Q1 2022 TFF Pharmaceuticals Inc Earnings Call
Yes.
[music].
Good day and welcome to the T. F. F Pharmaceuticals, Inc. First quarter 2022 earnings conference call. All participants will be in a listen only mode should you need assistance. Please signal conference specialist by pressing the star key followed by zero.
After todays presentation, there will be an opportunity to ask questions to ask a question you May Press Star then one on your telephone keypad to withdraw your question. Please press Star then two please.
Please note this event is being recorded.
I would now like to turn the conference over to Corey Davis. Please go ahead.
Thank you operator, Hello, everyone and welcome to <unk> Pharmaceuticals, first quarter financial and business results Conference call with me on the line today is Glenn <unk>, President and CEO of TFS.
Coleman Chief Financial Officer, Dr. Dale Christiansen, TFS director of clinical development, Dr. Bill millions of the University of Texas at Austin, and Chris Cano, <unk>, Chief operating Officer press release announcing our first quarter results is available on the TFS 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.
Factors that could 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 2022 quarterly report on Form 10-Q filed with the SEC and now it's my pleasure to turn the call over to Mr. Glenn Mass go ahead Glen.
Thank you Corey.
Good afternoon, and thank you for joining us today to review the company's first quarter operations and recent highlights.
This call I will provide an update on our overall progress then ask our Chief Financial Officer, Kirk Coleman to review, our first quarter financials.
Having announced our fourth quarter and year end 'twenty 'twenty. One results just a few weeks ago, we decided to provide a more focused formal commentary of our meaningful progress for this call.
This will leave more time for Q&A and please note that Chris Kanno, Dr. Christensen and Doctor Bill Williams, our president on today's call I will participate in that session.
Do you have have continued to build strong momentum in our pipeline and partnership activity in the first quarter of 2022.
And this momentum carries over from a very successful fourth quarter, we saw numerous accomplishments, including the final data from the phase <unk> study of inhaled four corners, all powder in asthma patients.
And the initiation of our phase II studies for both inhaled tacker limits and work on this all powders.
In addition, we began the phase one inhaled my close to my powder study in Canada to treat COVID-19.
Advancement of our pipeline programs continued in the first quarter.
Do you have continues to progress with the inhaled for Carnival and Packer limits inhaled powder phase III program.
With phase II studies will produce interim analyses late in the third quarter of this year.
This is a key milestone event as these data will be shared with potential pharmaceutical company partners and our licensing process.
That process has been initiated working with today are partners to introduce the opportunity and invite interested companies to begin diligence.
We have established a comprehensive data room and already have potential partners performing diligence as a result of inbound interest.
<unk> has also made <unk> powder available on a limited compassionate use basis when requested by investigators.
We have received very positive feedback on the first of these patients on Monday.
The treating physician shared results with us it supports the efficacy and safety target product profile for <unk>.
Work on this all inhaled powder in general this patient was considering only palliative care or is disease and now as reported outstanding efficacy and safety.
Jo Christian soon we'll be happy to share more details should you have questions during the Q&A.
<unk> also advanced the inhaled my close them I'd powder development program.
After completing enrollment in the 40 patient phase one study earlier in the quarter in April we announced positive safety and pharmacokinetic data showing that might close to my inhalation powder was well tolerated with no serious adverse events across all subject cohorts MP.
Importantly, the study also helped us identify what will be the optimal dosing level with the product in the phase II program.
At the six milligram dose level and I closer might inhalation powder is estimated to produce a concentration of 10 micro molar in the epithelia lining fluid in the lung delivery.
Delivery is a dry powder.
Which would be considered highly potent with respect to inhibiting viral replication.
A single administration of six milligrams and I close the mine inhalation powder to the lungs provided equal mean maximum drug concentration or C. Max in the blood is 100 milligrams delivered as a nebulize spray to the lungs and nasal cavity as demonstrated in our recent publication.
Furthermore, This study safety management Committee also expressed no questions or concerns.
About the safety and recommended the six milligram B I D dosing as safe a progression into phase two testing.
Further highlighting the product's potency in February we announced the results from recently completed.
In vitro and viral replication assays, which showed the nightclubs somite inhalation powder completely inhibited viral replication of both the Delta and omicron variants of Sars Covid two.
The results also show that our inhaled my clothes semi demonstrated complete inhibition of omicron replication and only one micro moment compared to the Pfizer and Merck anti virals that each showed complete inhibition of omicron at 2.5 micro molar.
In our view the high potency of inhaled my close to my powder suggests that the product may have major advantages over oral delivery, including improved safety and tolerability.
The program reflects the exact type of value, we hope to create and every one of our collaboration.
Which dramatically improved drug delivery.
There's an optimal amount of active molecule can be delivered while minimizing potential side effects to the patient.
We continue to develop by closer might inhalation powder in partnership with the new therapeutics.
As a potential antiviral to treat COVID-19, and other respiratory viral diseases.
<unk> Therapeutics is now evaluating the data <unk> generated for Knight closer might inhalation powder, which will inform the decision on the option to assume responsibility.
Further develop the compounds.
New and disruptive technologies are often supported by a steady stream of basic research and development, which over time leads to a significant body of scientific literature and this is clearly the case with thin film freezing.
At this year's R. D D meeting Dr. Bill Williams and his colleagues at the University of Texas at Austin.
Presented five separate papers, highlighting the versatility of thin film freezing technology.
These data also support the differentiation of thin film freezing from other methods to create dry powder, particularly in biologics.
In fact, one of the papers, which explored the use of machine learning algorithms analyze how thin film freezing impacts aerosol delivery of dry powder therapies. It received a poster on the podium recognition.
The research being conducted by Dr. Williams and his colleagues.
Demonstrates the versatility of this unique innovation and pharmaceutical formulation development and we look forward to highlighting additional research from our laboratories as they become available.
Turning our attention to our collaboration activity DFS.
<unk> announced a strategic partnership with the global CMO cattle and during the first quarter.
The client base of over 1000 companies, we are confident in the short mid and long term productivity from this relationship.
In particular, Cadillac will introduce thin film freezing towards targeted list of potential licensing candidate and with catalyst focus on biologics manufacturing provide.
Provide a clear path forward in providing a source for product in this key arena.
This matches very well the balance of TFS partnership portfolio.
I'm happy to report the PFF in catalysts have been working very well together to successfully launch the partnering effort and I look forward to reporting multiple successes as we work together.
During the quarter. We were also pleased to announce a second cooperative research and development agreement with the United States Army Medical Research Institute of infectious diseases, and the Geneva Foundation.
We consider our partnering activity in the government defense and other public related sectors as a core area of focus for our business.
And as applications are thin film freezing continues to expand we anticipate that our public sector collaborations.
Provided significant source of non dilutive funding over time.
Speaking of non dilutive funding.
<unk> continues to work to capitalize on the language in the omnibus budget legislation, which highlighted the opportunities created by thin film freezing.
We are working through supportive groups fully explore funding opportunities.
Now looking at progress on other existing collaborations.
<unk> is continuing to work with plus products, who recently announced the transaction with glasshouse.
This transaction will build a highly competitive company in the cannabinoid space.
As this partnership is freshly minted we are in discussions on a path forward on the TFS emulation cannabinoid products that have been successfully tested with consumers.
And finally, we are working with our development partners that augment to identify next steps for augment the $33 87.
Which has been identified as a highly potent monoclonal antibody, which we COVID-19 in preclinical animal models.
In general based on the robust pace of our ongoing partnership work in discussion.
We remain highly confident that 2022 we'll see PFF pharmaceuticals enter into meaningful monetize new collaborations.
While expanding many of our existing partnerships.
The number of companies in our portfolio continues to grow and the work we're doing under open M. P. A's and statements of work continued to progress with successful scientific results and extreme purpose.
The first quarter also saw PFF pharmaceuticals, bringing a wealth of new and diverse talent in the form of senior level and board of director appointment.
As the number of collaborations grow in our internal clinical programs advance in.
An appropriate level of investment is required to optimize such growth.
The new colleagues added to the PFF Pharmaceuticals reflects a company fast becoming stronger across all facets of our business.
We believe these additions will lead to the expansion of existing collaborations.
Forging of new and more strategic partnerships and the advancement of multiple programs into late stage testing.
All of which will generate significant value for our shareholders.
And with that update I will turn the call over to our Chief Financial Officer, Kirk Coleman for review of the financials.
Kirk.
Thank you Glen for the three months ended March 31, 2020 to research and development expenses for the company were $5 3 million.
Third to $5 3 million for the same period in 2021.
General and administrative expenses for the three months ended March 31, 2022 for the company were $3 2 million compared to $2 6 million for the same period in 2021.
The company reported a net loss for the three months ended March 31, 2022 of $8 4 million compared to a net loss of $7 7 million for the same period in 2021.
Weighted average common shares outstanding basic and diluted for the three months ended March 31, 2022 were $25 371781, compared with $23 million 140607 for the same period in 2021.
As of March 31, 2022, we had total assets of approximately $33 8 million and working capital of approximately $29 3 million.
At the end of the first quarter, our liquidity included approximately $26 4 million of cash and cash equivalents and with that I'd like to turn the call back over to Glenn.
Thank you Kirk.
Since our last call only a few weeks ago market conditions have clearly not improve what.
What hasn't changed is the pressing need for pharmaceutical companies to develop significantly improved drug formulations that can be more safely and efficiently delivered to patients.
The work, we're doing at TFS pharmaceuticals to address this significant demand places our company in a unique and in my view quite enviable position.
From the research being conducted at the University bench top all the way through to the progress we are demonstrating in the clinic and through our partnerships with.
The value being created by our thin film freezing technology continues to set new high watermarks quarter after quarter.
Without question, we believe our technology represents a true breakthrough in formulation technology.
And one that the industry has been seeking for decades.
As investors attempt to reconcile related short term market conditions against TFS demonstrable progress, we can only provide our shareholders with the assurances that our company will continue to work diligently to maximize value across every facet of our business.
This quarter, we did exactly that by signing a strategic collaboration agreement with catalyst entering our second crater agreement, Sam Reed and announcing positive data from yet another clinical stage pipeline asset with inhaled my closer my powder.
And we expect this steady cadence of pipeline progress and collaborative activity will continue throughout the year and beyond.
I would like to thank all of the T F F employees and key consultants for their contributions to the company.
I'd also like to thank the board and our shareholders for their support.
And with that I will turn the call back to the operator and open it up to questions.
Operator.
Thank you we will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad, if youre using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble our roster.
And the first question today will come from Jonathan Aschoff with Roth Capital Partners. Please go ahead.
Thank you and congrats on the progress guys.
For one of your internal programs can you provide any details about that TSS compassionate use patient now how they did.
Will you be treating any additional compassionate use patients.
Hi, Jonathan this is Glenn.
All of you that are asking questions I will either answer the question or ask one of the members of the <unk> team to respond.
To this question and actually really appropriate brookdale.
One thing that's been really working these programs personally all vigor.
I'll answer the question.
Thanks, Glenn and thanks, Jonathan.
So we received an update on this patient the patient has now been treated for 11 weeks.
This was a patient who had spent six months out of the last year prior to starting the compassionate use study.
Hospital, inpatient getting IV antibiotics and anti fungal when tolerated the patient.
Had experienced every side effect it could be imagined from anti fungal therapies and was essentially ready to give up.
Treatment and go home and.
And they were discussing palliative care.
When the idea of treating them with the inhaled what caught US all came along.
In the immediate aftermath the.
The patient has now been outpatient taking the inhaled <unk>.
11 weeks.
He has seen stabilization he had lost approximately 40% of his F E V. One lung function.
And in the 11 weeks he has lost less than 3%.
It stabilized on lung function. He is forced vital capacity has increased over that time and.
The patient is considered clinically stable for the first time in well over a year.
In addition to that.
One of the things that we speak about with as the positive benefits of the inhaled for cortisol is minimization of drug drug interactions.
And.
This patient who was on <unk> two.
Maintain his immuno suppression.
This patient has not had to have a dose adjustment to his tacoma, which would have had.
If you had taken the oral.
Work on this all there would've been major dose adjustments required to achieve level.
Level because of those drug drug interaction so all in all.
The results from this one patient are exactly why I went into this business to improve People's lives. Because this person has truly benefit from this therapy.
Thank you Bill so as you guys look at all the preclinical and the phase one results with fully intact.
What are your key takeaways and what do those takeaways.
Signal about the probability of success.
We will phase twos.
Yes.
So I think let me just ask from a business perspective.
Ill, probably give you a minute or two to thinking about your already spot. So.
As you know Jonathan and I think most of you who know the company.
With our data that we have.
Gleaned from the phase II trials, leading up to probably.
The latter part of the third quarter.
That will certainly be.
Based upon the phase ones and based upon what we're seeing from the phase one b and now, albeit one compassionate use patients hopefully more.
We think that that will be the final piece of the puzzle to attract.
Interesting companies to bid on licensing the product.
We've engaged <unk> partners.
I work with Trey either really outstanding firms.
Work.
Place, one or two assets in company with meaningful economics for <unk>.
Certainly from the business and revenue standpoint. This is a big piece of how we look at our capitalization.
Now from a clinical perspective, I believe I've always believed that the probability of technical and regulatory success here was extremely high.
Dale maybe the perspective, you can supply is it.
In actuality, our how is very impactful formed.
The clinical expectations, you had and what other whatever other comments you have please feel free to add.
Thanks Glenn.
So.
Just to take one step back we selected the Bora Carnival, the Tac and the nightclubs for Mike.
For the internal development programs because each of them is a validated drug.
Best in class.
In the case of <unk>, it's already used for 90% of lung transplant patients, but the problem is significant toxicity when delivered by oral because you have to put up to push up the levels to get enough into the lung to be effective similar message with more consol in order to get enough into the lung.
It can be effective.
That comes along with systemic toxicity and so in each of these cases. The premise has been we can deliver the drug effectively to the lung.
Reduce the toxicity and avoid drug drug interactions baidu direct topical delivery to the lung.
And so all of the non clinical and clinical data that we've generated to date fully support that premise.
As I just mentioned the.
The patient that is onto columnists and went on inhaled <unk> saw no need for dose adjustment, which.
That is one of the key premises this that it will be easier for the patients and the physicians to use because there will be limited drug drug interactions.
And we fully expect and I think we're seeing.
That the drugs can reach efficacious concentrations and so in all cases the programs as we've advanced they are performing exactly as expected and some of the results are.
It's hard to say better than we expected because we have high hopes.
But they are performing very well and we look forward to.
Generation of the final data and seeing this truly benefit patients in the future.
Thanks, Dale does a union action.
Right to opt in if they have not yet.
Or is that incorrect.
So as you know Jonathan we finish the phase one trial, we delivered all of the available information to them from those trials. There are still some data final tables as reported separately.
In essence, they do have we believe enough information to begin their diligence in fact, we did yes.
Questions from them this morning.
Directly to Chris are we speak to them all the time, so I would say.
Certainly.
Their option deliberation period has commenced and that.
You are correct they have an option if they exercise that option.
They will.
They will take over the development of my close Mike.
And you said has commenced the formal formal.
Time by which they have to say yes.
If you go by the letter of the agreement.
Yes.
Practically it commands.
And by the letter of the agreement we have.
Complete all the case report forms of it I believe they had an option for me.
Yes.
Actually the option period I mean.
I don't think people should be doing a countdown here for rocket launch, but yes.
And my feeling on the companies during the option period.
Thank you very much and good luck with.
Partnerships that are resulting from upfront non dilutive cash.
Hopefully sooner than later.
Optimistic thank you.
Thank you and the next question is from Daniel Carlson with Tw Research. Please go ahead.
Hey, Glenn Thanks for taking my questions.
First one is kind of a two part one here.
Just about the general market conditions I'm wondering if you've noticed that progressing your deals has been impacted at all by this and then.
Ladies and the second part is maybe you can update the status of the blurry impact out licensing process and the timing around that sure.
Daniel we have not noticed.
Obviously, you can't help but note.
What's happening in the marketplace, but I'll ask Chris to confirm this or not but I don't think that the market conditions have really slowed down any of the work that we're doing so many of the partnerships and by that I mean, the open ftes and statements of work.
<unk> been going off for some time with those companies that we believe are close to transacting.
If anything I would say some of the smaller companies and there are many in this lift for us.
Now Mark acutely concerned about our cash.
I think it does come up but it also has a slow down the pace of any of the work we're doing as it flows out any of the pace of the negotiations.
It hasn't changed any of the numbers that have been exchanged or work. The asks are.
Chris.
Do you feel any any.
Any color to add to that.
Yes, no. Thanks, Thanks, Steve.
So the question I have not seen a slowdown is due.
Due to market conditions for engagement with our collaboration partners.
There hasn't been an impact to us.
Yes.
<unk> said you wanted to talk okay.
Got it got it.
Chris.
I was going to say, what the timing on the Bora and Tac.
Dan So right now we're in the <unk>.
Operation process, so as Glenn mentioned earlier in his comments the phase two interim data.
A key milestone right.
So right now we're doing.
From a process standpoint.
We've done all of our work we've engaged with today they are representing us in this process with compile all of the diligence materials to the data.
That alone is.
Currently we do have potential partners in the data room are performing diligence right now.
We've also assembled a comprehensive list of potential partners.
We'll be reaching out and it's really all focused around delivery of the phase two interim data.
Gotcha, Okay that will take danaher and practical.
And I think I don't know, how many what I'm trying to get away from the numbers, but the last couple of weeks.
We've opened up.
A handful of new just in the last couple of weeks, New MTA is and as I think about it.
They're like mid tier so.
The pursuit of the technology.
As.
An opportunity to.
We formulated a new formulation.
It doesn't seem to be diminishing at all and then.
In other words it most most of our work is on N cen re formulations. So.
And that also I think makes us a little bit more bulletproof.
And well go ahead.
Sorry to do this you have I can't help but also say look.
You have to think of PFS as a platform technology company, we're not a biotech company biotech companies have 100% chance of spending money on studies. Our platform technology is going is value and we will bring in revenue and.
I think that speaks a little bit too.
Our being treated perhaps a little bit unfairly in the marketplace.
I get it but I just couldn't help a thing so sorry.
No problem that kind of segways nicely.
A question for Dr. Williams I'm, just trying to if you could help me understand the significance of the data that he presented at that conference last week that'd be great.
Yes, Thanks, Dan.
Hello to everyone.
So the data at the RTD meeting, we had five presentations and we were able to preserve on dip.
Applications of <unk> four it caught us all some of our new work on on biologics.
The DNA work it was very well received.
And in fact I was in several other presentations during the time and now the <unk> platform is regularly referenced by other speakers in the same breath that theyre talking about some of the competing technologies. So that's that's really good.
So that was the context of the presentations throughout that.
B J.
Great. Thank you.
And then one last question for me.
Just kind of related to the union and the close to <unk>, maybe you can talk about the potential for and are close to <unk> beyond COVID-19.
Sure so.
Uh huh.
I just have offered to the conference Bill referenced a catalog major presentation.
On their work in a big Big chunk of our TFS that was really nice to see.
We think theres a tremendous amount of potential for now close to minus eight is a potent antiviral.
Have they all speak about scientifically and clinically why but it does validate that.
We are doing an extensive deep dive strategically into what those viral infections are that would pose a lost opportunity.
We went into the exercise thinking, perhaps RSV and VSP, but.
We're also broadening that horizon, we've engaged a group to work with there helping us with the analysis, we're looking at pricing we're looking at the IP.
Issues. If there are any around what we would have we were talking to payers. So.
So it sort of validates the scientific and clinical hypotheses. We're also doing a deep strategic drive dive to understand what is our best path forward.
Have those data in the next two to four weeks to go along with <unk> working on clinical trials might look like cost for that so we have a good.
Understanding of not only important clinical significance might be but what the business opportunity might be now do we go out after this on our own right now Union would have the options first for that and we also think that these data will be helpful to union to see to help them deliberate.
Our path forward in Africa.
Great. Thanks, guys I'll jump back in the queue. Thanks.
Okay.
We wanted to add some clinical commentary on that as well.
Yes so.
There is published information out there.
As existed for a while showing that.
Now I close my it is broadly active agent against all Corona viruses with activity against the Mers coronavirus that came out in the middle East area as well as the original Sars coronavirus.
Emerged in the 2004 to 2006 timeframe.
And in addition to that it has been published as a 22 nanometer <unk>.
50 against RSV and it was.
Clinical isolates of both RSA RSV, a and B type strange so it's a broad acting anti viral against these respiratory viral pathogens that cause viral pneumonia.
And so we think that there's a high degree of.
Ultimately.
The vision would be that a patient experiences of severe upper respiratory infection that could be viral they called their doctor and they get this and it would be the amoxicillin anti virals for respiratory infections.
Got you that's helpful. And then maybe maybe available for the next Covid 'twenty, two or whatever so perfect alright, thanks, guys I appreciate it.
Thanks, Dan.
And our next question is from May Inc. <unk>.
Tony with B Riley Securities. Please go ahead.
Hi, good afternoon famous with Dot Hill on for Mike Congrats on the quarter and all the new additions to the team a quick question on the two internal programs first and then a quick follow up could you remind us of the enrollment targets for each of the trials and then what the interim analysis looks like in terms of the endpoints on safety and efficacy that you plan to.
Port.
Yeah, all of weakness that we decided to disclose that as you would know.
If we have.
No problem.
Yes, so we haven't disclosed the enrollment targets.
But I, so I'll speak more to the interim analysis.
Essentially what we're both of the studies are open label studies as you can imagine when youre doing a comparator between an oral and an inhaled therapy.
And especially when the oral therapy can require dose adjustment to hit a target blood level.
It is really difficult to think about how you're blind that so we are using completely objective endpoints things.
Seems like.
Overall survival.
Dose requirements for dose adjustment discontinuation due to.
Going on to salvage therapies.
Well as <unk>.
Thanks, you know in the case of work because all work almost all <unk> scans.
And and.
Looking at the cultures to CF, we're clearing the lungs.
And so all very clear objective endpoints and therefore.
We can do open label because the more the more objective your endpoints are the more acceptance to an open label trial is because you.
Don't have that.
Kind of judgment involved in determining an endpoint.
In the case of <unk>.
The interim analysis, there will generate.
Things like the differences between the oral and inhaled treatment failures that required salvage therapy.
We'll also be looking at as mentioned before a drug drug interactions.
Because many of the patients in this study.
Going to beyond <unk> or other.
Chemotherapy drugs that are interacting with <unk>, and therefore would require drug drug interaction monitoring and so it will be the proportion of patients that had you had there other concomitant medically medications adjusted due to.
The.
The introduction of the <unk>.
And overall safety and then overall.
Stabilization from a clinical perspective, how many.
How many achieved essentially clearance from the from the.
Of the phone gets from the lung how many achieved reduction in chess Cte scan infiltrates. So those are the things that will come out of the <unk> trial in the tact trial.
Again, it's open label and that's all one armed.
Because these are the patients that are going into this study are all receiving oral to Columbus, but are experiencing significant kidney toxicity to the point that their physicians are.
Contemplating either drug holidays or significantly reduced.
Doses of work on this all to try and spur the kidneys.
So we will be looking at.
The.
The stabilization of kidney function can we see that we either stabilize stop the increases in creatinine or reduction in GFR.
Ken.
<unk>.
Does it stabilize or can it even improve and then from the.
On the efficacy standpoint, we're looking at several different markers used.
Using different biomarker techniques from Endobronchial biopsies that can tell us if there is signs of acute rejection going on in the long. So we will be able to compare the.
The continuation of effective immuno suppression.
And prevention of rejection and the long along with stabilization of the kidney function.
Excellent. Thanks, a lot for that extra color, that's really helpful and looking forward to the analysis at the end of the third quarter.
Yes.
Thank you and the next question will be from Anthony <unk>, a private investor. Please go ahead.
Hey, Glenn Thanks for taking my call.
Yes. Thank you.
I was wondering if you could give us the status on the augment program.
And then followed up with.
Any updates you can give on the UGA com and <unk>.
N.
Okay, I'll give you an over the top on the <unk> program.
As you know we have been really enjoying our work with augment.
Great.
In the egg.
Later company, we've taken the $33 87.
Molecule.
Development.
Looked at the potency and <unk>.
Animal models against Sars, Covid, two and its variance.
And it's all been very successful we've seen positive.
Binding we've seen positive neutralization.
Neutralization that we've seen in the omicron variant.
Certainly not.
Same level.
As we've seen with the other variants.
A common theme as you know.
What monoclonal antibodies have become in the overall carrier.
To treat Covid COVID-19.
We have a number of I think very creative ideas in terms of how to continue to develop augmented 33 87.
There's a bit of a right turn from where we were headed I don't want to share those ideas.
I think they are very unique.
We don't want to tip.
We've come up with to the rest of the marketplace. We are working with one of our.
Scientific Advisory Board members to help us craft that strategy.
Do you have I don't know if you want to add anything to that but.
We still believe it and augment that we still believe in the compound.
We think we have something that has clinical value and we also believe that there is a need for a modern funnels in treating COVID-19 today and tomorrow.
Yeah, I don't know, if you want to add to that or not.
Okay.
Yes, thanks Glenn.
As Glenn pointed out.
Part of our commitment is to monitor ongoing and emerging.
<unk> as they occur and looking at the activity. So as we proceed we are.
Testing against various emerging.
Variants and ensuring.
And then it works.
And as you've seen with with the Omicron variant there has been.
And especially with <unk> now every commercial antibody that's already been.
Given EUA is either have the EAA removed or.
Or revoked.
And so it's a difficult place right now for Omics core antibodies in the Omicron World.
And so we're still assessing all of that activity.
Okay.
Okay. Thank you.
Okay.
Did you say repeat your second question.
It was on.
Could give any updates on.
The work you're doing with the UGA U Penn sure.
Well it goes one sure Chris.
Sure. Thanks, Glenn So other academic collaborations you had mentioned UGA Albert Einstein a new plan.
I'll take them one at a time, so we're working with Dr cartridge genre.
Right.
We've successfully completed our in vitro testing of our dry powder and we're in the <unk>.
<unk> is conducting awards in vivo study with their DSD for Covid.
We're performing an efficacy study in hamsters and this study is being is being done.
Formed in collaboration with researchers at December .
The Geneva Foundation.
So very excited about the work we're doing with Dr. Al Sandrock.
In collaboration with Docker type Ross at UGI.
So we've prepared dry powder versions of their universal influenza vaccine.
One that has added back as an adjuvant.
And so we've completed in vitro testing.
And in vivo testing in both mice and charts on our dry powder vaccines right.
And that allowed us will confirm that our dry powder preparation maintain the immunogenicity and efficacy of our drug.
Powder performed very well.
So we're in discussions with <unk> and <unk>.
And clearly defining next steps on advancing our TSS dry powdered version of their universal influenza vaccines and how into the clinic.
For U Penn our collaboration with Dr. Weisman, we've completed our initial mrna formulation work we'd.
We've identified our lead optimal formulations with.
We finalized protocols for animal testing.
We are preparing to deliver our GFS dry powder samples to doctor Weisman. So that they can commence these animal studies in the very near future.
We continue to push very hard on all of our academic collaborations.
Excellent. Thank you.
Thank you and the next question will be from Richard Deutsch with National Securities. Please go ahead.
Yes.
You for taking my call.
Cheers.
Almost.
Two broader landscape to have to get into one call.
Sympathize with.
People are trying to.
You'll get specifics I'm going to just ask one question and come back in.
Do you have enough time to get to a couple of them but.
You did just announce.
Another.
Major commercial partner.
Which is avatar.
<unk>.
If people don't know them.
They are on the New York stock exchange and even on this market conditions, there were $6 $8 billion.
Major Corporation.
Business.
Commercially successful can you tell us a little bit about.
What this partnership means.
Hello.
Aided to move forward and what they are.
Their milestones.
Going to do over the next.
Six to 12 months.
Well first of all thank you Richard for noticing that we did.
Put out a new corporate presentation, and I guess, Richard and doing his diligence noticed that it went up.
Commensurate with the press release.
Chris gets all the credit for this one so as you guys frankly for all the transaction so I'll have him.
Can you detail out there.
Great. Thanks, Richard So really excited about our partnership with that car. This is a new initiative. So the concept is formulating rts that dry powder.
For use in an intranasal device.
So with TFS.
Looking with AD par and.
And using their proprietary intranasal device. So we're running some initial experiments and that these initial experiments proves successful we believe that.
Dry powder when its unique attributes right.
Nasal.
Administration and this is not only for vaccines, but also for therapeutics, so depending on the compound and the disease state, which could be very advantageous for both patients and prescribers.
So the way that it's structured.
As many of the <unk> customers are looking for a dry powder intranasal delivery right and.
Brookfield and very similar inquiries from our partners and you deliver intranasal.
So the concept is Mary our respective technologies.
Dry powder technology with the App to our proprietary device.
And then we can drive our collaboration to address each of our respective <unk>.
<unk> needs.
Again, as I mentioned, it really depends on the compounds.
The disease state.
<unk> powder intranasal spray it could be very advantageous for delivery of vaccines.
<unk> therapeutics, so it's really proof of concept with doing some experimental work right now so I look forward to sharing our progress as we continue down this road at that point.
So thanks for the question Ross.
And also really as soon as you stick with the Cadillac partnership.
We as a team have the opportunity to visit.
Just a couple of weeks ago their site in Boston, which is a emulation side and theyre doing nasal work as well. So we anticipate that we're getting a lot we've got a lot more.
More opportunities to work on the intranasal space.
And the <unk> really should could not com at a better time. So this is all coming together quite nicely.
Operator next question next question I'm sure that question is from Ted Ketterer with TK Associates. Please go ahead.
Hi, guys.
Okay.
Glenn It would be very candid.
Elephant in the room is your balance sheet.
Three quarters of pets.
Sure.
And so far no progress in terms of the incoming revenues.
Alright question is.
Are we going to get diluted at $2. This year.
Or are you guys.
Anything can happen.
Go ahead put your balance sheet in the position where the people who go.
Markets for <unk>.
There's already been a run out of cash Gordon depressive stuff.
I think what Youre doing is fabulous.
That is great.
That's good.
$8 million of quarterly expenses, and you are adding it sounds like youre, adding expenses with three new people in five new partners.
Okay.
Just to correct you we capitalized through.
Through the mid part.
Next year almost everything through August .
More than nine months, we believe we're very well capitalized you know our business model.
<unk>.
I'll leave it at that.
We're well capitalized.
We monitor and manage our budgets extremely well.
And.
I have nothing else to say that that we've talked about our business model repeatedly said on this call that we are.
Extremely optimistic about our ability to close transactions with meaningful meaningful revenue.
Thank you Sir and the next question will be from Leo <unk> with Washington Capital. Please go ahead.
Hi, Glenn.
Good question.
Question regarding your open MTA.
Would you be able to.
Breakdown what percentage of the.
The MTA or biologics versus vaccines mrna labs et cetera.
Along those lines.
Okay.
Quick.
My friend, Chris kind of on a spot here right.
I bet he knows.
He may or May not know off hand, Chris if you could try out.
Please do.
Sure. Thanks, Louise Thanks for the question.
So if I take a look at all of our ongoing collaborations right and there are different MTA is via the <unk>.
Tremendous focus on biologics so.
All of our different entities.
87% of them are really focused on biologics.
And as Glenn had mentioned earlier all of these biologics are and CES right.
We're to the originator of the technology.
So I had two.
What I can share with you.
It is more of these collaboration projects right, we're focused on biologics over 87%.
Of that.
65% of these projects are oral inhalation as the primary route of administration of our dry powder versus 30% of.
Of our projects, which are more of a stable dry powder.
After reconstitution and injection as the route of administration.
A couple of other projects, which have alternate routes of administration.
But by and large.
There are a large number of projects that overlap. So we're working with partners on a dry powder vaccine.
And the second project with that partner is an oral inhalation and now with our new app engagement and arrangement.
Based on demand.
Now looking at intranasal delivery of our dry powder.
So hopefully that addresses your question a.
Little little context, we're focuses and where our MTA. So.
Great Great Chris that that's very helpful. Thanks.
We probably have time for one more question.
And our final question will be a follow up from Richard Deutsch with National Securities. Please go ahead, yes. Thank you again for.
You did mention in your presentation.
Yes.
Interacted with Glasshouse, which has finally purchased plus products and can you give us a little bit more of an update on.
<unk>.
Might see a decision on commercialization and I.
Want to.
Just to make one comment about pets.
About running out of money.
Obviously your business plan.
As monetization of Tac.
Closer to mic.
The <unk> products.
Government programs themselves.
<unk> into higher and higher levels of product development inventory purchase those alone would be enough to start a separate company. So I just wanted to throw that in there.
Comments seem to be.
Yes.
Out of line with the reality of what you've done.
Putting all of these.
Products into final stage.
Over the last year or two.
Yes, thanks for the color and other opportunities.
Clearly.
Specifically.
We have what we believe first and foremost Richard R. Our go to market assets are our formulations or I have to really again, a second call after call.
Plus there's been a remarkable partner to us and helping US develop these go to market assets they talk to customers in the marketplace.
Congratulations to plus four.
Culminating their restructuring with glasshouse.
The feedback I have from the <unk>.
<unk> management is that Glasshouses interested certainly.
And all this time, we have contingencies in place to get our our compounds to the marketplace as quickly as possible.
Everyone we've talked to.
It is very impressed with our compounds and.
As I said, we will hopefully do this to glasshouse.
But.
Yes.
If not we have contingencies.
We are excited about the opportunities here.
Our goal is to get the first commercial sale as quickly as possible realizing locate the plus situations didn't help with timing, but we used that time productively and.
We've got a really terrific array of.
Formulation taken.
Taken to the marketplace.
I just wanted to as before concluding.
I Wonder can we I personally one of the reasons the answer I gave on the Union. The option period is clearly engaged and the reason we're doing the work to look at what how big the opportunity is for the close of my that's that's it.
The spirit of our partnership I mean unions doing all the work they are doing to understand and be sure that we make the most out of the <unk>, we saw an opportunity and the work that we're to partnership and bringing our intellectual views and opportunities with refined numbers.
The partnership.
Makes the right decisions. That's all that's all I'm, indicating there so there's nothing other than what is in the agreement we have great data out of the phase one program and if anything as I close my opportunity. It's got much larger than we first engaged with union.
Or first started doing the work with union so all in there.
And Mike My summary comments are that.
It is TFS.
PFS is moving forward splendidly.
The opportunities are greater than ever.
Everything that you have seen and believe in CFS.
But I think even bigger than perhaps you may realize.
We'll come out of this period of market darkness.
And we're doing everything we can to be sure that.
The company will return great value to you.
And in the shortest term possible.
Want to thank my team. Thank all the investors and your support as you know I make myself quite available to us. If you have any questions at any time, you can contact me or Corey.
And we will answer your questions.
You all stay well and thank.
Thank you enjoy your evening.
And thank you Sir the conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Yeah.
Yeah.
Yeah.
Okay.
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Yeah.
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