Q3 2020 TFF Pharmaceuticals Inc Earnings Call
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Financial results conference call.
As a reminder, this conference is being recorded I would now like to turn the call over to your host Mr., Paul Fagan of T.F. Pharmaceuticals, Investor Relations you May begin your conference.
Thank you very much operator, Hello, everyone and welcome to TFS Pharmaceuticals, third quarter, 2020 financial and business results Conference call.
With me on the line today is Glen Mattson, President and CEO of GE Uh Huh.
Chris Coleman, Chief Financial Officer, Dr. billions of the University of Texas at Austin, Dr., Dale Christiansen TFS director of clinical development.
And Chris Kaino, TFS, Chief operating officer.
A press release announcing our Q3 results is available on the Ts Pharmaceuticals web site.
Let's take a moment to read the disclaimer about forward looking statements in the press release.
The earnings release and as teleconference. Both include forward looking statements and these forward looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made.
Factors that could cause actual results to differ are described in the disclaimer and in our filings with the US Securities and Exchange Commission, including the risk factor section of our 2019 annual report on form 10-K as filed with the SEC.
And now it's my pleasure to turn the call over to Mr. Glenn that's.
Good afternoon, and thank you for joining us today to review the company's third quarter operations and recent highlights.
During this call I will provide an update on our clinical corporate progress then.
And then I will ask our Chief Financial Officer, Kirk Coleman to review the Companys financials.
So happy to have Dr., Billy Helms from the University of Texas at Austin, well talk about some of the exciting progress, we're making in applying our thin film freezing technology to drugs vaccines and biologics.
And then Chris can now our chief operating officer, and head of business development, well update us on business development and operational initiatives for the company.
Blood level outcomes.
Our second clinical trial program tacker limits inhalation powder and important immediate suppressive, Egypt for the treatment of lung transplant rejection as demonstrated no clinically significant drug associate adverse events and it's phase one trial.
And has achieved substantial immunosuppressive blood levels.
These results give us a strong belief that TFS tactful limits will have a significant potential beyond lung transplant patients to ultimately include heart liver and kidney transplant procedures.
We also think there's potential for study PFF tacker limits examining a survival advantage cohort and transplant patients.
And on the closer my first in human trials are on schedule.
Finally, updating our partnership between the intermediary company and plus products is proceeding well.
Plus products as a working production line has been testing product now for quite some time with positive reactions from consumers to their concept tests.
During the quarter and responding to the needs of our pharmaceutical company partners. We took important steps to expand our manufacturing capacity to help development produced products currently under assessment.
This expansion with one of our Premier Cro's gives us a secure third choice for Austin film freezing dry powder inhalation products, we have plans to further expand our capacity at other locations.
Algae effort needed to succeed with these two complex biologic compounds in our platform was intensive and Dr. Bill Williams will speak to this later in the call, but it's important to note that these developments opened the door for other potential collaborations and these two new and important drug delivery modalities.
Looking first at our agreement with augment the Bioworks. This is a worldwide joint development and collaboration agreement to develop commercial products that incorporate augmented human derived monoclonal antibodies for potential COVID-19 therapeutics.
We had said after a successful private placement that we would add a fourth product to our internal development portfolio.
These products will be developed utilizing our thin film present technology to manufacture dry port powder formulations of these specific monoclonal antibodies for inhalation delivery directly to the lungs of patients.
The agreement also includes the development of formulations for parental administration, where our thin film freezing dry powder formulations can be reconstituted potentially mitigating the impacts of cold chain storage and handling.
And we also have the option of developing two additional augment the antibodies for indications other than co had 19.
Both companies have agreed to a 50 50 split of all costs and both companies have agreed the same 50 50 split of all revenues cash payments and our future cash payments related to the sales or license of the products, resulting from the joint development project to a third party.
This is a very synergistic agreement for both companies and we're looking forward to develop these monoclonal antibody therapies, along with our Viracon as all Tacrolimus and botanical programs.
We're also very excited about the prospects of our new relationship with Felix Biotechnology.
This firm is on the leading edge in the developing field of bacteria phage therapies.
We also have entered into a nonbinding letter of intent with Felix pursuant to which the parties have agreed in principle to negotiate and concluded a non exclusive worldwide license of our thin film freezing technology.
They would employ this technology to develop a bacteria phage based biotherapeutic for inhaled delivery directly to the lungs of patients.
And under the proposed collaboration development and license agreement, which we hope to sign with Felix shortly.
In exchange for the license of our T. effect technology fields will provide upfront payments development and commercial milestone payments and royalties on the eventual net sales of the Felix phage products.
The payments exclusive of eventual royalties could total up to $281 million.
It is important to note that the definitive agreement is subject to the mutual agreement of the parties and a number of conditions, including Felix biotechnology and successful completion of a series a financing.
We are very excited about the prospects for this deal and again it opens up the door for future applications and the exciting and growing field of phage therapeutics.
And now I'd like to turn the call over to Curt Coleman for a review of our financials.
Thank you very much client for the nine months ended September Thirtyth 2020 research and development expenses for the company were $7.6 million compared to $5.6 million in the same period in 2019.
The increase in research and development expenses. During 2020 was due to the ramp up of research and development activities. Following the completion of our IPO in October of 2019.
Ramp up includes our preliminary analysis in the testing of dry powder formulations of certain drugs and vaccines. We believe have the potential to become a product candidate.
General and administrative expenses for nine months of 2020 were $5.1 million compared to $1.7 million in 2019. The company reported a net loss for the nine month period of $12.7 million compared to a net loss of $7.2 million for the same period in 2019.
Weighted average common shares outstanding basic and diluted for the nine months ended September 32020, or 20 million 810004, compared with $4.4 million for the same period in 2019.
As of September 32020, we had total assets of approximately $43.2 million in working capital of approximately $40.6 million.
At the end of the quarter, our liquidity included approximately 41.6 million of cash and cash equivalents.
As of today November 5th the company filed a shelf registration statement on form S. Three with the Securities and Exchange Commission for future offerings of up to $100 million of the company's common stock.
The company's balance sheet and cash position are very strong with adequate financial resources to continue our near term and long term business plans. However, we believe it's prudent to have an effective registration in place that can help provide the company with access to capital markets. So that we can respond effectively to future business opportunities should.
They arise.
And with that I'd like to turn the call back to Glenn.
Thanks, Kirk and now I want to turn the call over to Dr. Bill Williams, who will talk about some of the groundbreaking work, we're doing using our thin film freezing platform and the broad field of biologics, including our efforts with augmented Felix and the University of Georgia. This is an area, where our technology is unique in its ability to reformulate.
These biologics into inhalable dry powders bill.
Thanks, Glen good afternoon, everyone.
For the next few minutes I would like to review at a high level, our thin film freezing process, what it does and the significant implications that it provides focusing mainly on the delivery of biologic therapeutics and vaccines to patients.
Also I would like to discuss how the thin film precinct process can facilitate and improved in the eventual worldwide distribution of these types of therapeutics by eliminating the resources and prohibited costs associated with cold chain storage requirements.
In handling.
We had developed the technology that can very rapidly freeze liquids that contain a therapeutic drug at a high rate.
We have greatly expanded the types of drugs that benefit from the thin film freezing process, including low molecular weight drugs that are water insoluble and now even more of biologics based drugs, including model called Atlanta bodies message or are in May our MRF.
Hi.
Naked and contained and lifted nanoparticles.
Small interfering or M&A or ESI or in a play.
Plasma DNA bacterial pages and a variety of antigenic vaccines, both advent and non edge invented.
We have discovered that these therapeutic agents maintain their chemical and physical properties as a dry powder and we have demonstrated this in both in vitro and in vivo studies.
How and why have we done this.
Well COVID-19, and the rapid search for vaccines and therapeutics have provided us the quick pivoting start and continued momentum to improve upon the drug delivery systems that are being developed to eliminate this virus.
And with this as a driver we are broadly applying our thin film freezing technology to many other diseases that benefit from similar therapeutic agents.
So why is stemmed from freezing so relevant to solve these drug delivery problems.
The thin film freezing process creates what we call a brutal matrix powder and in other words, a powder that has a high surface area low prosody and is easily shared.
All highly relevant and useful properties for drug delivery.
These types of powders are extremely well suited for administration by dry powder inhaler delivery the.
The tinterow freezing process is also well suited for providing a chemically and physically staple dry powder to facilitate long term storage without the need for cold chain storage also dry powders can be reconstituted at the point of the administration to the patient and.
Injected.
The key to this process and what differentiates it from other powder type formulation technologies is the rapid speed of our freezing it happens literally in milliseconds. This.
This rapid speed fully maintains the chemical and physical properties of the therapeutic agent and does facilitate its delivery.
For powders intended for delivery by dry powder inhalation to the lungs.
Our testing indicates that the portion of drug available to be deposited in the deep lungs has the potential to reach as high as 75% to 80% in other words. These brutal matrix powders made that them to increasing our highly aerosolized double using conventional commercially available.
Dry powder inhaler devices.
Why is this relevant.
And easily understandable benefit of this type of drug delivery application is to treat lung diseases in which the target site of delivering the drug is the lungs can.
Invincible oral delivery of the drug to the gastrointestinal tract can mean only a fraction of the drug actually reaches the ultimate target site of action the lungs, while the remainder of the oral dose of drug is delivered to other off target sites in the body potentially causing adverse.
Systemic effects in this situation a high dose of the drug must be administered to ensure that the required amount of drug actually reaches the loan.
And then halal version by contrast will deliver the drug directly to the target site of the disease the lungs.
And <unk> is that it can be applied to a wide range of biologic compounds as well and currently are thin film freezing process is the only technology that can effectively reformulate. These large complex unstable biologics into a dry powder for either direct delivery to the long.
<unk> or to be reconstituted back into a liquid form for injection at the point of administration.
It's this capability that is of extreme interest potential partners and drug companies, who are searching for new delivery modalities for their compounds.
They are large complex biologics that we are re formulating include them, our M&A, which is a single strand that are in a molecule that is complimentary to one of the DNA strands of the gene we are working with MRF today as therapeutic agents to treat COVID-19.
Another is ESI are in a which stands again for small interfering ribonucleic assets a class a double stranded DNA molecules it.
Our formulated as a liquid dosage form.
So what is cold chain and why is it important to address.
Cold chain refers to the requirement that a therapeutic product must be maintained at cold temperatures during its storage and distribution all the way to the point of administration to a patient.
A relevant example of a biologic product that requires cold chain storage are the end marinade liquid vaccines currently in phase III testing for COVID-19.
These vaccines must be stored at controlled temperatures that ranged from refrigerator temperatures to extreme freezing temperatures as coal that is minus 60 degrees C to minus 80 degrees C.
Even in the United States, maintaining temperatures as low as this requires significant effort and in less developed countries that don't have the required infrastructure for storage and distribution. This is just not possible.
We continue to demonstrate through our studies that we can convert these liquid products that contain biologics based therapeutics and vaccines into.
Into dry powder forms that are stable at room temperature and thus do not require such cold chain storage.
With that I'd now like to turn the call over to Chris Kaino, Our Chief operating officer, who can update you on more of the progress the company is making in these exciting areas. Thank you.
Thanks, Bill and good afternoon, everyone.
As I have shared previously the TFS business development team is laser focused on three key areas of growth for the company.
These three key areas are one growing the TFS pipeline of internal development programs.
Our pharma partnering efforts.
Three our government contracting efforts.
We continue to make great strides in each of these key areas.
Before I share with everyone specific examples of the progress, we're making with specific projects in each of these areas I thought it would be a good idea to take a few minutes to discuss the BD process.
Last earnings call I walk everyone through our BD process as we define it here at TFS and I received a few follow up questions and specific requests for clarity and insight into each of the BD steps.
So I think it will be helpful to walk everyone through our steps again, but this time take a deeper dive into each.
And ultimately perform some optimization work.
All done in collaboration with our partner.
We then select the optimal formulation and door formulations.
We run a batch of dry powder samples.
Delivered the dry powder samples to the partner for the partner to perform in vitro or cell culture knockdown testing.
This development effort was our announcement on November 2nd where we announced our joint collaboration and development agreement with augmented.
This opens new doors for TFS as we're collaborating in the development of monoclonal antibodies fulfill the 19th.
Testing that.
Our TFS technology works.
These transactions also provides the opportunity for Ts that to strengthen its expertise.
We are building our experience and expertise in each category of each complex compounds and we're now the market leader in dry powder formulations of monoclonal antibodies and phase.
Project, we're working with a top five farm accompany.
They initially centers one of their proprietary compounds that was extremely challenging to formulate.
We were successful in formulating a dry powder version.
We completed the in vitro tests, which were conformer confirmatory and we're now planning.
The in vivo testing, which will be performed next month.
This particular partner was so pleased with the T F best technology and the work being performed that they have now delivered us a second compounds.
In fact, we're now amending our initial M. T. A two <unk> include a third compound.
Since we last spoke we have entered into numerous new N T as with new partners.
We are working with multiple partners on various proprietary products.
It's always we appreciate the support of our investors and partners as we look to further the potential of our technology and our company and we look forward to updating you on our progress in the coming quarters.
And with that I'd like to turn the call back to the operator and open it up for questions.
Operator.
Thank you ladies and gentlemen, if you have a question at this time. Please press Star then one on your Touchtone telephone. If your question has been answered for Ya, What's your move yourself from the queue. Please press the pound key.
Sure Secondly, we think that the results could be so positive because of a lower dose going directly to the long for at least similar efficacy that the drug has potential to show advantages and survival. So we thought it was important to get that information out and.
Really reflect sort of an enhanced view.
An expectation of what we have for the asset.
And how long.
So I've friends milestones the number you're looking at it as a compilation of the Upfronts.
Development and sales milestones less royalty. So we haven't been disclosed me the specifics of.
These these dollars, but that's the structure.
Will be degrees, it's just to sort of give you the bottom line on what these deals are worth.
Maybe there's an aside and we've been working with Felix for quite some time.
Initially thought he has been on for Mike Congrats on all the progress this quarter and fantastic effort.
Question from US maybe first appeared.
This on that trial and report the results and then take it to the finish line with that specific trial.
Great. That's really helpful. And then kind of different everything that's going on you know across internally programs and then some of the other partnership that you recently enter it and you know may enter in the future.
You think you are closer to that.
Hey, Dale.
Yes, sorry could you just for clarity repeat the question for him answering exactly what you were asking sure.
Sure just wanted to know I'm kind of what you're seeing in some of the neutralizing in buying the assay that were conducted out with some of the augment a monoclonal antibodies using a tip that formulation.
Yeah. So [laughter] again generally we you know a mentor has isolated to a number of different antibodies. They are testing enter variety in a panel of different neutralizing I say, starting lets say the virus then progressing all the way to the active virus.
And we are working and we'll work to former formulate the dry powders and deliver dry powders to buy in vivo.
As part of the progression to the clinic that but these are fully neutralizing and potency potent as well.
Understood Thats it thanks for taking our questions and congrats on a great quarter. Thank.
Thank you.
Thank you and our next question comes from the line of Daniel Carlson will tell Lynch Research. Your line is open. Please go ahead.
Hi, Thanks, guys for taking my questions and congrats on all the progress first.
First question is just do you guys intend to undertake any new offerings from the shelf registration in the near future.
Actually how to.
Design that study and optimize it and so we are.
Consulting with.
Some of the industry leaders and the.
The academic tail wells too.
You know look into that.
Going forward.
Okay. Thanks, that's great then that.
Last question just about the vaccine program with the University of Georgia.
Seems to me that there's a lot broader implications of the success you've shown there and I'm just wondering if if.
You know other vaccine manufacturers or are you in contact with them and they are reaching out to does it have the potential to go far beyond Georgia, Here's the amendment.
Yes, Thanks, and you know what our practice is not to discuss transactions there haven't been consummated. So yes. There is a lot of activity in the vaccine space both.
New vaccines are like we're doing with the influenza vaccine that UGI, hey, working out some government programs and we're talking to companies about utilizing the technology in a number of different areas.
I think at this point, if you had a conjecture you know our opportunities to.
Partner with vaccine manufacturers potentially will fall into the second generation, but clearly as we do more and more of these deals announced more and more of these days.
Data, which is building a great foundation strong first and second floors, those those deals and opportunities will come.
Okay. Thank you.
Thanks, Thanks, guys I'll jump back in the queue appreciate it.
Question for Doctor Bill.
Is there one area.
To the most and using.
Yeah, that's the technology.
Yeah, Great question, what excites me. The most is applications biologics and it's something that we've worked on for a for a few years, but really with Covid as I said, one a few minutes ago with covid, it really caused us to pivot and explore in depth.
Just how useful symptom freezing as to biologics and and so that that's what excites me and we've got a lot of resources.
Geared towards biologic as we speak thanks for the question.
Thank you and congratulations.
Parents, she feel well.
Thank you.
Thank you and our next question comes from the line of William Morrison with National Security. Your line is open. Please go ahead.
Hi, guys, Congrats and all the progress Mcwhorter Uhm quickly union therapeutic shows how how are the milestones going and they come in and stretched out or how are you executing on that and then on the larger farmer potential J D. H <unk> where are the time.
Lines those thanks.
Yeah, Hi, Bill. Thanks, So you were really doing very well with the union products, where you've taken both the aural and powder. We're gonna have a pre INV meeting her in I M D and as quickly as we can get into our first in human trials, so things have been progressing well there.
And you know on the on the collaborations that we're working on go where it is Chris describe you know an hour really entering into you know.
You know the the Green zone or the Red zone cause it's kind of getting a football analogy here, we still got to get them over the goal line, but once you're transitioning into in vivo testing and these companies connect through now that they've got a formulation that they like and we've been able to do things that.
Frankly, they didn't even expect us to be able to do from a formulation standpoint, we crossover into in vivo testing. So we're we're getting we're at that stage on a number of a really important fronts with all of our deals are important and they're all going to be very positive for us but is Chris described we're really approaching that point.
On a on an F iron a platform an M on an M R and a platform and some others. So I don't want to give you a specific date, because we're absolute wreck frankly, not sure and I'd, rather under promise and over deliver but what we're really getting into the into the Reds out there and very very excited.
About it okay, just just to maybe address all of you on the phone.
I'm sure you can sense the enthusiasm of of the team here you personally I'm extremely bullish about our future we haven't credible potential for short mid and long term value creation as we advance our internal pipeline and we expand our partnerships I believe this is really just the tip of the iceberg.
And we were just working on these opportunities and pain really really close attention on the execution to our internal opportunities here for a tac closer might and now the augmenter monoclonal.
Great. Thanks, a lot great workers.
Thank you and again, ladies and gentlemen nephew had that question at this time. Please press Star then one.
[noise] and our next question comes from the line outside class.
Found her Stevens your line is open. Please go ahead.
Hi, Glenn I want to congratulate you and thank you on an amazing first year as a public company.
And a hell of a job and we appreciate it. My question is about I think you were talking about doing a three product deal with DARPA and I'm wondering how Ah how that is progressing if it is.
Yeah, we've alluded to darker partnerships in the past and for those of you that have worked with the government before you know that it takes a while to get these things finished lots of T crossing and I dining before you you get a signature. So we're we're in that process again, no undue percent guarantee that.
The signature will come but we're also again.
Pretty much on the go along with that one so hopefully that gets done and we were able to make a an announcement about that opportunity.
In the very near future.
Okay and one other question I know at some point you were in discussions with Bill gates and his team.
Call me, if you want to have any questions and stay well happy and healthy bye.
Ladies and gentlemen, thank you for participating in today's conference. That's does conclude the program and you may I'll disconnect everyone have a great day.
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Good afternoon, ladies and gentlemen, and welcome to the T. S. F Pharmaceuticals third quarter of 2020 financial results Conference cough.
As a reminder, this conference is being recorded I would now like to turn the call over to your house Mister Paul Fagan of T. F. F Pharmaceuticals, Investor Relations you may be getting your conference.
Thank you very much operator, Hello, everyone and welcome to TSS Pharmaceuticals third quarter of 2020 financial and business results Conference call.
With me on the line today is Glenn Madis, President and CEO of TFS.
Kirk Coleman, Chief Financial Officer, Darcheville Williams at the University of Texas at Austin.
Dr. Dale Christiansen TFS director of clinical development.
And Chris came out to Ya.
S Chief operating officer.
A press release announcing our queue three results is available on the TSS Pharmaceuticals website.
Please take a moment to read the disclaimer about forward looking statements in the press release.
The earnings release Endless teleconference. Both include forward looking statements on these forward looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made.
Factors that could cause actual results to differ Ah described under disclaimer and then our filings with a U S Securities and Exchange Commission, including the risk factors section about 2019 annual report.
Form 10-K is filed with the SEC.
And now it's my pleasure to turn the call over to Mister Glenn that's.
Good afternoon, and thank you for joining us today to review the company third quarter operations in recent highlights.
During this call I will provide an update on our clinical on corporate progress and.
And then I'll I'll ask our Chief Financial Officer, Kirk Coleman to review the company's financials.
Also I'm happy to have Doctor Bill Williams from the University of Texas at Austin, well, we'll talk about some of the exciting progress, we're making and applying a finished film freezing technology to drive vaccines and biologics.
And then Chris can now our Chief operating officer, and had a business development well update us on business development and operational initiatives for the company.
And then we'll open up the lines for your questions.
Have you seen from this afternoon press releases, we've had yet another enormously productive and accurate quarter, commenting this week with two very significant agreements.
What about Samantha bio works and most recently today with Felix biotechnology.
I'll discuss these two strategic development in more detail shortly but importantly, I want to emphasize with these two deals and then continued progress we're making with our clinical programs.
Teenagers validate dual track business model, you've established for the company and demonstrate the technological capability and market potential of our finished film freezing platform.
We've also made significant progress in our ongoing work with the University of Georgia, working with the renown Virologists Dr. Ted Ross, we have successfully reformulated for the first time, a potential universal flu vaccine into a dry powder for innovation and is there an equivalent efficacy too.
A liquid formulation.
Or three internal development programs have maintained strong momentum despite an extremely challenging clinical environment due to the covid pandemic.
Arlene clinical program for a cause all inhalation powder. The first clinical study ever unhealthy subject of direct to like dry powder formulation for the treatment of invasive pulmonary aspergillosis successfully completed phase one dosing and we'll answer phase two trials.
These results from the Phase one study were outstanding demonstrating safety and blood level outhouse.
Our second clinical trial program tackle them as in relation powder and important media suppressive agent. So the treatment of lung transplant rejection has demonstrated no clinically significant drug associate adverse events and is phase one trial and has achieved substantial immunosuppressive blood levels.
<unk>.
These results give us a strong belief that TFS tack premise will have a significant potential beyond lung transplant patients to ultimately include heart liver and kidney transplant procedures.
We also think there's potential for study PFF Packer women's examining a survival advantage cohort and transplant patients.
And on a close to my first in human trials are all scheduled.
Finally, updating our partnership between the intermediary company and plus products is proceeding well.
Plus products that they're working production lie has been testing product now for quite some time with positive reactions from consumers to their concept tasks.
During the quarter and responding to the needs of our pharmaceutical company partners. We took important steps to expand our manufacturing capacity to help develop and produce products currently under assessment.
This expansion with one of our Premier Cro's gives us a secure third choice for our finish off raising dry powder inhalation product, we have plans to further expand our capacity at other locations.
Dr Williams and his team at the University of Texas at Austin.
<unk> to report progress when they work and Repurposing I closer my an existing broad spectrum anti viral agent is in the same tone freezing and other techniques to enhance this is correct and COVID-19 therapy.
So to sum up briefly when you believe we have a remarkable technology that allows us to rapidly investigate prototype and develop a wide variety of compounds.
The market potential partners are recognizing are unique capacity and capabilities and this is creating a world of opportunities for us.
So now I'd like to take a closer look at this week's exciting partnering developments.
America Bioware Felix biotechnology represent potential breakthrough applications for our thing so I'm freezing platform and monoclonal antibodies and bacteria pages respectively.
The time and technology effort needed to succeed with these too complex biologic compounds in our platform was in Texas.
Dr. Bill Williams will speak to this later in the call, but it's important to note that these developments open the door for other potential collaborations and these two new and important drug delivery modalities.
Looking first at our agreement with augment the bio works. This is a worldwide joint development and collaboration agreement to develop commercial products that incorporate augmented human derived monoclonal antibodies for potential COVID-19 therapeutics.
We had sat after a successful private placement that we would have had a fourth product to our internal development portfolio.
These products will be developed utilizing our thin film freezing technology to manufacture dry port powder formulations of these specific monoclonal antibodies for innovation delivery directly to the lungs of patients.
The agreement also includes the development of formulations for parental administration, where a finished film freezing dry powder formulations can be reconstituted potentially mitigate any impacts of cold chain storage and handling and.
And we also have the option of developing two additional augment they have the bodies for indications other than COVID-19.
Both companies have agreed to a 50 50 split of all costs and both companies have agreed the same 50 50 split up all revenues cash payments and our future cash payments related to the sales or a license of the products, resulting from the joint development project to a third party.
This is a very synergistic agreement for both companies and when are you looking forward to develop these monoclonal antibody therapy, along with our work hard as all tack rowena's and botanical programs.
We're also very excited about the prospects of our new relationship with Felix Biotechnology.
This farm is on the leading edge in the developing field of backed carrier phage met therapies.
We also have entered into a non-binding letter of intent with Felix pursuant to which the parties have agreed in principle and negotiate and conclude a nonexclusive worldwide license.
Thin film freezing technology.
They would employ this technology develop a bacteriophage based biotherapeutic for health or liberate directly to the lungs of patients.
And under the proposed collaborations development license agreement, which we hope to science with Felix shortly.
In exchange for the license a R. T effect technology, Felix would provide upfront payments development and commercial milestone payments and royalties on the eventual net sales of the Felix phase products.
The payments exclusive of eventual royalties could total up to $281 million.
It is important to note that the definitive agreement is subject to the mutual agreement of the parties and a number of conditions, including shows biotechnologies successful completion of a series a financing.
Oh, you're very excited about the prospects for this deal and again it opens up the door for future applications and the exciting and growing feel that face therapeutics.
And now I'd like to turn the call over to Kirk Coleman for review of our financials.
Thank you very much Glenn for the nine months ended September 30th 2020 research and development expenses for the company, where 7.6 million compared to 5.6 million in the same period in 2019.
The increase in research and development expenses during 2020th was due to the ramp up of research in Delta development activities. Following the completion of our I P. O in October of 2019.
Ramp up includes our preliminary analysis and the testing of dry powder formulations of certain drugs and vaccines. We believe had the potential to become a product candidate.
General administrative expenses for nine months of 2020, or 5.1 million compared to 1.7 million in 2019. The company reported a net loss for the nine month period of 12.7 million compared to a net loss of 7.2 million for the same period in 2019.
[noise] weighted average common shares outstanding basic and diluted for the nine months ended September 30th 2020, or 20 million 810004, compared with 4.4 million for the same period in 2019.
As of September 30th 2020, we had total assets of approximately 43.2 million and working capital of approximately $46 million at.
At the end of the quarter, our liquidity included approximately 41.6 million of cash and cash equivalents.
As of today November 5th the company filed a shelf registration statement on form as three with the Securities and Exchange Commission for future offerings of up to $100 million of the companies common stock.
Company's balance sheet and cash position, a very strong with adequate financial resources to continue our near term and long term business plans. However, we believe it's prudent to have an effective registration in place that can help provide the company with access to capital markets. So the week respond effectively to future business opportunities should they.
Arise.
And with that I'd like to turn the call back to go on.
Thanks, Kirk and now I want to turn the call over to a Doctor Bill Williams.
Talk about some of the groundbreaking work redoing using our finish on freezing platform and abroad, Tioga biologics, including our efforts with Augmenter Felix in the University of Georgia. This is an area where our technology is unique in its ability to reformulate. These biologics into a hell will dry powders built.
Thanks, Glenn good afternoon, everyone.
But the next few minutes I would like to review at a high level art and film freezing process what it does.
And the significant implications that it provides focusing mainly on the delivery a biologic therapeutics and vaccines to patients.
Also I would like to discuss how the same film precinct process can facilitate and improve and the eventual worldwide distribution of these types of therapeutics by eliminating the resources and prohibited cost.
<unk> with cold chain storage requirements and handling.
We had developed the technology that can very rapidly freeze liquids that contain a therapeutic drug at a high rate we.
We have greatly expanded the types of drugs that benefit from that then they'll freezing process, including low molecular weight drugs that are water insoluble and now even more a biologic space drugs, including mottled call in Atlanta bodies Messenger RNA R. M R.
Hey.
Naked and contained and lipid nanoparticles.
Small interfering RNA or S. I R. A N a.
Plasma DNA.
Bacterial pages and a variety of antigenic vaccines, both adjuvant that and non adjuvant it.
We have discovered that these therapeutic agents maintain their chemical and physical properties as a dry powder and we have demonstrated this and both in vitro and in vivo studies.
How and why have we done this well COVID-19, and the rapid search for vaccines and therapeutics have provided us the quick pivoting start and continued momentum to improve upon the drug delivery systems that are being developed to eliminate this virus at.
And with this as a driver we are broadly applying arkin film freezing technology committee other diseases that benefit from similar therapeutic agents.
So why is stem from freezing so relevant to solve these drug delivery problems.
But then film freezing process creates what we call a brittle matrix powder.
In other words, a powder that has a high surface area low porosity and it's easily shared.
All highly relevant and useful properties for drug delivery.
These types of powders are extremely well suited for administration by dry powder inhalers delivery.
The 10th freezing process is also well suited for providing a chemically and physically stable dry powder to facilitate long term storage without the need for cold chain storage also the dry powders can be reconstituted at the point of administration to the patient and.
Injected.
The key to this process and what differentiates it from other powder type formulations technologies is the rapid speed of our freezing it happens literally in milli seconds.
This rapid speed fully maintained the chemical and physical properties of the therapeutic agent and thus facilitates it's delivery.
Four powders intended for delivery by dry powder inhalation to the lungs.
Our testing indicates that the portion of drug available to be deposited in the deep lungs has the potential to reach as high as 75% to 80% in other words. These brutal matrix powders made that film film Crazy are highly Arab sizable using conventional commercially available.
Dry powder inhalers devices.
Why is this relevant.
And easily understandable benefit of this type of drug delivery application is to treat lung diseases, and which the target site of delivering that drug is the lungs.
Conventional oral delivery of the drugs to the gastrointestinal tract can mean only a fraction of the drug actually reaches the ultimate target side of action the lungs, while the remainder of the oral dose of drugs is delivered to other off target sites in the body potentially causing adverse.
Systemic effects in this situation a high dose of the drug must be administered to ensure that the required amount of drug actually reaches the one.
And then Tailorable versions by contrast will deliver the drugs directly to the target site of the disease the lungs.
Greatly reducing the amount of drug required Ford administration and dust.
Less delivered to off target sites in the body and less related side effects.
A lower dose of drugs can be used by inhalation, which can enhance the drug safety profile and also reduce the potential for drug interactions.
To better illustrate this.
We recently published in the peer reviewed high impact Journal Pharmaceutics.
A paper on our end hilsman disappear made bite them film freezing and administered it by dry powder inhalation to animals.
Our high loading dry powder room, just severe formulations had excellent deliberate till the lungs, and the animals and exhibited high levels above the disappear and it's active metabolite and the lungs, exactly where it needs to be administered to exert its anti viral activity against COVID-19.
Yeah.
In addition, we have conducted similar studies on our and held in a close somebody powders made like until I'm freezing and we will soon publish our animals study results.
In addition, drug loaded powders made back then film freezing are not limited just to the use of an inhaler device. These powders can't be reconstituted at pointed the administration to the patient and injected or can be administered enter nasally or by nebulous Asian, we're very ill patients on.
The canticle them a license.
But what is truly remarkable about our 10 film precinct technology is that it can be applied to a wide range of biologic compounds as well and currently art and film freezing process is the only technology that can eat affectively reformulate. These large complex unstable biologics.
Into a dry powder for either direct delivery to the lungs or to be reconstituted back into a liquid form.
For injection at the point of administration.
It's this capability that is of extreme interest to potential partners and drug companies, who are searching for new delivery modalities for their compounds.
As I discussed earlier the biologics. We're currently working with and Reformulating include M. R. N E. S. I R N a plasma DNA.
Vaccines and most recently with the announcements from Argumenta bile works on their monoclonal antibodies and from Felix biotechnology on their bacterial pages.
Monoclonal antibodies, commonly referred to as nabs or a type of protein made in the laboratory that combine to substances in the body, including cancer cells.
There are many kinds of monoclonal antibodies and they are typically made so that the monoclonal antibody binds to only one substance.
The interest in the scientific community and model Cold'll antibody therapeutics, particularly for the treatment of COVID-19 is extremely high.
With the promise that they will harness the immune system's natural response to viral invaders. We are working to deliver a variety of different monoclonal antibodies as a dry powder for both needle free dry powder inhalation and injectable routes of administration.
And then the case of Felix Biotechnology, we are applying then film freezing to the formulation and delivery a bacterial phages back.
Bacteriophage is our bacterial viruses that infect specific strains of a single bacteria species.
Bacterial pages are highly relevant and of extreme interest to scientists and researchers as therapeutic alternatives to antibiotics because of the high prevalence of multi drug resistance to antibiotics for this reason it is suggested that they can be used either alone or in.
Combination with antibiotics to treat bacterial infections.
The other large complex biologics that we are reformulated include mrna, which is a single stranded RNA molecule that is complementary to one of the D. N. A strands of the gene. We are working with mrna is therapeutic agents to treat COVID-19.
Another is S. I R N, a which stands again for small interfering ribonucleic acids, a class a double stranded RNA molecules.
It is sometimes known as short interfering RNA or silencing are they and it's used to interfere with the translation of proteins. We're studying S. Irna delivery using then film breathing as a disease therapeutic and.
And finally, we are studying plasma DNA used for disease treatment as DNA vaccines for genetic immunization.
After significant research efforts, we recently reported results on our collaboration with the University of George's Center for vaccines, and immunology, where we applied them film freezing to U T I's universal influenza Hemagglutinate recombinant vaccines and studied if our <unk>.
<unk> was affected by and will affect the images of necessity and efficacy of these vaccines and dry powder form.
Art and film freezing processed successfully converted the liquid vaccine product into dry powders that elicit the equivalent neutralizing antibodies and protection against influenza virus infection come.
Compared to the non process liquid formula license.
We now have subsequent studies on these dry powder vaccines ongoing.
Ultimately the issues that we are critically addressing with these complex biologics and their formulations are two fold.
First facilitating delivery of the biologic to multiple routes of administration, including injectable Internasal and then halation.
And second addressing head on the cold chain storage requirement.
Those cost and logistics associated with cold chain storage.
When these biologics are formulated as a liquid dosage form.
So what is cold chain and why is it important to address.
Cold chain refers to the requirement that a therapeutic product must be maintained a cold temperatures during its storage and distribution all the way to the point of administration to a patient.
Ah relevant example of a biologic product that requires cold chain storage or the mrna liquid vaccines.
Currently in phase III testing for COVID-19, these vaccines must be stored it controlled temperatures that range from refrigerator temperatures too extreme breathing temperatures as cold as minus 60 degrees C to minus 80 degrees C.
Even in the United States, maintaining temperatures as low as this requires significant effort and in less developed countries that don't have the required infrastructure for storage and distribution. This is just not possible. We continue to demonstrate through our studies that we can convert these liquid.
Products that contained biologic space therapeutics and vaccines.
Into dry powder forms that are stable at room temperature and thus do not require such cold chain stores.
With that I'd now like to turn the call over to Kris K now our Chief operating officer, who can update you on more of the progress the company is making and these exciting areas. Thank you.
Thanks, Bill and good afternoon, everyone.
Cause I have chaired previously the T. F F business development team is laser focus on three key areas of growth for the company.
These three key areas are one growing the T at that pipeline of internal development programs.
To our pharma partnering efforts.
Three our government contracting efforts.
We continue to make great strides in each of these key areas.
Four I share with everyone specific examples of the progress we were making with specific projects and each of these areas I thought it would be a good idea to take a few minutes to discuss the beady process.
Last earnings call I walk everyone through our B D process as we define it here at T. S S.
And I received a few follow up questions and specific requests for clarity and insights into each of the beady steps.
So I think it will be helpful to walk everyone through our steps again, but this time ticket deeper guys into each.
First the T. S F. B D team has very targeted exercise, where we identify potential partners.
Is your company's working on certain compounds, such as tomorrow, and a S. Irna stage monoclonal antibodies among other complex compounds.
These are complex compounds that would benefit from the characteristics of the send some pleasing technology.
Each of these compounds.
Have specific challenges for example, these compounds stays formulation issues stability issues routed administration issues, such as delivery directly to the lungs, where they require cold chain.
Where they require a bulky nebulizer just the name of it.
Once identified we then strategically reach out to the decision makers at these companies with the intention of engagement and having an introductory discussion.
Apart an introductory discussion the next step is entering into a confidentiality agreement where C. D S.
The C D. A allows for a free exchange of ideas and facilitate a discussion, allowing T F that to create an awareness and to educate the potential partner aren't on our innovative technology.
The advantages of utilizing our technology on their proprietary compounds.
And to share the successes, we have had with similar partners annual compounds.
Based on the results of these discussions and identifying a project to collaborate on.
He then enter into a material transfer agreement for it N T. A along with the statement of work or an S O W.
Under the M. T. A we were able to receive the partners proprietary materials.
Prepare initial formulations.
Performed characterization work.
Do some aerosol testing.
And ultimately perform some optimization work.
All done in collaboration with our partner.
We then select the optimal formulation and or formulations.
We've run a batch of dry powder samples.
Delivered the dry powder samples to the partner for the partner to perform in vitro where cell culture knockdown testing.
To confirm the activity Immunogenicity indoor transfection as the case may be.
All of this work is confirm the confirmatory that indeed, it's white powder formulation is equivalent to or better than the original complex compound.
The next critical step is planning the Depo work, which usually consists of a mouse model with a dry powder will be administered to the mice along with other control arms to confirm activity liability and or Immunogenicity.
After this is depot work is completed and the results are confirmatory that both T F F and the partner will enter into a collaboration and license agreement.
This is the inflection point, where our partnership will evolve from lab scale testing to G. L. P. G M P manufacturing scale testing.
This requires a license from T S S.
I'd like to spend the next few minutes, giving an update on our ongoing projects.
Is glenda Bill discuss on October 25th 2020, we reported the positive results from our collaboration with the University of George's Center for vaccines and Immunology C V I quit.
This is a very exciting development for the company as we now have animal data that confirms that T. S. At bright powder formulations of vaccine maintain is high potency.
We are in strategic discussions with Ted Ross and the C. D I group.
On the next potential steps of developing these vaccines.
Including a potential partnering of these antigens from U G. A.
Working together with G U G. A to obtain further funding to perform a ferret study, which is the gold standard and influenza.
We are exploring all options at this time.
Another exciting business development effort was our announcement on November 2nd.
We announced our joint collaboration and development agreement with augmented.
This opens new doors for T. F F. As we're collaborating in the development of monoclonal antibodies for COVID-19.
As well this opportunity provide the at the the chance to develop additional maps or monoclonal antibody.
Other key respiratory diseases.
We're very excited to progress this collaboration and move this project forward.
Is Glenn also mentioned earlier today.
We announced entering into a letter of intent with Felix Biotechnologies.
This collaboration will further strengthen our position in the state space and further validates the benefits of the T. S. S technology to formulate complex compounds and a dry powder blue delivery directly to the lungs to treat specific respiratory diseases.
Both of those menta and Felix transactions are extremely important to T. F F for many reasons.
First these transactions encompass the T F that strategy for Parker.
T F F has the flexibility co develop products as.
As well as enter into a straight technology license.
These transactions also reflect that T. S F can execute on transactions.
Both that drive product development.
And financial upside for the company.
These transactions also validate the T S F technology.
Two formulation and activity testing that R. T S F technology works.
These transactions also provide the opportunity for T F F to strengthen its expertise.
We are building our experience and expertise in each category of each complex compounds and we're now the market leader and dry powder formulations of monoclonal antibodies and fish.
This is critical because it will allow us to expand into additional collaborations in both the mad and faith spaces with new partners.
And it allows T. S F to continue to build a concrete foundation in order to utilize our technology and transcend into other areas of focus.
We were building this foundation enhancing our technology and expanding our reach which will drive strong value for the company and its stakeholders.
[noise] another projects, we were working with the top 10 form a company back in July we entered into an M. T. A under which we're formulating their proprietary S. I L Renee into a dry powder.
We shipped to the partner hard dry powder samples and they perform their in vitro testing.
The results of the dry powder versus the original liquid solution was that it was equivalent.
Both the partner and T. S F O extremely pleased with the results.
We are now in the process of planning in vivo testing, which will begin later this month.
On another project, we're working with a top five farm a company.
They initially sent US one of their proprietary compounds that was extremely challenging to formulate.
We were successful in formulating a dry powder version.
We completed the in vitro tests, which were conformer confirmatory and we're now planning the in vivo testing, which will be performed next month.
This particular partner was so pleased with the T F best technology and the work being performed.
They have now delivered us a second compounds.
In fact, we're now amending our initial N T. A two <unk> include a third compound.
Since we last spoke.
We have entered into numerous new N T as with new partners.
We are working with multiple partners on various proprietary products.
Such as mrna S irna plasma DNA monoclonal antibodies bacteria bacterial H a D. D. S V vaccines, and we were formulating their proprietary biologics into a T at that price powder for installation.
Delivery directly to the one.
We're very excited for the future for these potential collaborations.
Well I had this opportunity I think it is extremely important to thank our strongest partner and most valued collaborator.
All of these business development efforts are supported by the tireless efforts of our collaboration partners at the University of Texas at Austin.
With the support of Doctor Bill Williams and his research team, we continue to expand the applications of the same sound pretty thing technology into new and innovative areas of drug delivery.
In closing from a beady perspective, we're very excited about the growth opportunities of our technology and of our company.
We believe that we have only scratched the surface of the many applications of the thin film please and technology.
Thank you for your time today I.
I will now hand, it back over to Glenn.
Thanks, very much Kirk, Chris and thanks to bill as well.
He's been another quarter of remarkable activity in progress for T. F F. The market places responding to the promise of our technology and our team continues to deliver it produced remarkable science. Despite the challenges is a global pandemic I'm. So proud of their efforts. There's always we appreciate your support of our investors.
And partners as we look to further the potential of our technology and our company and we look forward to updating you on our progress in the coming quarters.
That I'd like to turn the call back to the operator and open it up to questions.
<unk>.
Thank you ladies and gentlemen, if you have a question at this time. Please press Alright, then one on your Touchtone telephone. If your question has been answered why you wish to remove yourself from the queue. Please press the pound key.
Hi, first question comes from the line of Jonathan Ashcroft like <unk> Yeah.
Your likeness open. Please go ahead. Thank you very much Glen I was just curious why did you release the the interim phase.
Phase one S. A D dosing data for to call in this rather than a wait the full S. A T results, which any of themselves would it still be impartial phase one day that I was just curious what was the significance at all.
Yeah. Thanks, Jonathan that's a good question. So we were so impressed with uhm the results were getting.
In in that phase one data that in fact Doctor Gail Christmas soon is actually on the line what else is running all of our studies.
It started to make us really look at tackling this and the potential of the compound beyond even the indication that we're thinking gosh cause lung transplant.
So you know, we're finishing off <unk> sad, we're gonna be starting to mad shortly but.
We wanted to really be able to say hey look we know we have something really special here no adverse events. The blood uhm levels that were getting was so significant that when you look at this compound you know from our strategy standpoint, which would be to develop into the pivotal trial.
And then you know looking to find a partner that we think the asset itself is even greater value than we originally anticipated that I believe it was tremendous casualty on lung transplant into heart liver and kidney transplant and when we look at those indications tech or women's has a very very.
Again market share.
Secondly, we think that the results could be so positive because ah lowered goes going directly to the wrong for at least similar efficacy that the drug has potential the show advantages and survival. So we thought it was important to get that information out and uhm really reflect you know, it's sort of a I didn't hands view.
Okay and expectation of what we have for the asset.
And how long do you think I am trying to show survival.
Gail do you Wanna answered the survival question.
Yes, I and and I did want to add one more thing to what Gwen had said the the other aspect of that really is that we are interleaving the mad.
So the rest of the sad cohorts will be dosed, along with the starting of the Mad and so we have reached the point in the safety data that allows us to start the multiple dosing instead of waiting until till the end and that was another aspect of that really.
In terms of the survival aspects for for the lung transplant patients they the <unk> the.
The first year. It shows the greatest degree of survival and really the the key aspect would be to show that survival advantage that that one year time point and so it's really one year survival, where we would expect that and we would start treating subjects early on within the first month.
After transplant and we would be following them to that for Ya.
Thanks <unk>.
Thank you down Uhm a question for actually first of all I was wondering can we have any more felix financial details or is or just that's a blanket now.
Well I can give you the structure Jonathan Uhm.
We're doing it says we've been we're gonna do all of our licenses with meaningful I've friends milestones the number you're looking at it is a compilation of the upfront.
Development and sales milestones last royalty so we haven't been disclosing the specifics of.
<unk> dollars, but that's the structure movie degrees is just to give you the bottom line on on what the heels are worth maybe as an aside and we've been working with Felix for quite some time, we got great results as Chris described in our work you know getting the formulations.
This also helps them to their I P position with the compound we've using the T. F. F technology gives them, great differentiation and a high level of confidence that they're gonna, they're gonna be able to go out and and you said you were the funds and get this done quickly. So we can move ahead.
Okay, and what I joined the call late what went in and get ready to release, what's what's the what's gonna do with that.
Do with sorry, the phage inhalable fake.
Chris I don't know do you Wanna talk a little bit about and we are we're not disclosing the indication, but I guess I'll I'll answer the question because we were just it's it's in respiratory indication.
Okay. The last woman you prefer a bill as I think like this for pill as you're buying against competitors for these transactions certainly sounds like you're in quite a few talks could you. Please you know.
Put your finger as.
Hard as you can on how you differentiate.
<unk> film freezing from you know the technology available from your closest competitors you know going after the same business.
Yeah, I mean, the differentiating factors the type of powders that we were able to make with them film freezing. It's this freezing right enables.
You know the formation of these preble matrix powders.
So those verbal matrix powders are then you can do those to where it's a one step process that can they can then be delivered to the lungs or as an injectable for reconstitution you know for kind of the cold chain storage argument.
So that's that's that's the differentiating factor why do these biologics I mean, they're protein based they're sensitive to being in a liquid and and also they're sensitive to vibrations M. P. H and all sorts of stuff will will cause degradation and that's why they you know.
And that's what's happened to be in a cold chain environment and so we're we're able to to have a process that will you know produce this this type of powder and not affect their their stability or or.
By ability.
So would would your closest competitors you know maybe make a pattern, but it doesn't dissolve and uhm readily or athletes inhale the protein stone function, they don't fold properly or something like that.
Yeah. So if so a competing technology might be conventional waffle ization. So, it's very slow freezing and and the and the issue. There is the powder you get even if the biological stable. The powder. Your get is not in a form that can then be.
<unk> administered by dry powder installation that you would have to reconstitute and then administer by Netherlands Asia and so a lot of the nebulizer as our high energy you get a lot of sheer from the device itself and that can affect the stability of the the protein.
The other competitor for some of the biologics could be spray dry but that also exposes these biologics too significant sheer during the press process mechanical sure as well as heat it because it's a N a backward of process.
And so we believe well we don't use mechanical sharing and we don't use heat so right away where are our process is advantageous ober overspray dry, but that's how Jonathan that's how we differentiate took.
Okay and Jonathan Thanks, we have a lot of people in the queue. So I'm trying to think and follow up one on one thanks Jonathan.
Thank you and our next question comes from the lineup My arms <unk> B Riley Carolinas Open. Please go ahead.
Good afternoon, Mister Thornhill caused me on for my Congrats on all the progress this quarter and sent that through that thick a couple of questions from us maybe first piggy backing on some that were already.
The specific to the tackler limits program get to see it kind of progressing as it is can you talk to somebody that you know before you start to explore some of these other indication that it relates to heart liver and kidney and maybe in the context of you know any benefits with the inhaled delivery relative.
To tackle limits orally.
She has sort of a business strategy is remains room cat, we we plan on developing to drive by doing a pivotal trial and getting drunk I'm to the point, where it's it's ready for marketing approval.
Yeah, <unk> our business model you know in terms of resources to take the drug and invest in the drug to that point and at that point fine trying to partner so that that remains intact. However, our outlook in in our forecast.
Four cats. The limits are are much higher than I think they were when we started the program and therefore, we we mentioned the fact that we think is great opportunities to develop to dragging another indication.
So you know we went to the next step for us on it from her clinical development standpoint is to do the pivotal trial.
And everyone else is on that trial and report the results and then take it to the finish line with what that specific trial.
Great that's really helpful and then.
And everything that's going on you know across internally programs and then some of the other partnership that you recently entered in you know may enter in the future can you got to kind of what the recent manufacturing agreement with expert does in regards to production for both clinical trials and commercial scale I'd better get you capacity.
<unk>.
Well, we were constantly looking at expanding our contract manufacturing partnerships covid.
Be prepared to do the work and be able to satisfy all of the potential opportunities. We have so right now the strategy you focused on on C. M O partnerships and as we you know so when we go and we discussed for example.
No changes are ma'am or vaccines, we we know where we're going to go out. So we haven't you know put a capital plan or you can tend to put a capital plan in place to do our own bricks and mortar, but there are enough potential partners out there.
We're engaging in talking to <unk> to them. So it will have capacity to satisfy all of our internal needs and future needs. We can transactions that welcome that we're going after them.
Great and then if I can squeeze in one more maybe for sure who Williams just wanted to kind of understand actually he was really helpful to hear the process on kind of how the business development goes on but further augment sort of collaboration and some of the in vivo studies that are done could you talk to you know what you're seeing in terms of neutralizing or.
<unk> or binding assays and how that compares to what was observed with a M does appear.
On the this augment on the local antibodies Dale you Wanna, you Wanna, you'd think you're closer to that.
Hey, Dale.
Yeah, sorry could you just for clarity repeat the question. So I'm answering exactly what you were asking sure.
Sure just wanted to know kind of what you're seeing in some of the neutralizing and binding assays that were conducted with someone to augment monoclonal antibodies using a T F that formulation.
Yeah. So.
Again generally we.
I've meant to has isolated the number of different antibodies. They are testing and a variety in a panel of different neutralizing assay, starting let's say the virus and progressing all the way to the active virus and we are working and will work to form or formulate the uhm dry powders and deliver dry powder.
There's too bye in vivo as part of the progression to the clinic said that these are fully neutralizing and potency potent as well.
Understood that that's it thanks for taking our questions and congrats on a great quarter.
Thank you.
Thank you and our next question comes from the mind of Daniel Carlson, What challenge restart. Your line is open. Please go ahead.
Thanks, guys been taking my questions and congrats and all the progress Uhm first question is just <unk> do you guys intend to undertake any new offerings from the shelf registration in the near future.
[noise], Yeah Thanksgiving so the you know the.
Filing of the shelf registration I guess you would categorize it is procedural you know we were not.
Are you able to do that until the one year anniversary of your I P. O. So we did that whenever we have no actually if you look at our statements. We have a lot of working capital got capital Nashville substantial enough to support what we're doing now so we have no plans right now to raise additional fine.
So it keeps its there and I think it's good business to have it in place. It's it gives us an opportunity to be opportunistic should we need to be but right now our capital is sufficient to support the business as we go forward.
Okay.
Mm that's great. Thanks, and then about your work on yourself program I mean with the number of.
Covid associated after you, let's face it says that a big scene is there any chance that you guys would the excellent phase one day to your head could be looking at some sort of accelerated approval process in that program.
Yeah could you answer that please.
Yes. Thank you for is a very good question, we have been talking to.
To the F D a or to get information both from industry leaders in that space. We certainly think there is a case to be made the question is exactly how to design that study them and optimize it and so we are consulting with some of the.
Industry leaders and and you know they they.
The academic Kols too.
Look into that going forward.
Okay. Thanks, that's great and then.
That last question just about the the vaccine program with the University of Georgia, and it seems to me that there's a lot broader implications of the success you've shown there and I'm just wondering if if.
But you know other vaccine manufacturers are are are are you in contact with them and they reaching out to you does it have the potential to go far beyond Georgia, Here's 296.
Yeah. Thanks, Daniel Yeah, we our practice is not to discuss you know transactions. They haven't been consummated. So yeah. There's a lot of activity in the vaccine space, both new vaccines like we're doing looking influenza vaccine that UGA working on some government programs.
And we're talking to companies about utilizing the technology, yeah in a number of different areas.
No I think at this point gives you a conjecture you know our our opportunities to.
Partner with vaccine manufacturers potentially will will fall into second generation, but clearly as we do more and more of these deals announced more and more of these data which is building a great Foundation strong first and second floors, those those deals and opportunities will come.
Okay. Thank you. Thanks, Thanks, guys I'll jump back Nick you appreciate it.
Thank you and again, ladies and gentlemen, if you have a question at this time. Please press start then one and our next question comes from the line S. Keith <unk>. Please state your.
Company name and your question.
Hello, Glen estate those to stick those two builders congratulations again on such a wonderful.
According to the progress you've made it was really exciting I have one question and that is one one might may see some data from you some <unk>.
Chris can you handle the question on your sandwich.
Yeah sure. Thank you and thanks for <unk> for the clustered. So so that work is ongoing. So we are we have delivered we have formulated and delivered the monoclonal antibodies and so that in vitro work is ongoing the D. S. V. We are in the process of formulate.
So to answer your question probably within the next month or so we'll get some immediate in vitro data what the next step from there would be to seek additional funding to advance those programs.
Okay.
Alright, well, thank you very much I'll get back in the queue then.
Thank you.
Thank you and our next question comes from the line of keep you. Please state your company name and your question.
Yeah. So can you feel called Terry.
My voice how to get off the phone congratulations.
Yes S T.
I appreciate all your efforts.
Questions Doctor Bill.
Yeah, one area.
Nine two the most in Eugene.
That's neat technology.
Yeah, Great question, what excites me. The most is applications biologics and it's something that we've worked on for a for a few years, but really with Covid as I said, one in a few minutes ago with covid, it really caused us to pivot and explore in depth.
Just how useful symptom freezing as to biologics and and so that's that's what excites me and we've got a lot of resources <unk>.
Geared towards biologic as we speak thanks for the question.
Thank you and congratulations.
<unk> C O L.
Thank you.
Thank you and our next question comes from the line of William Morrison with National Security. Your line is open. Please go ahead.
Hi, guys, Congrats and all the progress Mcwhorter Uhm quickly union therapeutic Charles how are the milestones going to come in and stretched out or how are you executing on that and then I'll on the larger farmer potential J D. As her out what are the timelines.
Those thanks.
Yeah, Hi, Bill. Thanks, Oh, So you were really I was doing very well with the union products, where you've taken both of the oral and powder. We're gonna have a pre I envy meeting password I M D and as quickly as we can get into first thing human trials, so things have been progressing well there.
And you know on the on the collaborations that we're working on go where it is Chris describe you know an hour really answering into you know.
The Green zone or the Red zone cause it's kind of getting a football analogy here, we still got to get them over the goal line, but once you transition into in vivo testing and these companies can actually now that they've got a formulation that they like and we've been able to do things that.
Frankly, they didn't even expect us to be able to do it from a formulation standpoint, we crossover into in vivo testing. So we're we're getting we're at that stage was on a number of a really important fronts like all of our deals are important and they're all going to be very positive for us but is that Chris described where we're really approaching that point.
On a on an F iron a platform uhm and M on an M R and a platform and some others. So I don't want to give you a specific date, because we're apps, where I frankly, not sure and I'd, rather under promise and over deliver but we're we're really getting into the into the Reds out there.
Very very excited about it okay. Just just to maybe address I'll have you on the phone.
I'm sure you can sense the enthusiasm of of the team here you personally I'm extremely bullish about our future we have incredible potential for short mid and long term value creation as we advance our internal pipeline and we expand our partnerships I believe this is really just the tip of the iceberg.
And we were just working on these opportunities and paying really really close attention on the execution to our internal opportunities here for a tag close them I didn't know that York Manta amount of Arnold's.
Great. Thanks, a lot of great workers.
Thank you and again, ladies and gentlemen, if you have a question at this time. Please press Star then one.
And our next question comes from the line at that classifies found her Stevens. Your line is open. Please go ahead.
Hi, Glenn I want to congratulate you and thank you on an amazing first year as a public company mhm.
Done a hell of a job and we appreciate it.
My question is about I think you were talking about doing a three product deal with DARPA and I'm wondering how how that is progressing if it is.
Yeah, we've alluded to darker partnerships in the past and for those of you that have worked with the government before you know that it takes a while to get these things finished lots of T crossing and <unk> before you you get a signature. So we're we're in that process again, no hundred per cent guarantee that that.
The signature worldcom, but we're also you know again reading pretty much on the go along with that one so hopefully that gets done and we were able to make a an announcement about that opportunity.
In the very near future.
Okay and one other question I know at some point you were in discussions with Bill gates and his team.
About vaccines I'm just curious if if you are still talking or dancing with them.
Yeah. So we've talked to gate. So I've got a lot of things there is mutual interest I would say that at this point goes are still at the the discussion.
Page nothing is is really move forward to where I can say some things in the immediate offering but there's a lot of interest certainly and what we can do your gates's broke it's not a lot of things right now that makes their bandwidth a little bit limited and frankly, so are we so.
When you say, we stay in touch and hopefully one big something will come of that but.
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We're staying in touch.
Thank you I really appreciate it.
Thank you M S does <unk>.
Conclude our Q&A session for today conference and I would like to turn the conference back over to claim masses for any further remarks.
Yeah, I'm, sorry, if we didn't get to answer your questions. You all know how to get in touch with me and if you do have questions. Please. Please do that I also just want to conclude by thanking all of you for the support again the company and all the people that work here are doing an amazing job. We're really excited it has been.
A great ear, but it's only the beginning for us.
So I would ask all of you to please stay well and hard to believe in this 120 20 year, but we're actually getting into the holiday season. So I wanted to be one of the first to wish all of you a very happy and healthy holiday season.
Hopefully I'll get to enjoy the holidays in a positive way. So please enjoy and call me. If you want if any questions and stay well happy and healthy bye.
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may I'll disconnect everyone have a great day.