Q4 2020 TFF Pharmaceuticals Inc Earnings Call
Yeah.
Good afternoon, ladies and gentlemen, and welcome to the TFS Pharmaceuticals, 2020 financial results Conference call.
The reminder of this conference is being reported.
I will now turn the call over to our host Mr. Paul Sagan of PFS Pharmaceuticals Investor Relations.
May begin your conference.
Thank you operator, Hello, everyone and welcome to of TFS Pharmaceuticals, 2020 financial and business results Conference call.
With me on the line today is Glenn Maddox, President and CEO of TFS current Coleman, Chief Financial Officer, Dr. Bill Williams of the University of Texas, and Austin and Dr. Dale Christiansen, TFS director of clinical development, and Chris Cato and <unk>.
S Chief operating officer.
Press release announcing our 2020 results is available on the TFS Pharmaceuticals website.
Please take a moment to read the disclaimer about forward looking statements and the press release you and.
<unk> release and this 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 I've described and the disclaimer and in our filings with the U S Securities and Exchange Commission, including the risk factors section of our 2020 annual report on form 10-K filed with the SEC.
And now it's my pleasure to turn the call over to Mr. Glenn matters.
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 and corporate progress and.
And then I'll ask our director of clinical development Dr. Dr. Christensen the update us on the very significant progress, we are making and our internal clinical programs.
And then our Chief Financial Officer, her Coleman will review the company's financials.
We're also happy to have with us once again, Dr. Billy and from the University of Texas, Austin, who will talk about some of the exciting progress of new data, we're seeing and the application of our thin film freezing technology, the drugs vaccines and biologics.
And Chris can out of our Chief operating officer, who will update us on business development and operational initiatives for the company and then we will open up the lines for your questions.
While we are reporting on 2020 resolves and I can say that last year was one with numerous remarkable accomplishments and.
As we begin 2021, we are on course for a year of significant of outcomes as we move our internal pipeline forward and capitalize on the transactions already completed and secure important new partner agreements.
As you've seen with the press releases yesterday and today, we continue to build TFS and greatly enhance the value creation of the company.
Today, I will discuss the details of what T. F. F has accomplished and how these developments and set us up for near and mid and long term success.
I wanted to take just the moment to reiterate our thin film freezing technology and company business strategy.
The strategy is fundamental to our company and our commitment to sustainable value creation.
The first part of our business strategy is the development of and internal pipeline of products and <unk>.
Or to have Dr. Zhao of Christmas and review the progress we've made on the clinical front as well as discussing the path forward for these assets.
And I'm very proud of the clinical development programs as we've executed well on timing budgets and results.
The second platform of the TFS strategy is and partnering the thin film freezing technology, and collaborating with pharmaceutical companies and academia and the government.
And 2020, we're successful in this arena and we're confident of the number of these transactions will increase this year.
This confidence continues to build as we have new data about the ubiquitous nature of the technology and a broad array of platforms.
Later in the call the Williams and Chris can I will go into greater detail about the unique nature of these data the <unk>.
New partnerships, and specifically where the potential exists for building on our successes.
Thin film freezing of the game changer.
During today's call, we will discuss more details about the most recent transactions.
Specifically today, we announced the collaboration with the United States government. The formulaic counter measures to be used by our military forces.
Our technology will be used to develop a topical ophthalmic and inhaled products.
As a result, and very importantly P. F. F has been designated as an approved some contractor, which will enable additional work with the government and the prime contractor.
I would like to go into greater detail and we will do so once it's clear what information and I can share about the specifics of the work.
I can tell you the thin film freezing was selected for this contract based on a very rigorous diligence and this also bodes well for additional awards and developing products for the military.
We're incredibly proud of this accomplishment.
Yesterday, we announced the work, we're doing and partnership with newer Rx and the Green light.
Announcing feasibility agreements does not PFS of standard corporate practice, but given the collaborative nature of our partners. The current events of the COVID-19 pandemic the timing of the work and applicability of the real time events.
And that's agreed to the slow certain aspects of these partnerships.
It's a very significant and important partnerships and we look forward to working with these companies.
The Williams will specifically address the potential of thin film and freezing to impact the need for cold chain distribution and storage and his discussion and Chris channel update and greater detail opportunities and working and the mrna vaccine space.
I also want to take this opportunity to update you on some of the agreements we signed in 2020.
We issued press releases earlier this quarter about the data we have generated at the University of Georgia, and you Sam right.
You will recall that we were working on of Universal flu vaccine and UGA.
And on monoclonal antibody based anti viral vaccines that your family.
The initial in vitro data on both projects are very positive and we will now pursue and definitive in vivo data the confirmed animal activity.
Chris will provide greater detail and his segment of the call.
Our partnership with Union Therapeutics on the close of the mine is proceeding well we are approaching important first in human trials on both oral and inhaled version.
The Isle and Bill will elucidate further in a moment.
We continue to progress our partnership with Felix on their lead macrophage asset and the co development work on the augment the buyer works monoclonal antibody and its also moving forward as scheduled.
Details to follow.
Finally, our partnership with plus products and the cannabinoid space is at a very exciting inflection point.
Pluses working to enter a thin film and freezing version of cannabinoid into the commercial market later in the second quarter.
I can tell you that the selection of plus products as our initial partner was a wise decision.
Part of this demonstrated market success with their current product line and its.
<unk> been working diligently to get up and running to produce product and enter into the highly lucrative and growing market and California.
So you have this optimistic about this initial launch and the total market potential as we expand the distribution of products and to more markets over time.
In summary, PFS is on and amazing trajectory.
While we are proud of our accomplishments. This is just the per verbal tip of the iceberg the gras.
And as fertile and we're uniquely positioned to capitalize on this ubiquitous and disruptive technology.
Both of the our internal development efforts and the business development across the stakeholder base.
And so now before we go over to the franchise with the Cart Coleman I wanted to turn the call over to Dr. Dale Christiansen, our director of clinical development and we'll give you more detail on the outstanding Phase one clinical results, we achieved without truly and internal programs and the implications of these results on our potentially pivotal trials and the few.
For <unk> of all inhalation powder and the <unk>.
Relentless innovation powder Gail.
Thank you Gwen and good afternoon to everyone, who has joined yesterday and.
Every piece to give you an update on TFS internal clinical development programs.
Despite the effects of the pandemic on the clinical trials globally, and we've been quite fortunate and that the phase one trials of our two lead programs and have had only minimal time delays and most importantly, we made great progress and continued to generate the exciting clinical data from our human studies.
Okay.
And I'm, particularly pleased to provide a readout from the final data and our phase one clinical trial of board of Congress, all inhalation powder for the treatment of invasive pulmonary aspergillosis or IPA.
We chose to develop more of Columbus all of them because it is recommended as the first line agent for the treatment of IP of infections. However, it's not well tolerated and up to 20 per cent of the patients discontinued therapy due to adverse events or tolerability issues.
TFS and developing an inhaled dry powder version of work on the salt to effectively deliver the drug right to the side of the infection and the lung and we are happy to announce that the phase one clinical trial was successfully completed.
This study demonstrated the doses of 10, 2040, and 80 milligrams can be safely delivered twice daily using of dry powder inhaler device and no significant adverse events and.
A review of the final data demonstrated that there was no evidence of any treatment related or dose related trends and the single ascending dose multiple ascending dose part of the study.
No subjects experienced any dose limiting toxicity during the study.
In addition to the absence of significant adverse events at all dose levels in the study.
The pharmacokinetic profile demonstrated the mean peak plasma board of Carlos all levels reached concentrations of 227 nanograms per Mil following repeated dosing at 80 milligrams twice daily for seven days.
I mentioned the significance of this because of the these levels can be compared to our published report with the IV solution of work on this all being compounded and delivered the off label using the nebulizer and the dose of 40 milligrams, which resulted in mean plasma levels of 98 nanograms per mil.
Importantly, the Danish authors of the clinical study reported that 40 milligrams of Nebulize IV for a call and it's all solution was both safe and efficacious and the treatment of complex invasive pulmonary aspergillosis.
So our ability to more than double the blood levels that have been shown to clear of complex IPA infections provides confidence that dosing patients with the 80 milligram dose should prove efficacious for IPA and future pivotal trials and our data demonstrating safety and makes us even more confidence.
In addition to the very positive final data from the phase one clinical trial, and we're continuing to enroll asthma patients and the phase one b study to understand if the border on the salt inhalation powder is likely to trigger of bronchospasm and patients with hyper reactive airway disease.
Other inhaled anti infective drugs and demonstrated this effect and require pretreatment with the bronchodilator of prior to dosing.
We're completing dish reactive airway study to guide the clinical practice and patients with hyper reactive airway diseases like asthma and COPD.
The data from this study and from the completed healthy normal phase one study will lead to the initiation of the study that we considered the pivotal for eventual approval of work on the self inhalation powder, which will begin enrolling patients and the second half of 2021.
In addition to the border cause our results I'm pleased to report the dosing of the sad part of the Phase one study of our tech chromium and <unk> inhalation powder was successfully completed.
And the case at the CRO and US it's important to understand that the drug has a very narrow therapeutic index between the effective immunosuppression and toxicity.
The implication of this narrow window means the blood levels must be carefully monitored and clinical practice.
And the dose level of of the drugs has to be adjusted to achieve blood levels that are efficacious for immuno suppression, while not elevating the blood concentrations the levels associated with toxicity.
This is made more difficult because of the bioavailability and the problem.
It is poor and around 20%.
With a high degree of variability due to drug drug interactions that alter its metabolism and absorption.
For lung transplant patients therapeutic drug monitoring and she used to achieve maintenance trough to crawl and this levels from five to 15 nanograms per mil after transplant.
And to prevent acute allograft rejection.
Heart kidney and liver transplant patients typically receive a lower level of five to 12 nanograms per mil.
And our phase one study, we used therapeutic drug monitoring to measure when of sufficient dose level had been reached the TFS to crawl and the inhalation powder was able to reach 12 out of the trough blood levels between five and 16 nanograms per Mil and all subjects dosed with just the single inhaled.
Most of five milligrams of tomorrow on the inhalation powder.
This ability to efficiently reach therapeutic drug levels with arch equivalents inhalation powder and following a single dose without any significant adverse events is quite significant.
Reaching therapeutic blood levels of efficiently with low doses of the inhaled powder suggests that our product may have application beyond lung transplant patients where interactions with other medications can cause blood levels to changing and unpredictable manner.
This is particularly the case with heart kidney and liver transplant patients.
In addition to completion of the sad part of the clinical study and we've also completed the chronic toxicology studies of it. So that we are ready to move to and advanced phase <unk> trial that will build our data for eventual registration and lung transplant patients. After we complete the mad phase of this study.
And as with our work on this all pivotal trial. We expect this study to begin in the second half of 2021.
I also wanted to report the TFS pharmaceutical since initiated toxicology studies with RNA close of my products designed to treat COVID-19, Sars Covid two <unk>.
And other respiratory viral infections as you know over the past year. It's nightclubs somebody that's been identified as the drug with strong potential to treat a variety of viral infections and has been shown to exhibit particularly potent antiviral activity against Sars Covid two.
It's inexpensive and cost and has a very low toxicity profile. That's an FDA approved drug in clinical use however might close the mine has very limited aqueous saw the ability as well as low absorption and oral bioavailability, creating challenges for its development as a potential anti body.
The real therapy.
Our thin film and freezing technology has demonstrated improvements to the sorry, the ability of oral forms and Tycho on smart as well as to dry powder forms of the drug for true delivery directly to the lungs.
We intend to progress to clinical trials and as soon as the full report from the toxicology studies becomes available.
And finally at the end of 2020, we announced the collaboration agreement with augment of bio works to develop novel commercial products, incorporating augmented as Jim of dry monoclonal antibodies for potential COVID-19 Therapeutics I'm pleased to report that we anticipate beginning human trials for this therapeutic later this year.
And with that update I'd like to turn the call over to our Chief Financial Officer, Kurt Coleman per review of the financials Kirk.
Thank you very much tail for the year ended December 31, 2020 research and development expenses of the company were $10 7 million compared to $8 8 million for the same period and 2019, the increase and 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 <unk>.
2019.
The ramp up includes our preliminary analysis and testing of dry powder formulations of certain drugs and vaccines, we believe to have the potential to be become product candidates.
General and administrative expenses for 2000 20 million compared to $3 2.002 million 19.
The company reported the net loss of the year of $18 6 million compared to a net loss of $11 9.002 million 19.
Weighted average common shares outstanding basic and diluted for the year ended December 31, 2020 were $20 million and 425162, compared with 6 million nine O four nine and 83 for the same period and 2019.
At the end of 2020, we had total assets of approximately $38 7 million and our working capital of approximately $36 2 million.
At the end of the year, our liquidity included approximately $35 3 million of cash and cash equivalents.
And with that I'd like to turn the call over to Dr. Bill Williams, who will be talking about some of the groundbreaking work, we're doing using of our thin film freezing platform and the broad field of small molecule drugs as well as our work with large molecule biologics. This isn't an area, where our technology is unique and its ability to reformulate. These biologics.
And two inhalable dry powder.
Bill.
Thank you Kurt and good afternoon, everyone I'm very pleased to give you an update on what has been a very busy and productive quarter for the research team at G F of pharmaceuticals.
In terms of scientific impact of TFS pharmaceuticals, since our last update we have made significant advancements regarding our programs to facilitate my summary today.
Like to break the discussion down into small molecule drugs and biologics, let's first review our work on small molecules.
For our inhaled and the close of my dry powder for inhalation program, We recently reported and a bio archive preprint paper the development of of formulation to reach the lungs as of therapeutics for COVID-19, and the other viral infections.
And Hell dry powder formulation exhibited sustained the close of my concentrations, which is very difficult to achieve by other routes of administration due to the close of my very low water solubility and high first metabolism.
Specifically, we showed that and the close of my inhalation powder prepared by stem cell freezing not only proved to be safe after and acute three day multi dose pharmacokinetic study in rats as evidenced by histopathology analysis, but it also achieved.
The one concentrations above the reported IC 50, and IC 90 levels for at least 24 hours. After just a single dose administration and the Syrian Hamster model. We selected this hamster small animal model because hamsters are susceptible to <unk>.
Ours, Covid infection, and thus are of promising candidate as and animal surrogate to model COVID-19 disease. Our studies support the close of my dry powder inhalation formulation by thin film freezing for further clinical testing against COVID-19, and other viral.
The infections as mentioned by Dr. Christiansen earlier and this call regarding.
Regarding our oral the close of my formulation and we recently reported and the newly published peer reviewed paper on the development of and a more of a solid dispersion produced by hot melt extrusion and.
This is our companion anti viral the close of my products and improved oral product to complement our.
Dry powder TFS formulation of the close of my for installation that I just discussed.
Pacifically in our paper for the first time, we report that the and that close of my a more of a solid dispersion and formulation containing a polymer carrier increase the apparent drug solubility by about 60 fold relative to the current state of the art Crystal and form of the close the bike.
The a more of a solid dispersion of and the close of my achieved of more than twofold increase and oral bioavailability and rats compared to the close of market and hydrate. These results are highly encouraging for its continued clinical development.
Now I would like to discuss our advancements and applications of stem cell and freezing to biologics.
Biologics include mrna S I RNA and monoclonal antibodies as Chris Cana will describe TFS pharmaceuticals has multiple technology validation of agreements with pharmaceutical industry partners, let's first discuss our progress with mrna and.
And lipid nanoparticles.
The applications generally include pulmonary delivery to the lungs to treat diseases, such as lung infections, including viral infections and also include applying and thin film freezing to convert unstable liquid forms of the mrna and lipid nanoparticles into stable powder form.
That can be stored without severe cold chain constraints, and then reconstituted back into the liquid form for injection at point of administration to the patient.
The problem that the until freezing of solving for cold chain includes the requirement that presently the liquid form must be stored frozen either at minus 70 degrees C or minus 20 degrees C. Achieving only limited shelf life storage and in fact, the shelf life of either of these.
Additionally, as relatively short complicating distribution channels.
Based on recent work and my laboratory, we are highly confident the thin film freezing can be applied to current mrna vaccines to successfully formulate a version that can lessen the need for cold chain distribution and storage too.
To date collectively our studies confirm that.
And that the conventional method of slow shelf freezing and la <unk> as compared to the thin film freezing.
Has fell to successfully convert these liquids and the stable dry powder forms and we have been able to achieve this to convert the liquid form of mrna and lipid nanoparticle into a stable dry powder more stable than a direct side by side comparison to convention.
The <unk> and.
In addition, we have also been able to form stable dry powder forms of mrna and lipid nanoparticles that can be delivered by dry powder inhalation and.
In comparison, the current state of the art.
Our liquid forms of mrna and lipid nanoparticles deliver to the lungs as of liquid using a nebulizer nebulizer have low delivery efficiency, when delivering mrna and lipid nanoparticles to the lungs, whereas we are able to convert the liquid form.
And two of dry powder for installation, while preserving the physical properties of the mrna and lipid nanoparticles.
With our work on monoclonal antibodies for multiple partners, we have successfully converted liquid preparations and the dry powders, while maintaining the chemical and integrity and functionality of the monoclonal antibody.
These optimized powders have excellent aerosol performance properties, making them ideal for inhalation delivery to the lungs.
We have also found that these monoclonal antibodies can be stored at refrigerated or control room temperatures depending on the specific properties of the monoclonal antibody being studied thus and advantage for cold storage requirements. We.
We have also had the opportunity to of plot them film cruising to formulate cytokines and enzymes, that's dry powders to administer by dry powder inhalation.
<unk> lung diseases or to reconstitute back to the liquid form for administration to the patients at point of views.
And these protein based dry powders can be stored and control room temperature.
We recently published a peer reviewed paper on applying the unfilled freezing to the delivery of F. I R. A day and solve the lipid nanoparticles the problem that thin film preaching salt was the very low efficiency of lung deposition and when and held as of Nebulize liquid.
We confirmed that the film freezing transformed the S. I RNA from of liquid suspension into of dry powder, while preserving the chemical integrity and functionality of the SCR and night.
We continue to of plot them film freezing to protein antigen based adjuvant and vaccines, including marketed vaccines and vaccines currently in clinical trials intended for immunization by needle based injection after reconstitution at point of views on.
Or needle free directly as of dry powder, inter nasally or by inhalation.
These protein antigen based adjuvant and vaccines require cold chain storage during distribution and other methods of converting these liquid forms to their more stable dry powder form have not been successful because their immunogenicity is not preserved thin film.
Freezing has been successfully used to accomplish this.
We also recently reported and the preprint of bio archives the application of thin film freezing to the formulation of dry powder for installation of bacterial stages. The.
Problem. We are solving is that presently bacterial pages are stored and administered as nebulize liquid aerosols, but these liquid forms of bacterial pages have low efficacy when and held because of tighter loss and must be stored and a refrigerator to maintain their activity.
Each bacterial phage presents its own challenges and we are using them film freezing to formulate dry powder factor of pages one by one.
Lastly, our technology validation work on the virus vector based vaccines is progressing quite well and our goal for this work is to provide immunization by needle based injection after reconstitution at point of abuse or needle free directly as the powder inter nasally.
<unk> or by installation.
And our collaborations we are addressing the required cold chain storage as well as the lack of mucosal immunity and the respire Tory track when vaccines are administered by intramuscular injection and the low efficiency of lung deposition with vaccines are and held his nebulize liquid.
Aerosols.
We have successfully transformed these virus vector based vaccines from frozen liquid suspension form to dry powder by thin film freezing with minimal damage to the viruses. We have confirmed that our dry powder has excellent aerosol properties ideal for pulmonary.
The delivery.
I wanted to acknowledge and thank my colleague professors and wrong Cui for his significant contributions to our research programs and lastly, I want to thank you all for your continued support of TFS Pharmaceuticals, and the collaboration with the University of Texas at Austin and.
And now I'd like to turn the call over to Chris <unk>, Chief Operating officer, who can update you on more of the progress the company is making and its business development and partnership efforts Chris.
Thanks, Bill and good afternoon, everyone. Thank you for joining us today.
As I have previously shared the TFS business development team is laser focused on three key areas of growth for the company.
These three areas are one and growing the TFS pipeline of internal development programs to our pharma partnering efforts and three our government contracting efforts, we continue to make great strides and each of these key areas.
As Dale discussed we continue to expand our pipeline beyond our existing products, including <unk> Com is all inhalation powder <unk> inhalation powder and TFS might close some of it.
We're now actively collaborating on the joint development of a monoclonal antibody for Covid with our partners out of Hong.
Mento by of works, we continue to aggressively progress of this project to early stage development.
The T F F. BD team continues to hunt for new assets compounds that have specific formulation and delivery challenges that would benefit from the TFS dry powder technology and that would generate the differentiated and value added product for patients physicians and payors.
In addition, I want to update everyone on all of our pharma partnerships and the collaborations we were working on.
As Dr. Williams has described TFS is very active and the mrna space.
We have multiple active mrna programs underway.
And we're working with the large pharma partner formulating their proprietary mrna into the TFS dry powder for delivery directly to the lung.
We are also working with the mid cap pharma company delivering their proprietary of mrna directly to the lung via the T F F dry powder technology.
No two mrna and sort of the same but they do have similar delivery challenges, we were able to overcome these challenges with our innovative technology.
Announcing feasibility agreement is not yet that's the standard corporate practice, but given the collaborative nature of our partner.
The current events of the pandemic the.
Timing of this work and applicability to real time events TSS has agreed to disclose certain aspects of the new partnership.
We recently entered into a new feasibility and material transfer agreement with Greenlight Biosciences and mrna company in order to formulate the mrna COVID-19 vaccine.
As you are and as you may have seen and our recent announcement dated March night, we're working with Greenlight biosciences to formulate the mrna vaccine for COVID-19 into of dry powder.
Which will be quickly reconstituted on site for injection.
Therefore generating of more stable formulation, which removes cold chain storage and transportation challenges faced by many.
Not all of the current mrna competitive box.
In addition, we are working on other MRO and <unk> programs, and we are actively engaged and meaningful discussions with the leading mrna vaccine companies.
And we strongly believe that our thin film freezing technology will play an important role and formulating second generation COVID-19 vaccines.
To the best of our knowledge, we are the only technology able to formulate the dry powder of the mrna and <unk>.
Our T F F dry powder maintains particle size and superior aerosol properties has and encapsulation of efficiency of greater than 90% and maintains the activity level of the mrna.
As previously mentioned announcing feasibility agreements does not T. At the standard corporate practice, but staying in the Covid space and given the collaborative nature of our partner and the current events of the pandemic.
The effect that's agreed to announce another project T.
<unk> is working with neuro Rx on their product candidate.
Sami which is of VAT the deal.
Synthetic form of the naturally occurring peptide <unk>.
And in the long called Vasoactive intestinal peptide were vet.
This product is currently in the late stage clinical trials for critically ill COVID-19 patients and based on the results of these trials. The hope is to file and received emergency use authorization.
By formulating the P S at the dry powder version of that it.
It would offer patients and physicians and alternative route of administration of the <unk>.
For treating the disease state much earlier, which would be of tremendous value to COVID-19 stricken patients.
Also his doctor Williams discussed we are very active and the monoclonal antibody space.
We have multiple pact of monoclonal antibody, where mab programs underway.
As we disclosed back on February 19th we are working very closely with Doctor, John Guy and you Samad formulating their maps.
On the recent in vitro testing.
Very pleased to announce that the T. F that technology was able to generate dry powder forms of use safford maps that maintained the same activity as the initial liquid formulation.
This is a very exciting accomplishment.
Validates our technology and clearly supports pursuing the next steps of development.
That next step of development is in vivo testing and if successful T. S. F would seek non dilutive funding to move the vaccines forward and development.
In addition, we're working with another government agency on their proprietary babs generating the dry powder that exhibit very favorable aerosol properties, while maintaining high activity levels.
These mobs are in development has the COVID-19 therapeutic to be delivered directly to the lung.
We are also engaged with the large pharma company and we are currently formulating their proprietary mat per delivery to the lungs, and we are preparing for initial in vitro testing.
To round out our map programs, we continue to progress our joint collaboration and development arrangement with augment of bio works and.
In addition to these programs we are actively engaged and discussions with other leading mad companies.
And again to the best of our knowledge, we are the only technology able to formulate the dry powder of monoclonal antibody that maintains the activity and integrity of the Mab and has superior aerosol properties.
To complete our form of partnerships. We are currently formulating our partners SA RNA plasmid DNA Oligonucleotides day.
And <unk> peptides cytokines, AEP and D S. The product candidates.
On with many small molecules.
Also we recently entered into the collaboration agreement with the second leading academic institution, we are formulating the DSD vaccines and two dry powder.
This arrangement is very new but holds tremendous opportunity for TFS.
We hope to provide updates on this collaboration and in vitro testing and gets underway and testing results are achieved.
In addition, we are we continue to work very closely with our partners at UGI. We are pursuing the advancement of the universal influenza protein based product candidate that we announced our positive results on back on October 27, we.
We are pursuing additional protein based universal influenza vaccine candidates for more University of Georgia colleagues.
Last week, we were honored to present to the civics group.
Civics stands for the collaborative influenza vaccine innovation centers, we presented two and audience of over 80 participants, which included key opinion leaders and decision makers at numerous academic institutions and government agencies.
We were privileged to share with this group, our innovative technology and the exciting projects and programs we're working on.
Our strategy is to engage with key academic centers and researchers.
Positioning thin film freezing as the formulation partner and.
And then securing tech transfer and door licensing those assets to TFS.
Lastly, Glenn mentioned the government contract.
And his opening remarks, we hope to be able to share additional details on this arrangement and the near future.
Very excited about this contract, which now establishes TFS is and approve contractor and the government arena.
It opens doors for more opportunities for tea at the two apply its thin film freezing technology to different products for partnering opportunities with these government agencies.
And for additional value creation for T F F form.
In summary, the TFS BD team has been making tremendous progress and our partnering efforts. We currently have over two dozen and pharma partners that we are collaborating with.
And that list is growing.
And each of these partnerships and arrangements, we are taking our partner's proprietary compounds and formulating these compounds and our T F that technology.
These different compounds are being formulated on.
Optimize.
Tested and our labs and being shipped to partners for testing.
First the dry powder samples are run through specified in vitro testing by our partner to confirm viability and activity.
And the samples of run through and vivo testing by our partner to confirm knockdown and activity and animal testing upon successful in vivo results. We then expect to engage with these partners and the full blown collaboration and licensing agreement.
While I have this opportunity I think it is extremely important to thank our most valued collaborator and partner.
All of these business development efforts are supported by the tireless efforts and support of our collaboration partners at the University of Texas at Austin.
With the continuing support of Doctor Bill Williams and his research team, we continue to expand the applications of the thin film freezing technology into new and innovative areas of drug delivery.
In closing from a BD perspective, we're very excited about the growth opportunities of our technology and of our company.
We believe we've only scratched the surface of the many applications of the thin film freeze and technology.
We are highly confident.
As we have said repeatedly the T. S. F will close at least two signature development transactions and 2021.
We are laser focused on accelerating that outcome.
Thank you for your time today, and we'll now hand, it back over to Glenn.
Thank you very much Chris and thanks for the rest of the <unk> team who participated today.
And I realize that we presented you with a lot of very detailed information on today's call.
There's quite a bit to discuss and share of trusted you of a strong sense of the level of excitement and tea.
Oh the <unk>.
And for the future is what everyone involved is feeling and working towards every day. Our goal is to build a strong and a formidable foundation.
Accelerating and the positive outcomes.
Today, we share with you the positive progress, we're making with our internal pipeline.
The completed clinical trials of PFS for comments on and THF tax the limits confirmed the target product profile and the.
And set us up for meaningful pivotal trials.
In addition, and like most of my program is off to a strong start and since the co development of the augment the monoclonal antibodies.
In addition, we are tracking well on our collaboration with Felix and the macrophage space and plus products is moving ahead toward commercialization with thin film freezing versions of cannabinoids.
The Williams discuss the newest day that he and his colleagues of U T have generated most importantly, the dossier of data and the biologic Serena has grown significantly since the last time, we spoke of.
And Chris can I was given a strong update on the current status of our business development activities with pharmaceutical company partners Academia and the government.
The agreements announced earlier this week of Greenway and the newer Rx along with the important recently signed government provider agreements are truly significant.
We are laser focused on growing the portfolio of signature development agreements.
And as I said on the opening of the call the achievements of 2020 and the beginning of 2020. One are just the tip of the iceberg.
I believe we were on a steady trajectory of meaningful growth as a company, we have planted great fees and fertile soil the harvest should be brown of fall.
And as always we appreciate the support of our investors and partners and we.
And look forward to speaking with you next quarter.
And with that I will turn the call back to the operator and open it up to questions operator.
Ladies and gentlemen, if you'd like to ask a question at this time. Please press the star and the number one key on your Touchtone telephone.
To withdraw your question press the pound key.
And again that is star then one if you'd like to ask a question at this time.
Yeah.
Our first question comes from the line of Jonathan Aschoff with Roth Capital Partners. Your line is now open.
Thank you.
I was wondering.
On.
And now through the effort of course.
Yes.
Right.
Okay.
And.
Thank you.
Yeah.
Jonathan we can barely hear you could you, possibly repeat that question.
Yes can you hear me now yeah, that's much better and in fact I'm trying.
Great. So can you give me any more specifics about the effort at plus products and why did you partner with them and how will you expand and cannabinoid because they are a fairly significant part of my model.
Yes. Thanks for the question, Jonathan So and as I said on the call first of all of them as you know, we Havent intermediary company RTR, that's run by Rob <unk> Who's the managing director of connect capital. So he is indirect contact with plus and actually we of folks out there and this week and are beginning to produce.
<unk> product and one of the facilities.
We believe that price has a great plan for.
And commercializing their testing of bunch of different formulations as we speak.
They're doing great science, the have great market penetration.
And and California, as you probably know there ever edibles products and once they get into the market pluses, giving me some very robust.
Commercial forecast that.
Our well north of $100 million, almost $200 million and we get a very significant royalty on the sales once plusses and the California market.
And we plan on expanding.
And price on our TR plan on expanding the penetration nationally.
Either through price or through other partnerships. So we believe that this is going to be a very lucrative endeavor, four plus and through our TR and.
And a meaningful contributor of revenue to TFS and the very very near future very exciting.
Thank you Glenn on the next one to the Tac.
And that data looks pretty strong and I was curious if you could get a bio equivalents approval outside of lung.
Okay.
And to answer that question can I turn that over to Dr. Christensen.
The al could you answer that please.
Yes, Thank you Glenn.
So it is.
Let me, let me take one step back it is possible that there would be what is essentially a matching.
Exposure level.
Ultimately the widely varying PK.
Among individual subjects and.
And each subject they do dose adjustments to reach a.
On the the.
The therapeutic drug level and so what so it's not just the straightforward.
Dose with one dose of oral dose with a.
Equivalent dose of <unk>.
The inhaled and show that they given the equal and exposure.
And so theres, a little more to it than a normal B E.
That would be required and so that is something that we are certainly evaluating what it would take to take.
Net there with the FDA.
Okay, and I didn't see that much on the boree asthma trial can you tell me anything about that.
Well again.
Yes, yes, thank you Glen and <unk>.
Internally, we are continuing to enroll subjects and I can say.
And that to date, there has been no bronchospasm, but.
And again, we're just continuing to enroll patients.
Asthma patients and the study and.
We look forward to completing the study.
And the next couple of months.
Oh, yes.
The reason we're doing that is we wanted to be able to include asthma patients and the pivotal.
Trough of work on and fall and the FDA required to be able to see that we have and that caused any bronchospasm and these patients towards the airways and so far.
The data is the quarter of everything we've seen and all of the clinical trials that we've done for Oregon tax et cetera.
Thanks, Jonathan Thanks, Glenn.
Our next question comes from Ram <unk> with H C Wainwright.
Hi, This is the mobile and dialing in for Ross of Roger can you hear me okay.
Yes.
Alright awesome field.
Two questions. So just the start up I know you're running off on file and you're obviously planning to start the phase two study for GAAP before in the near future. So I'm just trying to understand sort of explains on.
What are the similarities and differences between these two trials and what new information Youre planning to obtain from the Osmose study that will not be a focus of the.
Upcoming phase two study okay.
As I, just said and payouts folks and we.
And we decided at the urging of the FDA to run a study in asthma patients to be sure. We can include them in the trial.
Looking at PFS for Carnival powder.
And the phase II trial. So this is a way to enhance the patient population of the next trial.
Okay, alright, thanks and.
With respect of the upcoming Phase two study how do you define expert and the study and what specific metrics will be given the importance.
So the trial will be powered for non inferiority and the efficacy and we will mine the data versus your efficacy and this doesn't mean that we don't expect to see better efficacy.
On the.
The power will be non inferiority of and efficacy and.
And at a better adverse event profile.
Okay.
But the effect here.
The backlog so we understand delivering.
So the lung of treating lung indications, but the.
And the traffic to like what is the rationale of begin delivering drugs to the lat longs for treating non lung indications such as kidney disease, and so on and what kind of challenges one could potentially anticipate during this route.
And what are the possible ways to attack the salaries.
Could you give a brief answer and then I'd like to move on to other questions I have a lot of people on the queue. Thank you.
Yes.
Briefly on.
The columnist has widely.
Differential bioavailability base.
Based on.
Somebody of heat and the high fat meal is poorly absorbed and someone if they eat.
High fat meal, because it's very.
Pat Voluble and not water soluble and so it stays in the GI track. There are also wide variations and Tacoma.
Bioavailability based on other other drugs that are taken orally and so when it's delivered via the long you bypass all of that gastrointestinal.
And the interaction of drug drug interactions that would occur there and that gives you a more defined.
Tighter PK range from a from a single dose from a given dose and so we think that that's going to be the advantage.
And ultimately it will be balancing the lung levels and potential for.
Any toxicity and the lung versus <unk>.
<unk> system or the.
The advantages gained by safety versus any potential for localized toxicity and the lung, but we're addressing that from our toxicology studies.
Thanks, Garo and won't be happening.
They're on.
The one other on further calls I just want to be sure of that we get some art questioners on the line. Thank you so much of your understanding.
Our next question comes from the last one Tony with B Riley's Securities.
Hi, Good afternoon day, and congrats on the progress so Huntsville, many friends and the new government contract announced today and thanks for the comprehensive update appreciate you taking our question so maybe.
And I think the deal here.
So great to see you can go with the higher dose 80, Meg versus 40, Meg and the.
Just curious as you think about the SBA dialogue like.
And when they want you to also briefed you on the list therapeutic effect of doors.
In other words would you have two different dose and your and your pivotal study.
Yeah.
And again, just if we kind of brief answer we're running.
And there are a lot of folks on the queue.
Yes.
Good question, but ultimately for anti Infectives. They want you to be at the highest tolerated dose that doesn't induce toxicity. So that you can avoid the potential for development of resistance and so theres no requirement to go to a minimally efficacious dose because thats, where you would see resistance develops.
Understood and then maybe for Chris of quickly on the other.
And the last update you had said there was a broad initiative with an irony I adopt and kind of player on.
I'm just curious.
The kind of work that is progressing on that front and.
And and trying to kind of also visualize the world obviously of different modality that youre doing a lot of and Miami.
How should we how should we think about you know one of these partnerships getting to a meaningful inflection point and how big you could provide us in light of obligation you had the BSA I mean of modality.
Perhaps you can answer that yes.
Sure. Thanks, Glenn and thanks for the question Mike. So so we're really excited about our work.
As you mentioned, we did speak of last quarter about the top 10 pharma company and that work continues and.
And I've shared with everyone. It's a process right and so when we received the materials formulating the materials optimizing in vitro in vivo and so it does take time.
Continuing to pursue that partnership that continues very well as well as I earlier mentioned, we're dealing with over 24 different partners and so we're flowing everyone of successfully through our pipeline.
And as I closed and my comments.
We expect to do at least two signature transactions of this year.
That's our goal and.
And I'm, obviously laser focused on exceeding that goal.
And I can ask the same.
Great color on that.
You know what.
The bigger companies.
We're doing really outstanding data the data is very supportive.
I'll come back with another round of.
Of experiments they want us to do and the all of these are coming out positive.
Sure.
We're moving everything very steadily towards.
And at the end of the experimentation, but when we bought the listeners to really honestly, we have so many shots on goal I have this big whiteboard and my office with all of the companies and we're working with them.
That's the only way, we can really keep track of where we're at so.
We more than anybody wanted to get these things to the finish line. We know they will get to the finish line. We're moving we've done so much already and.
Yes. This is Jeff.
Book of the Iceberg of I think we're getting very close and.
Okay.
I really appreciate the color and maybe Glenn and other time I'll push you on how many C. D E and M. D. As you have in place, but I do want other space.
Bill the does this.
And just quickly the if I may can you share some data of that.
Any qualitative color on the authorization of which the thin film.
And modern and and I'm also not just looking at stable at the end goal and so it did benefit but also on this wind the Bud mucosal immunity and very important to investors as they think about transmission and sterilizing immunity.
Could you maybe comment on that and and maybe if any color how am I the name of might be different from the again.
The ability standpoint, when you think about other protein based vaccine of crude cars.
And you've kind of adjusted at all.
Yeah, Yeah. Thanks, Matt Yeah excellent question. So I have recently and my research lab, we look directly for the first time at one of the the.
Two mrna vaccines that are approved for emergency use for the Covid. So I am.
Actually have looked at those about them film freezing one of those vaccines and we've done a side by side comparison with conventional authorization and.
And our dental increasing powder.
<unk> maintained.
Maintained the encapsulation of the MRO and I and the lipid nanoparticle.
<unk> produced a dry powder that to date has been stable as of dry powder at room temperature for several weeks now so and we've done this and we compared to conventional <unk> and where that was not able that process was not able to per.
Produce the original nanometer particle size upon reconstitution, so I am highly confident dent on presumed works with the mrna lipid nanoparticles, especially in one of the two vaccines that are approved for Covid right now and.
And then Brooks or guards to inhalation, yes, several of the the partners that we're working with day.
Beside the mrna and lipid nanoparticle for lung delivery more bicoastal immunity and.
And and our again, even if the conventional equalization happened to work with their particular mrna lipid nanoparticle.
Modality they could not.
And they couldn't.
Not a powder, that's amenable to inhalation dry powder inhalation.
So thin film freezing is and and it's working for those applications. So hopefully that answered your of really good question.
And above that.
And my extra we move on to other questioners, we can always kind of a way of catching up and by the way.
All of you on the line, we will stay on the line as long as you have questions so well.
We're so excited about the fact that you're all interested and have questions here. So.
Looking at the clock here.
Yes.
Our next question comes from Jason Mccarthy with Maxim Group.
Hey, this is Michael accumulation on the law on for Jason Mccarthy, Thanks for taking the question.
So the figure we are coming up on time, so I'll just keep it keep at two of Shaw and we can always circle back at another time.
The C give us any color on the on the kind of trial size of the needed for the pivotal studies of Bari and tack, especially as we're heading towards those studies as early as late this year.
Yes.
If I can.
We have not been public with announcing the number of patients and those pivotal trials.
Upon receiving the of worry.
And final report and waiting on the Tech report.
We are still kind of looking at the specifics of those trials well, we'll let you and Jason note and as we got those numbers.
The last book, although I will tell you of the FERC Doug.
And <unk>.
Of the worry pivotal was about 140 patients with.
Which is pretty consistent with what we've been thinking all along but if you could give us a little more time to zero in the out of conducting some advisory boards with some really notable investigators to help us craft that and we are going and meet with the agency.
The run our protocols by that.
Alright, Thank you and then.
Just one more if you don't mind I'd like to see if you could discuss and just a bit more greater detail what exactly that the subcontractor license means and what that allows you to do with the U S government that would've been more difficult before.
Well gradually I'm really glad you asked that question and Cogs.
We are so unbelievably excited about this opportunity I can tell you that we really hope to be able to go into.
Great detail on what we're doing here.
We had a kickoff meeting yesterday and the.
We're waiting to hear of just how classified and.
The government agency feels this information is.
So we're really at the Mercy as you kind of stand.
Of the government agency to allow us and the other subcontractors and the <unk>.
Mary contract to make an announcement what I can tell you is that we've we started talking with the contractor on.
All of the almost a year and a half ago I'd, probably alluded to the potential of a government contract coming and some of you on one on one conversation.
We went through and incredible diligence process, where we were compared the other.
Other potential Formula later, and we also know based on this work and the.
And the position to look at not only and.
Generation to the lungs, but intranasal and specific in this arena topical formulations and formulations to be given to the eye.
So what does this do current TFS number one great opportunity.
We can't disclose the financial terms of at this point.
We are now set up to.
Somatic lean and systemically the of contractor to do the.
The government so.
We've been talking to the government of other potential opportunities.
Entities, we've organized here internally and we are working the system the contract and we're working with and a very experienced in this arena.
I really hope.
Hope that all of the investors that are listening to this call.
Although and we can't see really.
Open about the terms and what's happened here as we've ICB appreciate for a significant opportunity the says.
Not only and the government arena and on all of our outreach and all of our partnerships.
Unless the ASP I wasn't going to say this and.
I Hope you can hear on our voice and <unk>.
Half of the team.
And what tremendous work, we've done and what a great position and Testament.
And two is how disruptive this technology is.
Lots of exciting stuff. Thanks for taking the questions. Thank you so much for the question.
Our next question comes from Daniel Carlson with the Tw Research group.
Hey, guys. Thanks for taking my question and I'll try to be quick and earlier and overtime.
Regarding RNA modalities, you seem to be seeing good activity.
What gives you the confidence that you can formulate mrna SA RNA.
Et cetera, and due and payable dosage formulations.
And Dr. Williams could you answer Daniel.
Sure Hey, Daniel Great question. So Fortunately, we have experience and our research group.
And with probably five different <unk>.
And a lipid nanoparticle formulations from.
From different partners and.
And I mentioned a minute ago most recently.
And I've used and the research group.
The central and Freesync technology to work directly with one of the two approved mrna and lipid nanoparticle COVID-19 vaccines and so the powder produced from those we have characterized.
Those powders and they have characteristics that are amenable to.
Inhaled.
Delivery by dry powder inhalation and so we've done it we know it can be done and.
And what we do is we focus on the parameters each mrna lipid nanoparticle the different composition of its kind of and it.
Its own.
The unique properties and Thats part of the of our technology validation studies, that's what we're coming up with the best approach to use on each individual one.
Thanks for the question.
Yes.
And one thing I want to add before Dan Youre kind of if you have any of the questions, but we will have a PFS of science day.
And we're looking at.
And on time and in late May early June so we will be announcing that and.
And the reason, we're picking their time and so a lot of them with some more mature data and at that point and maybe some more partnerships and the academic space. So stay tuned for the specific announcements on.
And on that.
I am sorry, Daniel and interrupted or others.
Our next question comes from Bill Morrison with National Securities.
Hi, guys. Thanks for taking the questions.
Try and right right fast as they can lots of good stuff going on but did you say there was 20.
Great and then a couple of dozen.
<unk> and biologics or both biologics and small molecules.
Yes, Hi, Joe good to hear from Europe, and doing well so.
We're trying not to him count specifically, it's north of 24 and <unk>.
Thank God, Chris did a really good job of giving the graph of the different opportunities. We're working on and you mentioned monoclonal of mrna and fire and a phage and Pep toys.
GSV vaccines, we do have a couple of partners and truly we're doing work with for quite some time. They are just sort of formulation of new chemical entity plays the fact.
One of the first companies, we mentioned without specifics.
Top five company, where we actually now are working on three of their compounds. They have actually asked us to.
Do GMP materials for.
And vivo testing they won't let us use their name yet, but we hope we hope that in the near term offering back we'll probably experience on some revenue from that.
The transaction just for manufacturing so it really expands and.
Every week and it just kind of grows.
And each of those categories and.
And I can fill you on this because we don't want to say it's 25. This week 28 next week or two.
We're going to the kind of keep doing the 24 and above.
So and we were not having a check ourselves on numbers, but the final of the funnel is really fall.
Our next whiteboard Christmas, probably chuckling, because it comes in or weakness and the race and the names and some of our revenue rates and even <unk>.
Adding and so.
And it is on.
And if you ever thought of when Youre on.
<unk> and myself and Sullivan and the Guy would juggling seven and price at one price.
And kind of like what we're doing here, but its comments on volume.
Yes so.
And then just on.
On on Union of any update on the upfront.
Yeah, So Dave and Bill mentioned that the.
Friday is going to be triggered by the conclusion of our first in human trial and those trials are initiating so I would look for something definitive there and the <unk>.
The other part of the year.
Beautiful thanks, guys great job.
Thanks Bill.
Our next question comes from Doug Williams with Williams resource.
Hi, Glenn.
I'd like the firstly say congratulations to you and the medical professional so on your team.
And that you guys have done a phenomenal job year to date as well as the last year I notice of annual but.
I'm more interested and the current times and I was in the prior times, but do you guys have done a wonderful job so.
I just have one question and.
I'm sure a lot of investors have been disappointed with the results of our stock and the marketplace and the last day or so with the.
The last two announcement of that just that were.
And out and of course, we all have to realize one thing that we are of micro cap and.
And the biotech sector and that the biotech sector itself and the marketplace ran out of favor I guess weeks ago and.
And took ahead of I don't know what the was 30%, but significant and we were just the part of that so we have to just live with those kinds of things but.
Wanted to relate to neuro are X and the announcement you made yesterday I think there were some things and there that one totally unnoticed because I felt this was a very significant firstly the management team of that company is superb the very very high level.
It is from big pharma and biological companies.
And and the release, we talked about what we're doing for them and that's fine, but I think this particular opportunity.
And it's very close it's not the norm of what we have and our pipeline.
They are and the process with that I'm, probably going to pronounce this wrong and so semi.
And a trial that the FDA dictated to them should be for 28 day endpoint.
To achieve what they're achieving with this product to do something with I forget the name of the cell.
The controls a lot of the oxygen slash blood and and the.
Body and is extremely important and with Covid, that's cell gets damaged and that's one of the parts of the cytokines and whatever else cars thereafter.
So they have.
Started to have success with this trial and I don't know how many people are currently in it but.
But they were discovering early on and the trial that the results were good.
And that they were starting to achieve more than they thought they would.
And that it would continue to be achieved beyond 28 days.
They went back to the FDA and said Hey, guys. This really should be a 60 day and point not a 28 day and point and the FDA and the last several days.
And with them and extended it to the 60 days.
So my question is if you can add some color.
As to how we fit in there with the powder and how quickly we can determine if we're doing it for that particular drug how we can determine.
That could be applicable to be used and that trial or an extension of that trial, but obviously they are already at the end of the 60 days of assuming results to ask for an emergency use authorization from the FDA. So my question is does any of them.
And appreciate how close of this all is and.
How we fit into that if at all.
First of all thank you for the question and I think you kind of great job on anything and fully understanding why we are.
So.
I think it was such an important transaction for both new Rx and the company.
And Chris is the closest to this.
And just how much of the credit for bringing the power and so Chris do you want to comment on on.
On <unk> question I just start before you do I think this is a very.
And now I guess situation too.
Some of the early work we did.
Build it on Reem desert here with the hope that when range for index sort of had been effective which is I guess, we're still wondering about we would have been the ability for the take that product earlier on and to the less severe COVID-19 patients, but your appreciation of our close. This is you really grasp the.
Real value here, Chris and I Hope I Didnt feel you split your Thunder.
Could you comment please.
Yes, absolutely and thank you for the for the question and thank you for <unk>.
The support.
When it comes to neuro Rx.
Really excited about it.
And being able to formulate the death rate and deliberate as the dry powder to treat COVID-19 stricken patients is really exciting for us right right now theyre treating critically ill patients right and so we've always viewed if we can create the dry powder, we can treat.
<unk> earlier, and the sickness or disease state so.
No.
You are correct that this is really at the goal line there I'll just call it their lead asset <unk>.
This.
It's still and we're gonna be doing feasibility work and this I view as kind of a second generation of the.
Their lead product.
So hopefully I addressed your questions satisfactorily.
Okay. So we want and what we can't be involved and in essence, and the 60 day window.
But it would be a secondary product the add on or comment on related to date because of if it's approved at the end of the 60 days that it works and they're going to file for <unk>.
And the.
Is there going to be out with the product obviously, yes sure.
And we think.
The follow on would be right behind it. So you have a lot of this will come right on.
The discussion right.
On on how quickly.
The work can be done and we've got a lot of experience and thinking through.
On the sort of transition from the existing product.
And the powder version.
Probably still needs to be some some and.
It would be able to comment but im on.
And some predawn toxicity work and then the amount of bridging you have to do and the clinical.
Arena.
To be determined.
And how we use the word of exciting on my wife to find in other word here, but.
It is a very terrific opportunity for us well I'll use the word exciting on I'm able to do that and thanks for the answer to that I think you gave of the color of it I was looking for and congratulations on that deal and it's terrific.
Thanks.
Our next question comes from Stephen Glassman private Investor.
I've got your name on the Street.
How you plan on monetizing the work Youre doing on the Universal flu vaccine and what's the strategy there.
Sure So Steve.
<unk>.
And what we're hoping to do is be.
The.
As engaged as we possibly can with all of the leading.
And our flu vaccine academic researchers and hi.
Tech transfers from the academic institutions.
And the PFS and then as the individual flu vaccines or antigens of developed with all of the <unk>.
And non dilutive funding to bring those forward and then it kind of becomes Steve if you can imagine.
The bake off of our beauty caucus, one or two of those will emerge right.
And as they emerge to be the leading potential the universal flu vaccine. We then we'll be able to and the work that we're doing take those forward and then more than likely find the commercial partner to take them into further development and so we're trying to be.
And again, that's worth sort of ubiquitous.
Around partnering and that was really the purpose of the civics.
The presentation, we gave which was enabled by Dr. Ted Ross of UGA, where we presented I think the 84 participants on the line.
We want the technology would expose bill and Dale and John calling presented.
And we have a second academic institution that has agreed to work with US we're actually just working on the materials. They are internal policy is not to let us announce that until the first data are generated the two months away.
And then there are actually two other.
Academic institutions that are on the Mount Rushmore, and if you will of universal flu vaccine.
Researchers and we hope to.
Having engagements with them and and others that are interested so once we have those.
The dominant transfer.
We think we're out of a high likelihood of getting.
On non dilutive financing and then monetizing them through partnerships.
180 million doses per year, and this country, that's a very big opportunity.
On the cloud.
Especially with the new index.
Great.
Yes, it'll be much more ubiquitous because of dry powder was the young young children and very old sales people take it as well plus will be way more of that gives so less resistance.
And thank Steve about where all the parts of the world that can't.
Access the vaccine for for a number of reasons, especially if any of your refrigerated right. So if there's any point any price at all where this technology plays as the.
And the ability to bypass the cold chain and either have made needle and vaccine through the powder or reconstituted and vaccine. So.
And I'm glad these questions are coming because it gives us an opportunity to really talk about just how big these opportunities.
Very exciting and there will be of use that word.
Question for Dave If I may.
Have there been any problems inhaling the powder.
In vivo and human trials for any substances and grocery actions.
Thanks, and that is of good question. So.
So far in both you and all of our clinical trials and asthma patients and healthy normals for <unk>.
There have been a few patients that have experienced headache.
A few that seem to have.
And a mile wide head and neck headedness that appears to be most likely due to the inhalation and and some of that practice, but in general.
And this goes across the board. The there there are no experiences of course for either to current wellness reports of costs. Following the installation of either to <unk> or <unk>.
And even more importantly, there has been no reported drops and FTB one that's the ability to inhale that.
And is indicative of the induction of bronchospasm and and adverse impact on the long so.
To date in all trials, all the healthy normals as well as patient theres been no pulmonary function testing.
And has shown on the any abnormalities.
Excellent. Thank you Dan Thank you everybody.
Welcome.
We have a follow up question from the line of Daniel Carlson with GW Research group.
Yeah, Hey, Dr. Whether it's just to follow up on the Covid vaccines.
No that there's internal programs and there's other technologies out there do you see any other technology as being competitive with TFS on these.
Not that I'm aware of no I mean the.
The question at the end of the day as weather conventional authorization will work if it's a product for reconstitution back to illiquid for.
And for injection of the point of use but for inhalation and for a lot of these products.
<unk> conventional authorization as of as I mentioned earlier, it's too slow of freezing process and so you get damage to the to the lipid nanoparticle, which causes a degradation of the mrna and that's the that's the type of data.
We're finding because we do that comparison in our studies, that's our that's like our.
Troll to understand that so.
Yeah, Great question.
And then if I could just follow up one more question. You said you have run one of the vaccines the COVID-19 vaccines and I'm wondering if that was done under the MTA or if that was done.
As you did with Rems desert beer, just going out and getting it on your own the beacon yeah.
I'll answer that the annual Bill ran and as a researcher and Thats all I can say at this point.
Okay. Thanks, guys, great Great progress I appreciate it.
Yeah. Thank you.
That concludes today's question and answer session and I'd like to turn the call back the Cline for closing remarks.
Well for all of you that of staying on with us for the entire call it's greatly appreciated.
For those of you that know me on we're highly accessible we love to talk about what we're doing here.
So you don't know me well, we are very comfortable and we'd love to answer your questions. So thank you for your support and hope you all are well and stay well and we look forward to updating you on our progress as we move forward. Thank you very much.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
And then.
Okay.
[music].
Yes.
Yes.
And.