Q2 2019 Earnings Call
Welcome to the chorus call leasehold and operator will be with you shortly.
Have your first and last name.
David Brown.
Our company with.
Hey.
We are.
That can induce immune recognition across multiple different cancers.
We've identified antigens from this target class to enable us to create off the shelf.
Multi indication therapeutics, where pan indication therapeutics for solid tumors as well as hematologic cancers.
Dr. Meyers will tell you more about this shortly.
Further our proprietary CTL exploring PD, one antibodies are advancing towards a planned to be filing in 2020.
Given our accrual status to date, we've recently triggered our interim analysis, which is now actively underway.
As we've previously disclosed our molecules are at least as clinically active is commercially available molecules and we plan to present data before the end of the year.
We expect to remain on track to file our first CLA earlier than anticipated in 2020.
We also plan to commercialize our proprietary sealy for NPD, one in the us and leverage partnerships for outside of the U.S.
Next I want to share another update.
Our next generation Sealy for a Gen 11, 81, a molecule that I am personally very excited about.
Our scientists designed and developed this molecule to be best in class.
Our antibody can address the shortcomings of the first generation CLA for.
We expect this product will expand the benefit of earlier approaches.
From less than 20% of patients who benefit.
To bring the majority of patients more than 60% of patients.
Otherwise experience a suboptimal response to first generation CTP four is due to a genetic polymorphism.
Other molecule agent 11, 81 is designed not only to address the current limitations of first generation molecules, but to substantially expand the commercial potential of our PD one beyond what first sensitivity for combinations offer.
We anticipate early clinical read outs of our next Gen Sealy for by the end of the year.
We plan to commence combination trials of our next generation Sealy for with our own PD, one and the second half of this year.
Agenda, our cell therapy based subsidiary continues to build on the progress we shared during our last call.
Most imminent is the I., Andy filing for our proprietary allogeneic cell format for patients with solid tumors.
Agendas as unique and is differentiated from other cell therapy companies in that it has.
Access to Agenuss is proprietary checkpoint modulating antibodies are synergistic combinations.
As well as Agenuss as broad a novel portfolio of vaccine therapies.
We believe these combinations are necessary and critical and making cell therapies more effective.
And durable.
Agenuss is the only company who has all of these modules modulatory therapeutic approaches in house.
Additionally.
Our proprietary phosphopeptide tumor targets or Pts.
Our highly prevalent across patients with solid and hematologic malignancies.
And we are able to leverage these targets to generate cell therapy approaches, which will speak about shortly.
Finally, our unique allogeneic cell format is designed to improve tumor targeting.
And may eliminate the need for Lymphodepletion.
Lastly, our earlier innovations continue to be important catalyst for at least one blockbuster product for our partners sales of GSK Shingrix vaccine powered by our Qs 21 has achieved over a $1 billion in revenues in its first year of launch is on track to reach $1.3 billion in revenues this year.
Through funding from the Bill and Melinda Gates Foundation, we are advancing the development of an alternative manufacturing process of Qs 21.
To ensure a continuous future supply of this very important match event.
Our preclinical results to date support complete biologic comparability between our revolutionary approach to the original source of material from the Chilean so part tree.
I will now turn the call over to Garo.
Thank you Jen.
As you can see.
A lot is going on.
And a lot must go on in order for us to defeat cancer.
If it were easy to do it.
It would have been done already so by definition it isn't.
But Jim very well summarized all of our key accomplishments.
Including the attributes and design the advantages of our immuno oncology agents.
While we have put a lot of emphasis on our trip foreign antibodies.
Deservedly so.
Because they are the most advance in the clinic.
And there are a lot of them in our portfolio.
We must also not overlook the significance over the rest of our portfolio or are you only know reach.
These include our cell therapies.
Particularly our allogeneic cell format about which we haven't talked very much.
Which includes our proprietary targets.
We expect to file our first cell therapy I ended this year.
Also important in our portfolio.
He is our off the shelf vaccines targeting our proprietary ptcs, you'll hear more about that in a bit.
As Jim mentioned, we filed our first time beyond these class or vaccines very recently.
Before I go on I would like to refer.
You had to the slide that exemplifies our innovation. So we're going to do things a little bit differently, we're going to reflect on some of what has happened operationally with drivers.
And why there is a disconnect between our accomplishments and the value.
So the first thing if I can refer you to the slide that exemplifies our innovation manufacturing and development capabilities.
This bar chart.
Shows our performance.
Relative to leading.
And much larger Io companies, it's really represents the number of wind these filed in the past three and a half years.
In immuno oncology.
And as you can see here, we are number one in the number of ideas that have been filed in immuno oncology.
To be able to advance 39 days for a company of our size and resources is nothing short of a miracle.
Certainly we are pleased by our outperformance of the industry peers.
In delivering discoveries to patients.
We are developing drugs and innovating sites, we're doing this with tremendous speed and conviction.
We control our performance and frankly, we are damn good at it.
As this chart displays our progress is evident in our proprietary pipeline and our country contributions to our partners.
Including Merck and inside where our represented here as well and our most recent partner Gilead.
Our execution has generated milestones and milestone payments.
As a matter of fact before our call. This morning.
We announced the achievement over another milestone in our julliard collaboration with the I., India acceptance of Asian 20 373.
A differentiated CD 137 also known as four one VB molecule that Joan Joan spoke about earlier.
Next few may ask with Suntrust filler operational performers why is it that agents stock price and market cap has remained depressed.
We have completed a detailed review all relative market capture viral companies that were valued at up to $500 million at the end of June .
Here are the outperforming.
Aspects of our company. So we have outperformed our peers in market cap of companies below 500 million in the last 12 months, we've gone from number eight.
The number one.
In the past year.
And I might add that some other companies on this list head market caps of much higher values, a year ago and two years ago.
Of course.
This is not a point of comfort for us.
We believe the value of our company should be substantially higher based on our portfolio and our ability and resources to continue to innovate.
However, it is important to know that the industry and the peer group performance has suffered due to lack of breakthrough innovations. After the commercial successes of the first generation immuno oncology products.
So the perception.
Is that immuno oncology has hit a wall.
In fact in our conversations most recently with some notable analysts on Wall Street, Theyve pretty much given up on expecting anything remarkable coming out of immuno oncology.
And the consensus is perhaps that there will be no more innovations in the future.
We believe this perception is wrong.
It is just what is wrong is the pervasive perception was 10 years ago. When people believe that immuno oncology would never be a factor in the treatment of cancer.
Here's why the recent rig brinker immuno oncology and why we believe the perception is wrong.
Of course, our believing the perception is wrong will not help the situation, but we will come true our solution in just a bit.
The first generation Io agents comprise the low hanging fruit.
Companies went after targets that were well established like city on May four and PD, one and well research.
The field of Io is still young.
And the expertise in academic and research institutions.
As well as companies large and small is still relatively sparse.
So innovation with second generation in immuno oncology agents and most importantly, the knowledge on how where and when to use them, including determining the right combinations.
Has been slow in coming.
Investors and venture capital is engaged in a feeding frenzy because of the success of the first generation products have been disappointed.
And the group has underperformed.
Apart from select cell therapy companies very few.
In fact, if you look at the performance of immuno oncology stops larger small alike.
Agenuss is the top four out of 29 oil companies in the past 12 months.
Once again.
Yes, we are have outperformed the traditional Io group in the past year, but is that satisfying to us.
The answer is absolutely no.
So the next question is what will change you may ask.
To get our value to where it belongs.
We expect our broadband novel pipeline to be the key driver for value creation.
Our pipeline is shown in the following slide.
Our engine has delivered 13 I NDS.
And 11 are already in active clinical development today.
The next 12 months or less will bring clinical data from these programs and that is unprecedented in our history and I believe in the immune oncology industry growth. So many potential data points coming up in such a short period of time.
As you can see from our pipeline, we have a nice balance of partnered assets, which are advancing with no cash burden on us.
There is a total of six partner antibodies.
Oil in clinical development.
But also there are a significant number of wholly owned assets in our portfolio shown in this pipeline slide.
This balance we expect will drive additional collaborations going forward.
Some very significant.
The implications of these collaborations for us will be transactions with upfront cash.
Some we expect to be substantial upfronts, we expect future transactions will be increasingly ex U.S centric, meaning.
We expect more and more of our asset rights for the us to remain with us in the future for Agenus to benefit from the potential blockbuster status of some of these agents for agenda is to build a substantial commercial business to provide us with cash flows and profit needed to reinvest in the future of Io.
With an intent to eradicate cancer.
And benefit all our stakeholders.
Including you.
Let me now switch gears and tell you how we have achieved the number one status in R&D filings for innovative therapies.
Our integrated capabilities from antibody discovery to cell line development to GMP manufacturing.
Our key to our ability to build a pipeline of products quickly and at lower costs.
Indeed, these advantages also allow us to manage a larger portfolio of discoveries and development programs at much lower cost and with higher quality and efficiencies there would have been possible without these internal capabilities.
Our job.
Is to invent.
And advance novel products.
A few highlights.
At our last earnings call. We said, we have advanced 11 nine deals in the past three and a half years and we plan on filing three more.
In fact, we have already delivered on two of these.
Hi, Andy.
And expect to file two additional line DS before year end.
These include our allogeneic cell therapy R&D among others.
In a few minutes, you'll hear Dr. Paisley Myers speak about our platform for cancer antigen discovery, which is proprietary to us.
These first formulated energen targets are potentially powerful for immune education via vaccines.
And also for cell therapy tuck ins.
They may be ideally suited.
For solid tumors.
Both in terms of efficacy and safety.
As Jim mentioned, we plan to develop register and launch our PD, one and city of a four in the us.
With a first indication and second line cervical cancer.
We believe that we will explore the rest of the world partnerships to expand our footprint.
And also very importantly allow access to patients outside of the us to our agents.
Cervical cancer is a difficult disease.
And the best available medicine delivers up to.
15% responses.
With PD one monotherapy.
Remember, we're not talking about cures were talking about 15% responses that are essentially relatively shortly.
We believe we have an opportunity to improve these response rates.
And perhaps even impart some cool cures with our combination strategy.
And on that note, we also plan on pursuing cancers.
Beyond cervical cancer.
Specifically with our second generation CLA for combinations, which can potentially provide us with the opportunity to significantly expand the market for our own PD, one and for our other agents by targeting these many other cancers.
Before I turn the call to Dr. Paisley Myers.
A few words about a valuable acquisition that we made in 2015.
This is fatima.
Thats immune Andy elegant proprietary science and technology from Dr., Don hands lab.
At T mobile World class scientists are driving innovations that can have significant impact on cancer vaccines.
And cell therapies, all for cancer patients the benefit of the cancer patient.
One of the scientists pursuing these innovations as Bob Paisley Myers, she is with US today with her first earnings call appearance.
Paisley will describe the features of this technology platform that can enable more effective medicines for patients with cancer.
We believe this nasty disease can only be concurred with the drill bit pursuance of pristine science in Io.
Paisley's work represents a sample of our pristine science Paisley.
Thanks again.
And is there anything I Miss anything.
In summary correlated anything.
And our unique here.
I completed my badly resets in the lab backward.
At the University of Virginia were focused on the discovery and unique humor owning antigen in essence the cancer.
Canada high and the surveillance in the immune system, we can expose the cancer. If we can make that human fingerprint visible to the immune system.
We have unique and proprietary said anything that can do just that.
We were affected Pat as Pat Hi, Sumit hernia, where PTC.
These target rather than an important class of general target therapies.
In there and for ease of understanding you can think of the principal target like NFV Cemetery salads humor.
Peter Kirlin, Targetable and lead to direct single product from multiple different cancer.
Mechanism allows me to transform these target into products that can benefit patients.
Most importantly, even this is the only nimble immuno oncology company and has the tools to bring a combination of immune modulating antibodies with cell therapy acting.
The tools necessary to deliver high impact therapies.
Specifically, we can leverage these target to develop proprietary Anthony cell therapy that can advance solid tumors grossing highly specific and therefore expected to deliver without the tactic setback with current therapies.
We can combine our allogeneic cell therapy approaches with antibody for aftermarket.
And we can deliver this vaccine for hematologic or solid tumor.
PCP very attractive targets for immuno therapeutic development for three reasons.
Fair.
Either tumor specific.
This regulated cellular signaling event with lead to their presentation.
There is a phenomenon that is specific to cancer.
Therefore, these targets are not expressed on the surface in the room here.
That is the therapy for cancer specific.
And therefore unlikely to be delivered without the taxes the current therapies.
Thank you.
Peter highly sedimentation within a specific cancer as well as the crop.
We have identified engines are common in the majority of patients the campaign.
This means that these initiatives will be widely applicable to a large portion of the affected population.
And lastly, ptcs are any units.
We have shown in preclinical studies in these units are capable of generating an immune response against cancer, which leads to the specific healing of those targeted cancer now.
Our first product moving into the clinic in the first nine ppt targeting vaccine designed to create immune MPC with and now and its events include anything representing 95% a patient with the disease.
We expect that this move as this approach will stimulate a bride and robust anti tumor immune or not minimizing the risk of residual disease and relax.
In addition to that and cell therapy company is developing a first of its kind fully human PTT specific TCR.
Hi. This is Anthony has shown that this TCR is explicitly fassler petsense specific and very sensitive and his tumor killing and in vitro model.
Additionally, this PCR presented tumor growth and experimental mouse model.
We expect that this product will be in the clinic in 2000.
In conclusion, ptcs represent a proprietary and flexible center product design to create off the shelf therapies, which are designed to deliver anti cancer benefit across tumors. They carried Korea.
Thank you very much phase three for the very nice summary of the fantastic work, that's going on with our antigen and to serve discovery efforts will transfer peptides.
As I mentioned.
Our strategy is to balance between monetizing a portion of our discoveries every year.
While.
Increasingly keeping rights to North America for some of our very valuable assets.
We expect to generate meaningful clinical data in the next 12 months on both partnered and wholly owned programs.
This we expect to help our efforts to monetize and our ex us rights with significant value consideration.
Our strategy in this regard will be tested with our second generation CLA for anybody currently in clinical development with prospects are generating early but potentially meaningful clinical data by year end.
Our ability to control key components of immuno oncology combinations that is checkpoint modulating antibodies neoantigen vaccines, adjuvants and adaptive cell therapy approaches both TCR and car T based.
All of these in house, we believe is a key advantage from a development flexibility and pricing perspectives.
Cancer is a complex disease.
And we believe that the right combination will be key to delivering optimal benefit for patients.
Our cell therapy business agenda as has made important progress on the advancement of the pipeline.
With R&D filings expected this year as you heard before.
Before turning the call over to Christine for Recapping, our quarterly financial report.
I wanted to summarize a few key strategic points.
One.
We have developed and have been successfully practicing.
A complete set of capabilities and immuno oncology agents in our efforts to rapidly deliver.
Hi impact products.
We have an outstanding pipeline of novel and second generation immuno oncology agents.
That we expect will deliver substantial benefits for patients with cancer.
Three.
Our operational excellence has put us on a path to be a late filing that remains on track and could even be ahead of schedule.
And for.
We are emphasizing smaller focused trials to achieve high response rates, specifically targeting patients who are not being effectively treated today by first generation immune oncology agents.
Now I will turn over to Christine Klaskin to provide a brief financial highlights summary.
Thank you now.
We ended the second quarter of 2019, with a cash balance of $122 million as compared to 53 million at December 31 2018.
For the six months ended June 32019, we reported a net loss of $34 million or 24 cents per share compared to a net loss for the same period in 2018 of $79 million or 76 cents per share.
During the first half of this year, we recognized revenue of $96 million, which includes revenue from our transaction with Iliad and noncash royalties earned.
We also recorded $20 million of non cash interest expense due to our liability related to the sale of future royalties.
Our operating expenses for the first half of 2019 increased by $29 million as a result of the advancement of our programs.
For the second quarter ended June 32019, we reported a net loss of $52 million or 38 cents per share compared to a net loss for the same period of 2018 of $25 million or 24 cents per share.
Both of these periods results include noncash items.
I now turn the call back to Gal.
Thank you Christine.
In closing we expect the following key catalyst for 2019.
One.
Completing accrual of PD, one and sitting away for trial by year end.
And sharing data from our preclinical or pre planned interim analysis. Both of these are designed that is there.
Pre planned interim analysis is designed to lead the product approval in the U.S.
On the data outcomes.
True upon a successful outcome of these trials, we expect to file our first female age in 2020 .
Three.
We plan to initiate a first in class combinations with our second generation Citalia bore.
With our proprietary PD one molecule in the next few months.
For advanced additional breakthrough discoveries and file at least two additional line. These for the remainder of 2019.
Five.
Advanced our next generation best in class molecules into the clinic.
Including our selective T Reg depleting depleting by specific age and 12 23.
Very interesting product.
Thanks.
Advance our cell therapy programs and heavy gentris funded independently.
And seven.
Very importantly, we expect to complete one or more business development transactions in 2019.
We are committed to our mission of delivering for our patients and for all our stakeholders.
Our efforts.
And staying power over the last 25 years speaks for this commitment.
We are always thank you for your staying the course and joining us on this journey.
Now we would be happy to entertain your questions.
We will now begin the question and answer session.
To ask a question you May proceed Star then one on your Touchtone phone.
So you are 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.
Our first question comes from Harsha Gowda pull shetty with B. Riley FBR. Please go ahead.
Hi, Good morning, Garo, Thank you for hosting the call and congrats on the tremendous progress this quarter.
A couple of questions on my end. The first one is more of a general one with regards to your pipeline.
Hi, guys. Dennis is pipeline is so extensive it does provide the opportunity to unlock.
As you know different opportunities into the areas of oncology as you said in your prepared remarks, a lot going on and the loss and a lot much gone to defeat cancer and I agree, but I guess the other side of the argument is that it's also sometimes hard to streamline your focus towards maybe what.
A key in the short term while it is a bit of a hard question I can imagine could you maybe help us understand what are the top three priorities for the company.
Going into the rest of the year I mean do you know.
Oh 2020.
Sure.
Very good question, our sheet and no arguments with your.
A reflection on the fact that you know we need to focus on certain things out just to start remember our focus.
His immuno oncology.
That is treating cancers, using immuno oncology ICL tools.
So to have the flexibility to be able to utilize our reagents our tools are treatments.
Maximally gives us a major advantage and so thats, a very important point to consider because to go with a narrow process. So saying, let's just concentrated on one or two leads I think is a recipe for failure and perhaps it is the reason why so many immuno oncology comp companies have failed to deliver appropriate second generation products. The next generation of immuno oncology.
Our strategy is designed to not do that and in fact, it's designed to maximize our probabilities of success.
Now with regard to your specific question of concentrating on three things.
If I were to pick three things to really focus on for the remainder of this year and into next year.
Among others it would be one to complete the enrollment of our Registrational trials. So we can file our BLE and we eventually become independent financially.
Two advancing our next generation sitting over a four to generate very meaningful data as soon as possible and we believe that product is going to be very value added for us for potential ex us partners as well as for patients.
And three to complete at least one.
Or more.
Important business development transactions that could help us in our pathway to financial independence going forward.
So those are the three key priorities does that answer your question.
Yes, yes. It does get thank you that's very helpful. I guess, just one more from me.
Piggy backing off of what you just said that the CTO <unk> four and PD. One you know read out quickly approaching those are you able to provide a more crystallized timeline on regulatory submission and commercialization or do we have to wait till you know data comes out.
It will I'll, let Jim speak to that but the regulatory filing will be in the second half of 2020.
And commercialization shortly thereafter as soon as possible by June July two.
Thanks, Scott Thanks, how should that be a question. That's absolutely correct. We mentioned during our last call that our accrual is going very well with our lead Citypoint PD one.
We anticipate filing that the law earlier than we have previously disclosed and we're on track to do that so as I mentioned at the beginning of the call.
We now trigger the interim analysis and expect to be sharing data more publicly relatively.
Okay. That's helpful. Thank you so much for the color and I look forward to the exciting updates to come thank you.
Thanks Peter.
Our next question comes from Matt Phipps with William Blair. Please go ahead.
Good morning, guys. This is Rob Andrew on for Matt Phipps, Congrats on all the progress and thanks very much for taking my questions.
So obviously just going back to the sequelae PD one combo trials I know you mentioned the interim data is expected later this year just going for is unlikely to be a a medical conference and can you give any further information on what data. We can expect that with respect to kind of patient numbers any other details that you can provide at this time.
And then secondly can you provide any additional details on indications you guys thinking about beyond second life mine. So the cool for agent 20.
34, and the PD lone CTL they come about thanks very much.
It is the perfect person to answer that question. Please.
Thanks very much. Thanks for your question, so I see Chile, four and PD, one data that interim analysis, what we're saying is it will be a meaningful analysis with a meaningful number of patients I hesitate to share with you right now the final number.
The data at the interim analysis is underway actively now this analysis will demonstrate.
It will share a more robust dataset to demonstrate that our products are active in second line cervical cancer and just a reminder density PD, one as a monotherapy and PD one CTG for as a combination therapy, where we believe we can expand the response rates.
And the durability of response in patients with second line cervical cancer.
We anticipate sharing these results out at a major conference.
In the absence of that will certainly inform the.
Our stakeholders and the mechanisms that are otherwise available. So we will be certain to publicize that data as soon as soon as available I'll also share that we anticipate sharing some additional data.
Some major medical conferences that will reveal the activity the clinical activity beyond second line cervical cancer and other indications where we've seen activity.
That appears to be what our experts call unusual our responses in certain indications. So those data in cervical and beyond cervical will be presented at a major upcoming conferences and all of these will support.
Carol outlined is our top priority and that will be to register and launch sensitivity for PD, one combination and PD one monotherapy for patients the second line cervical cancer.
We will develop register and launch in the U.S., we will seek partners for ex US and we will also enable access to these active agents to partners, who have complimentary technology, who need access to active PD, one and CTP four molecules. So all of that activity will be updated in our next our next call as we continue to make progress.
That's great thanks very much.
Our next question comes from Brian was new ski a private investor. Please go ahead.
Hello, Garo. Thank you for taking my questions my questions are.
Threefold, one is regarding the best financing.
So you can give us an update on that.
The second part is if you could maybe give us more color on the.
Independent financing of agendas.
How is that going.
And also a third.
Maybe in a general sense, if you'd give us an idea president Trump is mentions that you know he is going to be.
Pretty horse right to try and how that might be utilized by some of the mill.
The coach community.
Oh go ahead with maybe give us color, maybe if that can help.
Accelerate.
Programs that you've outlined thank you.
Thank you very much.
Let me ask answer the first two questions and then I'm going to make a comment on the third one that has trend address in more detail.
So the first question is about as best as you know, we announced best which by the way is a very innovative financing mechanism and I know there was a lot of confusion at the time as to whether or not Janice is going into the crypto contributors.
And and I am sorry about the fact that there was this confusion.
That impeded our ability to take it forward at that time combined with obviously the.
The state my associated with it.
So called crypto currencies.
And so we slowed down the process and in our last earnings call I made a statement that we expect to come.
Complete a financing with best or with any other mechanism that is designed for project financing by the end of the year and that remains on track now we believe best will have utility in many different formats in our industry and perhaps in other industries going forward. It is a novel idea. It is in incubation so to speak and.
We will be in the forefront when the time is right, but suffice it to say that we do plan on completing a best based or a.
Product based financing by year end for PD, one and perhaps for security for as well.
The second question is about agendas.
When will the independent financing for Gentris, you put into place. So we have been.
Going back and forth on this.
Possibility and we haven't decided that since we're so close to entering the clinic and the value inflection for a company once it enters the clinic with an eye in the filing goes up significantly we will slow down the process in order for us to benefit from that value inflection. So.
The.
Timing of that I anticipate will be in the next few months and probably be coincident with our entering the clinic.
Now the third and very important question by the way and thank you for this.
Is an issue that is.
Nobody's fault on one hand.
But it is very frustrating for us.
And it is also very tragic for cancer patients.
In the last few months alone.
Several patients that have come to my attention.
That have lost the battle for cancer, and even though I'm the CEO of Agenus and we have access to many many reagents.
The bureaucracy of the system and I don't mean, the FDA by bureaucracy or the system I'm talking about the bureaucracy of the entire medical establishment.
Our impede the speed with which some novel therapies that could be lifesaving to reach patients.
I lost.
A 26 year old bring you in Colombia.
Law students to gastric cancer, a few months ago and just about two weeks ago. We lost a mother of three in her thirties to breast cancer and the frustration is that we knew about these cases that come to my attention personally appealed to me.
And somehow the system prevented us to get some of the novel medicines to them in time to potentially saved their lives. So thats.
A sad reality today.
We're working very hard to change it.
But specifically your question about right to try which is a very important consideration. The FDA has allowed the industry to make some progress on all the progress that would like to make but some progress in this regard but jen.
Maybe you can provide some detail. Thanks for your question, Brian right to try his legislation for those of you who aren't aware that enables patients.
Who have life threatening diseases with.
Really nothing available for them that's approved they can enable access to these treatments.
They're the now legislation that will support this access however, as Carol mentioned there are many steps in the process that are independent of regulations and as the FDA and that requires willingness of treating clinician to treat the patient.
To take the time to actually submit the required documentation that's required to enable the product to ship to that patient.
And the institutions these hospitals to support physicians and enabling access so giving time to clinicians.
To prepare the documentation thats required.
This has no impact on a generous and the reason I'm sorry for that the right to try itself is we have a lot since our inception weve been committed to enabling access for the individual patients who need access to our therapies.
So when patients require access or request access and they have at treating clinician, who supported by their institution to enable access we without question will support that initiative and enable access to our products. Our products. So nothing has changed from our end, we are hopeful and optimistic that perhaps the regulations and legislations will remove some of the challenges in the process, but we still need to have treating clinicians who are who have the time and interest and willingness to support access and hospitals and institutions to enable that access and thats still a hurdle right now for patients and their families.
Thank you very much for taking my call.
Our next question comes from Zachary Ralston with retail. Please go ahead.
Yes. My question is in regards to spring unit is selling faster than anticipated and I Wonder is there any timeline you paying off against the debt associated with the development of that.
Sorry can you paraphrase that question clearly so we know what it is.
Okay. So there's debt associated with the development of shrink and the vaccine is selling faster than anticipated.
So I'm wondering if you guys have a time frame some wins genus is that will be paid off with that vaccine. Okay. So this is a big confusion and I apologize for this it's a it has to do with accounting standards, rather than anything else as something because of the unknown nature for the accounting system.
Of this particular royalty monetization transaction. It is recorded as debt on our balance sheet.
Which it is it is categorically isn't so we show on an entry in the balance sheet or is that.
Upwards of a 150 million plus.
And the reality is we Havent see Roe.
And I underline is zero exposure associated with that accounting entry. So we have zero debt with.
With.
Our royalty monetization process, what happens is that as the royalties are paid off to the company that we sold the royalties to that balance sheet entry.
Get extinguished, but under no circumstances would that translate to a debt for us.
Okay. So is there a timeline on when that balance sheet entry will be fully extinguish.
It is.
To be fully extinguished.
But remember it is not debt that will be fully extinguished. It's the entries that will be fully extinguished.
Sorry.
It is now only debt associated with the.
With the balance sheet with the royalty monetization.
Okay. Thank you for your thoughts.
This concludes our question and answer session I would like to turn the conference back over to go Orman for any closing remarks.
Thank you very much Brendan.
Just in closing I know that in the past Oh, we have been advised to restrict questions from non qualified institutions and analysts.
Is that policy will change.
I have decided to change that policy, so that every single investor retail investor.
It has an opportunity to ask questions of course, we ask your questions to be well thought through.
And so that we don't waste People's times on the call, but we welcome your questions going forward and if you have any additional questions post this call that you'd like to submit to us through our Investor Relations auto feel free free to do that as well.
But as you know we are.
Improving our communications with all constituencies very importantly communications with the investment community analysts and that process is ongoing.
We have a newsletter gets published every two weeks.
That is both an agenda centric piece as well as it will be increasingly and educational piece for the industry.
On the subject of immuno oncology, so that this very complex scientific and medical field becomes clear to people that.
Follow us invest in us and for people that do this for other companies as well.
And so that is our mission and we will continue with that.
Of course every time, we do something now, there's misunderstandings and confusions and other things that happen and so bear with us and we will clarify those misunderstandings and confusions and please be proactive in conveying your ideas to us so that we addressed them going forward, but thank you very much for your time and we look forward to your being.
And part of the agenda is family going forward.
The conference has now concluded. Thank you for attending today's presentation. It was minimal disconnect.