Q4 2021 CohBar Inc Earnings Call
Good afternoon, My name is Kyle and I'll be your conference operator today at this time I'd like to welcome everyone to co bars fourth quarter and full year 2021 financial results conference call. All lines have been placed on mute to eliminate background noise. 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. Please note. This conference is being recorded now I'd like to turn the call over to Jordan <unk> director of Investor Relations at Khobar.
Thank you Kyle and thank you everyone for joining <unk> fourth quarter and full year 2021 financial results Conference call. Joining me on today's call is just theoretical by Chief Executive Officer, and Jeff You know cause ice Chief Financial Officer, I would also like to take this opportunity to welcome Dr. Nick Oaxaca cause by a newly appointed.
Chief Medical Officer will also be providing remarks today.
Following our collective and Mark will conclude with Q&A at which time, Dr. Ken Grindstaff SVP of research well all right.
Cobalt is financial results press release issued earlier today and may be downloaded from our website echo by Dot com.
Before we begin I'd like to take a moment to remind listeners that the remarks on today's conference call May include forward looking statements within the meaning of the securities laws. These forward looking statements include but are not limited to steven's regarding the company's business and financial strategies plans and expectations for its pipeline product candidates.
The therapeutic and commercial potential of the company's pipeline product candidates in other therapeutic somebody might've plus platform statements regarding ongoing and planned research and development activities, including planned clinical trials regulatory status in the strategy and the timing of announcements and updates relating to our regulatory filings.
In clinical trials.
So partnerships and our capital resources financial and operating performance and ability to fund our operation for.
Forward looking statements are based on current expectations projections and interpretations.
While the number of risks and uncertainties that could cause actual results to differ materially from those anticipated by co pack.
These risks and uncertainties are described in our registration statements reports and other filings with the Securities and Exchange Commission and Apple applicable Canadian Securities regulators, which are available on our website at Khobar dotcom SBC that Gov, and SEDAR dot com as well as in the Safe Harbor statement included with today's press release.
You are cautioned that such statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward looking statements.
Cobalt does not undertake any obligation to update publicly or revise any forward looking statements or information, whether as a result of new information future events or otherwise.
Now I'd like to turn the call over to Joe threat Goodbye, Chief Executive Officer, Joe.
Thank you Jordan and thank you everyone for joining us this afternoon.
This past year, it's been an eventful one for Khobar. We're pleased to have made important advancements in 2021 across all aspects of our business.
Our programs, our human capital and our financial strategy.
We announced positive topline data from our first clinical trial in the process of demonstrating clinical proof of concept for our platform and approach.
We nominated our second clinical candidate for clinical development.
We continue to develop our motto plus platform.
Key members to the board and leadership team, which strengthen our ability to execute.
I'd like to highlight two of those recent appointments Dr 10th grind stuff in the newly created role of senior Vice President of research, where he was responsible for overseeing our discovery and preclinical activities that doctor, Nick Vlok us as acting Chief Medical Officer.
Kansas is a molecular cell biologist and biochemist with extensive experience in drug discovery several companies in the Bay area, including co bar, where he previously served as VP of biology for six years.
As a result, he brings considerable institutional knowledge and familiarity with our minor plus technology platform, which has enabled him to hit the ground running in his new role.
Part of the rationale for bringing him back to the club our family is to increase our discovery activities, which we will discuss in more detail in a few moments.
Yeah cause an accomplished pulmonary and critical care physician, who did is training and then served on the faculty at the Mayo clinic in Minnesota He.
He subsequently moved into industry and has extensive experience in all phases of clinical development, but first in human trials three phase four studies.
Because also worked across a wide range of therapeutic areas from hematology dermatology to respiratory.
Notably the ladder also includes work in idiopathic pulmonary fibrosis. The initial indication we are pursuing for our C. P 50, 138 S III program.
Well, Nick has worked with industry leaders such as Genentech. He also has experience at smaller companies like Kumar.
Finally, he has expertise in biomarker discovery and the strategy for using Biomarkers, that's clinical predictive or prognostic markers give.
Given his wealth of experience, we are thrilled to have them as part of the cobalt team.
In addition to adding 10 connected to cope our team and our press release today, we made several important announcements about the direction and focus for the company in 2022 and beyond during our remarks today. Our goal is to walk you through the thinking and implications of these announcements.
I believe the cobalt is beginning 2022 from a position of strength.
This will be an important year of execution for us and we've been working hard to align our development strategy with our resources and the commercial competitiveness of our pipeline.
To that end, we've decided to focus on several key areas.
We are prioritizing the advancement of our IPF program C. P 50, 138 S III towards the clinic.
And well, we will be providing some important updates on this program later in the call.
We are investing in our novel platform to identify potential new product candidates with compelling scientific advantages.
As part of that process, we have decided to de prioritize our oncology programs.
Finally, with clinical proof of concept demonstrated in our C. B 42, 11 program. Our plan is for the future clinical development of this program to take place in the context of a partnership.
Okay.
Now I'd like to provide some more detail on one of our primary focus areas for 2022 advancing C. P 50, 138 S III towards the clinic for I P F.
Often disease that results in increasing fibrosis or scarring of the lungs and that continues to have a high unmet medical need for new effective therapies.
The two FDA approved drugs to treat IPF have modest clinical effects on the disease and are limited by significant tolerability issues, including gastrointestinal side effects and in the case of Pirfenidone photosensitivity issues.
Although current standard of care can slow the rate of loss of lung function. It has not improved or stabilized.
And patients continue to have high mortality rates and a poor quality of life with life altering symptoms.
Despite these drawbacks. The currently marketed drugs have done well commercially with annual sales exceeding $1 billion for Pirfenidone had approximately $3 billion for an intended it.
We think IPF is a significant opportunity where C. P 50, 138 S III could make a real difference for patients.
The IND, enabling studies for this program continued to progress.
The purpose of these studies is to ensure that C. D. 50, 138 does three can be reliably manufactured.
And to demonstrate safety and animal models prior to subcutaneous dosing in humans.
We have successfully scaled our manufacturing necessary to support the initial clinical study.
In terms of safety, we have not seen any notable systemic toxicity to date and our ongoing written our nonhuman primate studies.
These results substantially Derisked the program.
At the higher dose levels in our Monkey studies, we have seen some local skin reactions, which is not uncommon in the early stage stages of development of peptide therapeutics.
For example injection site reactions were seen in the initial development of many G. L. P. One agonists.
Additional formulation work enabled this class a peptide therapeutics so become a cornerstone in the treatment of type two diabetes generating sales of approximately $13 billion in 2020.
Well, we have identified several formulations of C. P 50, 138 S III with encouraging solubility and stability after.
After extensive consultations between our team and our expert formulation and toxicology advisors. We have decided that further formulation work is required prior to filing our A&D.
We believe improved formulations will enable us to not only decrease the risk of local skin reactions in humans, but can also increase the systemic exposure of C. P. 50, 138 S. Three which has the potential to translate to better efficacy in IPF patients.
Although we are still finalizing the exact implications for our timelines, we now expect to file the IND in the second half of 'twenty 'twenty three with our initial human studies will start shortly thereafter.
This timing was impacted by several important factors, including the additional formulation work.
Well as delays in working with our CRM in China related to increased shipment times and the recent disruptions from the spread of COVID-19 in Asia.
While we are disappointed in this delay we believe that taking the time upfront to it to further improve the formulation mitigates risk and it's likely to save us time and money in the long run through reducing the risk of skin reactions and enabling a broader range of doses in humans, which taken together increases the likelihood of a successful phase one study.
And it has the potential to enable higher dosing and our subsequent studies in IPF patients.
In addition to these activities our R&D team is working diligently to identify potential biomarkers associated with C. D 50, 138 times three treatment and to further elucidate its molecular target.
Nick will discuss the importance of this ongoing work and its implications for our clinical development plan for C. P. 50, 138 does three in a few minutes.
Yeah.
Another area of focus for us is securing a partnership to enable further development of C. B 42 11.
In 2021 we recognized a critical milestone in the company's history. The positive topline data from our first clinical study.
With the phase one a one b trial of CB 42, 11, which is under development for the treatment of Nash and obesity, we demonstrated clinical proof of concept not just for this program, but also for the broader proposition that novel analogs of mitochondrial peptides can have important systemic effects in humans.
As you recall in the one b portion of the trial, which involves obese subjects with nonalcoholic fatty liver disease.
Treatment with C. B 42, 11 resulted in robust and significant decreases in markers of liver inflammation, which suggests an improvement in liver health compared to placebo as.
As well as significant reductions in glucose levels, indicating an improvement in metabolic homeostasis.
Beyond these exciting efficacy signals the study met its primary safety endpoint.
The clean systemic safety profile. It's T. B 42, 11 validated our hypothesis that analogs of naturally occurring mitochondrial peptides well have fewer off target effects than drug candidates develop from natural sources.
And as I mentioned earlier, our work to date and C. B 50 138 S. Three it provides further support for this proposition.
This not only decreases the risk the development risk of our product candidates, but also provides the potential for important clinical and commercial advantages.
We firmly believe in the potential of C. B 42, 11 and are working to secure a partnership to support additional development of this program.
Turning towards the remainder of our pipeline.
Excited to report that we are increasing investment in our minor plus platform to identify additional peptide families significant potential to result in valuable new treatment options for physicians and dramatically improve the lives of patients.
In fact, we believe we've only begun to scratch the surface of the potential of our peptide library and we expect that this additional investment in our discovery efforts will pay dividends in the future leading to the identification of additional indications, where our peptides can bring substantial advantages.
Due to this realignment and our strategy, we have decided to pause further investment in our oncology programs.
While we continue to believe in the potential of these novel analogs oncology is a particularly competitive space with multiple approved drugs in a crowded development pipeline.
As part of this effort. We are also evaluating where our C. D 50, 64 analogs fit into our future development plans.
In all cases, our focus is on moving forward those programs with the highest scientific and commercial promise.
We look forward to providing updates on our discovery work on future calls.
It is my pleasure to now introduce Dr. Nick Floccus, our acting Chief Medical Officer, who will review our current thinking about the clinical development plan for IPF program in more detail Nick.
Thanks, Joey and good afternoon, everyone.
I'm very excited to be joining the cobalt team and to help with realizing the therapeutic promise of this portfolio novel mitochondrial peptides.
Our growing understanding of the role of mitochondria has clearly shown its not just the engine itself, but also I'd plays important roles in critical biologic disease pathways such as fibrosis.
Joey mentioned I'm, a pulmonologist and over the years have taken care of many people with lung fibrosis, both in the clinic and intensive care unit and I'm intimately familiar with the devastating burden of disease and the unmet need for these patients.
I'm looking forward to helping me <unk> 50, 138, gosh three into human studies molecule that has the potential to provide a novel and effective class of therapeutics to IPF patients, who still need new medicines that will improve their lung function prolong their lives and improve.
The quality of life.
As a reminder, C. D 50, 133 is a member of the family of peptides that have shown broad anti fibrotic properties in multiple in vitro and in vivo models of IPF.
Based on studies conducted in cultured human lung cells. These peptides are pizza work by reducing the production of key proteins involved in fibrosis and by inhibiting pathological fibrotic process of so transformation from healthy lung cells the fibrotic cells.
<unk> in a therapeutic mouse model of IPF, we showed the treatment of animals, beginning one week after the induction of fibrosis with bleomycin.
Positive effects on old study outcomes.
Reducing the level of lung fibrosis measured by the Ashcroft score and lung white as well as the levels of collagen accretion in deposition.
G. P 50, 138 Dash three also has the potential for an improved safety and Tolerability profile, which could provide important clinical and commercial advantages are the current standard of care.
The anti fibrotic effects of C. B 50, 138 dash three in the rodent bleomycin model of lung fibrosis is highly encouraging and provides us a strong rationale to move forward with human studies in patients with IPF and potentially expanding from these initial opportune.
T into other fibrotic conditions.
The Bill would effectively on these encouraging in vivo findings and to optimize the probability of success for a Thursday in IPF patient study near term development of C. D. 50, 138 Dash three we'll focus on expanding our core understanding of the molecule and its effects in two.
Key strategic areas.
Through 10th and his team's ongoing efforts, we will further refine the depths and fidelity about molecular understanding of C. B 50, 138 dash three's relevant biologic effects, which in turn we expect will support the additional build out of a biomarker and pharmacodynamic approach.
In the clinic for the IPF studies.
Second we plan to clearly define C. B 50, 138 Dash Three's safety Tolerability and pharmacokinetic properties in initial human studies across a broad range of dose exposures.
This will enable a well informed approach to dose ranging in IPF patients.
We believe the learnings from these two strategic areas of drug development are foundational for effective study design for our IPF program.
And we will optimize the balance of probability of success against resource and time considerations.
Most effectively and efficiently achieved this following the submission and clearance of IRI and D. Clinical development of <unk> 50, 138 Dash three will begin with a phase one single ascending dose and multiple ascending dose study in healthy volunteers.
As one clinical research unit.
We plan to quickly followed this study with a multi center phase II study in IPF patients.
Well <unk> had previously discussed conducting a combined phase one two I study under a single study protocol. We believe our current approach carries a number of advantages.
From an operational perspective, having two separate protocols is a more efficient way to move forward without significantly impacting the overall development timeline.
By utilizing a dedicated phase one clinical unit, we expect that recruitment of this phase one study will be accelerated and enabled the intensive monitoring required to generate the necessary PK safety and Tolerability data from this study.
In addition, this approach also affords us optionality for the Phase II study and decoupled from the IND filing.
By separating the phase one and phase two studies the design of our first study in IPF patients can be optimized on the foundation of accumulating C. D 50, 138 dash three clinical and biologic data and ongoing input from our close collaboration with leaders in the fields of <unk>.
P S biology, and clinical trial design.
Altogether. This will help inform T design elements of the phase two trial, such a study duration dose levels and the most appropriate proof of concept endpoints beyond safety Tolerability and PK.
Overall, we believe this approach increases the chances of a successful and Docker rich phase two IPF study and as I mentioned earlier is not expected to result in an impactful delay to study initiation.
We are continuing to work closely with pulmonary leaders in the field of IPF as we build toward a phase one study in healthy volunteers and a phase two and Ips.
As Joe stated the phase one study will start shortly after our IND filing.
And with that I'll return the call to Joy.
Thanks, Nick I'd now like to ask our CFO , Jeff <unk> to walk you through our fourth quarter financial performance Jeff.
Thank you Joe and thank you everyone for joining us this afternoon.
Total operating expenses in Q4, 2021 were $2 $8 million as compared to $4 $4 million Q4 2020.
Which is a decrease of approximately $1 $6 million.
Research and development expenses, which included a vendor credit of approximately $173000.
We're $800000 in Q4, 2021 compared to $2 $7 million in the prior year period.
The decrease of approximately $1.9 billion.
The decrease in research and development expenses was primarily due to lower clinical trial and preclinical costs due.
Due to the timing of those expenses.
In terms of G&A, our general and administrative expenses were $2 million in Q4 2021.
<unk> to $1 7 million in the prior year period.
The increase there was primarily due to higher stock based compensation costs.
For the quarter ended December 31, 2021 cohort reported a net loss of $2 $8 million or four cents per basic and diluted share.
Compared to a net loss for the quarter ended December 31, 2020, a $4.7 million or eight cents per basic and diluted share.
Net loss included noncash expenses of approximately $600000 for the quarter ended December 31 2021.
$600000 for the quarter ended December 31 2020.
Excluding the noncash expenses Cobalts net loss was $2 $2 million for the quarter ended December 31 2021.
As compared to $4 $1 million for the prior year period.
As we begin 2022, we're in a solid financial position with $26 $2 million in cash and investments as of December 31st 2021.
As previously announced in the fourth quarter of 2021, we executed on an equity financing mix, a difficult market backdrop and biotechnology, bringing.
Bringing in gross proceeds to the company of $15 million.
Subsequent to the quarter end, we repaid the last remaining promissory note.
Totaling approximately $500000 in principal and interest.
As a result, we currently have no outstanding debt.
The cash burn for the quarter ended December 31, 2021 was approximately $3 million.
We continue to estimate that we have sufficient capital to finance our operations into the second half 2023.
Now I'll turn things back over to Joe Joe.
Thanks, Jeff before.
Before we take your questions I'd like to reiterate our key focus areas for 2022.
First we are continuing to complete the necessary studies to enable us to file our IND for <unk> 50, 138 deaths three well also proactively exploring formulation improvements to increase our probability of success as we move into the clinic.
We now expect to file our IND for this program in the second half of 'twenty 'twenty three with our first in human study to shortly follow that filing.
In parallel Kent and his team are working to further define the mechanism of action of this peptide analog and to identify relevant biomarkers that could be useful as exploratory endpoints in a subsequent phase two study.
We are also increasing our efforts to further characterize our extensive library of peptides derived from the mitochondrial genome.
Two identify those peptide families that show the most promise for further development.
In addition to the scientific data, we will be conducting a thorough commercial analysis to identify opportunities, where our peptides can provide meaningful value to patients and physicians.
Finally, we are seeking potential partners for C. B 42, 11 since we believe that is the best way to move this asset forward.
In summary, 2021 was an important year for Khobar, we gained additional confidence in our motto plus platform through the clinical proof of concept data with C. B 42, 11, and a strong preclinical anti fibrotic data for CB 50, 138 test three while also making significant improvements to our team.
I'd like to take this opportunity to thank our company's founders doctors Cowen Basel I am intruder, who have transitioned from our board of directors to our scientific advisory board or <unk>, where we continue to access their guidance and expertise.
Looking ahead, we are extremely optimistic about the future and we are focused on execution in 2022 to achieve our goals and continue to advance our programs.
I would like to thank our shareholders for their continued support which is an essential component of both our prior and future successes.
Kyle can you. Please open the line for questions.
At this time, we will be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue you.
You May press star two if you'd like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
One moment, please while we poll for questions.
Our first question is from Kristen Costco with Cantor Fitzgerald. Please proceed with your question.
Hi, good afternoon, everybody. Thanks for taking my questions. The first one that I had for you is what do you think as farmers broad view on the Nash space right now considering you're looking to secure a partner here for CB 42 11.
Typically what do you think that these larger companies are looking for in a drug as well as understanding around the regulatory space.
Yeah.
Thanks, Kristen I appreciate the question. So you know obviously, there's been a lot of companies that have been focused on the Nash space for development of new assets, given the very large market opportunity that that represents.
And we've been out talking to you know the usual suspects in terms of the types of companies that are interested in.
In continuing to pursue Nash and I think that the the pharma companies broadly it's yeah, it's hard to generalize because I think each company takes a slightly different view, depending on you know how they view a one.
The you know the Nash opportunity into how well that either fits or doesn't fit with their broader strategic objectives and sort of the rest of their their pipeline and portfolio.
So there's some companies I think that are taking a wait and see approach.
To see what happens, but there are also definitely a significant number of the companies.
That are continuing to evaluate the space that they believe it's a very large opportunity and they want to make sure that they have a seat at the table and in a in a way to participate in that potential opportunity and so they're looking at you know a variety of different factors, including yeah. The stage.
The stage of development, what's your your mechanism of action, how that either is a synergistic with or different than what other companies.
<unk> are arguing they certainly want to look at the safety profile given some of the.
I'm just sort of later stage issues. There. So I think it's a complex assessment.
That they are undertaking but I you know I think we've been encouraged that the companies are continuing to evaluate Nash assets and we've been like I said been in discussions with with lots of them. So in terms of the regulatory path.
You know I think that there is.
Ongoing you know sort of a tension I guess between sort of the the way the regulators and at least in the U S and Europe are looking at approval and endpoints and that does create some additional complexity in terms of thinking about you know sort of global.
Commercializing our products on a global basis, but I think you know that this is the first time, that's happened and I think big pharma is used to those kinds of challenges in working through them.
Okay. Thanks, and then part of your prepared remarks, I highlighted plans to develop additional novel peptide families with the might've bus platform and then also to prioritize some of the earlier work in oncology, So maybe I could ask broadly, which therapeutic areas, you're considering giving some of the preclinical.
I'll work that you've conducted here is really focused on metabolic effects across a number of signaling pathways that might be relevant for all different types of conditions frankly.
Yeah, a great question I appreciate that I might.
He used this opportunity to let the doctor can't catch Grindstaff speak to that since he's the one leading that charge.
Yeah, Hey, Thank you Joe Thank you Kristen for the question right.
Obviously, you touched on a point, where we feel we establish significant expertise around metabolism fibrosis and inflammation.
And obviously can teach us those formats to interrogate our micro cluster form.
But we're also exploring undisclosed disease areas at this time and as we as we gain information or we gain additional data along these lines provide updates, but you know the Gulf of research continues to be to identify novel peptide.
Potentially novel M of ways, and we feel this establishes a strong scientific rationale for the utility of these peptides to treat specific diseases as well as providing the scientific justification for advancing.
New program into development.
With the hope that that will further diversify our pipeline to address a wide range of indications and you know we were very encouraged by.
The continued publications in the field the growing body of evidence in the literature on MVP and we feel this provides for proof of concept.
Physiological importance.
As well as the potential utility of the use of these peptides as therapeutics. So.
We're leveraging the expertise that we have.
And but we're also developing.
Additional formats in order to interrogate we'll provide updates.
As that work progresses.
Does that answer your question.
Yes, it does and maybe the last one I have kind of it goes off of this a little bit and maybe it's a more longer term question for the company, but you talk about diversifying the asset than the indications you're going after but how should we also be thinking about potential synergies within one assay.
So for example, 50 138.
The preclinical effects that you saw across a number of cloud.
Inflammatory cytokine.
Do you think something like this could also have effect elsewhere or are you really just kind of looking to diversify all the assets collectively in an unique indications. Thanks again.
Sure no. Thanks, Chris that's a great question as well so yeah. The way that we're thinking about it we have discussed in the past you know we've been very impressed by the broad anti fibrotic and anti inflammatory effects that we see with the 50 138 family of peptides.
And so while our initial indication with 50 138 S. Three is IPF as we've discussed.
We have also been in parallel looking at other anti fibrotic models are.
To look for further potential indications for that peptide and so the work that we're doing now in terms of all the I N T, enabling work in getting into the clinic and and establishing sort of all of the important parameters that Nick discussed around the phase one study would be informative and helpful. Not just for IPF that could also then provide a solid foundation for that movie.
<unk> into additional indications for that particular peptide and so when we're looking and we find this peptide families that have these broad sorts of of features we do.
Currently do and we plan to continue in the future for additional additional peptide families look at you know potential synergies and other add on indications and that's certainly about our plan of 50 138 is to start with I T. F. And then look at a potential indications beyond that.
Okay.
Thank you.
Thank you.
Our next question is from Kumar, Roger with Brooklyn, Brookline Capital markets. Please proceed with your question.
Thanks for taking my questions are with regards to the formulation improvement block is it more related to like.
And our nanoparticle based on what kind of I D.
What is being done in the crime.
Ah Thanks Gabor.
So what we're really doing here is as we mentioned in the prepared remarks were seeing some local skin reactions, which is not an uncommon feature in peptide therapeutics, but our work on the formulation here is really about improving the.
The formulation in a way that would allow us to continue with subcutaneous dosing. So our plan here is to.
Still deliver the peptide subcutaneously, which we think you know it makes the most sense for this particular peptide and Nik maybe if theres more maybe you want to comment on our thinking there.
Yeah, I think that's right Joe regarding the subcutaneous the ultimate go as I had mentioned earlier was that.
The perfect set up for our IPF program is to be able to have a broad dose ranging approach in the phase one and so we really really would like to have the formulation optimized to have as broad a range of dosing as we can as we can manage in the phase one characterize.
PK very carefully in the safety so that in the phase two IPF study, we were able to likewise, those broadly and give ourselves every opportunity to show that.
Changes in lung function and outcomes that were hoping for.
Okay, and you're right.
Got you.
Okay.
What's happening with that product could be used for the.
Finally.
Yeah.
That's correct, yeah, we've already done some some scale up work.
And we're planning to use that that that's all GMP material that we can then use in subsequent studies.
So we're.
Confident on the manufacturing process.
Okay and you also talked about further evaluation of the mechanism of action and what that involved and any thoughts on that thank you.
Sure.
So you know I think I'll I'll ask maybe you can talk about a little bit about what we're doing and then and then Nik maybe if you want to follow that up with sort of how M. L. A you know it is relevant for us.
For IPF, but Kent, you want to start there.
Yeah, that'd be great. Thanks, Joe Thanks, Good luck with your question.
As we touched on obviously you know we've got some impressive data involvement both in in fibrotic readout as well as.
Anti inflammatory aspects for the 50 138.
Yeah.
Our focus really is has been you know ongoing right now to develop.
In vitro and in vivo.
Models that we feel are translatable that we can use to really interrogate both a fibrotic aspects as well as the anti in Florida and transitory aspects.
The ladder focusing on things.
Like cytokines and Chemokines.
And looking at Readouts for activity, where we announced the facts of the 50 138 dash. Three so you know these are kind of the classic type of models I'm sure familiar with Kumar that we have.
Continue to interrogate and looked for.
Positive activities there.
Can not only expand as Nick mentioned R. R.
And hopefully protect PD markers that we'll be able to use in our phase two clinical studies, but also to use those to work backwards and cover our molecular interactions that are occurring in vitro systems and hopefully identify oh.
MLA for this class.
Thanks, Ken Yeah, and maybe just to build on a couple of the points that you made.
I think a couple of things you know as Ken and I work closely together to think through Mark because that would be relevant for IPF and talking with a number of the.
Field leaders in the biomarker world it's.
It's clear that there are a couple of approaches to take both looking at biomarker is.
As a indicator of.
P D or pharmacodynamic effect.
Generally as it relates to fibrosis in the lung, but also specific.
Related biomarker is and that's where a lot of the focus will be I think it's also really important to understand that the program is not going to be dependent on absolutely nailing down the same away in P. D. Knock us I think theres a lot of examples not leased.
Which within IPF, where I'm moving drugs for wood.
Based on in vivo findings and a high level of FX that we know are good with the with the molecule.
Can lead to success in both the Philadelphia.
Tentative are good examples of that that has been effective they still room to move and improve on those but.
Hum.
Clarity around the M away and Pharmacodynamic markers in in those molecules.
We're not clear so we feel generally that the forward momentum for the clinical program is in good shape.
There's work to be done in and we think we can really build we can to put together a good program, but it certainly is.
Is not a prerequisite for us to get into a into the clinic and ultimately I P F.
Okay, great. Thank you so much.
Thanks Omar.
We have reached the end of the question and answer session and I will now turn the call over to Joe Sarrett for closing remarks.
Well. Thank you everyone for joining us. This afternoon, we look forward to updating you on our continued progress throughout the year Carl would you. Please conclude the conference call.
This concludes today's conference and you may disconnect your lines lines at this time. Thank you for your participation.
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Okay.
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