Q4 2020 Palatin Technologies Inc Earnings Call
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Ladies and gentlemen, and welcome to the packaging technologies fourth quarter and fiscal year end 2020 operating results conference call.
As a reminder, this conference is being recorded.
Before we begin our remarks I'd like to remind you that the statements made by taligent that are not historical facts may be forward looking statements.
Statements are based on assumptions that may or may not prove to be accurate and actual results may differ materially from those anticipated due to a variety of risks and uncertainties are discussed in the Companys. Most recent filings with the Securities and Exchange Commission.
Please consider such risks and uncertainties carefully in evaluating these forward looking statements and Palatins prospects now I would like to turn the call over to today's host Dr., Carl Spana, President and Chief Executive Officer of Palatin Technologies. Please go ahead Sir.
Thank you good morning, and welcome to the pallets technologies fourth quarter fiscal year, and Twentytwenty call I'm Dr., Carl Spana, CEO and president of collagen with me on the call today is Steve Wills College, as Executive Vice President Chief Financial Officer, and Chief Operating Officer on today's call, we will provide financial and operating updates, including the impact of the.
Cobiz 19 pandemic, we sincerely hope that you and your families are safe and healthy as you deal with the wife poultry changes brought about by the cold at 19 pandemic today, Steve will provide the financial update as well as the update on our re acquisition by leasing Amax Pharmaceuticals.
Focus my update on the progress of our development program, specifically P.L. Ninesix fourthree for dry eye disease phase two and RPL 8177, Koby 19 program.
[noise]. Thank you Bill good morning, everyone.
Starting with the financial update.
Having said that however in fiscal year 2020 financial highlights net.
Net loss for the fourth quarter ended June 30 of 20 27.3 million or three cents per basic and diluted share compared to net income of 52.2 million or 25 cents per basic and 23 cents per diluted share for the comparable quarter 29.
Net loss for the year ended June Thirtyth, 2020 was 22.4 million or 10 cents per basic and diluted share compared to net income of 35.8 million or seven.
Or 17 cents per basic and 16 cents per diluted share for the year ended June Thirtyth 2019.
The difference in net loss and net income between the quarter and you're right a June thirtyth 2020, compared to the quarter and year ended June Thirtyth 2019.
It was due to the recognition of license and contract revenue pursuant to our license agreement with a bag of 60.3 million for the quarter and year ended June Thirtyth 2019.
As of June Thirtyth, 2020, pallets, and had 82.9 million in cash and cash equivalents compared to 43.5 million as of June Thirtyth 2019, and no debt.
We believe that existing cash.
Capital resources will be sufficient to fund planned operations through at least September Thirtyth 2021.
Our strong cash position of approximately 83 million at June Thirtyth, 2020, and no debt coupled with the 12 million. We received on July 2020 from a bag.
Plus an additional $4.3 million due from a bag March 31st 21 provides us the financial resources to significantly advance our anti inflammatory and autoimmune programs and make complimentary targeted investments to our leasing program.
Moving over to Bobby.
Why do you see.
Is that FDA approved for pre menopausal women with hypoactive sexual desire disorder or HSDD.
Well at least he is the first and only FDIC approved product for the as needed treatment for pre menopausal women, who are experienced distress or intra personal difficulty due to low sexual desire.
This treatment is available as the subcutaneous self injection and a prefilled disposable auto injector pen for use in anticipation of a sexual encounter it.
It is estimated that HSDD affects one in 10 pre menopausal women.
As an historical recap pallets in license to North American rights to finally see two way back in the first quarter 2017, we received 60 million as an upfront payment.
During the period.
The second quarter of 2017 through the first quarter of 2018 pallets and received two.
25 million as cost reimbursements.
And a 20 million dollar regulatory milestones for the under acceptance by the FDA.
At least it was approved by the FDA in June of 2019 peloton received a 60 million dollar regulatory milestone at that time in the aggregate we received approximately $165 million since the first quarter of 2017.
In January of 2028, Meg announced that after a strategic review of its assets of it that's a assets and business model. It decided to commence a process to divest by lisi and another female health care product.
In July of 2020 pallets in announced the mutual termination of its license agreement with AMAG, whereby they see under.
Under the terms of the termination agreement pallets and regained all North American development commercialization commercialization rights for by the SEC.
Hey, Mag made a 12 million dollar payment to Palatins at closing and we'll make a 4.3 million payment to pallets and on March 31st 2021.
Pallets and assumed all by leasing manufacturing agreements and they Mag will transfer all information data and assets related exclusively to buy lisi, including but not limited to existing inventory valued at cost of approximately $15 million.
Hey, Matt will provide certain transitional services to palatin for a period of time to ensure continued patient access to policy and regulatory compliance during the transition period back the palace Pat.
Palatable reimbursed same actually the agreed upon cost of the transition services.
We we believed the filing season important treatment for the millions or pre menopausal women suffering from HST day, our goal with the my leasing program is to demonstrate value in the marketplace by increasing patient that patient demand and to access.
Our objective is to Relicense, the U.S. rights to a committed womens health care company.
Haven't taken steps to ensure no disruption for patient access to buy Lisi, we are working to expand awareness of the condition and treatment and a highly targeted and informed manner enhance and streamline patient access.
An increase insurance coverage.
Peloton is exploring its options pertaining to enhancing the commercialization of IVC, including but not limited to discussions with potential collaboration partners that currently market female health care products.
Pellets and continues collaboration discussions for territories outside the currently licensed territories of China, and Korea, and anticipates executing multiple agreements through calendar Twentytwenty one.
In the interim Pat.
Pallets and strategy implements and informed and highly targeted approach to marketing okay.
Focusing on telemedicine, social media and digital advertising we are.
We are committed to working with payers and health care professionals.
To ensure women with HSDD have continued and affordable access to buy these.
Well at least see remains commercially available through specialty pharmacies, avella and bio plus and patients also have the ability to connect with a health care provider through telemedicine.
I'll now turn the call back over to Carl.
Thank you Steve.
In the past year, we have required at least you face the global Coke.
Tobey 19 pandemic two major challenges that were unforeseen that have changed the way we operate our company.
Having a well financed and managed company has allowed us to address these challenges effectively and with minimal impact on our operations.
I'll start the operational update with the impact of the Cobi 19 pandemic.
A primary concerns have been the safety of our employees patients and health care partners, we use it.
We instituted a work from home policy in early March that remains in effect for our office staff.
In the past quarter, we have reopened our research laboratory Fortunately most of our key research and development partners continue to remain in operation I use and.
I use and Teleconferences various online meeting platform, we have met effective continuing to advance.
Our programs. However, we understand even with resumption of activities. There can be further disruptions to business activity based on a resurgence of the virus and we will be prepared for this potential outcome.
Dr. Twentytwenty, we acquired by leasing from Amex Pharmaceuticals, as a reminder.
Hey, Max divestiture of at least he was based on strategic and operational changes at Aonec and not the potential value of OVC.
You've covered the details of the re acquisition and the strategy and operational objectives for releasing.
Under his direction, we have assembled an excellent and motivated commercial team that is dedicated demonstrating the value of at least we believe our strategy will allow us to demonstrate the potential value of at least in a cost effective manner. Our ultimate objective is to relicense ability to a committed partner jury to continued availability as a treatment option for pre menopausal women with HM.
DD financed return our investment.
Palin has a primary scientific focus on them line Accordant system, which is involved in the regulation of energy balance, including food intake sexual function and resolution.
Islam a tour responses are.
Our first success with a lot of court system program is based on the role of adequate assistant regulating sexual function.
This research work resulted in the discovery of IVC its eventual approval by the FDA as the first as needed treatment for pre menopausal women with HSDD.
Our current research is focused on developing drugs that target the ability of that a lot of important system to resolve or turned down information we.
We have developed multiple drug candidates that in preclinical models have demonstrated the potential to resolve a variety of inflammatory disease condition.
[noise] [noise] research conducted by us and others have shown that targeting immune cells with Atlantic wouldn't drugs results and there is resolution of pro inflammatory processes. These pro.
These pro resolution activities include mediating conversion of immune cells from an inflammatory to a regulatory state the inhibition of the production of Paul Pro inflammatory cytokine such as TNF alpha into six others Upregulation of anti inflammatory cytokine such as interleukin 10.
In addition, some a lot of corn system plays a role reducing that by brought it response that occurs as part of many inflammatory diseases. The fibrosis, resulting from a celebratory disease has long term negative consequences for the health of patients.
Therefore, we believe that a lot of course drugs targeting immune system will have broad utility in treating inflammatory diseases. We have develop clinical stage drug candidates, who diseases, such as dry eye disease non infectious uveitis retinal diseases. We also have a clinical stage drug candidate for gastrointestinal diseases, such as ulcerative colitis.
Unlike what drugs targeting immune system P.L. ninesix for three and a phase two study in dry eye disease using eye drop formulation in January 2020.
Dry eye disease also known as Clarence.
Perfect Thats divided seca effects, the cornea suggestive of the pie, resulting irritation redness pain blurred vision causes are varied and we believe that by activating Atlantic wouldn't system locally PL Ninesix fourthree will reduce inflammation that underlies many negative aspects of dry eye disease yeah.
In July of Twentytwenty. The study was fully enrolled with 160 dry disease patients and we are on track for data in the fourth quarter of calendar 20 property.
Hey successful study will provide the data required to advance PL ninesix for three I'll talk solution into pivotal phase three studies, which will start in the first half of 2021.
With data coming later this year I would like to review the trial design, our regulatory strategy and what a successful trial might look like.
Endpoints for dry eye disease clinical studies are divided into two categories signs and symptoms assigned his direct evidence of disease examples our colonial lesions to tear production system.
Assistance or patients experienced aspects of disease and examples are blurry vision and itchy eyes.
Phase three pivotal studies will need to achieve statistical significance on the co primary endpoints of a sign any symptoms of dry eye disease.
The PEO Ninesix for three phase two dry eye disease study is a multicenter randomized controlled study comparing PL ninesix for three to placebo with a 12 week treatment period.
The co primary endpoints are a sign of dry eye disease, which in this case is inferior corny unforeseen staining and they sent them, which is after discovery we have.
We have also included multiple secondary endpoints that measure my 463 effects on signs and symptoms of dry eye disease.
It is typical to use only a single primary endpoint a phase two study with multiple secondary endpoints.
The discussions with the FDA, we chose to use co primary endpoint with the strategy that the current phase two study could potentially be used as one of the two required phase III pivotal studies vocal primary endpoints are statistically significant.
[noise], we have designed the study so that multiple outcome support successful transition into phase III pivotal studies.
These potential outcomes include statistical significance for both co primary endpoints statistical significance for inferior foreseen.
Corning foresees, Danny any secondary symptom endpoint for statistical significance for Akamai discomfort, a secondary signed endpoint.
Following this strategy reduces phase two risk and allows for the potential of the current phase two study to cap is one of the two required phase three pivotal studies, reducing cost and time to a new drug application.
The market for dry eye disease treatments represents a substantial commercial opportunity with over $2 billion annual sales and continued growth based on patient demographics, we believe the potential efficacy and favorable tolerability and safety profile of PC held nine six fourthree will allow for substantial market penetration of the dry eye market.
Now moving onto our PL 8177, pulmonary disease and co in 19 program and preclinical disease models. PL 8177 has demonstrated anti inflammatory activity as the ability to protect lung tissue damage due to fibrosis as.
As a potential treatment for patients with Coca 19 infection.
8177, maybe just the inflammation lung fibrosis associated with progressive disease.
The second quarter of calendar 2020, we held a discussion with BARDA concerning PL 8177, as a potential treatment for patients with cobot 19 infections one of the outcomes.
The question was the advice that we move PL 8177 forward and begin discussions with the FDA concerning a potential PL 8177 clinical study koby 19 patients.
In the second quarter Calvin Twentytwenty, we submitted a pre investigational new drug application data package to the FDA and we see detailed device on the requirements to progress PL 8177 into clinical studies.
Following our current deal eight Oneseven hundred 19 plan, we are conducting all the required activities needed to file it hi, Andy and begin clinical studies with PL 8177, and Cobot 19 patients. These include such activities as clinical protocol development.
Election of a contract research organization clinical trial site identification and manufacturer field 8177 and placebo doses.
We target completing these activities in the third quarter calendar Twentytwenty. However, covert 19 related scheduling at our contract manufacturer has resulted in a clinical study dose is not being ready until the fourth quarter of Calvert Twentytwenty. So.
So these activities will now be completed in the fourth quarter of this calendar year, allowing us to file I, Indeed, with the FDA and began to clinical study of PL eight one set of assets as we have discussed on previous calls press releases and in our 10-K landscape for treating and conducting clinical studies over 19 patients is rapidly evolving would you.
Which impacted design risk and ability to conduct clinical studies and covert 19 patients as we.
As we have considered the risk and uncertainty of conducting colder 19 clinical studies at the start of the PL 8177 clinical study is subject to receiving external funding and operational support and we are in the process of applying multiple government programs that provide some support.
Our clinical trial for retinal disease indication is now scheduled to begin in the second half of calendar 2021. This represents an approximately two quarter delay, which is due to the impact of the code 19 pandemic. We are using this additional time to expand our clinical and scientific understanding medical and system at Taco inflammatory disease.
Updating or O'connell release formulation for PL 8177 added.
As a treatment for ulcerative colitis and other inflammatory bowel diseases, we are conducting all required preclinical activities [noise].
[noise] and drug product manufacturing to begin a phase two proof of mechanism study, which is targeted to start patient enrollment in the first half of calendar Twentytwenty one.
Now finally based on our research work on a naturally peptide system, our drug candidate PL three NIE for naturally peptide receptor agonist will be evaluated as phase two a clinical study in heart failure patients with preserved ejection fraction.
The study is a collaboration with two major academic medical centers and is being supported by an American Heart Association Grant.
All required approvals are in place and drug tested provided to the clinical trial site and we expect the first patient in the study in the fourth quarter of calendar Twentytwenty.
You can find additional information on our programs on our website www dot peloton dotcom.
Past year has certainly had its challenges as multiple external events impacting our operations in response, our executive management employees and board of directors acted quickly to adjust our business operations. We have been able to continue to advance our programs addressing the Cobi 19 pandemic, we took immediate actions to ensure the safety of our employees patients and health care.
Partners, we put in place operational processes that have allowed our employees remain highly productive.
Our ability to continue to advance our development programs and our healthy cash position will allow pallet into emerge. This pandemic in a strong position. However, we will also remain diligent putting plans in place should the virus make resurgence.
A major development was our re acquisition of the North American rights for the Lisi from Amex Pharmaceuticals, we believe the potential of a lease as a treatment for pre menopausal women with HSDD and view this as an opportunity to increase the value of our company under Steve Wills direction, we have put in place an excellent commercial team and they plan to demonstrate the commercial value of at least.
To support our objective of licensing elysee part.
Partner committed to realizing his value.
Our Chinese and Korean partners with our support are now advancing by leasing into clinical studies to support their regulatory submissions for ultimate approval and sale of at least in those territories.
Our dry eye disease program, we initiated and completed enrollment in a phase two clinical study.
We are on track for data by year end caliber 20 today. If the study is positive we are positioned to move into phase three pivotal studies in the first half of calendar 2021.
As we look forward to 2021, we will continue to deal with the operational challenges posed by the Cobi banking pandemic, we have a strong pipeline of novel clinical drug candidates and we will remain focused on their advancement.
Based on the research were completed in the past year, we are positioned to start clinical studies and Coke 19.
Patients also leidos and retinal diseases and Twentytwenty one in closing I would like to thank the powers and team and our development partners for their rapid adjustment to a new working environment and their continued dedication to the advancement of ITC commercial activities and our novel drug candidates.
Thank you and we'll now open the call to questions.
Thank you very much ladies and gentlemen at this time, we would like to open the floor for questions. If you would like to ask a question. Please press star one on your telephone keypad now again that is star one to ask a question well pause for just a moment as we waited for questioners to Q.
Our first question will come from John Newman Canaccord.
Hey, My question I, just wondered if you could talk a little bit more about the transitional service agreements in place for by leasing and just how that's going to allow you to continue.
Continue to support commercialization of the products kind of in the interim here and also just how.
It's happening really at very little cost you. Thanks.
Hey, John it's Steve Thanks, Thanks for the question.
To beat it to be.
Forthright Pelican when we were.
Once we got to the position that we knew we were going to be taking the product back and shaken hands with with AMAG notwithstanding the.
The payments and the releases, we knew we had to get any commercial and regulatory functions that we didnt have in place.
Entered into a transitional services agreement with a Mac and we did that the the one item we've always been very strong as you recall, we invented the product we took the CMC right away, but things regarding say the pharmacovigilance to quality.
The government reporting the market access oversight. So those are some of the specific functions that we engaged with with a Mac. So over the next.
Several months were in the process of transitioning all those functional areas to Palatin and that would would would include both internal or or or outside third party resources. So were comfortable that we have sufficient time to do this in an orderly and.
And form fashion and what was most important was that to make sure that that we had all the functional areas in place with agreements. So there was no patient access disruption and also to ensure all the regulatory compliance aspects were taking care.
Okay, great. Thanks, and then.
And then I just wondered.
In terms of the dry eye data that are coming up in the fourth quarter.
I know that you're looking at foreseen staining.
I was just curious as to what we should focus on there. If it's mainly just kind of a read on the primary endpoint.
If we should also be considering.
Signs and symptoms and things like that thanks.
Sure well as I mentioned on the call John.
The signs and symptoms are the two requirements.
Foreseen staining is a measure of inflammatory lesions in the eye inferior just means it's the bottom part of the eye and part of that is just due to the way the studies be run of the bottom the I can be a little bit drier many times. So the way I think about it is.
Yes. This was a first attempt.
We took a little bit risk by doing co primary endpoints.
I think the risk is worth it because if we do hit them both.
We believe this will count as one of the big.
Phase three pivotal studies with it.
But there is a whole host of from an EBITDA perspective, they're fairly agnostic there are a variety of signs that one can use.
And symptoms that one can use requirements for ultimate approval is that you hit one sign in one symptom in two phase III registration study.
So so far.
So from US as we said there are multiple outcomes will be as long as we hit one of the two co primaries and.
And show very strong evidence of the fact.
Something on the opposite side.
We will go forward and we will go forward and progressing the phase three so.
So thats the way I think about it with regards to some of the other things I would focus on our popular comfort is important.
Current therapies that are out there.
Restasis Zygo.
Topical steroids speak generally all have.
Tolerability issues stinging off pace.
Dumping is such a thing so I think pocket without Tolerability is a key commercial attribute and comfort is a key commercial attribute that we think peel it one.
As field nicely for three is going to have.
Okay, great. Thank you.
Thank you very much. Our next question will come from Joe Pet Guinness H.C. Wainwright.
Doing hope everyone's well and thanks for taking the question call I'm actually going to segue off of one of your wrapping up comments in your prepared script, when you reference Steve and the commercial efforts ongoing right now for by leases. So I wanted to see if there's any particular details you can share with us about.
Hey, how you are really keeping the profile high I know you did touch on some things in your prepared comments, but more specifically can you give any level with regard to how scripts are going and the type of coverage that occurred.
She currently has thanks.
The second pass that off to Steve I do want to just comment one thing that we didnt have in the prepared script.
The process.
Process of distribution for barely see what.
Was put in place by a magnitude specialty pharmacy that Steve has really.
Relate to you.
Fortunately due to the relatively rapid withdrawal of support for the product by Amec.
In the fourth quarter of last year that process of distribution. So that was getting the product from the manufacturer to the to the pharmacy from the pharmacy to the patient needed some attention and and so we say tender loving care.
Before we would be in a position to really start.
Evaluating the marketing.
Or the or the targeted marketing of buy leases and we're now at the coming to the I mean, so although it's been very quiet from our perspective, and I know investors keep.
Contacting us and what's going on it's been a very very busy period of time, particularly with receiving the commercial group, making sure that the patient access so in other words feel the product coming through the system and the patient experience is really optimized ad.
And he's done a great job with that and now these pharmacies are really performing at a much higher level reached a level that they need to be performing at and we're now in a position to really begin to look at the marketing.
Aspects of the program back to Josh I'll turn it over to Steve maybe you can articulate on where he wants to go where we're going to take this program.
So as Carl mentioned this is the.
I think it may help if I frame going back to the national launch by a Mag for by Lisi was was September were within a few months they were averaging 2500 scripts per month.
And that that figure was ahead of their their base projections, So frankly things, where we are going well.
But in January 2020, as we mentioned post the strategic review of a mags.
Business model, they decided to divest.
Two the two there are two other assets, specifically by leasing and Intrarosa and notwithstanding the divestiture process the.
The investment the marketing with.
With turned off.
They started going through reductions in force regarding the Salesforce. So no question and the no way trying to be defensive the the scripts were impacted.
Last month, we averaged less than 40% of that 2500, which I'll do the math for everybody quickly that's less than 1000 scripts per month.
That is not a surprise to us at all.
It's you have to make an investment with with products when you're launching them and our investment and Amax investment was initially around the education and awareness.
As Carl mentioned and I want to be very clear on this point, it's not a I mean could we have turned on the faucet in.
And started investing some of them some marketing dollars right away. The short answer is yes, but we weren't prepared not not so much peloton, but if you will the thereby lisi.
The way we want the experience today the way, we want the weather's the pace or the consumers.
For the access it wasn't in place the way we thought it should be in place and that started with the pharmacies. So weve made some modifications to the pharmacies that will absolutely increase and screen.
And streamline the pace the patient access and patient experience and we also.
We attacked the distribution and the coverage as of right now we're up to approximately 60% of what they have how they calculate the covered lives we.
I have engaged some some some excellent third parties to to assist US with this were not territory I will get to the best people. We can to move forward and give us give us advice. Our target is to get 75, if not 80% of covered lives, which is a very good number to shoot for whether we can accomplish that by the end of the year or there.
First quarter, we're working on it but we're now we've now made the steps whereby we can now consider.
If you will to relaunch from a marketing standpoint, so thats going to take place in the fourth quarter could be within the next 30 days no more than 60 days. We now have the let's just call it the machine and a much better position from a pharmacy standpoint from a coverage standpoint from an access and distribution standpoint, and so it's when we.
We're going to be investing these these these marketing dollars in the fourth quarter, we're going to have a much higher probability of success.
And the other thing I'd like to just expand on is we.
We were we're not going to be doing what you call. A I mean, if this was one of the large companies they would be doing it with a cover 19, it may be somewhat impacted but maybe going after a national Uh huh.
A national launch from a marketing promotion standpoint, that's.
That's not what we're going to be doing where we're going to be doing what we call. A it's we use the for the term geo targeted highly informed.
Cutting approach what that means is we're going to be more snipers sentiments than shotgun approach, we have a lot of data.
AMAG spent significant dollars on the launch there is a lot of data and some good data that came back in the in the first three or four months.
We engaged a third party growth the specializes in the digital marketing approach and the social media and we're very close to turning on to turning on that switch so we're going to be targeting mulch.
Multiple regions throughout the United States.
A significant number of regions, but the regions, we put metrics together and metrics being as always we try to be data, driven where where are the high prescribers where are the consumers that have already been engaged to a certain extent from the digital work that that Aemetis has done in the past and has has continue in a nice way to where do you want to go fishing you want to go fishing, where the fish are.
So with that we had.
Whole map of the United States on where we thought where the where the hot spots Con I, then decided to let's overlay the insurance coverage in those hot spots and that made some of the hotspot even more attractive.
Certain areas, we don't have as good a coverage yet and.
We're working on that but those are the areas that from the filtering standpoint, we're now prepared to go forward. So in summation. We believe we've made modifications that needed to be made to the.
At least the process and the program and we are prepared again within the next 30, if not 60 days of turning on that highly informed geo targeted marketing approach.
That was probably longer than you anticipated, Joe So I'd, probably need a little step awarded there, but let me let me pause here to save costs and I were responsive.
That was that was fantastic. Thank you very much for that and I guess, another segue well first I don't want to put words in your mouth, but it certainly seems like you're not just sitting around waiting to find the who you're going to out license the drug to or partner with so it sounds fantastic. So thanks for that so.
So with regard to out licensing or partnering I guess, what kind of partner are you really looking for and I don't want to put you on the spot here, but do you have any timing updates.
Well I'll get I'll give a little preamble and turn it back over to Steve.
What we're looking for someone who sees the value in by Lisi and feels that it fits there we are female health franchise and positioning as complementary to their current.
Your portfolio as willing to commit to really moving forward in a way that we think as we move forward and we will give us a return as set for the investment I want to point out one thing.
There were some complications in the way Mag went to try to out license or sell or disposed of by Lisi, However, you'd like to put it and that one this was bundled with another product.
And they also really looking for someone that would just step in the license agreement that existed between a bag and palatins.
So now that they have and that poses pose some complications with their partners. It didn't want the two products their companies.
Companies that want to slightly different it didnt fit the license and fit the way they were viewing it so no.
Not too surprising to us since the acquisition, we've had actually pretty good interest and I'll turn it over to Steve now and he can kind of fill in some of the details on that in the timing.
Thanks for the.
As always we're gonna be data driven I mean, we have some flexibility notwithstanding.
The cash that we have on our balance sheet as of June Thirtyth. We did receive 12 million from a mag is in combination with the transfer and the release and we have another $4.3 million due March 30, onest on it's going to take.
It's going to take it's going to take some time to show the value.
And I think that's that's the better way to go away where weve.
We're making.
We've made modifications made corrections whatever you want to classify them as to put us in a position to to show.
You have at least in the marketplace.
But notwithstanding that we have started the process, we do have an outside banker that that we work with.
I wouldn't call it a process why similar to what.
Hey, Matt good where they made their their plans known they want to divest the product where we're looking to see what type of interest is out there at this stage, maybe a few quarters down.
On the line and as Paul mentioned, we can be flexible we have.
We have a lot of expertise around.
The areas other than if you will the commercial so.
So a tradition of Relicense, absolutely, we can consider that sort of a time pass if the company can handle all the various fund.
Functions, but we also have some flexibility whereby a company that may be just more.
Commercial and they want.
Peloton to handle the CMC and maybe.
Maybe some of the lifestyle. Nonetheless, all the additional indications clinical or that type of work. We we could also can.
Consider that because the flexibility that we have and the expertise we have.
So announced Adamas still does not call me back Joe So I can't give you a date, but where we feel very comfortable that we put the right.
[noise] items in place.
So as we progress if something does.
Start start getting more advance we absolutely would consider it but the takeaway. There is we were we've already started some discussions now just to see what what could take place now or at some point in the future hopefully that's helpful to you. It certainly is thanks, a lot guys. Appreciate all the extra details.
Thank you very much.
Your last question will come from Michael Higgins Ladenburg Thalmann.
Good morning. This is Edward on for Michael I. Appreciate you guys, taking our questions just a few more to wrap up here.
For that.
Phase three trial for the dry I am just wondering how many sites you are expecting to enroll for that one.
Sure.
So the phase two obviously had.
It had much less sites and we had we had sites in the northeast and the southeast for Phase three pivotal study. The requirement is that you have it really has to represent more real life situation. So you would be looking to add multiple clinical trial sites across the country.
These patients are very easy to find so I would you an exact number I don't have it off the top of my head, but generally that would be it in the in the 50 plus range and what you want to have enough. So that your spread out across the country and it is truly representative of the practice of healthcare in the United States. So he's generally tend to be between 50 to 100, depending on the size.
So the study and these studies are particularly large they're not multiple thousands of patients where you feel you need quite a few sites.
So that will be in that 50 to 100.
Throughout the country.
Okay. Thanks on the content.
And then for 90 643, I'm wondering if you have any partnership plan for this asset and then if we zoom out a little bit I'm wondering if there are any other pipeline assets you would partner and then what timeframe would you be thinking about.
Partnership.
Sure so so.
Cooler space, we have not yet met aggressive and thinking about or looking we're seeking partnerships in part from the standpoint of we have potential multiple opportunities there and with the cash position that we have we'd like to potentially consider maybe holding some of these assets a little bit longer maybe even thinking about.
Potential commercial transition there are a lot of smaller ocular companies.
That has single products that may fit with some of the types of opportunities that we have.
So we havent looked at it from that perspective yet.
I'd say that we wouldn't do it and not to say certainly on great strong positive data for Ninesix fourthree interest coming in that we wouldn't partner, but at the moment, we haven't been aggressive because more looking at a longer term strategy and the occupy the space certainly relative kaleidoscope that's one.
Thats, one where we actually do have earlier interest.
I have some ongoing discussions, particularly ex us.
Certainly it's not one you asked a proof of concept, we really would have partners who want to partner.
Not that it's a lack of belief in the in the product we think it's going to be great mechanism for.
Right, which caskets hassle diseases, but just because of the nature of that indication.
After getting patients the treatment options that are out there you really make sense to be partnered with a company that has multiple assets in Ulster fleitas or another G.I. indications, where they can position it appropriately and it really fits in their portfolio. So it's not.
So it's not really one that we said we would do on our own at <unk>.
Certainly anything in heart failure space.
Pending data coming out of that program that would be a partnership we wouldn't go forward there on our own we would partner.
So I hope that helps clarify yes.
Yeah, Yeah, absolutely I appreciate all the details and.
And speaking of hard fairly really quickly just wondering if you could provide any details on when that data might be available or if that's not necessarily up to you guys.
Well in EPS as I'm sure, we'll see it.
In real time. This is phase two a study patients.
Patients are in hospital and they are having what is known as a.
Right heart work up because they have they have preserved the jet they have preserved ejection fraction and many times. They that's that's due to a.
Issues on the right side and hard as opposed to less.
So data will come in in real time.
I think that you'd have to have a number of patients and I would think the middle of 2021 would be the first time you'd have enough patients through to get a good sense. This is truly a.
[music].
The basis of this study is the fact that heart failure with preserved ejection fraction predominantly in many times occurs and females and women.
And there are no effective treatments, yet and they represent 50.
50, 50% almost 50% of that hardly the case happens objection fraction. So there was a strong clinical need here, particularly in women and the American Heart Association Association go Red program is a a funding mechanism what looks to fund opportunities that are particularly suited towards female patients. So this.
Study is really a proof of mechanism study and is a very young the academic groups are highly interested in this.
Naturally peptide mechanisms in this indication and it's really determined to see if this mechanism before you go into larger patient numbers will this does this mechanism have a really good chance of working or not so it is an important study and.
And one where you have a positive outcome would really have the potential to transform treatment of patients with the Jackson fraction and certainly one where the critical need is very high high to treat these patients, but I would say middle of next year, probably earliest and again because of the academic nature in the end the granting of it.
We'll have relatively little.
Impact on that.
Got it appreciate all the detail too.
And then just finally in your prepared remarks, you mentioned that you had the.
Applied for funding from a few different organizations for the covert project. They working on I'm. Just wondering if you could talk about who those organizations are that you are reaching out to show I mean is there and it was a.
The one that we're most interested in is called active thats a collaborate collaborative between BARDA.
And I think NIH and a few other organizations and.
Reason why we're most interested in that one is because it's more of a handoff. So in that process. If we get selected as part of the active program. They really we take the compound over and really conduct the trials and I think that would be get the compound is best chance of success.
Vera.
Yes, a couple of other there were a couple other programs sponsored by NIH.
That was that we're looking at and getting applications ready for.
But I think active is the one that we're currently we are very happy application in and we're waiting for initial feedback on it.
That would be the one that most suited for for the compound.
One of these that we would like to avoid is in the current situation.
We're starting to get advice that doing studies of the U.S. would be difficult that we may need to go to South America, the gifts that he's done and.
So that's one of the reasons why we consider how we go forward. The program, we really would like subsea support the U.S. month to come back to for example would be very helpful. Because you get into the U.S. clinical trial site is much easier and much faster.
Got it makes a lot of sense.
Well good luck certainly with active and I appreciate you taking the question.
Great. Thank you.
Thank you very much.
At this time I would like to turn this conference back I'm sorry.
Our speakers for any closing remarks.
So this is Karl speaking again on behalf of myself and Steve and board of directors and all employees of pallets and we certainly like to thank all of you for the time you've taken on the call today, obviously being an annual close a little bit longer than normal hopefully we've been able to convey.
BSS and enthusiasm that we have for the acquisition of IVC and the continued effort that we have on building out an ocular franchises and other lot of consistent based anti inflammatory drugs.
We are quite excited here.
The crew is working very hard we are really.
Really looking forward to Twentytwenty, one hopefully a little more normalization of operational activities and general life.
And we look forward to really the success that we will have in moving our programs forward. So we'd like to thank all of you again once again for being on the call. Please stay safe where mass social distance like a broken record, but it works and hopefully we'll have some vaccines and newer treatments maybe appeal a once every seven so thank you all and have a.
Great day.
Thank you very much ladies and gentlemen. This now concludes our conference you may disconnect your phone lines and have a great rest of the week. Thank you.