Q4 2020 Viridian Therapeutics Inc Earnings Call

[music].

Welcome to day, Viridian Therapeutics fourth quarter, and full year, 2020 conference call.

At this time, all participants and are in a listen only mode.

A question and answer session will follow the formal presentation.

If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.

As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host Dan Ferry of Lifesize Advisors. Please go ahead Sir.

Thank you operator.

Good afternoon, everyone and welcome to our fourth quarter and full year 2020 conference call.

Today after the market close.

We issued a press release, providing our fourth quarter and full year and 2020 financial results and business updates.

A replay of today's call will be available on the investors section of our website approximately one hour after its completion.

After our prepared remarks, we will open the call for Q&A.

Before we begin I would like to remind everyone that this conference call and webcast will contain forward looking statements about the company.

These statements are subject to risks and uncertainties that could cause actual results to differ.

Note that these forward looking statements reflect our opinions only as of today.

Except as required by law, we specifically disclaim.

Any obligation to update or revise these forward looking statements in light of new information or future events and <unk>.

Actors that could cause actual results or outcomes to differ materially from these from those expressed in or implied by such forward looking statements are discussed in greater detail in our most recent filings on form 10-K, and our other periodic reports on forms 10-Q, and 8-K filed with the SEC.

I would now like to turn the call over to Dr. Jonathan Violin Verde, and as President and Chief Executive Officer, Jonathan the floor is yours.

Thank you Dan and good afternoon, everyone. Thanks for joining us for our first quarterly update call as Meridian and therapeutics.

I'm joined today by Derek Katz, our Chief Medical Officer, and Jason Leverone, Our Chief Financial Officer.

I'll begin with a brief overview of the business and the development pipeline highlighting key progress we've made in recent months.

I'll, then turn the call over to Darin and joined US in January to provide an overview of thyroid eye disease and unmet needs, we see as opportunities for our candidate therapeutics to address.

And then Jason will review the financial results for the fourth quarter and full year 2020, We'll then open the call for questions.

Let me start by saying how pleased I am with the execution of a complete transformation of our business over the last six months.

This started in October with the merger of private and Iridium therapeutics with public Newbridge and therapeutics with a concurrent financing and <unk>.

Creating a brand new company.

I'm happy to report that we've made remarkable progress since then on many fronts and highlight a few we've integrated our operations and teams and Viridian is now based and both Boulder, Colorado and Washington, Massachusetts.

We have begun expanding our team to support our new mission and to build viridian for long term success.

This includes the appointment of I'll hit that in and as our Chief scientist and October Saar.

And he cofounded private viridian and brings to our team a wealth of antibody discovery and development experience and R&D leadership from both large pharma and small biotech.

We also appointed Barrick cats, and internationally recognized and neuro ophthalmologists as our Chief Medical Officer in January.

And introduce himself and his background to you today, but I am thrilled that iridium has attracted someone with this depth of experience and certain patients and leading clinical programs.

Most recently Barrett was at bridge Biopharma, where he develops therapeutics to treat orphan diseases.

I'm also happy to report that Barrett as quickly assembled a top notch ophthalmology team recently hiring and SVP of clinical development and VP of clinical operations, both of whom have deep experience and the ophthalmology space.

And as previously announced I was appointed President and CEO and joined the board in January.

And I'm truly delighted to be leading this company as we embark on a new path and seek to discover meaningful medicines for our patients.

Finally, we rebranded the company to route and therapeutics to reflect our new corporate strategy.

And which focuses on perceived gaps and how the biopharma industry contemplates and delivers innovation.

We believe we can pursue clinically validated targets with proven technologies and trusted modalities to bring new entrants to market, while taking less of the biology and technical risk and so often characterized as our industry.

We see opportunities to develop medicines that will be valued by patients payors and providers as exemplified by our program and thyroid eye disease.

The successful integration of our team recent appointments financing and rebrand and have strengthened our ability to develop a promising product pipeline.

Our lead program the Rd and per well one is focused on patients who suffer from thyroid eye disease, or Ted which is a common sequela graves disease.

And that is a sight threatening autoimmune disorder affecting your eye and tissue surrounding the odd, causing significant clinical problems, including impaired vision and risk of blindness, and a profoundly impairs patients' quality of life.

Currently there is only one FDA approved treatment for this indication and intravenously administered monoclonal antibody called <unk> that targets. The IGF one are the insulin like growth factor one receptor.

And this medication can be administered by infusion, which results and added costs and barriers to access for patients.

As a result, there remains and underserved community of 10 patients who either cannot access or do not adequately benefit from this newly validated mechanism of action.

The clinical science and this field is young and there are many unanswered questions about the dosages durability and best regimen of intervention and we intend to explore.

I'd now like to discuss the significant progress we've made and our R&D portfolio.

Our lead asset and the Rd and old one is and IGF one of our targeted monoclonal antibody, which we obtained under an exclusive license from image and.

And this antibody had previously been developed by Sanofi as E V E 16, and 42 and administered to over 100 oncology patients.

The data from that clinical program gave us a head start from development and has informed our plans to evaluate efficacy and thyroid eye disease.

I'm pleased to report that our own work has confirmed and extended data and the peer reviewed literature, our antibody <unk>.

Oh, one binds the same region of the IGF and ours to peso, but it does so with higher affinity.

It also blocks signaling for example, IGF one stimulated receptor phosphor relation and the same way that depends it does.

Looking ahead, the key step to opening a new R&D and initiating clinical trials as manufacturing new drug substance and drug product.

I'm pleased to share that we have completed early characterization.

And the data suggests the antibody is very well behaved for example, we've already been able to achieve solubility of 150 Megs per mill with good viscosity.

And this is the concentration that may be suitable for subcutaneous injection and we are working to further develop and characterize this formulation.

I'd also like to make a few comments on manufacturing.

And we've been closely watching the industry wide manufacturing challenges confronting biologics over the last year.

And as I'm sure you've noticed demand for biologics manufacturing is up and supply has been constrained both because of raw material shortages, resulting from unprecedented COVID-19 vaccine requirements and because operation Warped speed is displacing some manufacturing lines to make way for Covid vaccines.

We developed our manufacturing plans with great care and invested and three redundant CMC routes and an attempt to mitigate delays and uncertainties and stuff that would not have been ordinarily necessary.

And I'm very glad we did and manufacturer where ultimately working with has not been impacted by operation Warped speed and successfully completed the required tech transfer and begun manufacturing.

We can now confidently state that we expect to have clinical drug product on hand, and the third quarter and anticipate filing and R&D and the fourth quarter.

I'd like to express my thanks to our project team for so carefully navigating the complicated landscape. The Covid has created.

Looking ahead beyond the R&D filings, we continue to focus on testing <unk>, one per safety Tolerability and proof of concept as soon as we can and believe we'll have data from thyroid eye disease patients and the second quarter of 2020 two.

Once we have that data our goal will be to move quickly to evaluate different doses of <unk> one to inform dosing paradigms that we would then hope to test and pivotal studies.

Barrett and his new team has been hard at work optimizing our clinical development strategy and we look forward to sharing.

And our plans once we discuss them with the F D. A.

In parallel with the development of Vod and over one and we've also initiated via <unk> and <unk> program.

So to us and next generation IGF Oner antibody designed to reduce dose with a goal of expanding the settings of care by enabling convenient subcutaneous injection can.

And you do this with engineers and antibody with three key features including our highest entity per the IGF one arm.

And by a physical characteristics that support formulation to high concentration with low viscosity.

And and FC modification to extend half life, a clinically validated approach to reducing cumulative dose.

We believe the combination of these three features could reduce the dose required to deliver efficacy and thyroid eye disease, thereby enabling convenient low volume subcutaneous injections.

Our discovery team under his leadership rapidly evaluate and a series of potential candidates and window the field to a standout molecule, which is now and early manufacturing.

We remain on track to file and R&D for Abo two by the end of the year.

We plan to initiate clinical development by evaluating O two and a phase one single ascending dose trial in healthy volunteers.

In addition to safety and Tolerability pharmacokinetic and Pharmacodynamic data will help us to understand the potential for efficacy at lower doses and purchase has that or the Rd and old one.

We expect to have this data and mid year 2022.

Next I'd like to spend a few minutes discussing our discovery pipeline.

And our VR D and O three program. Our discovery team is evaluating some very early hypotheses for improving IGF oner antibody performance beyond what we've achieved a total of one and one two and.

These ideas pan out will be ready to allocate resources to advance this program to development. So we can stay at the forefront of the thyroid eye disease field.

We're also making good progress on PRT and O four which is an antibody discovery program sharing the same strategy as a thyroid eye disease program.

Clinically validated target and a branded market with low competition and our hypothesis for a compelling product profile that we can pursue without taking on high biology or technical risk.

We're not disclosing the target or indication yet for competitive reasons. However, we remain very excited about advancing this program to nominate and clinical candidates.

Finally, we continue to evaluate new opportunities to add programs to our portfolio that match, our strategy and we plan to select targets and indication as the V. R. D. N O five program later this year.

I'll now turn the call over to Barrett to offer some additional insight into thyroid eye disease its impact on patients and currently available therapy Darren over to you.

And thank you Jonathan.

It's been and exciting few weeks to say the least since I joined the team and I appreciate having this opportunity to provide an overview of where we are and our strategy for moving O O one and O O two into the clinic as well as the development of our preclinical pipeline.

And we just take a moment and provide a brief overview of my own background.

I'm trained as a physician.

And internal medicine neurology.

Homology with some decades of experience as a practicing ophthalmologists and to narrow ophthalmologist.

And have an extensive understanding of eye diseases, including Ted and the real world impact. These debilitating diseases have on patients' lives.

My career includes the residency and neurology at Harvard and <unk>.

Second residency and ophthalmology a tough.

Followed by fellowships and neurology at Boston Children's and.

Neuro ophthalmology at UCSF and in neurology, and the National Hospital, and Queens Square and London I served in leadership positions within the American Academy of Ophthalmology.

Association of University Professor of Ophthalmology.

And the association for research and vision and ophthalmology.

And well I've held the Georgia chair and ophthalmology as professor of Ophthalmology, and neurology and neurosurgery at the Albert Einstein College of Medicine.

Also served as their director of the office and clinical trials, both had Einstein and Montefiore and New York.

In terms of R&D.

Always had a strong attraction to helping identify and developing new therapies.

And active as a clinician scientist and a trial list and.

And during my time as chairman of the Department of Ophthalmology, and GW, I formulated and and sponsored a joined fellowship along with Dr. Wiley Chambers of the theater and ophthalmic drug development clinical trials and regulatory affairs at the F. D. A.

And then has the opportunity to transition really full time to drug development with high Tech, which developed the first anti VEGF product for HAE M D.

Following that I worked and ophthalmology drug discovery at Fovea Danube and Gen site.

And joining viridian I. Most recently worked at bridge bio surfing as President and Chief Medical Officer of both retina mechanics, and fortify their two ophthalmology subsidiaries.

So I'm delighted to join us from Radian team it shares my commitment to improving patient outcomes and areas that deserve additional efforts to me truly unmet medical needs.

In addition, giving the startup culture and energy of this company I recognized how I could have an impact as we pursue such orphan diseases.

Haps, most compelling and when you from me is the opportunity to work on too fast moving programs.

Thyroid eye disease.

Disease, I know well.

I know these patients.

And care of these patients.

Ted is in fact, a debilitating disease causes double vision and <unk>.

And facial tissue changes potential blindness, all of which significantly impact a patients quality of life and it pose a high physical and mental burden.

Ted caused the signs and symptoms that interfere with the patient's ability to read to drive and to comfortably navigate activities of daily living.

Deposits is the only FDA approved treatment for Ted it's and intravenously administered monoclonal antibody targets one G. F. One hour it's treatment entail eight intravenous infusions administered once every three weeks.

Total treatment of 24 weeks.

<unk> reduces proptosis tends to quiet the associated inflammatory signs and symptoms.

Peace.

Treated patients demonstrated improvements and double vision diplopia and also enhance quality of life.

And as assessed by patient reported outcomes.

These positive effects are not without cost or complication well.

And we're excited to have seen these data and the Fda's approval just last year.

All of this is just the first GAAP and this translational science story.

There remain many unanswered questions, what's the best dosage.

The best number of infusions and what's the best spacing between infusions what's.

What's the durability of the peso.

I can tell you my therapy and REIT treatment.

How effective is the peso and.

And patients with more chronic disease, where those patients with optic neuropathy.

And where those patients with visual loss.

And so and we believe there are lots of loose bricks to explore and improve upon here, which is our goal and developing Oh, one and O O two.

In addition, we believe subcutaneous administration.

Which we aim to deliver with our Oh two program.

And maybe even with our or one program could offer significant benefits to patients in terms of convenience continuity of care fewer complications and lower cost of therapy.

Patients currently receiving to pass this is a treatment center to receive each infusion requiring travel to and from the appointment and adding to the cost of administering the medication and therapy.

In addition, repeaters and infusions, because repeated pain and practical disruption and the lives of these patients over 24 weeks.

This brings me to our plans.

Our activities have accelerated over the past months, we've been actively building our clinical team we recognize that our people are our most important and valuable assets and we're delighted with the talent, we've been able to attract to date.

I have a very clear philosophy for drug development easily summarized.

Be creative.

And he adaptive.

Limited only by our imaginations.

Be able to implement and execute with precision.

And similarly, let us strive to do the right thing.

And do the thing right.

I'll now turn the call over to Jason who will discuss our financial results for the fourth quarter and full year ending 2020.

Jason.

Thank you Barry and good afternoon, everyone.

And we entered 2021 and a strong financial position and this year, we look to advance multiple programs and thyroid eye disease, while expanding our discovery pipeline.

As John mentioned and the fourth quarter, we added approximately $115 million and cash from the merger and concurrent financing.

The financing resulted in net proceeds of approximately $86 1 million.

As a result, we are well positioned to support the clinical objectives of our two lead programs and Ted and.

And to enable the advancement of preclinical candidates and our discovery pipeline.

We ended the year with $127 6 million in cash and investments, which we believe will be sufficient to fund our operations and in the second half of 2020 three.

Turning to revenue and expenses, which we also summarized in our press release issued after market today.

Revenue was 0.1 million for the quarter and $1 1 million for the year.

This compared to 0.9, and $4 5 million, respectively for the comparable periods in 2019 Rev.

Revenue decrease last year, primarily due to a decrease and R&D expenses reimbursable to us under our prior collaboration agreement related to the legacy micro RNA programs.

Research and development expenses were $15 3 million for the quarter and $28 3 million per year.

This compared to $8, four and $34 8 million, respectively for the comparable periods in 2019.

The increase in R&D expenses during the quarter was primarily due to a noncash license fee under our license agreement, we entered with Suncor and December.

Overall, R&D expenses decreased year over year.

This was due primarily to decreases and personnel related costs and clinical trial expenses associated with the legacy micro RNA programs last year.

These increases were partially offset by a noncash license fee under our new license agreement with Suncor.

We also reported acquired in process research and development expenses of $69 9 million during the fourth quarter and full year 2020.

All IP R&D expenses resulted from the acquisition of private viridian.

The acquisition cost.

Allocated to acquired IP R&D with no alternative future use was recorded as an expense at the acquisition date.

We had no acquired IP R&D expenses from 2019.

General and administrative expenses were $5 5 million for the quarter and $13 3 million for the year.

This compared to 2.5, and $11 6 million, respectively for the comparable periods in 2019.

The increase and G&A expenses last year was due primarily to increases in professional and personnel related costs, including consulting and contract labor.

Finally.

As of March 15th 2021, our total shares of common stock outstanding on and as converted basis was.

It was approximately $30 9 million.

This included $7 2 million shares of common stock and approximately $23 7 million shares of common stock issuable. Upon the conversion of approximately 355000 shares of preferred stock.

Our shares of preferred stock became convertible into shares of common stock. Following the results of a meeting of our shareholders, which occurred on December 31 2020.

And with that I'll ask the operator to open the call for questions.

Yeah.

Thank you at this time, we will be conducting a question and answer session.

If you would like to ask a question. Please press star one on your telephone keypad and confirmation tone will indicate that your line is and the question queue.

You May press Star two if you would like to remove your question from the queue.

For participants using speaker equipment and may be necessary to pick up your handset before pressing the turkeys.

One moment, please while we poll for questions.

Our first question is from Chris Howerton with Jefferies. Please go ahead.

Hi, everybody. Thanks for taking the questions and of course, congratulations and a transformative and of last year.

And so for me I think maybe just two questions. Some of the the inbounds that I've gotten recently from investors first would be you.

In terms of our interactions with the regulator and getting regulators excuse me and getting and I and do you filed.

By the end of this year I guess it would be helpful. If we could just get a little bit more color on what the operational activities that are gating to getting the eye and do you filed a would be one question and then the second question is what features in particular, you're hoping to gain alignment with on the F D. A and the subtext to that question.

And is that you know what would be the plans and expectations. If the F. D. A did not allow you to go directly into Ted patients.

And then the third question is related to freedom to operate so we've had some questions recently around the idea of whether or not you would have freedom to operate within the context of Ted given the fact that horizon, where other competitors may or may not have a blocking intellectual property.

Thanks for taking the questions.

Great. Thanks, Chris.

Good afternoon, and good questions. So.

Why don't I start with the IP question and then we'll turn to the regulatory question. So we are very confident and our freedom to operate keep in mind, we're not developing and Biosimilar, we're developing and what we think will be best in class product.

And and the Big picture.

When you look across pretty much every biotech indication there's multiple antibodies going after the same targets TNF CD 20, PD, one IL 17.

The the pathway. We have ahead of US we think provides us ample free or to upgrade and so we're just very confident on it.

And then.

And Oh, and I'm, sorry in terms of regulatory interactions.

So are.

We really are going to decline to comment on until we've completed our dialogue.

And we'll deliver.

And we'll share our thoughts on our.

Plans on the far.

And of those conversations, but we're we're very comfortable with where we are in terms of our plans and and their timing.

Okay, and then outside of discussions with the regulators is there any other operations or gating factors that you just need to accomplish to get the I N D filing.

But the key the key focus and and the biggest effort has been on manufacturing where and as I said, we've made some very nice progress.

And.

Despite the headwinds everybody's been patient and Covid, where.

I think were quite confident now that we're on a good path to.

We've done what we need to have done to support the IND by the end of the year.

Okay, alright, well, thanks for taking the questions and I'll hop back in the queue.

Our next question is from Jason Butler with JMP Securities. Please go ahead.

Hi, Thanks for taking the questions and congrats on all the progress we've achieved and and the short period of time.

This person is somewhat of a follow on question can you just talk about your progress with with clinical trial site selection and how youre thinking about where to conduct the trial from both AR VR D. O B R. E N O one and our two verses where the peso was was studied in clinical studies as well as words.

And you know the sites, where it's most frequently used commercially.

Yes, Hi, Jason.

And Darren can you comment on that please.

Luckily for US frankly, this is a relatively smaller community of tertiary care physicians, who wind up making therapeutic decisions for these patients.

And it's a small community we know each other and.

And we know the sites that were used in the past.

We also know that many of these sites are interested in continuing their clinical trials. We're aware that there is many of the patients out there that do not qualify for this drug and we've been thoughtfully talking to the potential P ice insights about their level of interest and facility.

To become up and running as a site with relatively quicker.

Quickness and so what that means is we're casting a net widely we're casting and that most especially in North America for this but we're optimistic that the sites and the Pea is and the patients are out there for us.

Great helpful and and then Burton you talked about some of the you know potential learnings from the past development program and in terms of you know dose and dose regimen and.

Opportunities to further evaluate would be our D&O are one can you maybe talk about what your biggest learnings from the commercial launch of <unk> has been and how that plays into your thinking about the development programs.

And I guess, what I would say is I would rather not comment on another company's behavior.

And good or bad and certainly horizon has much to be congratulated for.

But most compellingly for us we want to establish a proof of concept and with efficacy of our antibody and we fully expect to explore dose ranging activities and look at other avenues of administration. Besides the intravenous infusion.

Okay, Great and then just last one from me.

What will be the gating steps to giving more color on additional programs like the our D. N O O. Four is it is it pattern.

Is it patent related or will you wait until you are close to entering clinical development or both or other things.

Yeah.

Thanks, Jason and that so that's that's obviously a competitive consideration and that's that that's a balance we'd love to share what we're doing we're very excited about it but.

But you know don't want it to tip, our hand too early and so you know what when the balance papers discussing what what exactly did you know force for will.

We will we'll happily share it but we haven't really given guidance on when that might be.

Okay, great. Thanks for taking the questions.

Our next question is from Leland debt got a shell with Oppenheimer. Please go ahead.

Hi, Thank you for taking my question and and my congratulations as well it sounds like and.

<unk> progress from the subcutaneous Ah possibility for 001 just.

Just wanted to get kind of further color, where you think you are and and that opportunity or are you. Do you think you need more development of the sub Q formulation or is it just a matter of more kind of testing and evaluation and should that move into the clinic could you. Maybe if you could describe to us a bit more what are your clinical development plan would be that kind of alongside the IV.

As you move into.

2022.

Sure Hi, Leland and yeah, that's exciting progress.

And really looks highly likely now that we can achieve a formulation that's appropriate for the kind of convenient low volume subcutaneous injection that we think would make for an approved product.

We'd like to be ready to explore this route and the clinic. After we've established the IV proof of concept.

But yeah, I think of it as a really nice upside potential for this program.

When we conceived it below one that debt.

Baseline was that it would be.

And I E.

And IV drug.

I was thinking that sub Q as possible now and it looks more possible, especially if it is active at relatively low doses and that that of course and the next thing that we need to figure out is.

And what doses deliver the efficacy that these patients need.

Got you so it sort of is it a question perhaps of increased frequency, but sub Q.

And and therefore getting the same amount of drug on board or you don't really know yet you'll have to wait until clinical evaluation for kind of the.

The dosing intervals and the the amounts.

Right, there's obviously a trade off between the amount of drug you get the frequency with which you have to give it and.

The key thing we need to learn to make.

Nick I understand what what that profile might look like as the doses that deliver efficacy and that's that we can find that out with IV dosing.

Alright, Great and then if you could remind us for one or two do we have a sense of what the dosing and triples would do this claims and.

And though it's still preclinical but.

And on the day that you have if you could either remind us for sure.

Share with us what the view is on on the frequency.

Yeah, Great Great question, we really need the human PK to understand that and I'm actually really excited about.

The first clinical experience, which we think will be healthy volunteers.

And the PK from that study should help and answered. The question that you just posed and so even before we have some efficacy data from that molecule and I'm, hoping mid.

Middle of the year next year, if we have some nice proof of concept that from a one that will support that we're able to find molecules that deliver the kinds of efficacy that the deposits as shown this mechanism can do so if we establish that we're able to find molecules that deliver efficacy and then we have and hopefully some impressive PK out of.

Oh, two and that would put that program and a very good position, even before we get into thyroid eye disease patients.

Right Yep, Okay, we'll look forward to those updates thanks very much for taking my questions.

Our next question is from Laura Chico with Wedbush Securities. Please go ahead.

Good afternoon, guys. Thanks for taking my question and just wanted to start off maybe Oh, one and the phase two study.

And you know Bert you talked about earlier around the SL.

And essentially setting a high bar here I'm just curious if you could maybe opine a little bit on what you actually need to see coming out of the phase two study in order to consider advancing Oh, one I guess also and the context of O. Two if it's more on just that and similar efficacy is there other benefits you.

Looking at just on the Oh, one side and then I have a follow up comes from the wall.

Great. Thanks, Laura this is John and the other day or at least please go ahead.

I think that's the peso has shown very very impressive efficacy.

And the efficacy comes at a cost.

There are significant downside to this intervention with that drug and.

In terms of patient and convenience patient cost and frankly side effects from muscle spasms to deafness to inflammatory bowel disease.

To glucose intolerance, and we expect in fact with our antibody to be able to mitigate the side effects and be first in class.

That's very helpful and just in terms of my follow up question, and then and I think you've kind of answered this a little bit, but I'll, just clarify and Oh, one and O O. Two should we presume that you would be considering advancing both in parallel in the future and I guess you know.

Garrett mentioned, there might be opportunities to pursue both the acute Ted space, but also the chronic and certainly seems like one may be better suited there so and just to clarify would you be looking to advance both of these and parallel.

Going forward.

Sure sure I'll I'll take that one.

Look at worse its redundancy to have these programs and parallel right. It's multiple shots on goal.

And at best is the half life extension and other features that we've engineered in total.

And to work it could be meaningfully better and over one so it very much satisfies our goal of staying at the forefront and field Bill.

And that the kind of questions that youre raising are extremely interesting, we just need to see some clinical data from these molecules to understand how the pieces fit together.

Okay. That's helpful. John and maybe just one quick one to sneak in here and just in terms of R&D expense.

And as they indicated cash runway into the second half of 2020 three but wondering if you could just kind of talk a little bit here about the cadence and spend in 'twenty, one just what Oh, one and O T and progressing towards the clinic here, thanks very much.

Sure, Jason and that's all you.

Great.

Thanks, Laura I think the first thing to point out is our expenses and our burn or and will not be comparable to last year. Our operations are different you know prior to the merger we were in a cost cutting mode, but this year, where we're really investing to build out the team advance those programs like you said at the same time and also invest.

Meaningfully and our discovery pipeline so we.

And we Havent give giving guidance exactly unexpected and I do expect some degree of variability quarter to quarter, but what we've tried to do is really carefully consider this and are reflected cash guidance today.

Thanks very much.

Our next question is from Michael Higgins with Ladenburg Thalmann. Please go ahead.

Thank you congrats guys and our continued progress a couple of questions for you from this week's news out of China with volume all those companies Dennis Biopharma.

And which are your assets are well noted.

And if you can give us any guidance as to the progress of those plans.

Obviously, it's a it's a theme that's leading that but are there also seems to be your assets. So we can put some timing a feedback from you and also any any feedback on the terms and.

And we might when we might see some some activity there.

Sure. Thanks, Michael maybe I'll I'll describe that and that's a little bit since it is a new company. So this is.

And it's based in the U S and China.

And as he noted it's founded and led by strong teams better interest both U S and China biotech.

And.

We've granted Dennis rights to develop and commercialize our IGF oner antibodies and China, where we know there's high unmet need and we see numerous ways of working with us to maximize the value of our thyroid eye disease programs worldwide.

We haven't disclosed numbers really.

What we're focused on at the moment and but it's a highly collaborative relationship. There's just a lot of value and working with them as we generate data.

Worldwide to maximize the value of our programs.

Just a follow up on that and if I could.

Might be something might we see something posted and may from Q1 related to the terms of this agreement that's announced in March and also and are on the other half of that is and their potential for reduction and cost as you proceed and development.

Yeah. So we've we've not shared and your plans and stuff.

And what we will and wont disclose them obviously any relationship like this is helpful. But I'll point back to the cash runway to chase and has mentioned it was really our baseline and how we'll be operating.

[laughter].

Thanks.

Just one last question on that.

In terms of the timing there and Europe is it fair to think that they're roughly two to three quarters behind and regulatory wise and I guess [laughter] I guess the second one here sorry.

What should we look for from Europe is that also a similar kind of a timing thing.

Yeah. So.

And so really can't comment on Genesis plans for China and.

And while we're certainly interested in Europe, we've not said anything about our specific claims there.

But certainly we would reiterate our interest.

I appreciate it thanks John.

Yeah.

Our next question is from Vernon Bernardino with H C. Wainwright. Please go ahead.

Hi, everyone, John and Jason and.

Thanks for taking my question and connect with you.

Dr Katz.

And true, perhaps a question and more directed towards you.

And from your learnings.

And the side effects, which here and go there and other than.

The routes or different routes.

And the administration just wondering if you had and what's happened and I didn't know what.

There are efficiencies that you could probably gain from the development pathway for all of you already and Oh, one and Oh, two such debt it could be Oh actually advanced faster or do you think it will probably follow the same kind of timeline.

And I'm, saying and size of studies and so on.

Okay.

Yeah, we we've not said anything about our later stage development timelines, but I'll, let derrick comment on the <unk>.

General question.

And I think one of the advantages of the strong efficacy of.

This receptor blockade is the large response between the drug treated patients and the placebo treated patients. So what that means is and and as you've seen and other studies and Ted. This means that you can get away with smaller numbers of patients, but again, we're talking about our drug and we expect to be doing this and it very carefully.

The planned development path that will be vetted by the agency to help us walk through the steps that will be needed to bring this through to the Ted patients and to do our exploration and both of the dose ranging needs and have the alternative routes of intervention.

And your basket and it's.

Because of the differences.

And if you know and and that's how you can probably hear again.

Oh, why some of those same side effects or.

Is it a matter come here and so as far as dosing and therefore, a cheaper and a better efficacy.

And I think both to be Frank.

Okay. Thank you and I appreciate that and Hum.

And the progress on the <unk>.

And congratulations on the combination I look forward to your and your days.

This concludes the question and answer session I would like to turn the conference back over to Jonathan violin for any closing remarks.

Thank you and thanks, everyone for joining us today and as I hope you've heard we're very excited about our recent progress and upcoming milestones and we look forward to updating you as our programs and dance so with that we'll close the call.

This concludes today's conference call you may disconnect. Your lines. Thank you for participating and have a pleasant day.

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And.

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