Q4 2021 TFF Pharmaceuticals Inc Earnings Call
Good afternoon, ladies and gentlemen, and welcome to the T F. A pharmaceuticals fourth quarter and year end 2021 financial results conference call.
As a reminder, this conference is being recorded I would now like to turn the call over to your host Corey Davis of lifestyle Advisors. You may begin your conference at this time.
Thank you operator, Hello, everyone and welcome to the <unk> Pharmaceuticals fourth quarter and year end 'twenty, one financial and business results Conference call with me on the line today is Glenn Madam President and CEO of TFS, Kurt Coleman, Chief Financial Officer, Dr. Dale Christiansen GFS director of clinical development, Dr. Bill William.
So the University of Texas at Austin, and Chris can know DFS, Chief operating Officer press release announcing our fourth quarter results is available on the GFS Pharmaceuticals website.
Please take a moment to read the disclaimer about forward looking statements in the press release the earnings 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 are described in the disclaimer and in our filings with the U S.
S Securities and Exchange Commission, including the risk factors section of our 2021 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 fourth quarter operations and recent highlights.
During this call I will provide an update on our overall progress.
There was a lot to share after my discussion of our Alaska leader of clinical development Dr. Dr. Christensen to update us on the progress, we're making on our internal clinical programs.
Oh Dale's remarks, Kirk Covid, our Chief Financial Officer will then review the company's financials for the quarter.
When curt's comments, Dr. Bill Williams of the University of Texas at Austin will provide an update on the latest R&D applications.
I'll finish off freezing platform technology, which continue to expand as well as opportunities to continue to expand our intellectual property estate.
Finally, Chris Kendall, our Chief operating officer, and head of business development, well update our progress in that arena, and that's what I'm, saying something freezing technology.
Can use to generate expanding interest on the part of industry pharma and biotech partners.
Some of the world's leading academic research institutions and the government.
Without question 2021 can be best described as a year of significant corporate achievements.
Robust activity on the partnering front, coupled with the advancement of our internal clinical stage pipeline candidates should provide our shareholders with confidence that we are building significant sustainable growth and value are fully executing our corporate strategy.
Obviously, the recent weakness in the capital markets have created conditions that in our view do not accurately reflect the progress. We have made over time. However, we know that building partnerships and generating positive clinical data are important achievements that create value for our shareholders.
So despite the current environment, we are more optimistic than ever that our progress on all fronts.
Will be recognized and rewarded.
Let me start by briefly describing the progress we've made in our clinical stage pipeline.
I'm happy to report that the investments we made in developing our internal pipeline assets.
April goes to advance both of our inhaled workout as all Hell Teck relentless into larger potentially pivotal phase II trials that began at the start of the year.
In a few minutes there are Christians, Sam will describe in more detail. These innovative clinical programs, but for now I'll provide just a brief overview and explain the significant potential of each program.
We are applying our thin film freezing technology to develop an improved formulation of the antifungal work hard at all.
Our inhaled workout, it's all powder as a target product profile that will improve upon an orally administered work on exalt right delivering the drug directly to the infected lung tissue in patients with invasive pulmonary aspergillosis.
Our clinical trial is designed to demonstrate efficacy, while they're proving the safety profile of the existing drugs.
Specifically in patients who require more chronic use of workout exalt. If patients were prophylaxis of infections is it drives in fact, we recently hosted a PFS Science day last December feature.
Featuring a presentation of our Doctor Karsten Schwartz director of the cystic fibrosis center and parts to have Germany.
The presentation, which is available at <unk> website under the events and presentations section.
<unk> is an important kols based perspective on the broad potential of T. F F worry to support the current use of the oral formulation.
As we think about developing internal pipeline candidates are.
Focus is not to just reformulate and existing or novel drug per se, but rather develop a new formulation.
Strong clinical potential to advance the current standard of care.
Based upon the clinical data generated to date.
Emerging profile of inhaled workout is all powder.
The opportunity to do just that.
We look forward to providing updates on the phase two program as we move forward.
We're equally excited about the potential to improve the current standard of care with our inhaled formulation of tack relentless.
CFS It health Tech relentless powder target product profile.
Who's delivering immunosuppressive levels of tack relentless directly into the lungs, following transplantation, while reducing the patient's overall systemic exposure.
Presently tacker limits is administered intravenously, the lung transplant patients immediately following surgery to prevent acute rejection of the transplanted locked.
Unfortunately higher doses of Tacker lemons are often required to prevent acute rejection.
This could lead to considerable systemic toxicities.
By delivering tack relentless directly to the walk by.
By using our thin film freezing technology.
We hope to achieve sufficient immuno suppression.
To avoid any systemic toxicities associated with both the IV and oral delivery currently available.
These toxicities are quite liberty ever extreme negative effect on renal function.
In our view the successful development of inhaled JAK relentless powder offers the potential to significantly improve upon the current standard of care of patients receiving immunosuppressant therapy, following a lung transplant.
We're also confident that TFS in health Tech are 11th powder will demonstrate similar advantage in patients who have received heart liver and kidney transplants as well.
The potential of the product can have a profound effect on a significant number of patients.
Our internal commercial market forecasts.
Thirdly project sales potential in excess of $1 billion, making T. F S inhaled sacrilegious plywood or a blockbuster drug.
Yeah that we're in phase two development for both T. F F inhaled JAK relentless and workout is all is.
It is important to note that the trials are designed with an interim data analysis.
These interim data will be available in the latter part of the third quarter.
He will serve as a major inflection point for our company.
As noted in our corporate presentations is our goal to partner these assets with a pharmaceutical company.
Has the ability to optimize these products in the commercial setting.
That process has already begun and cruise Canada will discuss the approach later on this call.
Upon the successful closing of those transactions, we look forward to a meaningful modernization and creation of value for our shareholders.
We also made considerable progress with our inhaled by closer by program.
I got October we'd have Canadian approval for testing that closer in.
In humans and just last month, we announced highly positive data showing the ability of our inhaled by close of iPad or significantly inhibit viral replication of the avocado variant of the Sars Covid two virus.
These data show the remarkable potency anti viral drug.
When delivered directly to the long at a low concentration and held by close of our powder produce very strong anti viral activity.
Given this level of potency, we believe held by close of I'd powder could offer a potential with respect to safety and Tolerability.
Over oral delivery.
The full phase one study data set will be available next months those data will be shared with our partner Union therapeutics.
Union Therapeutics will then have some time to exercise their option to further develop and help their classified powder.
<unk> believes strongly in the anti viral potential if my closer by COVID-19, and beyond we are evaluating additional indications the potential for near closer I get involved receiving non dilutive funding to move forward, where there is an opportunity.
In addition, we are working with our partner augmented by works on augment their 33 87.
Went to 33 seven is a potent monoclonal antibody that we were developing to treat Sars COVID-19 two <unk>.
Thus far in animal testing, we've demonstrated positive data on all of the Covid variance, including the Delta variant.
We have shown binding to Ava crime, and we're assessing the neutralization profile of augmented with $33 seven on that variance as well.
Will discuss further in his section.
And finally, we continue to work with plus products on refining the thin film freezing formulations of cannabinoid.
Very happy to report that we are receiving very positive feedback from plus other consumer testing.
Our goal is to launch T. F. F versions of cannabinoid is a safe substitution for vaping.
It is imperative that the TFS formulations pizza preferred product profiles by the users.
The target product profile is focused on an easy to use inhaled product that delivers a desired experience.
We believe that we have now reached that threshold plus products as an excellent partner and has worked closely with TFS to refine our formulations and test the products with consumers.
Pluses in the process of restructuring their company.
<unk> been told that they are close to announcing a successful outcome.
We look forward to partnering with plus.
Bringing these products to the marketplace as soon as possible.
We're also discussing that he is F cannabinoid opportunities with additional partners.
P F F in house, our latest collaboration with the global C. D about catalysts on March 1st.
We're very excited about this agreement has catalysts significantly expands our access to manufacturing capabilities, which has been a major question you asked by a potential pharma partners about producing product.
This has been especially true in the biologics space.
Clearly addresses this need.
Got it and then we'll also offer authentic film freezing technology to a targeted list of their over 1000 clients.
Catalog has a significant amount of sales resources to enable that effort and we expect that the P. F. F portfolio of collaborations will greatly increase as a result of this outrage.
I wanted to address the status of our business development activities, because canada or greater detail them in a few minutes.
The work with potential licensing partners is proceeding very well.
A list of partners continues to grow as well as the number of open projects.
We understand that the investor community wants to see T. F F side, a number of meaningful licensing transactions.
T F F team very much shares this desire.
Company is very confident that this will happen and we will realize the value contribution to the company.
Each partnership is different and requires a great amounts of work to complete the required experiments.
Fully demonstrate the value of the thin film freezing technology.
This is especially true in the biologics space.
We've not been faced with any specific scientific challenge that cannot be addressed.
Our partners remain highly engaged and we're working diligently to get to the finish line.
We will continue to report progress and when given the go ahead by the partner share their names with you.
Continuing to focus on our accomplishments I'm pleased to note that we recently entered into a second cooperative research and development agreement with the United States Army Medical Research Institute of.
Factious diseases also known as you separate which is part of the U S Army Medical research and development command.
In the U S Army's Premier institution and facility for defensive researching the countermeasures against biological warfare.
And the Geneva Foundation, a nonprofit foundation that supports that advances innovative medical research within the U S military.
Through this collaboration.
The F S pharmaceuticals, and you separate.
Valuate the immune response of a dry powder recombinant vascular stomatitis virus severe acute respiratory syndrome coronavirus two glycoprotein vaccine.
Using TFS thin film freezing technology.
The Ngos develop a single easily administered and temperature stable set of countermeasures to protect our war fighters against multiple viral pathogens, such as Sars Covid, two Ebola Marburg and others.
This is a second grader announcement, we've announced over the past two years.
We're very proud to build the government partnerships.
So important in developing effective countermeasures to potential bioterrorist threats and see the future of public health in general.
These creators are in addition to the contract we have with lighthouse and DARPA.
Formulate additional countermeasures administered and unique formulations, including the nose eye and skin.
Also in the government area I'm very happy to in house, and our efforts to expand and attract opportunities.
Within the U S federal government and builds on our ongoing collaborations with your Safford DARPA and other agencies, we have been engaging broadly with congressional members to elevate awareness of dry powder approaches with thin film freezing dry.
That allow for vaccines to be Physiochemical stable.
We saw this language included in the recently passed fiscal year 2022 government funding Bill.
That was recently signed by President right it.
The language is not binding.
Elevates the opportunity for securing funding by providing notice to the related agencies, such as H H S that Congress is interested and monitoring progress on this issue.
You will note that the legislation that the language is specific.
Thin film freezing.
Moving on in respect of recent corporate developments I'm pleased to announce the appointment of Brandi Roberts to our board of directors Randy.
Randy has over two decades of financial management expertise within the life Sciences sector.
As we continue to grow and develop more strategic relationships with our existing and future partners.
Randy its expertise and experience on data really help us navigate.
Larger and potentially more complex partnerships.
While also bringing us to manage through periods of significant company growth.
I welcome Brandi to our board.
Look forward to working with her for many successful years to come.
Today, we're also announcing that Dr. Brian Windsor will be stepping down as Chief Scientific Officer and board member to focus exclusively on his role as CEO of luck therapeutics.
Brian has been with us since our company's founding.
Many significant contributions both respect to scientific achievements.
And as a board member.
He was especially helpful as we prepared for and executed our IPO.
Like to thank Brian for these contributions and wish him the best in his future endeavors.
If that is also proud to announce that.
Doctor Anthony Hickey will assume the role as Chief Scientific Officer for T. S F.
Doctor Hickey is professor Emeritus and former co engineering and molecular pharmaceutics.
The echelon and school of pharmacy at the University of North Carolina at Chapel Hill.
Doctor Hickey is also an adjunct professor of biochemical engineering at the University of North Carolina School of Medicine.
So he has also been a member of the T. S. A scientific advisory board since its inception.
Please join me in welcoming congratulating Doctor Hickey.
I also would like to announce the appointments of three senior executives, who will bolster our leadership across key areas of our business Dr.
Doctor, John calling has joined as vice president of product development and manufacturing.
Dr. Greg Davenport, as vice President of government and strategic initiatives.
And Paul badly as head of regulatory affairs.
Each of these executives have significant experience in their respective fields.
And as our partnerships and programs continue to expand the depth of scientific knowledge medical expertise and relationships will be tremendous assets help further grow our business.
I realize that they just delivered a significant amount of abuse and likely left out other elements of our progress. Thank you for your attention and patience. Let me now turn the call over to our head of clinical development Dr. Dr. Christensen, who will discuss our clinical programs in greater detail.
Dale.
Thank you Glenn and good afternoon to everyone, who has joined our call today.
Our productivity continued in the fourth quarter, and we continue to make significant progress by advancing our internal clinical development programs.
Let me begin the clinical update by discussing our T. S F for cortisol program.
We are developing border cotylosaur inhalation powder for the treatment of invasive pulmonary aspergillosis or IPA.
I T. A S in invasive fungal infection of the lung that causes significant mortality in patients with lung diseases, and those with compromised immune systems, including patients on immuno suppressive drugs following transplants and those with severe neutropenia following chemotherapy for leukemia.
Last quarter, we completed our phase one b trial in asthma patients. As a reminder, this study was performed to allow us to understand if patients with asthma or other hyper reactive airways due to lung disease would be experienced bronchospasm when the inhaled where cortisol was administered and this was a necessary step to allow those patients to be <unk>.
<unk> in the phase two trial.
With this study complete patients with asthma and COPD will be eligible to participate in our future studies.
We have also initiated our phase two trial in patients with I P. A.
The design of this study has been modified from our original study design and is now an open label study that will randomized patients to receive either 80 milligrams of inhaled for Consol twice a day or two received oral work on this all in accordance with the prescribing information.
This change is due to the prescribing guidelines for oral work on US all that provides for increasing the recommended 200 milligram twice daily dose.
As high as 300 milligrams twice daily if the patient response to treatment is inadequate or to reduce the dose to as low as 100 milligrams twice daily if the patient is unable to tolerate treatment at a higher dose.
In clinical practice these dose adjustments have reduced the discontinuation rate due to dose limiting toxicity.
But it does come with the additional burden of monitoring drug levels in the blood and associated liver enzyme function of the patients in order to identify the appropriate dose for each patient.
It is our belief that delivery of the 80 milligram inhaled dose directly to the lung will feed these patients and their physicians from the burden of repeated lab tests and dose adjustments to find the goldilocks zone with high enough drug levels in the blood to be efficacious, but not so much that it is toxic to the liver is where heart.
In our open label design, we will be able to determine the frequency of dose adjustments required to keep patients on oral work on this all and compare that's just a single inhaled dose.
Another important milestone we achieved was that we also began dosing in a lung transplant patient with work on this all inhalation powder in a compassionate use study.
This particular patient had previous fungal infections in the lung and experienced significant adverse events, while taking world, where cortisol and other anti phone calls to treat these previous infections.
This patient is infected by a non aspergillus fungal species that is susceptible to border cortisol.
Since the presence of non aspergillus fungal species makes ah patients ineligible for our phase two study in I P. A.
The treating physician believed the T F F score of Commerce, all inhalation powder would provide the optimal results for this patient.
Effectively delivering devor cortisol directly to the side of the infection more importantly for this patient.
Potential for efficient clearance of the fungal infection is combined with reduced systemic exposure that could otherwise adversely affect patient due to drug drug interactions with their immunosuppressive medications that prevent rejection of the allograft had long.
I am pleased to report that the patient is doing very well on hard work on those all inhalation powder and the information received to date supports our treatment and safety hypothesis that underlies the development of this product.
We'll continue to monitor the efficacy of the work on this all inhalation powder in clearing the last common fungal species, while also monitoring the safety of the drug.
As well as any drug drug interactions that do arise we will continue to treat more patients under this compassionate use approach when the appropriate medical need as documented by our network of physicians.
In addition to advancing our border cortisol inhalation powder to phase two testing we've initiated a phase two trial activities in Australia, which arched chromous inhalation powder in lung transplant patients.
This study will be performed in patients with stable lung allograft function, but who are also experiencing a level of net for toxicity that is causing their position to reduce their to kronos blood levels in order to spare the kidney.
These patients face a choice of risking rejection of the lung transplant or losing their kidney due to Tacoma Ms induced nephrotoxicity.
And up to 5% of lung transplant patients eventually undergo secondary kidney transplants.
Our non clinical studies demonstrated that when TFS tacoma's powder is delivered by inhalation greater levels of tomorrow and this drug are retained in the lung tissue compared to the systemic exposure in the blood.
Indicating that we can reduce the patient systemic to grow in this levels.
To better protect the kidney while delivering sufficient concentrations of the drug into the lung to maintain the immuno suppression and reduce the risk of transplant rejection.
In this study we will be dosing patients for sufficient duration to measure potential rejection.
Along with the stabilization or recovery of the kidney function.
Next I'd like to provide an update on the development of RNA close to my dad relation powder for the treatment or prevention of Covid infections.
On our last call, we announced the dosing of the first subjects and in January we completed the dosing in this study we've locked the database and expect to receive the unblinded data in the weeks to come.
Delivery of nightclubs might inhalation powder directly to the lung represents a highly promising approach for COVID-19 .
Was recently confirmed when we announced that our in vitro studies show that night close them I didn't hibbitts replication of the Omnicom variant of Sars Cov two.
The potency of that close to my derives from the drug's ability to inhibit human cellular targets in respiratory yourselves that are required for viral replication.
This is in contrast to viral targeting drugs because the human host cell machinery is the target. This means that mutation of the virus does not allow for mutational escape from drug efficacy.
Our future studies will position inhaled my close Tonight for outpatient use so that patients diagnosed with COVID-19 can pick up the.
The drug from a pharmacy and self administer at home.
We believe the lower overall dose.
And limited systemic exposure will result in reduced adverse events compared to oral coca targeting anti viral products a very important differentiator.
The leading oral anti viral for Covid is comprised of an anti viral agent known as nobody traveled here that is paired with raton. It there the function of return of areas to inhibit the cytochrome P 450 enzymes step three eight for.
That metabolizes the anti viral compounds inhibition of Sip three eight for insurance that enough of the anti viral drug circulates in the blood.
To reach effective anti viral levels. However, the ton of ore as contra indicated with many critical drugs that are used by patients with complicated conditions.
These conditions put them at risk for increased severity and deaths from Covid.
This means that many of the most at risk patients cannot take this medication.
Most of my just not burdened by the same issues in the levels, we are delivering to the lung would not suffer from similar drug drug interactions. So that it can be administered therapeutically and potentially prophylactic lead to these high risk patients.
Finally, as the underground and now Omicron D. A to wave has hit the utility of monoclonal antibody therapies has essentially evaporated with regeneron and Lilly antibodies proving ineffective against on the Crown and the Vir G S K and astrazeneca products being ineffective against P. A too.
We have found that our lead monoclonal antibody August 33, 87 that we have been developing with augment to bio works binds to the omicron spike protein with high affinity however, along with our colleagues at augment to we continue to assess all thirty-three eighty-seventh neutralization data while determining the specific path forward for this asset.
These discussions also include involvement with members of our scientific Advisory Board and with that update I'd like to turn the call over to our Chief Financial Officer, Kirk Colon for a review of the financials Kirk.
Thank you Dale for the three months ended December 31, 2021 research and development expenses for the company were $6 9 million compared to $3 1 million for the same period in 2020.
The increase in research and development expenses. During 2021 was due to increased preclinical activity related to them to close them out and increased clinical activity related to inhaled for consol into chromous programs.
The ramp up also includes our preliminary analysis and testing of dry powder formulations of several drugs and vaccines and we believe have the potential to become product candidates.
For the full year 2021 research and development expenses were $21 3 million compared to $10 7 million in 2020.
The increase in research and development expenses during 2020 one.
It was mainly due to increased manufacturing costs clinical and preclinical expenses related to the close mind.
For Carnival and Tacoma.
Columnist programs increased payroll and related expenses and increased stock based compensation.
The increase in research and development expenses also includes a preliminary analysis and testing of dry powder formulations of several drugs and vaccines owned or licensed by third parties that we believe may lead to the ally sensing a R. T F F technology for the development of dry powder product candidates.
General and administrative expenses for three months ended December 31st 2021 were $3 2 million compared to $2 9 million in 2020 for.
For the full year 2021 general administrative expenses were $10 6 million compared to $8 million for 2020.
The company reported a net loss for the fourth quarter of $10 million compared to a net loss of $5 9 million in 2020 for the full year 'twenty 'twenty. One the net loss was 31 million versus a net loss of $18 6 million for 2020.
Weighted average common shares outstanding basic and diluted for the three months ended December 31st 2021.
We're 25 million 371781, compared with 22.759 million 329 for the same period in 2020.
As of December 31st 2021, we had total assets of approximately $40 7 million and working capital of approximately $36 9 million.
At the end of the fourth quarter, our liquidity included approximately $33 8 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 inhalable dry powder.
Thank you Clark and good afternoon, everyone. I am pleased to report that we have had another productive quarter on many fronts for expanding the thin film freezing technology platform and differentiating it from other technologies, we have published in high impact journals important new research on several.
Aspects of them film praising <unk>.
Including all the preparation of dry powder for installation containing monoclonal antibodies made by them filled crazy.
This new research confirms that the aerosol properties of an anti PD one monoclonal antibody made by them film freezing were significantly better than powder prepared by conventional shelf freeze dried.
Also when stored at room temperature for 10 weeks, the anti PD one model.
What'll call antibody in the powder was stable, whereas the same formulation stored at the liquid was not.
It is evident that the antibody is not stable one stored is a liquid at room temperature all the shelf symptom freezing solves that limitation.
With respect to heat stability, we reported that the addition of a pharmaceutical acceptable excipient formulation was able to significantly raise the glass transition temperature of the powder, a key metric to predict storage stability.
Which is expected to further increase the storage stability of the molecule antibody.
Importantly, the PD one binding.
<unk> of the anti PD, one monoclonal antibody before and after tenfold freezing we're not different.
Lastly, we showed that another monoclonal antibody and anti TNF Alpha.
Also be converted to a dry powder by thin film freezing.
For comparison, it was reported that when infliximab the anti TNF Alpha monocle antibody contained in the product remicade.
When it's processed by a spray drying process.
It's binding ability was reduced by over 20%, which is an unacceptable reduction.
So applying dental preaching to the anti TNF Alpha in our study had superior results compared to spray drying another antibody based off the Infliximab paper, we concluded that delta three strike can be applied to produce stable arris realizable dry powder symbolical antibodies.
Or pulmonary delivery.
As Glenn noted earlier in this call. It is clear that central freezing applications are now viable across an expansive range of molecular structures, including biologics and we continue to grow the number of projects in development utilizing thin film freezing for next generation bottle call antibodies.
<unk> proteins and many other biologics.
Next we have successfully applied dental freezing to formulation of dry powder vaccines containing the adjuvant M. F 59 or out of Ax, which is a similar adjuvant M at 59.
So why is this significant.
Vaccines containing these important adjuvant are difficult to formulate and stabilized.
These adjuvant like in about 59, our nano emulsion based vaccines that are now used in seasonal and pandemic influenza vaccines.
However, these adjuvant vaccines require a cold chain for storage and are sensitive to accidental freezing.
Our new studies confirm that dental freezing can be applied to convert vaccines containing it about 59 or out of ax from liquid to a more stable dry powder, while maintaining the immunogenicity of the adjuvant vaccine base.
Based on our studies to date Delta freezing can be used to prepare dry powders multivalent universal influenza vaccines as well.
We are very excited about these results, which again point to the versatility of the bell breathing technology and its potential to enhance vaccine formulation development.
So these highlight just two of our most recent published research papers from our group of them feel pricing and we also plan on publishing additional research very shortly including a publication that will describe the development of powder formulations of the lipids Abel adjuvant a S. So won't be containing vaccine.
<unk> using thin film freezing.
This adjuvant a S. <unk> b is important since it is the adjuvant used in the FDA approved shingles vaccine for herpes zoster and shingles and it gives us as the adjuvant in malaria vaccines that are being tested in phase II clinical studies now.
Finally, we will present five key papers at the upcoming respiratory drug delivery conference, which is being held in Orlando, Florida. In early May the theme of our talks will be to provide this influential audience with our most recent data on applications of them film precinct.
To stabilize and deliver biologics.
It differentiates unfilled praising from other technologies for proteins.
And to discuss applications of artificial intelligence to facilitate the drug development process for products made by tenfold Crazy.
In closing I want to acknowledge my colleague Professor General inquiry and our team of dedicated researchers at the University of Texas at Austin for their significant contributions and collaborations I also want to thank Dr. Tony Hickey for agreeing to serve.
As Chief Scientific Officer, Tony is internationally recognized for his expertise in drug delivery and drug therapies and this will greatly complement our efforts.
Thank you for your continued interest and support and I'll now turn the call over to Chris <unk>, Chief operating Officer, and Vice President of business development for TFS Pharmaceuticals, Chris.
Thanks, Bill and good afternoon, everyone.
Thank you for joining us today.
The GFS business development team.
Focused on three key areas of growth for the company.
These three key areas are one growing the TFS pipeline of internal development programs.
Shoot.
Our pharma partnering efforts and through our government and academic contracting efforts we continue.
To make tremendous progress in each of these key areas.
For today's call I will be focusing on our unique collaboration.
With both our pharma partners and our academic collaborators.
First with our pharma partners, yes that continues to be very active in the biologic space.
<unk> projects are steadily advancing as key experiments get us closer to satisfying the request by our partners for the data they need to execute licensing agreements.
We also continued to increase the number of partnerships each quarter.
Lastly, we are in continuous discussions with a number of new potential partners discussing additional feasibility projects.
These biologic projects include but are not limited to different stages monoclonal antibodies fads SA RNA oligos.
We're in a plasma DNA peptides proteins yesterday lengthy virus and that Obama's among many other classes of complex biologics.
<unk> continues to work with its partners to key applications of the GFS dry powder technology for biologics.
First application is formulating our partner's proprietary biologic each with stable dry powder or inhaled delivery directly to the lungs for certain respiratory diseases.
The second application involves taking our partner's proprietary biologic vaccines and formulating these stable dry powder version for reconstitution and injection, which is not subject to cold chain storage.
Our experiences that's shown every biologic drug substance that we received from our partner is unique and has its own set of challenges.
Other words, there is no one size fits all solution.
Tremendous amount of formulation work and testing takes place for each biologic problem.
Through numerous rounds of formulation work and testing.
<unk> is able to fine tune, our technology, and our processes to discover and optimize a unique and innovative dry powder formulation for that specific biologic drug substance.
These efforts are all performed in a direct interactive and collaborative manner with all of our partners.
As an example.
We have multiple mrna programs with numerous different pharma partners.
Ross the board our TFS dry powders have shown exceptional physical attributes which include very favorable particle size.
Holly disparity of PDI.
And very high encapsulation efficiency rates.
On the physical chemical testing attributes TFS is also testing the integrity of these mrna products like a capillary electrophoresis, where C test.
Our CE testing shows that following the application of ARX, yet that dry powder process integrity and activity of the mrna shows minimal loss, whereas equivalent to the original mrna, which is a critical measurement and determining the retention of the compounds physical chemical and biological properties.
We have shipped our TFS mrna dry powder samples to multiple partners.
For some partners, we are awaiting transfection assay testing results.
For others, we are awaiting confirmatory physical chemical and molecular integrity testing to be completed by the partner.
For others, we are awaiting results from stability testing of the mrna dry powder at various temperatures and pipelines.
And for some other partners we are conducting animal studies.
These efforts do take time and for each partner across all our different biological projects on a case by case basis.
Partners are requesting different stages of testing and or different datasets in order to commence licensing negotiations.
In many cases the partner funds. The work that has gone beyond what was planned in the original N T. A statement of work.
Rest assured that in all cases TFS continues to take a very aggressive approach with its partners to reach our goal of entering into collaboration and licensing agreements with each of these partners.
Now let me provide some brief updates on some recent partnering activity.
As recently disclosed on our website.
Pleased to be collaborating with Pfizer on multiple projects.
This work is moving along very well.
And TFS is generating positive data on these projects Pfizer continues to review and evaluate the data in real time.
We continue to aggressively move these projects forward.
Also as we just disclose on our website, we are now partnering with Astellas.
We are applying processing formulating and testing the do you have that dry powder technology to formulate a dry powder version of a specific problem.
Being sensitive to the confidential nature of this project, we cannot disclose any further details at this time.
But hope to be able to provide more color is this project evolves when we receive the proper disclosure approvals from installs.
As Glenn previously mentioned.
Very pleased to be partnering with Catlin.
This partnership will provide <unk> with the opportunity to work with Cadillac and expanding our access to scale up manufacturing capabilities. While at the same time, you think TFS access to a very large customer base to evaluate the applications and benefits of the tea at that technology.
We believe this collaboration and ultimately lead to additional licensing partnerships for TFS, providing us with a potentially meaningful source of revenue over time.
At TFS there are many applications of the <unk> dry powder technology, we continue to aggressively explore and expand into new areas indoor applications of our dry powder technology.
Most recently she has entered into a new feasibility arrangement with the new undisclosed partner.
Youre moving forward on a new initiative.
The concept of formulating the <unk> dry powder for use in an intranasal device.
T S up along with our partner or exploring the applicability.
Specially formulated yet that dry powder.
Our partner's proprietary intranasal device. These initial experiments grew successful we believe the unique attributes of the DFS dry powder can be expanded to include additional routes of administration.
Depending on the compound in the disease state it can be very advantageous for both patients and prescribers.
As Glen mentioned earlier, we have finalized a new credo with you Sam right.
This is our second creative with your sandwich.
With our partners, we will be evaluating immunogenicity and protective efficacy of the CSF dry powder version, although the yesterdays vaccine for Covid.
Very excited to progress since animal work with our partners and continue to advance this asset through the next stages of development.
We also continued to make very good progress with our academic partnerships.
Collaboration with the University of Georgia.
Last year, we filed the publication related to the application the GSI technology to formulate certain agents. These were adjutants utilized in our mouse Immunogenicity study, which we reported on back in October 20 <unk>.
Also with our partners at E G E.
You receive favorable efficacy data set.
Second we are now in discussions with UGI newly defined the next steps on advancing the CSF version of Uga's Universal influenza H a recombinant vaccine.
With the Albert Einstein College of Medicine, we are now moving our VSP program, which are both animal studies and stability testing.
And with Doctor drew Weissman at the University of Pennsylvania, We have completed our initial <unk> formulation, where we.
When we have finalized our protocols for animal testing and we are scheduling the liberty of arts, yet that dry powder samples to doctor wisely to commence these studies.
As it relates to our internal programs, we have recently engaged <unk> partners as our financial advisor to leave the partnering process of both our lead assets.
Yeah, Laurie and T at that time.
We have prepared virtual data rooms in advance of this process and we currently have interested commercial partners performing extensive due diligence exercises.
As mentioned earlier upon receiving the phase two interim data.
That will be actively engaged in asset acquisition and licensing.
Since.
In summary, the GFS BD team has been making tremendous progress in our partnering efforts. We continue to grow the number of collaborations with pharma partners and academic collaborators as well as we continue to grow our government contracting efforts.
All of the strategic effort to expand the applications of our prism technology.
In closing I would like to thank our partners at the University of Texas at Austin with the continuing efforts and support Docker Bill Williams and his research team.
Can you expand the applications of the thin film printing technology into new innovative areas jumped all over it.
Thank you for your time today enjoy your evening I will now hand, it back over to Juan.
Thanks to the Al Kirk Bill and Chris.
And I apologize for the length of the call.
We're always faced with a try and challenge in order to collectively communicate the breath of our work and opportunity.
As I mentioned in my earlier remarks, Yeah, that's just continuing to execute across all facets of our business.
While the current market conditions make it challenging to reflect the progress in our share price on assure our shareholders that validation of our core drug delivery technology only continues to grow and as shown by the continued expansion of our partnered programs coupled with the success, we are demonstrating and advancing our.
Internal clinical stage assets, which are rapidly approaching the opportunity to partner and monetize.
Yeah. In fact has achieved significant recognition of validation.
With the light brightly shining on the thin film freezing platform by the pharma industry Academia and government.
The opportunity to work with catalyst, there's also a significant boost to.
Our capabilities and potential.
As we continue to execute on our business strategy, we believe.
Closer alignment between the growing value of our technology platform and our company valuation could eventually be realized.
I think all of the P F F employees and consultants for their contributions to the company.
Board and I, thank our shareholders for your support.
And with that I'll turn the call back to the operator and open it up to questions.
Operator.
At this time, we'll be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two.
Question from the queue for participants using speaker equipment, and maybe necessary for you to pick up your handset before pressing the star keys, one moment, while we poll for questions.
First question comes from the line of Jonathan.
With Roth Capital Partners you May proceed with your question.
Thank you guys and good afternoon I was wondering if you could first tell us the significance of the recent close to my data now more specifically, how do you directly correlate in vitro drug correlations with what to expect.
To achieve in the first trial in humans, which is kind of a very different macro environment.
Thanks for the question Jonathan This is Glenn Dale could you answered John's question in place.
Yes. Thank you Jonathan for the very good question.
So we have done a number of things to help make that correlation one is that we have published data where we administered.
The TFS my close my powder directly to the lungs of hamsters rats, and we were able to quantify the amount of Oh, my close might in the lungs in the lung tissue as well as the empathy with aligning fluid the fluid that lines the lungs and there we saw that we would.
Delivering far more than the one micro molar concentration.
Also we are delivering a clinical dose where we saw say.
Safety at six milligrams delivered twice daily.
With that six milligram dose and an estimated volume of approximately 50 milliliters of fluid in the lungs.
That gives us a concentration of the peptide or a close Mike.
In the lung lining fluid of greater than 100 micro molar so.
When we saw a one.
One micro molar concentration effectively inhibiting a complete viral replication, we know that Ah by delivery of our dry powder, we are exceeding that concentration throughout the testing both in the hamsters rats.
In vivo as well as with what we would expect from the humans.
Thanks Dale.
What do you guys think that union needs to see from the phase one to close to my trial to elapse to conduct phase two.
Yeah. So.
We have been getting really nice feedback from union on all of the work that we've been doing Jonathan Yeah. We think are.
The work, we've done and what we'll see in the final tables of the phase one data will certainly meet to clear the hurdles of what unions are expecting.
You know what we don't know as you know.
The Union.
Current overall strategies army, but from her from what we've done in terms of data generation and what we've been promised them that we would do.
We've done everything that we think God should get them to exercise their option. So we're positive about that they will have time to assess that after day all produces the final tables.
Certainly we want union to exercise the option.
And we would go on from that point.
Okay. See you guys. Just said that you were very keen on partnering the non biologics that you'll have the Tac and the board and I was kind of wondering you know when will we see phase II tack envoy data that would be the kind that would be enough to drive someone to partner.
Yes, let me take the latter part of the third quarter, Jonathan will have a meaningful interim analyses to XI.
Here with.
The partners that are lining up.
This process with track.
So these are open label studies. So you know we think certainly by you know I would say the latter part of the quarter, we will have enough data for them to decide.
You never know I mean, these partners could could decide to.
They can offer before they see data if.
If I were them I wouldn't [laughter], but so we're preparing to do this the right way and it didn't have the day there'd be sort of the final you know.
Piece that they need to make this offers everything else that we've done all of that data rooms.
Pat and information so they should be ready to make offers as soon as those data are made available.
Okay. Thank you and just one fast last one is your latest croda developing multi pathogen prophylactic products or single pathogen prophylactic products.
Dale could you handle that one.
Yeah.
Yes, so the their current creator.
It covers a single.
Product initially that.
That we will that is a proof of concept for the approach.
That will then lead to additional testing of other against other pathogens.
But you can make a product where I mean.
Or you intend to make a product where they can take one hit the protected against many things and you don't get back to shoot them.
That that is ultimately the goal, but but yes. It is established the first one and then we can make them multi valent after that.
Okay. Thank you guys. That's all thanks Jonathan.
Our next question comes from the line of my Young men with the B Riley Securities. You May proceed with your question.
Hi team. This is actually William on for my own Mcdonalds today really appreciate the update and all the progress that you've been making.
Two questions here from US first thing you could provide a bit more detail on how investors should think about the path to monetization for each of the crowd has entered with the ease of Amarin and then would also be good to understand the significance of the government subcontractor designation and some of the barriers to entry.
Which confer a competitive advantage to T F N b.
Yeah. So we look first of all thank you for the questions and.
Thanks for standing in for my regards to him.
So the craziness gives us a great opportunity.
No to develop products that ultimately.
And inherent a customer in the government and as those creators work you know then beyond any sales to that customer you know we would be.
Being able to look at other commercial opportunities through that work and it also gives us.
The non dilutive opportunities to further expand the utilization of the technology and he is very very important biologic areas on the DARPA program we.
We are subcontracted through Idose.
And all commercial terms and sales of anything that comes out of that work with DARPA on countermeasures also will have a monetization effect on our revenue generation effect for TFS. So a lot of the Devil's in the details and once the data are and how quickly we can get these.
Things through the development cycle, but we do see that deserve and you've got the government as a customer and then of course anything beyond the government sector.
TFS, we benefit from sales there as well.
Yes.
Excellent makes sense and then additionally is there any extra color you could provide on how you plan to create value from the external programs, including the universal influenza vaccine with D. A.
Helix technology plus products relationship following the restructuring.
Sure So Dan.
I asked them to a head for us with Uga's herself to disrupt the data ideally.
T F F where like the secure the exclusive rights to the tech transfer of that technology.
<unk> from U G. A and just like we've done for example in the U K.
Case with augmented by works, where we've invested in the asset to a phase one trial, we would rather do that alone or seek non dilutive financing and at that point. Once we've demonstrated safety through phase one and find a partner to take that forward.
That's one of the reasons why we've brought Greg Davenport onboard that's really.
Works.
Grant side of things work all the different departments of government, including you know beyond DARPA about looking at BARDA, and I add et cetera, and we've been pretty active in making them aware of all the work that we're doing there.
So once we have the animal data and then what will make the effort to secure the tech transfer and move that asset along.
He says he asked her out they can.
So we're really feeling very good about where we stand right now one of the we've learned a lot and pluses it's been a terrific partner in helping us refine our formulations and do a commercial testing or we did discover and I think as you're aware, we're positioning the T F F cannabinoid.
As a substitute for vaping healthy substitute for vaping.
And so there's you know basically this is direct installation of the Tfl formulations either through a capsule.
Or direct innovation through some other devices that we've.
It worked up with our friends at a plus.
And when we did discover that when you inhale THC directly to the lung, albeit you got a very nice experience you also T. J T. C seems to be an irritant you get a little bit of a cough. So those single in your chest and or a resident a formulation.
[noise] expert John calling.
It was really refine those formulations I don't feel at Liberty to share you, what we've done to modify the formulation successfully.
That was really are extremely positive.
Commercial response and now as we look forward.
Doing some more testing.
This hopefully in the process of finishing up their restructuring.
And I'm moving the product into a commercial launch and we do have some backups there we've.
Certainly have been talking to other companies about our technology.
Allergy, but we feel that plus has been a loyal partner they've been on her way they've helped us really get to the point, where I think we're ready to enter.
And so the marketplace in a very very meaningful way.
One thing we've learned is that it's a tough market its highly competitive.
Lot of price pressure, but again, that's why we've taken the time to really refine this these formulations to the point, where we've gotten the feedback from the marketplace.
These are very these are can be and will be a very desirable product. So like it's taken a little longer than we thought we learned some things formula equally that we've been able to address we've been through multiple multiple iterations of lot of work a lot of creativity.
And now I think we're at a pretty important inflection point, well, we'll see where plus lands in the next hopefully a few days or weeks.
Understood appreciate the color and I appreciate you're entering our questions and congratulations again on all of the great work. Thanks Bye. Thanks. Thanks, Thanks for those kind words I appreciate it.
Our next question comes from the line of Daniel Carlson with T. W. Research Group you May proceed with your question.
Yeah. Thanks, Glenn lots of interesting tidbits from your call. So a couple of quick questions I see that as Astellas as you said to the slide deck and I know you can't comment much about that but maybe you can comment about what the criteria is for adding any of these major pharma partners to your slide deck.
Yeah. So thanks, Daniela and her hope you're doing well. So the first thing that I you know I guess I should share is very very few.
The partners, we have been working with our work with <unk>.
Really want to give us an opportunity to share that we're working with them and you know in many cases I think as Chris articulated well you know, it's if you're if you know that our company is working with P. F F.
On dry powder formulation, that's not hard.
Figure out what we're working on right and a lot of these situations.
It it becomes a concern over.
Competitive advantage now.
These companies understand that we're not working with them exclusively in these spaces.
But they're there they're really hesitant to two.
Go ahead and.
Share with us now.
Now remember these companies, we're working with for a long time and the workers matured quite nicely to the point, where you know I think they feel and we feel.
It's a good time and it makes sense for us.
Two to share the name of the company clearly it's very selective.
We only want a share of those companies that we think you know well.
It would be meaningful to our investor audience.
And I think you know hopefully you know, maybe onesies and Twosies, you'll see more and more of these show up on.
On our list and at the same time those companies that are in a listen you know when it will close transactions with that so yeah I'd take it as a good sign.
Certainly if things weren't going well you know they would not want us to share their name, but don't take it as if it's not going well when companies don't want us to disclose so it's a as you know we were happy to when we can when we think it's gonna be.
Would be meaningful to an investor to see that we're making progress.
Gotcha. Thanks.
I found it very interesting that you're doing compassionate use and Lori I'm, especially in a different indication so kind of a multipart question here just how broad are the indications here for compassionate use where where is that interest coming from and how does this impact the overall program.
Yeah, David do you want to answer that please.
Yes, Thanks, Daniel very good question.
So.
The interest is coming from for this particular patient that we started and so I'll talk about the current patient and then I'll talk about the overall plans.
The current patient is someone who already has a history of fungal infections that were treated with anti phone calls.
And the patient when they were given oral or IV doses that would be used systemically.
The patient had very severe tolerability issues.
And there were other country indications that made it so that the patient.
Could not take more cognizant orally <unk>.
Because it is the best.
The best drug to treat the fungus that's growing in his lungs eye. They the physician felt like this inhaled route.
And delivery of the drug right to the side of infection would be best or the best way to approach it in and lower and have the lower systemic levels.
That has translated to again this is a lung transplant patient where the.
Where the subject is on to crawl and us and other immunosuppressive drugs.
No drug drug interactions or are a problem and in fact this patient has had minimal drug drug interactions and they require dose adjustments have to grow on us. So it really does support our hypothesis that we can potentially.
Well, we will get some.
Okay data for efficacy out of that but it does support that we deliver lower systemic concentrations that require fewer drug drug or a drug dose adjustments for a drug in our interactions with the others.
Going forward for other patients that we might take into the trial again, we would be predominantly looking for subjects who.
This general.
Hi.
You know, it's red where they would not be somebody who you know theyre not occurring in a location that you know in a country, where we're operating sites for a clinical phase II clinical trial.
They would not be people, who you know who or have drug drug interactions that would complicate their treatment, otherwise and who in a.
Especially in lung transplant heart transplant kidney transplant that type of patient.
Ends up with these infections, that's kind of who were thinking about for this type of study.
But it is really a one off case.
Case by case basis looking at the data for the individual patients and making sure that.
This is the right drug to treat their infections.
Thanks, Dan It seems like great validation for the program. So congrats on that and then Glen One last question, you mentioned and they like the omnibus.
Package as specific language with thin film freezing, which makes it almost seemed like Alex do you guys can you can you just provide any more comment about.
That whole.
That whole situation.
Yes, so Daniel we you know there's a lot of things that we do here that we're not par.
Public about in fact, if we were public about everything that we do these calls would take two hours not one hour and in fact, we apologize for the late but.
But we have been working on a lot of different levels. When basically this whole issue of cold chain stores started to gain attention to our technology and one of those arenas, we kind of viewed it each time.
Wondering kirk's terms as a lottery ticket right, but yeah. We we we brought some people in that didn't know how to do this kind of work and clearly you know the technology offers a lot of value in that.
Every.
Body in the government that everybody in the commercial world and clinical development World. So make a long story short we were able to you know prison.
Present, new technology to people that are in a position to move things like this forward and government appropriations.
And as a result of that work and the perceived benefit of the technology. We were able to have this language you added to the omnibus legislation, which just so happens specifically.
Use the language of thin film freezing.
Power's they they must skull powders, but its power powders.
And you know, we're really excited about that and you know so it's basically no guarantee you're funding. This is a in the 'twenty two fiscal year budget for HHS to pursue and they have notice to be able to fund activities here.
And now it's our job to go after that was right and.
We have lots of really interesting ideas about how they can help us.
So you know.
It's.
It's an amazing technology.
Companies really had a terrific year.
No.
News will have a lot of news coming up partnerships to come and this is just another way that we could create value for our patients.
Patients and our shareholders.
Yeah, well you do have a lot of Bosnia Glenn so congrats on all the other options.
And so far keep up.
Okay. Thanks.
We have operated anybody else in the queue.
We do not like to turn it back over to you for closing remarks, okay well.
Thanks to all the questioners all the listeners.
I'm always available to add some color to what we've been able to describe that to this afternoon.
I want to thank my team.
They are really remarkable and what they do and we're really looking forward to.
Where this is all headed.
During our days weeks and months and we look forward to.
Our next earnings period and earnings call I wish you, all well stay healthy and happy and Oh, we'll talk to you soon appreciate it right.
This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation and enjoy the rest of your day.
Okay.
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Yeah.
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