Q2 2021 TFF Pharmaceuticals Inc Earnings Call
Yeah.
[music].
Please stand by.
Good afternoon, ladies and gentlemen, and welcome to the T. F F Pharmaceuticals second quarter 2021 financial results Conference call.
As a reminder, this conference is being recorded.
I will now turn the call over to our host Corey Davis of lifestyle Advisors you may begin your conference.
Thank you operator, Hello, everyone and welcome to the TFS Pharmaceuticals second quarter 2021 financial and business results Conference call with me on the line today is Glenn <unk>, President and CEO of TSS Kirk Coleman CFO, Dr. Dale Christiansen TFS director of clinical development, Dr. Bill Williams, the University of Texas.
Austin and Kris can out TFS Chief operating officer.
Announcing our second quarter results is available on the TFS Pharmaceuticals website. Please take a moment to read the disclaimer about forward looking statements in the release the earnings release and this teleconference. Both include forward looking statements and these statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made factors that cause.
Cause actual results to differ are described in 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.
Thank you Corey good afternoon, and thank you for joining us today to review TFS second quarter operations and recent highlights during the call I'll provide an update on our clinical and corporate progress and then ill ask our head of clinical development Dr. Jeff Christensen.
Just on the <unk>.
<unk> progress, we're making in our internal clinical programs.
Following Dave's remarks, Kirk Coleman, our Chief Financial Officer will then review the company's financials for the quarter.
Following Kirk's comments, Dr. Bill Williams of the University of Texas at Austin will provide an update on the latest R&D advancements using our thin film freezing platform technology as well as an update on the expansion of our intellectual property estate.
Finally, Chris <unk>, our Chief operating officer, and head of business development will update us on business development and operational initiatives for the company with the value of our thin film freezing technology is enabling us to expand the number of meaningful partnerships with pharmaceutical companies academic institutions.
And the government health agencies.
We will then open up the call for your questions.
As we enter the second half of 2021 PFS is now poised to reach several value, creating inflection points and the <unk> and <unk> development programs.
Each of the therapeutic markets represent a substantial commercial opportunity for our company we.
We estimate the yearly market potential for both compounds to be meaningful.
<unk> is forecasted to take a significant share of the invasive pulmonary aspergillosis market focusing on the patient segment requiring treatment beyond 30 days.
For <unk>, we have forecasted sales potential to exceed $1 billion once approved for lung kidney heart and liver transplant patients.
Given the optimal pharmacokinetics of our inhaled formulations, we are confident that both worry intact will demonstrate efficacy and better adverse event profiles over the oral formulation is currently on the market.
Let me briefly review our progress made to date and then what investors can expect in terms of our catalysts in the second half of 2021.
In July we announced the successful completion of single ascending and multiple ascending dose studies for Tak <unk> limits.
Later in the call Dr. Christensen will describe the significance of these data in greater detail on why PFS <unk> represents an exciting opportunity in the setting of lung treatment.
With respect of our account as well earlier in the year, we announced the successful completion of the phase one clinical trial and based on these results <unk> plans to study the 80 milligram dose with Tfl boring and the planned pivotal trial.
So for you the investors I want the message to be clear <unk> Pharmaceuticals is now poised to enter 2022 with pivotal trials being conducted for our two lead internal programs each of which represents a substantial commercial opportunity.
At our present valuation I believe that many investors are simply not paying close enough attention to the progress. We've made to date, but was expected advancement of TFS tacker limits and for accounting fall into pivotal testing, we anticipate a positive shift in how investors perceive the value of our internal.
Pipeline.
<unk> has two later stage differentiated proprietary drug candidates each targeting highly attractive markets with the potential to generate significant future revenues.
To help investors better understand the TFS story, we held a virtual science day event back in June.
Writing, our thin film freezing technology and its applications in transplants and vaccines.
The event featured three key opinion leaders perspective, Dr. Deborah Levine from UT health, San Antonio provided background on lung transplantation. The current toxicity limitation of oral tacker limits for immuno suppression and the potential improvements with an inhaled formulation of <unk> limits referencing of course.
Our <unk> program.
Dr Kartik, Sean drawn from the Albert Einstein College of Medicine, then discuss the benefits of using the TFS technology to create a dry powder pulmonary formulation for our VSP vaccine against COVID-19.
Dr. Ken Ross from the University of Georgia discuss his experience utilizing the PFF process for creating a universal influenza vaccine for pulmonary delivery and its potential benefit over their existing annual vaccination.
For those investors, who could not attend our science day, the webcast and presentation materials for this event can be accessed on the TFS corporate web site.
As the TFS development programs advanced <unk> Hall, <unk> limits and I close the mine and our antibody collaborations with augment the biosciences. We also understand the importance of building the company's capabilities to further support maturing clinical programs.
As part of that effort today I'm very pleased to announce the formation of TFS Pharmaceuticals Scientific Advisory Board.
We have assembled an extraordinary group of accomplished individuals who are globally recognized as thought leaders in their respective fields. The.
The members of the TFS Scientific Advisory Board are Dr. David Cornfield, Dr. Cornfield was professor of pulmonary medicine, and the director of the center for excellence in pulmonary biology at Stanford University.
Dr. David Denning, perfect, who is a professor of infectious diseases and global Health University of Manchester.
Dr. Anthony Hickey director of the University of North Carolina, UNC Chapel Hill catalysts for rare diseases.
Dr. J Peters chief of pulmonary and critical care medicine at the University of Texas Health Science Center in San Antonio.
Dr. Ted Ross Professor at the University of Georgia, and the Animal Health Research Center Center for vaccines in immunology and the department of infectious diseases.
Dr. Michael <unk> Professor of Medicine, and associate Dean for Global Health at the UAV School of Medicine in Alabama.
And last but not least Dr. Drew Weizmann professor of medicine for the permanent school of Medicine at the University of Pennsylvania.
I'm sure you will agree that this is outstanding scientific Advisory Board.
These re now an expert's share the interest in the potential of the thin film freezing technology and are excited to help contribute their expertise and guidance to help the company optimize its potential.
At this point in our company's growth. We believe that this was the right time to have significant depth and expertise in medicine medicinal chemistry, virology and the formulation sciences as we continue to advance multiple programs, both internally and for our numerous and growing portfolio of partnerships.
The full biographies of our SAP will be posted on our company website.
Before moving on to a review of our existing partnership and business development programs.
I also want to share with you some important additions to the PFS team.
In the area of manufacturing and product development, Dr. John <unk>, who will be transitioning from his current role as a consultant to a full time position as vice president of product development and manufacturing.
John has been a key contributor to TFS since its inception now as the internal programs progressed in a number of partnership programs increase.
I've asked John to join the team in this role.
We have also added another key person to this group reporting to John that person is Don Owens, who will join the company as director of product development. John has an extensive background in the field of inhaled drug delivery and formulation.
Now having reviewed the progress on our internal programs and company growth initiatives, but.
Now let me review the recent developments in our external partnerships.
As you all know the TFS business strategy has two elements applying the thin film freezing technologies developing products internally and then licensing those assets to partners for commercialization and then licensing access to the technology the pharmaceutical company partners to formulate their assets.
Last quarter, we highlighted our worldwide licensing agreement with Union Therapeutics, the thin film freezing to produce both an oral and an inhaled version.
Importantly, recent data from Union suggest then that closer mine is effective against the new prevalent COVID-19 variants.
PFS is progressing the development of <unk> and will begin the phase one programs later this year.
Just recently <unk> announced additional progress in our second COVID-19, directed program with our partner augmented <unk>.
PFS and augment that announced the selection of a lead monoclonal antibody <unk>.
Gosh, three $3.87.
Which is being developed for the prevention and treatment of COVID-19.
Similar with our Union collaboration we considered our partnership with augmented to be an important example of how our thin film freezing technology can be applied to develop proprietary therapeutics addressing a large unmet medical need in the area of public health.
And also demonstrates the application of the thin film freezing technology in biologics.
We are also pleased that Cadillac biologics has been selected to conduct cell line development utilizing our proprietary <unk> platform and to lead drug substance manufacturing and scale up efforts for <unk> 30, 387, as the program advances through our clinical development.
Our work with plus products on the thin film freezing versions of cannabinoid has entered into the market testing phase.
Plus has successfully produced formulations that they determined to be ready for consumer input.
We expect feedback from those efforts shortly and finally, our work with newer Rx in Greenlight is also moving forward well.
Currently were working with the majority of the top 20 pharmaceutical companies as measured by sales and some cases on multiple open MTA is at various stages.
A number of material transfer agreements and statements of work also steadily increases.
I remain highly confident in our ability to close two meaningful transactions by the end of 2021.
This has been our stated annual goal for licensing transactions.
Later in our call, our Chief operating officer, and head of business development, because Ken I'll provide a more detailed review of our partnership and business development activities.
Before reviewing our quarterly financial results I want to turn the call over to Dr. Dr. Christensen, our head of clinical development, who will give you more detail on the outstanding progress we continue to make with our programs.
Yeah.
Thank you Glenn and good afternoon to everyone, who has joined our update call today.
In the last quarter, we made tremendous progress in our internal clinical development programs.
Our first quarter conference call I provided details about the safety and pharmacokinetic results from our phase one trial of inhaled <unk> powder or TSS worthy and healthy normal volunteers.
Deep data were used to initiate a phase <unk> study in asthma patients to understand if the TSS Laurie is likely to trigger bronchospasm in patients with hyper reactive airway diseases, when dosed up to the 80 milligram dose that we intend to pursue for pivotal clinical studies.
Despite the effects of the pandemic on clinical trials globally, we continue to enroll asthma patients and have demonstrated that the 40 milligram dose was well tolerated and upon completion of the safety review of pulmonary function testing and complete clinical data.
Dose escalation to the 80 milligram twice daily dose was approved we're currently completing the enrollment of that 80 milligram dosing cohort.
Importantly, this reactive airway study sets the stage for our pivotal studies by providing guidance on whether patients with asthma, where other diseases with hyper responsive Airways pre.
Pre medicated with bronchodilator or whether this pre treatment will not be required.
To be clear pretreatment without stop development, because other anti infectives that or inhaled do require pre treatments, but if we don't require pretreatment or labor claims would be cleaner than those compounds.
The data generated to date suggests that we have a clear path to initiate our phase two study and to get this moving.
We have begun to interact with regulatory agencies to define endpoints for the pivotal studies and we will file for regulatory approvals to start treating patients with invasive pulmonary aspergillosis by the end of the year.
In addition to the border Congress all results I'm also pleased to report that dosing of all subjects in our phase one study of <unk> inhalation powder was completed successfully.
We have also completed the chronic toxicology study that is required by the FDA for registration and we are preparing for a phase II study in lung transplant patients.
Turning to our Science day, Dr. Levine provided guidance that lung transplant patients undergo therapeutic drug monitoring of maintenance 12 hour trough coldness levels. So that they achieve blood levels of five to 15 nanograms per mil after transplant.
Seem to these blood levels for oral <unk> is required to get a high enough concentration of <unk> in the lung tissues to prevent acute allograft rejection.
In our phase one study in healthy normal subjects, we dosed for a total of seven days and found that the TFS formulation has been hailed to Columbus is greater bioavailability than oral programs.
And with a one milligram twice daily dose of inhaled charcoal unless the mean blood levels of the subjects in the cohort reached almost 15 nanograms per mil.
That's the upper limit of what's needed for successful immunosuppression in lung transplant patients.
We believe this ability to efficiently reach therapeutic drug levels with our <unk> inhalation powder dramatically reduces the risk for the program.
Furthermore, this data when coupled with the demonstrated deposition in the lung during toxicology study.
The ports are working hypothesis that we can reduce systemic exposure to levels that are safer for the kidney and other organisms, while maintaining sufficient levels in the lung to prevent rejection.
We are currently preparing for dialogue with regulatory agencies and expect to initiate phase III steady activities by the end of the year.
Turning to our partnered programs I also wanted to report the TFS Pharmaceuticals has completed dosing and toxicology studies with our <unk> product designed to treat COVID-19, and other respiratory viral infections.
These data are supportive of continued development and we expect enrollment in our phase one study of <unk>.
Inhaled my close Mike to begin in early Q4.
Finally, we also announced that we had selected a lead monoclonal antibody.
As part of our collaboration agreement with augment to bio works together with argument.
Selected catalyst biopharma to manufacture the antibody for toxicology and clinical supplies and this work is ongoing with promising early results.
We've also been screening for binding and neutralization.
All of the lead antibody known as <unk> G $33.87.
Measure potential efficacy against newly emerging variants as an ongoing part of the development program.
We were excited to find that our lead compound neutralizes. The delta variant that is currently sweeping through the U S in locations around the world.
Exciting data underscores the critical need to accelerate development as AEG, $33, 87, which could provide a critical therapy not only for newly infected patients.
Preventing infection in patients who are at high risk of COVID-19, complications once infected with Sars Covid two virus.
This becomes possible because the stable dry powder created using the TFS process can easily be administered at home.
And the dose reduction that can be achieved by direct pulmonary delivery means that more people can receive the drug for every manufacturing run.
The stability at room temperature also means that it can be more easily distributed to places where the cold chain requirements of most biological drugs limit their availability.
And with that update I'd like to turn the call over to our Chief Financial Officer, Kirk Coleman for review of the financials Kirk.
Thank you very much sale for the three months ended June 32021 research and development expenses for the company were $2.8 million compared to $2.6 million for the same period in 2020.
The increase in research and development expenses. During 2021 was due to increased preclinical activity related to the close minded and increased clinical activity related to <unk> <unk>.
<unk> also includes our preliminary analysis and testing of dry powder formulations of several drugs and vaccines, we believe have the potential to become product candidates.
General and administrative expenses for the three months ended June 32021 were $2.4 million compared to $1.3 million in 2020.
The company reported net loss for the quarter of $4.7 million compared to a net loss of $3.8 million in 2020.
Weighted average common shares outstanding basic and diluted for the three months ended June 32021 for $25 million 369, $1.44, compared with $19 million 71658 for the same period in 2020.
As of June 32021, we had total assets of approximately $57.2 million and working capital of approximately $53.9 million.
At the end of the quarter, our liquidity included approximately $52.1 million of cash and cash equivalents.
And with that I'd like 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, particularly with large molecule biologics and how our technology is unique in its ability to successfully transform these complex molecules into an available dry powder bill.
Thank you Kirk good afternoon, everyone.
I am pleased to report that we have continued to advance the science and partner applications supporting them film freeze drying.
This includes strengthening our robust intellectual property portfolio.
We have filed an international patent application based on our work on biologics and completed supporting work for three additional provisional patent applications.
Just on our work on vaccines adjuvant and monoclonal antibodies.
Our most recent research for providing stabilized powder forms of liposomes liposome based compositions.
<unk> adjuvant vaccines and monoclonal antibodies is key to further applications up income freeze drying to the stabilization and pulmonary delivery of vaccine antigens and monoclonal antibodies.
We have continued to publish and file intellectual property around our innovative work and applying them film freeze drying to the delivery of low molecular weight hard to deliver drugs as well as biologics.
These activities are key to our continued work to differentiate improved the advantages of our process and powder characteristics to therapy as enabled by the thin film freeze drying process.
We were invited by the American editorial board of the Journal Kona powder and particle journal a high impact internationally recognized journal that publishes papers and powder Science technology.
And we just published a paper titled the development of thin film freeze drying and its application to improve delivery of biologics as dry powder aerosols.
This is important recognition of our technology and its impact.
Also our paper titled the closer <unk> inhalation powder made by thin film freezing multi dose tolerability and exposure in rats, and pharmacokinetics and hamsters was recently published in the high impact Journal International Journal of Pharmaceutics.
And the papers findings directly support the company's efforts developing inhaled dry powder to close to my to treat viral infections, including COVID-19.
Lastly, our paper based on our research collaboration with Takeda vaccines that began during a poster presentation at an Aps farm side 360 meeting a couple of years ago was recently published in bio archive.
And recently peer reviewed by the International Journal of Pharmaceutics.
This paper confirmed that thin film priest, drawing successfully transformed a liquid suspension form.
Of a bi valent norovirus vaccine candidate adsorbed onto aluminum oxy hydroxide into powders bite them film freeze dried without causing antigen loss or particle aggregation.
All while maintaining the potency of the antigens within a specified acceptable range.
Notably we showed that the potency of the antigens in our dry powders was maintained in the specified acceptable range for eight weeks at 40 degrees C, 75% relative humidity in a completed stability study thus.
Thus confirming the potential to eliminate the cold chain requirement for transport and our storage of this adjuvant that vaccine. These findings have broad applicability to other adjuvant vaccines that we are currently working on.
Our technology validation efforts for applying thin film freeze drying to partner compounds has been robust as highlighted by Glen and Dale at a high level I'd like to describe some of those efforts.
First our work with Augmenter monoclonal antibody <unk> 33, 87 has confirmed that thin film freeze-drying resulted in stable inhalable dry powders suitable for dry powder inhalation.
<unk> recently confirmed the antigen binding and virus neutralization activities of this model call antibody and the powders were indistinguishable from the monoclonal antibody before being subjected to thin film Freeze-drying. These efforts will allow us to demonstrate that a sufficient does today.
$33.87 to achieve a neutralizing concentration in the lungs can be delivered using an already approved commercially available dry powder inhaler device.
Note that we are similarly, validating other partner monoclonal antibodies with the goal of stabilizing and delivering them as dry powders.
Next we continued to validate the applications of them filled tree is driving to stabilization and delivery of partner mrna lipid nanoparticles, including those for improving cold chain requirement.
And creation of dry powders for inhalation. These studies demonstrate the benefit of the intermediate freezing right and very small interfacial area as used in thin film freeze-drying, such as maintaining particle size of the mrna and lipid nanoparticles and the encapsulation efficiency.
<unk> integrity and function of the mrna and lipid nanoparticle as.
Compared to the.
<unk> of spray freeze drying, which has high interfacial area and sheer stress created during the atomization step.
Next we have applied thin film freeze drying to various other partner peptides and proteins.
And confirmed their potency stability and deliver ability as a dry powder, including those to improve storage stability and delivery by dry powder inhalation.
I would like to acknowledge my colleague professors and wrong Cui for his continued commitment to our efforts to leverage them film freeze dry to solve.
Drug delivery problems I would also like to acknowledge the significant contributions postdoctoral fellows Chase's moon.
Willie Sakes, PCR and high you shoe for their dedication and commitment during these most trying of times during COVID-19.
I want to also thank the graduate students supported by the sponsored research agreement and technology validation agreements with Tsi pharmaceuticals for their scientific contributions upon which our platform as possible.
Thank you all for your continued efforts in supporting PFF Pharmaceuticals, 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 in its business development and partnership efforts Chris.
Thanks, Bill and good afternoon, everyone. Thank you for joining us today.
As previously shared the TFS business development team is focused on three key areas of growth for the company.
These three key areas are one growing the TFS pipeline of internal development programs.
To our pharma partnering efforts and three our government and academic contracting efforts, we continue to make great strides in each of these key areas.
For today's call I will be focusing on the wide breadth of different modalities, where the TFS technology has differentiated itself from other dry powder technologies.
<unk> continues to be very active in the mrna space. We currently have 10 ongoing projects and we are in discussions with other potential companies to discuss additional mrna projects. This number continues to grow.
We are working with pharma partners to formulate their proprietary mrna into a dry powder.
For some partners, we are formulating a dry powder for inhalation.
Delivering the dry powder mrna deep into the lung to treat respiratory helmets.
For other partners, we are formulating their proprietary mrna vaccines intuit dry powder to form a more stable vaccine that is not subject to cold chain storage and transportation.
This dry powder is then quickly reconstituted for injection on site.
Cold chain storage and transportation continues to be a tremendous challenge for many regions of the world.
TFS also has many other nucleic acid projects underway, including formulating <unk> RNA oligonucleotide plasmid DNA and other RNA compounds into our TSS dry powder.
These programs predominantly focus on delivery of the nucleic acid formulated as a dry powder for delivery directly to the lung to treat different respiratory diseases.
TFS continues to be very active in the monoclonal antibody space formulating either Matt or Fabs.
We currently have eight ongoing projects and are in discussions with other potential companies to discuss additional antibody projects.
The number of antibody projects is on the rise.
As mentioned previously we have made very good progress with our partner augmented by works and we continue to build our expertise in formulating antibodies used utilizing our innovative dry powder technology for delivery of these therapeutics directly to the lung.
The TSS dry powder technology is differentiated when it comes to formulating both peptides and proteins.
We are currently partnered with each different companies formulating their proprietary peptides and proteins.
The number of our vaccine projects continues to grow we are currently formulating numerous vaccines seven projects as of last month we.
We are currently in the process of negotiating with you Sam Reed in order to put a new crater.
Cooperative research and development agreement in place we.
We expect the creative to be signed over the next few weeks.
This creator will progress one of our vaccine projects into an animal efficacy study.
PFS is also working with four different partners on their proprietary sage products again by formulating a dry powder, which after testing reflects minimal tighter loss and high viability, we can deliver active phase directly to the lung.
On the government contracting front, we continue to work very closely with lineups. The prime on the DARPA contract. This is the first government contract for Tsi and we are actively pursuing additional government contracting opportunities.
With our academic partnerships, we continued to make very good progress with Ted Ross at the University of Georgia, We are moving our universal influenza program into a second species of animal testing pre.
Previously we reported our results in the mouse Immunogenicity study and we are now moving into <unk>.
With Kartik, Sean drawn at the Albert Einstein College of Medicine, We are now moving our BSB program into animal studies.
With true Weissman at U Penn we are beginning our initial mrna formulation work and have finalized our protocols for animal testing, which we expect to start in the next month.
In summary, the TFS BD team has been making tremendous progress and our partnering efforts. We continue to grow the number of collaborations we have with pharma partners and we continue to expand the application of our thin film processing technology.
The TFS pharma team is currently working with a majority of the top 20 pharma companies and we have ongoing discussions with many others as we continue to expand our collaborative projects across the wide range of modalities.
From an IP perspective building our patent portfolio is a key value driver and foundational component of the TSS corporate strategy.
As of August one 2021, TSS has 58 issued <unk> filed patents.
Patent protection and exclusivity is interwoven into the fabric of everything we do at TFS as we grow our company and expand our technology.
In closing I would like to thank our partners at the University of Texas at Austin with.
With the continuing support and efforts of Dr. 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.
The BD team is focused on closing at least two signature licensing transactions in 2021.
We are very well positioned to meet this objective and we continue to foster future growth opportunities for both our technology and our company.
Thank you for your time today enjoy your evening I will now hand, it back over to Glenn.
Thank you Kjell Kirk Bill and Chris Let me conclude this call by saying that TFS pharmaceuticals remain steadfast and confident in the progress we are making to build short mid and long term value for you our shareholders.
We're making steady progress on our internal portfolio of clinical assets.
And producing strong data and a positioning these assets for meaningful value creation.
Remember, we are a platform technology company applying film freezing to both internal and external opportunities.
Our business model has already created significant opportunities that are moving ahead with purpose with numerous and diverse partners.
The team is intensely focused on execution of our existing programs as well as delivering transactions on the business development front.
My confidence level continues to grow on a daily basis.
As always we appreciate the support of our investors and partners and we look forward to speaking with you next quarter and with that I'll turn the call back to the operator and open it up to questions.
Yeah.
Thank you if you would like to signal with questions. Please press star.
One on your Touchtone telephone.
Joining us today use a speaker phone. Please make sure your mute function is turned off to allow your signal to reach our equipment.
Again that is star one if.
You would like to signal with questions and our first question will come from Jonathan Aschoff with Roth Capital partners.
Thanks, a lot Glenn I was wondering if you can tell me about how you a green light.
Is going and how it might be energized by our recently announced snack.
Hi, Jonathan how if you will so we generally don't make a lot of comments about the partnerships in this case I can.
We've got a really.
Really good interactions of Greenway, we've worked on the materials.
Produce some some really stellar results and formulation.
I'm actually quite excited about the fact that.
<unk> been able to gain financing.
This gives us an opportunity when we do get to the level of a transaction, we can do a meaningful transaction.
We will not do deals where there's not meaningful economics. So.
Greenlight funding is really a very very positive.
The staff and the relationship with them. So that's that's moving along and even looks better now that they're funded right. So thanks for the question.
Yeah.
Also are you still confident in cannabis revenue third quarter this year.
Yes, Jonathan So you have one chance in one chance only to launch a consumer brand right. So we have really done a lot of formulation work with plus.
And right now I think we're at the point, where we are.
Positioned to.
Test these formulations in difference.
Put ups with consumers and once we have a good handle on what that reaction is assuming there is no tweaks, we need to make we will be ready to move forward.
Okay time for third question or should I get back in the queue, Yeah sure Jonathan issues here.
By activities by year end 'twenty, one for bohrium Tac unique patient dosing with some earlier activity.
Yes, so if you want to take that I don't want us easier trials. So I'll, let you.
Speak to the okay.
All of the ones that's.
Because I want to compliment daily he's just doing as as the whole team Jonathan and incredible job. If you look at.
The trials the outcomes the amount that we've been on time and on budget.
<unk>.
And the team a real big Shout out here, but go.
Go ahead please.
Thanks, Glenn and thanks, Jonathan.
Yes, Jonathan for the question.
So we are doing everything we can to push.
Push into scientific advice meetings and.
So that we can negotiate some of the endpoints and then get our regulatory filings in place.
And.
Unfortunately.
We're going to be doing our best to actually dose patients by the end of the year.
But some of that is dependent upon regulatory approvals and how various countries handle those regulatory approvals.
Could be pushed back based on but but we will we will file for approval and hopefully we'll have everything in place and be dosing. The other thing with all of these trials as you know is that even if you have.
S sites activated regulatory approval drug on site you may not end up with the patients ready to enroll so we're going to we'll be doing everything we can to make sure that everything is in place and we hope that those patients come this year.
So Jonathan it's in our headline rate so.
Yes, we have some more we will get the Rad data back from.
On <unk>, we will publish the.
Phase one data report on Tac.
We intend to do everything we can and we intend to be.
Sure.
Moving forward with the phase twos pivotal trials by the end of it.
Thank you Glenn and Bill Thanks.
Thanks, John.
And our next question will come from Jason Mccarthy with Maxim Group.
Hey, this is Michael accumulates on the line for Jason Thanks for taking the question and congrats on the progress this quarter.
Thanks, Mike.
So now I'd like to ask just <unk>.
Regarding the timelines and tacking boree.
It looks like we're on track to enter those pivotal studies in the second half and.
If I recall that was supposed to be relatively short positioning potentially for filings in the first half of 'twenty two.
Are we still looking at that timeframe and then based on the enrollment you have seen in the phase one how should we look at the timelines for data in those.
Yes.
We believe that will have the interim analysis data in the first half and the trials will probably now concluded in the second half.
Next year Michael.
Yes.
Alright, Thank you very much.
Thank you and then.
Going forward it looks like.
Quickly approaching.
Tack and border crossing that finish line, so I'd like to ask.
In your view what comes next it seems like much of the pipeline is in the form of your platform collaboration.
So is this more more so how we should think about the future.
Or do we expect to get some additional internal pipeline compounds that come on board.
Yeah, Great question and it speaks.
Our strategy. So you are right.
First you think about the fact that Kirk mentioned that we do have some.
<unk> capital that will cover that fee to trials that we acquire.
And then engineered Curt's assumption here is also that includes no which is really extreme assumption.
<unk> revenue generate generation from our transaction. So we plan on identifying are there internal portfolio opportunities and if you look at our last.
Transaction.
It was a codevelopment with augment it right so when that transaction.
We agreed to share the costs of the preclinical and clinical work through phase one.
And then look for a partner going forward, so I'm, not saying definitively that we do more transactions like that but it could be some of those that could be something we would take on.
<unk>.
We are as I said.
We are a drug development company and what was also quite a technology to either internal assets or partner assets and will keep churning. So.
I think the quintessential short mid and long term value creation opportunity here and if you listen to Chris.
The partnered programs are growing dramatically increased the patent portfolio and a 58 and go out of some of your quarter at <unk> 45.
So this is just.
It really.
It's just accretive every day in terms of how many more opportunities, but yes to answer your question to shortly we will look to add to the internal portfolio, either with partnered programs or or programs that we would do by ourselves.
Alright. Thank you very much and then just one more for me and I'll hop back in the queue.
Okay. So sometime last summer you were discussing a TSS formulation of room that severe and we havent heard much on that recently, but the reason I'm, bringing it up is because gilead recently stopped developing their own inhalable room that severe due to deposition challenges so what I'd like to ask is.
Were you able to get lung deposition with your investigator formulation.
And tenants be thought of as a Prime example of just how difficult dry powder inhaler formulation can be and the value of the platform.
Im going to give this off to the man who do the work in that sector. Williams. So bill could you comment on Europe, Yeah, Yeah. Thank you Glenn Yeah. So we have sown.
Multiple rodent models, one of which was hamsters and thats the preferreds infection model for Covid, we showed a very good <unk>.
Deposition in the lungs, and we model that.
And the two papers that a rep or one type of I referenced in the script. So we believe we can do at Gilead.
To the best of our knowledge was testing a liquid form and it does it goes to show you that these inhaled drugs.
Our difficult the formulations are difficult we spend every waking hour trying to figure these out and we believe with the room disappear we nailed it.
And up through animals at least so great question. Thank you.
Alright. Thank you very much of that is a great example.
Just how broad the application is here and we actually think we.
Has to be tested.
We solve their problem.
At least in terms of drug getting deposition is it an effective therapeutic.
Not only would remain to be seen here, but.
Bill I think solve the formulation trial.
Yes, thank you very much.
Thank you.
Thank you and our next question will come from Nick <unk> with B Riley Securities.
Hi, good afternoon team that fits all hope ASEAN for my own. Thanks for taking our questions. Maybe just a brief one for Glen kind of billing.
After last question nice to see the progress across the dock and Laurie.
Graham and looking forward to see those trials start, but as you kind of think beyond that.
It would be great. If you could opine on any thoughts you had on the Philip Morris that Taro transaction that that close today and how do you think about kind of expanding the platform.
Into that consumer space, including your discussion with plus product et cetera.
Yes, <unk> I mean, obviously we've watched.
Philip Morris interest.
Delivery companies.
As I sit here today.
Certainly.
Focusing on execution and moving our business forward and.
<unk>.
Certainly we're always be opportunistic, but more importantly, I think.
We're just getting our focus is on creating value for the shareholder.
That moves onto some other opportunistic activity so be it.
I think some of the parts here right now or perhaps worth more than the whole, but that remains but I think that's getting closer to kind of catching up to it because the whole is starting to look pretty good so.
We just we come to work every day thinking about moving moving the needle forward in closing more partnerships.
Et cetera. So.
I think thats the best way I can answer that question.
To answer the whole question, Eric Your second part noted.
That's very helpful. And then maybe just a quick follow up is do you have any deal seats that you are reviewing right now that you can talk about.
The answer is yes, and I can talk about that and I don't think you'd want me to.
They may.
We're looking to create meaningful economics and hopefully these discussions will result in that and.
When we have the deal signed will reported.
But we were at all levels with these partnerships that Chris described.
In vitro in vivo in term sheet.
Alright, Thanks, a lot thanks for taking our questions and congratulations on the progress.
Thanks, so much I appreciate that they hold on my answering okay.
And our next question will come from Daniel Carlson with T. W Research group.
Hey, guys. Thanks for taking my questions and congrats on the progress.
First off Glenn on <unk> limits.
Clinical PK data is released so far shows that the drug can reach blood levels needed for systemic immunosuppression and I'm wondering if you have reason to believe they can lower the dose for lung transplant patients to a level closer to what is used in the other transplants like heart liver and kidney.
I guess, we got to give everyone a deal could you take that one please.
Yeah.
Yes, Thanks, Brian and thanks, Dan for the question.
So.
To date.
As you mentioned, we have the clinical PK data that shows that we can reach that upper limit.
14, 15 range with a low dose, we're getting about 80% bioavailability.
In our 26 week toxicology study what we've demonstrated is that we can achieve about 3% to port fold higher.
<unk> levels.
Drug to columns in the lung tissue.
Paired to the blood and.
So what that gives us is the ability to when you dose for the oral perspective or from an oral route you have.
Of course, the blood level high enough to get enough into the lung to.
Prevent the rejection in the in the lung tissue itself.
But because we have a higher blood level or a higher tissue level from the inhalation.
We can reduce the blood level and still have that same or more in the in the lung tissue and so we think that.
Essentially this is by topically delivering it to the right.
Right to the site, where it needs to the immuno suppression and then we can reduce the systemic level down to levels that would be protective of the kidney.
Got you Okay. That's helpful. Thank you.
Switching gears.
Yeah.
<unk> has shown activity against the Delta variant and I'm wondering if you've tested against the new Delta plus variance.
<unk> as mentioned recently.
Okay.
That's going to be for you all SEC.
Okay. Thank you.
Again, a very good question. So the Delta plus debt that has been mentioned it has the full complement of mutations that are into the delta variant, but it's also picked up this case for 2017 and mutation.
And that <unk>, 17, or <unk>, $4.17 and mutation.
Also in the beta variant that was first identified in South Africa last year.
And we already have data showing that on $33.87 works against the beta version. So we have strong reason to believe that $33.87 will work on the Delta plus.
And we are.
Again as each of these new variants emerge. It takes there is a lag time in being able to get all the reagents to keep reporting that testing, but that is something that will be coming out.
Okay great.
Then.
Glen can you.
Talk a little bit more about your relationship with Catlin.
Yeah, Hi, Greg actually I'm glad you picked up on that Daniel.
So we're very pleased.
<unk> obviously.
One of the leading hospitals.
CMO, especially in the area of biologics so.
The fact that we have catalysts onboard to help produce the augment EMEA.
<unk> is a great signal because they now become.
A provider of manufacturing GMP materials in behind.
That can help us satisfy the needs of our maturing.
Discussions with partners right. So it is an evolution here, we've never talked about manufacturing before right. So.
Except for our internal pipeline, which was satisfied with the relationships, we have a core Rx and irises experience.
But now you are into this whole sort of biologic sterile product environment, right, which is really being.
The Genesis was and as all of the partnerships that Christa described and those categories. So getting cattle and on board is really critical because we need to develop.
<unk> capacity and expertise to it.
Start producing products as these products get into animal testing and beyond.
Actually even in the sterile environment so.
Me and running this business Holistically and looking at the lifecycle and the evolution of the business.
That's a great great partner.
Frankly to the investor that should be signaling something.
It is so I think that you know.
Congratulations for picking up on that.
I generally don't like to be a lot.
Hyperbole, but putting mentioning catalyst I think should signal to just where we are in the lifecycle, especially on the biologics.
Yes.
Great. So congrats on that and then one last question for me if I could.
No.
Three year vaccine work with to help relieve cold chain issues in a company that has been working over in Africa on some vaccines dyadic and I'm wondering if you've done anything in conjunction with them at all.
Okay.
Had permission from their CEO as phases.
So mark Hamill filings with SEC.
Gratulate Mark on this transaction with <unk>, which again is good I think because Americas Mark from capital do some things, but we have successfully formulated vaccine candidate.
And I think it is.
Now we have the opportunity I think really hopefully again.
Fully hypothetically look at.
How and if we can move that project forward.
Great Okay, well congrats on the progress.
We don't comment on.
While these MTA.
<unk> with number one a lot of companies don't want us to.
In the case with Mark because we are close with marquee.
You said you feel comfortable disclosing that we have a relationship.
Yes, okay, well, thanks, guys I appreciate it I'll jump back.
Okay, maybe we have time operator for.
One or two more questions. If there are any others.
Question will come from Richard Deutsch with National Securities.
Yes, thanks for taking my call and if you don't mind.
A little upon here.
Your presentation just breathtaking.
Okay.
Oh really.
Such a detail broad and incredible presentation, especially for what you've done in the last quarter, it's phenomenal.
I got a couple of quick questions first of all I thought I heard you say.
Out of the business deals that have been percolating for a while did you say you actually put out finished term sheets that are under review right now.
We have we do have term sheets in place with some partners and Richard I, just want to be really clear.
Mean that we're going to get transactions done with these partners, but we are the terms sheet.
Okay.
But and look I wanted to say well why wouldn't you do it maybe the economics won't be right. Okay.
Or something happens in diligence, but.
Yes.
To put a big qualifier on that so.
Hold on a second one you said youre going to get a deal done in.
In two weeks, we do have some term sheets.
And thats good.
Alright, well I mean.
You've got a term sheet out there that youre happy with mummy use it's all a matter of it going on out there, saying you are happy with them either because we do.
F term sheets, okay, okay and the other thing.
Okay.
Might be able to.
If there is a deal will be done to get it done.
Value creating way.
Yeah, well, if you give them the ring and are they going to do is accept thats pretty much progress.
Other thing I've got a whole list of all your projects.
As everyone can hear more numerous than anybody can deal with but there are some very very short term things that are coming up when.
When do you expect or have you heard about orphan drug.
Standards to protect <unk> limits.
We actually have orphan drug status already.
For Tucker limits that was I guess about a year ago or so.
Actually we see yeah.
I did I misspoke, I'm looking for <unk> or yes.
Yes, we are.
In the process of applying for the orphan designation before council.
And what's the timeframe on that.
Yes, I don't want to say, specifically again I don't want to give everybody.
A date because we are at the mercy of the regulatory authorities right. So.
But it is something we are pursuing.
Okay and you also had the G L P.
Results coming are those going to be showing up soon.
GOP result, good laboratory practice.
Uh huh.
Help me deal or a build.
Richards.
So we.
Sorry, we do have DLP Tox studies that have been completed and ongoing.
And we also have good manufacturing we've been manufacturing GMP for all of our clinical work to date. So we are fully gx GCE GMP DLP and GMP compliant for all of our work.
Well, that's just outstanding progress for.
A company your size, it's incredible well. Thank you very much I appreciate your presentation.
Thank you.
Richard for your support.
Operator, maybe one more if there's someone else in the queue.
At this time there are no further questions Sir.
Well. Thank you operator, thanks to my team to all of those that are still on the line with you. Thanks for your support I heard you all too.
Stay healthy I want to tell you I'd be careful out there.
<unk> Europe granddaughter is recovering from Covid coffee Yahoo girl. Thanks.
But coming back so be careful I want you all to be healthy.
Well and happy so thanks again for your time and your attention and good afternoon.
Thank you and that does conclude today's conference. We do thank you for your participation have an excellent day.
Okay.