and is the owner of worldwide Digi deck. That's an again, please I would love to comment on, obviously partnership.
Unknown Speaker 8:30
Thanks, Joe.
Unknown Speaker 8:32
I'm very glad to be part of this new organization and help transform health care for the benefit of patients. As you know, patient engagement, remote patient monitoring and management have become the cornerstones of exciting new approaches to preventative accountable health care. With the launch of new Gen health we will be will be able to enable provider organizations to put to put this exciting model of innovation into practice
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So I'm very, very excited and privileged to be part of this organization. And looking forward to it. Thank you.
Unknown Speaker 9:06
Thank you very, very much stuff and have been. So this partnership here for us, you know, since COVID, started back in late January, and became such a, you know, monster to have
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returned to pretty much all business in the United States. We've had to rethink some of the areas
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of business that we're in, and how to, you know, be like a chameleon. So pretty much at adopt to putting our infrastructures in place that are in place to good use. So, here we're going to introduce this program throughout different distribution channels, Arizona, our partners clinics in Arizona, utilizing their
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doctors and patient populations for this program.
Unknown Speaker 10:00
Like to get a comment from Sanjay Kumar, who was running our Arizona operations, and one of the general management team members. So if you would love to have you to give a little bit of color on what you've been able to set up in Arizona,
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the breadth of the partnerships that we have there, and the patient populations where this program
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can immediately start giving real results not only for the doctors, not only for the patients, but for Gen X's
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income streams. So please, thank you. Thank you. So as you are aware that Arizona is the third third largest Medicare market in the country, we've been working in setting up
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our provider network for the past four years, have had tremendous experience in this area of work with Dr. Patel at wealthcare and as other subsequent HMOs. And as the
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everybody's aware of Dr. Patel is is the leader in the industry when it comes to Medicare HMOs.
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Currently, we are partnered with four large primary care clinics, actually three primary care clinics and one
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endocrinology, probably one of the largest in the country with the 14 endocrinologist under one roof.
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With these four providers they have close to 50,000 Medicare recipients active the key word is active in their practices. And and they are willing,
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excited and ready to go. And I believe just for these four clinics, which are our initial beta site and then we will spread out to Florida and California. But we will first beta these clinics in Arizona and then take it to our MSL also with ginger
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Alexa has in Oklahoma, Texas and other and four other states. I believe just these four clinics should make us, one of the market leaders in the country. And I think I'm very confident that we will be one of the top four or five
Unknown Speaker 12:17
remote patient monitoring companies in the country. I'm pretty confident about that. And with that, I wouldn't take much more of your time. And I thank you very nice.
Unknown Speaker 12:29
Thank you, Sanjay. So this program that we're about ready to watch, you know, we had initially looked at many, many remote monitoring companies and why would we do that? Well, you know, right now, it's all about telemedicine. It's all about remote monitoring the costs of pandemic situation and because the federal government as well as states now have put in big dollars to be able to take care of patients.
Unknown Speaker 13:01
From a home setting, so we jumped into this business Why? Because we have the patient populations. We have the doctor partners, and we have the networks to get these, these this program up and running. And it's probably one of the best programs we've seen. Dr. Levine and his team have put together an excellent program.
Unknown Speaker 13:23
Probably one of the most sophisticated systems we've seen one of the more few friendly, user friendly gooeys and applications for the patient, as well as
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the diagnostic equipment that's given by the doctor to the patient after education to use at home so the doctor can monitor the patient and provide
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the necessary care and benefits to those patients. So we're pretty excited about this program. Our infrastructure is set up.
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Dr. devina team is
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fantastic job and building out his whole infrastructure. And it's a perfect partnership that we believe we can get up and running very quickly, as well as really Scott revenue with this whole program quite quickly. So let's move on now to some of the vaccine deals that we've put together. And that we are working on,
Unknown Speaker 14:23
which will substantially change Gen X, for the better moving forward, give us the necessary credibility in one of our platforms, that $50 million has gone into plus over the years, and we're finally starting to get recognized for our vaccine work infectious disease, primarily with
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our development work in source code. So we
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last week, we find a Li for a guaranteed 400 million
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dollars if our vaccine is approved in China, with Chinese partners,
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once we're working on the contract now with the lawyers and our lawyers, and we believe that we will have this contract sign with a $5 million upfront payment,
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they will pay all of the work in China, everything.
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The clinical trial works, the manufacturing
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and then getting it through the approval process with the Chinese FDA, which then we would receive a $20 million
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success fee, and then a 20% or a minimum of $2 per dose, which gets us gets us to that guaranteed 400 million
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initially, so it could be much higher, but as of right now they're guaranteeing if success, at least $400 million in revenues to generate
Unknown Speaker 16:00
On a royalty stream, so we're very excited about that. We believe that we're working hard to get those contracts done. The big thing there is to get that upfront payment of $5 million, make it real, which we believe will occur. Did they have the signing, that's what
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we've negotiated and
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our Chinese plant potential partners are right now.
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eager to get to work, so quite excited about that program.
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The next program that we announced was our partnership with Ben Thai Kenda. Malaysian company, and the infrastructure and engineering space that will build out manufacturing facilities for us in our partnership, to
Unknown Speaker 16:53
manufacture the vaccine for the people of Malaysia. That deal calls for
Unknown Speaker 17:00
on contract signing, which is my fact that I have a final call to go over the final details of the contract.
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That's 100 $50 million deal up to 100 $50 million.
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We get two and a half million dollars on contract signing,
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which will be used to further develop the vaccine.
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And then they pay for all the costs in Malaysia to throw the, the vaccine through their Malaysian FDA, get that approval.
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We get a licensing fee of 17 and a half million dollars and then
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vaccine royalties of three and $4 per dose for them with distributed simulation people. So we're very, very excited about that program.
Unknown Speaker 17:53
And that partnership, we believe that that will be sign
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within the next coming in the company.
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coming days, and we'll get our first two and a half million dollars on that signing. So we'll be able to further along our vaccine, which is,
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you know, been been difficult for us because we're a small company, and we need that assistance and most of these partnerships to make, make this work. And we're just very happy that decided to get that recognition. And we're able to move forward with what we believe will be one of the better solutions for COVID.
Unknown Speaker 18:30
So our next agenda item
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is we were notified last week from were notified last week from Canada, that after an extensive Canadian review, and over 60 submissions from companies
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and we've been working with Canada now for the last six months. With the whole Canada. We were turned over to the Canadian and our
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See branch of government,
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which we were notified, they want to move our vaccine forward
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for helping Canadians
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in the early stages of discussions, and we're confident of a successful positive outcome. So, you know, we've put extensive work in with Canadian authorities over the last six months, we've worked with their FDA, we've worked with their
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Health Canada, to make them understand what the opportunity is and
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what our solution fully can be expected to do is successful. We believe we will be successful, and we're very proud to be working with the Canadians, as well as providing a real solution to the Canadian people.
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That deal was consummated by Gen X pharmaceuticals Canada, our wholly owned subsidiary, and that's where that
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work will be done, as well as our our Chinese partners contract that will also will be done through
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Gen X pharmaceuticals Canada. So we're very excited about the new developments in the countries and the partners in those countries believing in our pathway and us providing a real potential solution for this pandemic.
Unknown Speaker 20:27
So, that's, those are the big items that were on the agenda, obviously, like to give you a quick update on all to sell. We're excited about moving that forward. We're quite thankful to Gary and his team at all to cell for hanging in there with us.
Unknown Speaker 20:47
But our big goal is to get that acquisition done. And I'd love to turn it over to Gary to give an update on what ultracell is because they've been moving solid beautifully with their programs and
Unknown Speaker 21:01
I'd even love to hear all the great things that Gary's been doing, Gary, if you would love to hear an update on all your developments and
Unknown Speaker 21:10
be sure tech. Good morning, everyone.
Unknown Speaker 21:14
Yeah, so basically, everybody has gotten a little bit of pushback or big pushback from the pandemic. And all eyes and ears are on the vaccination as we can all appreciate. However, we still were following our process of getting all of our, you know, regulatory stuff in place. We are in the process of execution of Lauren's study in South America. So we're just waiting for the ethics committee to sign off and give us final approval. We have all the insurance and all the all the material necessary that are required in in place.
Unknown Speaker 21:53
We have a human study in Italy that was pushed back obviously because of transplants put on hold
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So our team in Italy has gotten all the approvals with the government over there. So we're actually on right now we're being informed that we're given a date where we can execute the human trial. This will be the first in the world to demonstrate in
Unknown Speaker 22:18
the encapsulation technology uses these human islet cells to reverse type one diabetes. So we're very excited about that. And having the fact that we spent two years getting the approvals was a big stepping stone monumental stepping stone for the company.
Unknown Speaker 22:38
We're also working in house with scaling up our encapsulation technology, because we have been pinged by many companies out there, whether it be academic institutions, or commercialized companies to utilize our encapsulation technology.
Unknown Speaker 22:55
Simply for the from the standpoint we feel it's the probably the best in the world and
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The fact that we have five years of human data to support it.
Unknown Speaker 23:04
So we're really in good shape with that. And that's one of our goals to create a revenue stream also, with our encapsulation technology. So we pretty much got a lot on my plate right now. And we think that we're making some nice progress in spite of what's going on, you know, across the globe. But we think we're in pretty good shape and we're looking forward to continue to move the studies along coordinate.
Unknown Speaker 23:33
Thanks, Gary, I really appreciate the update and can't can't wait to consummate and finally close all to sell. Now, we believe we'll get into that a little bit. You know, how we're going to close it and
Unknown Speaker 23:48
add all the new developments in financing space, which we'll get to. So I'd like to move on to one of our other agenda items we have strategically
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Partnered and sent find an LSI
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with a Texas based diagnostic company.
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That company has its emergency use application and right now for COVID testing,
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which we believe they will get. The technology is probably one of the best out there that we've seen.
Unknown Speaker 24:26
That's also another business that we can move through our doctor networks as well as
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utilize this with their patient populations for testing. The company also synergistic, not only in infectious disease, but in cancer diagnostics that they're working on. And she strategic li li Stein with them and they have fun. That's been funding them. That fund will fund the Gen X $20 million in an up market deal.
Unknown Speaker 25:00
that we're working on.
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And $10 million will be utilized to acquire 51% of this diagnostic company.
Unknown Speaker 25:11
It's, it's something that really just synergistically fits perfectly with both of our main platforms,
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cancer and infectious disease. And we're quite confident that both all three entities ourselves Gen X
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diagnostic company, as well as the font wants this to happen, and we're working right now on contracts to make that happen. So we believe in the coming
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weeks,
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all of these agenda items will have a positive outcome is no guarantee is that obviously,
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still negotiations to be doing and they're ongoing until final contracts are signed. But we're quite confident that
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all parties involved in any of these transactions are highly motivated to get these things done with Gen X. So
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very proud of the developments that we've been able to put together
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as well as
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you know,
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how to change our business a little bit based upon what's going on today,
Unknown Speaker 26:25
you know, in the world with this pandemic, so we're quite excited about it all. And now I'd like to give some updates on where we stand with our existing businesses like to turn it on the call over now to Tony de Lisi. Tony is CEO, Ola region, and as everybody knows, that company's been somewhat devastated in regard to
Unknown Speaker 26:51
you know, the effects of what's been going on throughout the United States with the pandemic. As you know, good luck will win.
Unknown Speaker 27:00
Wouldn't there we, we got our federal
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federal contracts on the VA hospital system, as I'm sure everybody's aware of back in late March. And unfortunately, the VA hospitals
Unknown Speaker 27:14
believe except 20 of them are all still closed down for any of these types of services that excelligence could provide benefit with. So Tony, I'd love for you to get an update and what you got you and the team has been doing during these very tough times that we will face.
Unknown Speaker 27:34
Absolutely. And thank you, Joe, for the introduction. as Joe put it, the we were awarded by the SAS the sack is the strategic acquisition center of the VA. were awarded a BPA contract in late March, biologics Blanket Purchase Agreement contract, which gives us the ability to conduct business in all hundred and 65
Unknown Speaker 28:00
of the hospital that are associated with the VA. In addition, the clinics that are out in the communities there's over 1000 clinics that we have potential access to now, this contracts is a really coveted and awarded very few organizations prior to get back on track, and we're working within this VA and select hospitals to run the pilot clinical studies that were needed, as well as get ready for a presentation that could be submitted along with the BPA contracts
Unknown Speaker 28:34
to the committee, the value analysis committees for this analysis with that COVID hit and the VA is shut down. All elective surgeries were shot. They are beginning to reopen very slowly. One of the issues the VA has with reopening is that these clinics for elective surgeries this small and the waiting room
Unknown Speaker 29:00
have small, and many of these patients are handicapped and cannot walk. And they're brought in, in wheelchairs for the most part. So several people, you know, a loved one, a caretaker, have to bring these patients to the clinic. And with the spacing that's required, they're only going to begin opening at 25% capacity, and what is to be able to accommodate the patients. So we've not been able to fully take advantage of the contracts as of this point. But we've been doing in the in the meantime, is we've been working with rep solutions, which is an organization that supplies representatives. It's the recruiting organization, and we've been getting ready. So the Giro, we've interviewed well over 80 individuals who have probably going to move forward into the VA initially with 12. But simultaneously we'd like to launch into those clinics within the VA those thousand claims
Unknown Speaker 30:00
As well as some of the podiatry offices that do surgical procedures at the office, because we did get our Medicare coverage as well. So with those things said, we've been diligent in recruiting, hiring, screening, interviewing some top sales representatives, including representatives that have called on the VA system for one pharmaceutical company or another, many of them in the wound care space, but they're now currently with hired and looking for 1099 contracts. So the relationships are in place and they know the, their way around the VA systems how to navigate and they have relationships that are strong with many of the surgeons. So that's what then we look forward to the sort of launch as this COVID scenario dissipates. And we're very excited about the potential opportunity within the VA hospital and some of the clinics that we're going to launch into
Unknown Speaker 31:01
Great, thank you very much. Thanks very much for the update. Tony.
Unknown Speaker 31:07
like to also get a comment, if I would.
Unknown Speaker 31:11
Jason terell, Chief Medical and Chief Scientific Officer on the acquisition that we will be making on the diagnostic space and how that kind of fits nicely with our own diagnostic business we own today.
Unknown Speaker 31:26
I think here it's adopted, adopted Jor el, and his synopsis on what we'll be acquiring as well as how that fits nicely into our business model. People be great. So Jason, if you would.
Unknown Speaker 31:42
Yeah, absolutely. Thank you Joe.
Unknown Speaker 31:44
We are very excited to have this opportunity to partner with Amer bio. They truly have a fantastic team of lab professionals there and are setting up an amazing operations and laboratory facility and importantly, they're leaving
Unknown Speaker 32:00
product is the aim of gene COVID-19 diagnostic test, which I consider will become the best most preferred diagnostic test on the market. And this is perfect timing, as Joe said, because it entirely complements and supports our COVID-19 vaccine development program and the large clinical trials that will soon be conducting. And this this test is so unique. I'd like to take just a minute to kind of explain the test and the opportunity that it will provide to us
Unknown Speaker 32:35
that it's it's called the imaging 2019 novel coronavirus detection kit. And it's a nucleic acid based real time polymerase chain reaction or RT PCR test, and it detects nucleic acids of the SARS
Unknown Speaker 32:53
COBie two genome.
Unknown Speaker 32:55
It's unique in that it has a wide variety of different specimens that it can be
Unknown Speaker 33:00
On these in these oropharyngeal swabs nasal pharyngeal swabs,
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nasal interpreted swabs, also nasal pharyngeal washes and aspirants
Unknown Speaker 33:14
as well as Bravo elvio or novasure specimens, which is more than the typical standard tests can be used on.
Unknown Speaker 33:23
And in addition to the standard collection processes that are currently being performed in hospitals, physician offices, satellite clinics and drive thru facilities that we see popping up,
Unknown Speaker 33:36
Amy will be providing FDA approved home based sample collection kits. And this is mine the fastest and most important feature sources of COVID-19 testing. So with their with the broad range of specimens they can test with the broad access to the different means and methods of collections. I feel that Ava is perfectly positioned position to capture the magic
Unknown Speaker 34:00
A number of tests across the full spectrum of collection methods. And what makes their lab unique is that they're using cutting edge top of the line devices for nucleic acid extraction, and automated PCR testing.
Unknown Speaker 34:19
In this provides really three things, improved accuracy, improved turnaround time, and a very high test capacity. When we talk about accuracy, all nucleic acid PCR tests that are FDA approved are highly accurate. And most of these by who and CDC standards require detection of two genes that are expressed by the virus.
Unknown Speaker 34:44
The imaging actually chose for for and as expected, and the clinical studies that we've seen today, it has outperformed all the other similar tests. And this is important obviously, because higher accuracy means fewer false positives.
Unknown Speaker 35:00
Fewer false negatives and ultimately better care better outcome from patients. They also have an advantage in speed testing turnaround time.
Unknown Speaker 35:10
With their new reagents and advanced lab systems, they can turn this test around with under just a few hours of analysis time.
Unknown Speaker 35:20
This is a big improvement. And it's important because, you know, faster reporting means faster diagnosis, it means earlier initiation of treatment, and again, better care and outcome for patients. And lastly is their testing capacity. This, this facility in Texas will be able to perform 1.4 million tests per month. And that's astounding and for context, the entire entire US is performing, you know, slightly over 20 million tests per month. Texas alone is performing more than 2 million per month. And we know that the current testing could
Unknown Speaker 36:00
acity overall in the healthcare system cannot meet the current demand for tests. And importantly, in the future, as students return to school when employees return to work, and restrictions are eased, will undoubtedly see a major increase in the demand for tests. So aima is here position to absorb a very significant portion of all these tests that will be faced with in the future. And as Joe said, they've applied for FDA, emergency use authorization, their submission back it is as strong as it could possibly be. And I expect to see approval in the coming days, two weeks. So with that, Joe, I'll turn it back to you.
Unknown Speaker 36:48
Thanks, Jason. I really appreciate that. So I'd like to now get an update from regenesis.
Unknown Speaker 36:55
Ricky you want
Unknown Speaker 36:57
even update please?
Unknown Speaker 36:59
Yep,
Unknown Speaker 37:00
regenda Corporation is alive and strong.
Unknown Speaker 37:03
Our company is regenerative medicine company focused on the development of a novel hydro gel to treat different forms of irritable bowel syndrome. And we have found that
Unknown Speaker 37:15
our focus mark is going to be in ulcerative colitis with a view toward krones.
Unknown Speaker 37:21
We continue to continue development and drug we're hopefully finalizing a formulation very shortly. With help from the University of Pittsburgh and Steven battleaxe and his team at McGowan Institute.
Unknown Speaker 37:31
We have a view toward the clinical trial starting into one in Australia, under the direction of
Unknown Speaker 37:41
Tom speroni, who's a well recognized global leader, the AI space and
Unknown Speaker 37:46
we have Steven Wexner, who is our chief medical officer and has provided some great direction on the development of clinical trial applications in alternate locations including Israel. So our
Unknown Speaker 38:00
Short term play is to continue our development, get ourselves in a position to initiate clinical trials. Obviously, the COVID thing is slowed things down. But to the extent we're able to move that forward, we're doing that as quickly as possible. And we're just optimistic. Thanks.
Unknown Speaker 38:20
Thanks for I appreciate the update. So
Unknown Speaker 38:24
I'd like to make a further comment. So, you know, with our vaccine work that now it's like to catch fire with, with partners and countries, and we are in discussions with other countries, as we've announced before, we believe that more and more, we'll see the benefit and
Unknown Speaker 38:47
the real potential solutions with our vaccine work.
Unknown Speaker 38:53
And we believe that in the company Moz is the reason why we couldn't get a couple more big partnerships.
Unknown Speaker 39:00
On the table, we are in discussions with a few other countries. And we'll hope hopeful that occur. Now also like to just update anyway we, we just recently heard from bata and BARDA.
Unknown Speaker 39:16
We were deficient in a couple of areas, which we knew about, which is our protocol for FDA, which now we've put that package in the pre package ind package in, we've gotten our responses from the FDA would have been nice to have that in there. So that was an area that we were deficient in, as well as the cost for using the three m as your agent. At the time. We didn't have any safety data on that, or any of the
Unknown Speaker 39:47
testing,
Unknown Speaker 39:49
preclinical data, so we were able to get that from the NIH and a reference letter for that Agilent
Unknown Speaker 40:00
Prior to our submission or application submission, we're now we have that that approval to use the reference,
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