Q2 2020 CohBar Inc Earnings Call
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Good afternoon. My name is areas and I will be your conference operator today at this time I would like to welcome everyone to Cobar second quarter 2020 financial results Conference call. All lines have been placed on me to eliminate background noise.
After the presentation there'll be an opportunity to ask questions.
To join the question Q you May Press Star then one on your telephone keypad.
Should you need assistance during the conference call you may signal, operator by pressing star and zero.
I would now like to turn the conference over to Jordan Terrasi Director of Investor Relations I Cobar. Please go ahead.
And thank you everyone for joining called <unk> second quarter 2020 financial results Conference call.
On today's call is Steve angle corporate Chief Executive Officer can I be Cobots, Chief Scientific officer, and Jeff Thiede, Alcobra Chief Financial Officer.
Thank you filing and financial results, that's really where issued earlier today and maybe downloaded from our website at <unk> Dot com.
Having it she's joining the why back you can access the slide presentation on page uncle Bobs website to follow a lot.
Jeff will begin with an overview of the second quarter financial results, followed by a business and R&D update even cats.
Well, we begin I'd like to take a moment to remind listeners that marks 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 statements regarding the company's plans and expectations that needs to be 42 11.
Drug candidate program.
Another program.
In commercial potential of the companies, who need drug candidate CB 42, 11, and other mitochondria based therapeutics.
Regarding ongoing and planned research and development activities potential partnerships and our capital resources and ability to find their operations forward looking statements are based on current expectations projections and interpretation.
All the number of risks and uncertainties that could cause actual results to differ materially. Some thought was anticipated by cold. These risks and uncertainties are described in our registration statements.
And other filings with the Securities and Exchange Commission and applicable Canadian Securities regulators.
Which are available on our website at <unk> Dot com I see that God and see Dot com and what was in a safe Harbor statement included with today's press release.
Cautioned that such statements are not guarantees of future performance and their actual results may differ materially from those set forth in the forward looking statement.
Does not undertake any obligation to update publicly or provide 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 Jeff You know Cobots Chief Financial Officer, Jeff.
Thank you George.
Thank you everyone for joining us this afternoon.
Jordan mentioned, if you're having issues with Webex slide presentation is posted on the home page of the Cobar works like.
Exactly.
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It's Jordan noted I will begin with a review the financials, followed by a business overview by Steve.
Ken will then review the recent developments in our clinical and preclinical program I will conclude with Q1 day.
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Excellent.
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I will now provide you with a summary of our financial results for the second quarter ended June 32020.
Fair to the second quarter ended June 32019.
Total operating expenses in Q2 2020 were $2.936 million.
Compared to $2.957 million in Q2 2019.
Approximately $21000.
Operating expenses included non cash cost $693000 for the quarter ended June 32020.
$700000 quarter ended June 32019.
None of the non cash cost cooperating expenses in the current year quarter were $2.243 million.
That's compared to $2.257 million than the prior year period.
The decrease of approximately $14000.
Non cash operating expenses include stock based compensation depreciation and amortization costs.
Research and development expenses were $1.545 million in Q2 2020.
Compared to $1.418 million in the prior year period.
An increase of approximately $127000.
The increase in research and development expenses was primarily due to higher consulting costs.
And then increase in expenses related to our continuing development peptides.
General and administrative expenses were $1.391 million from Q2 2020.
Compared to $1.539 million in the prior year period.
The decrease of approximately $148000.
The decrease in general administrative expenses was primarily due to lower recruiting and travel costs.
For the quarter ended June 32020, Cobar reported a net loss of $4.103 million or nine cents per basic and diluted share.
Compared to a net loss for the quarter ended June 32019 of $3.058 million or seven cents per basic and diluted share that loss included non cash expenses of $1.779 million for the current year quarter at 800, a $5000 for the prior year period.
During the noncash expenses cohorts net loss was $2.324 million for the quarter ended June 32020.
As compared to $2.253 million for prior year period.
Total non cash expenses include stock based compensation depreciation and amortization cost an equity modification costs.
Moving to the balance sheet as of June 32020, Cobar had $12.3 million and cash cash equivalents and investments.
Compared to $12.6 million in cash cash equivalents as at December 31, 2019.
The cash burn for the quarter ended June 32020 was approximately two and a half million dollarss.
During the quarter, we wait we raised approximately four and a half million dollars using our aftermarket offering facility.
We estimate that based on our cash and investments balance as of June 32020.
We have sufficient capital to financial operations into the third quarter of 2021.
This revised one way Guy. This is the result of the funds raised in our ATM.
Extending the maturity date of promissory notes.
These from option to warrant exercises and delaying certain expenses, which we do not expect to materially affect our R&D programs.
During the quarter end the company extended the expiration date of warrants that were issued as part of the company's private offering completed in July 2017.
The expiration date of these warrants was extended from June 32020.
September 32021, what the balance of the terms and conditions of the warrants remain unchanged.
The company occurred a noncash modification expense charge of approximately $1 million to extend the warrants.
Subsequent to the quarter end the company entered into amendments with certain holders of its unsecured promissory notes.
The amendments, including modifications to the promissory notes, which is extending the maturity date June 32021.
On June 32022, and granted participating note holder certain other Reits and benefits.
For a detailed explanation of these amendments we see note 11 to our form 10-Q that was filed earlier today.
I'll turn the call over to Steve Steve.
[laughter].
[noise], Steve Steve Your line is life.
Oh.
Welcome everyone to our Q2 2020 call.
There are three key thing that are important for you to no. We have resumed the phase one be study and are expecting topline results in the first quarter 2021.
We announced new women are a preclinical results in our Cobot 19 Arts program today and expect to have a flow preclinical milestone.
Over the next three to nine months.
And for people interested and mitochondria Cobar remains one of the few vehicles or investing in the therapeutic potential of this new and emerging science next slide.
What is the Cobar opportunity we are the leaders developing a new class therapeutics based on our founders discovery.
Mitochondrial peptides regulate multiple systems and the body.
Think about that.
Prior to 2001, and Dr. Cohen discovery people thought the mitochondria were just powerhouses of the cell.
Because it isn't new class therapeutics. It represents a large untapped and exciting group a potential compounds over 100 peptide and over a thousand analog had been discovered and county.
We are targeting a wide range of diseases that are associated with mitochondrial dysfunction.
Why do you called me a base therapeutic.
Benefit I'm over a billion years of evolution and may generate entirely new approaches to disease.
We need new and different approaches the old ones may not have worked well.
We are taking advantage of the approach that the body has developed itself.
In the last year, the company's portfolios grown from two programs to five we're no longer just a dash focused company and have programs targeting hard fibrosis and oncology.
We have a number of expected near term milestones, including preclinical results and three programs and the nomination of the new clinical candidate by the ended the year.
The phase one B C. B 42, 11 clinical study has resumed with results expected in the first quarter of next year.
We have a comprehensive IP strategy and we enjoy a first mover advantage.
We are the leaders in the developed but Oh mitochondria based therapeutics.
Our IP portfolio is significant and continues to expand.
Next slide.
The revolutionary discovery behind Cobar as technology platform is the finding the mitochondria or more than the powerhouses. The sell that we learned in biology class and John.
So regulate sell organs and systems across the body.
This was a stunning discovery.
To put that in perspective, it is very rare for biotechnology company to discover such a large potential group of compounds that have not been discovered or developed previously.
Not the discovery approaching sequences any human genome.
Or the marinade proteins from companies like return.
I have so many potential compounds and discovered.
We are in the third generation of discoveries.
As Dr. Cohen.
Where's the us entering new era, the understanding of the complexity well organic small processes, whereby micro peptides that are Titan biological agents determine human pheno type.
Along side large gene.
In fact micro peptide may encompass and order of magnitude larger array of genes.
Then large protein.
We believe the size of this opportunity.
His past.
The results rough programs are showing us that we are actually identifying novel approaches to these diseases, which may provide added benefits. This is a kind of exciting scientific discovery that old great hope.
Or long suffering patience and humankind in general.
Next slide.
Based on the last two decades research overcoming mitochondrial dysfunction represents a very large opportunity for cobar.
We believe gold bars peptide they hold the answers for a number of major diseases shown on the right in this picture.
This is because mitochondrial dysfunction underlies multiple chronic an age related diseases.
Hi of D.A., leading causes of death.
Our associated with the impact.
Mitochondrial dysfunction.
Spending on these diseases represent as much as a how trillion dollars annually.
Yeah, well, probably not surprise you.
Mitochondrial dysfunction will turn out to be a large player.
In the susceptibility to co bid 19.
Diseases like diabetes, <unk> cardiovascular disease.
Maybe improved in parallel.
Due to the underlying mitochondrial dysfunction.
This dysfunction occurs when the mitochondria fail either due to aging.
Or lifestyle behaviors and other causes.
Next slide.
[laughter] died benefit from a billion years of evolution.
And today I provided novel mechanisms of action.
Which may provide new approaches to diseases.
For example.
Maybe 42 11 regulate the flow of free fatty acids from a different sites. This is a unique approach and the Nash space and is synergistic with existing therapies.
Another example is our Apple in AG, which uniquely buying to the App, one receptor and thereby resulting in a reduction.
Vascular leak edge fluid accumulation and cytokine storm.
Kind of the though.
That's a.
Co bid the D.
We are encouraged by our women are a data in cards, which Ken will share in his section.
In a similar action, our anti fibrotic and do you see our core inhibitor programs have demonstrated unique mechanism of action, which may provide more effective solutions and diseases as high unmet needs well potentially being better tolerated.
Next slide.
You can see our pipeline has expanded note that each one of these compounds represent a different family.
Tied structures they are not the same.
Each program is targeting multiple indications.
This is a true portfolio.
By multiple shots on goal and multiple events.
Of course with an expanding pipeline we are regularly evaluating our priority.
Currently our program priority our Nash.
Yes, I brought a peptides for IPO.
When agonists for Cobot 19 Arts.
Next slide.
That's cool coal bars founders, where the first to discover mitochondrial dry peptides, we have the advantage that being the first mover in the states. We were first to discover and first to develop.
We have 12 issued patents.
That have issued that.
Cover both composition of matter.
And methods of you.
We identified 100 peptides and the genome and then developed over a thousand analogs.
These analog.
Picket fence again other companies that might want to work in the same space.
And we continue to expand our IP portfolio and expect to remain a leader in this space.
Hi.
Regarding our gold some recent accomplishments first of all we presume the phase one be clinical trial.
We expect to identifier next clinical candidate for pre R&D studies by end of year.
With finite R&D fun. It is critical that we remain focused on the most important programs. We regularly prioritize our spending based on potential and progress currently our highest priority programs are the anti fibrotic and coupled with 19 associated Arts and then.
Hey.
The new Cobiz 19 hard target, we're investigating funding opportunities with the U.S. government agencies, such as NIH and BARDA.
And also looking to see if we can get their health and expediting the research.
I also know we were pleased to be added to the Russell.
And we were able to raise 4.5 million aggregate to ensure that our programs continue to be funded appropriately.
Our plan remain the same in that we continue to.
Need to find the programs ourselves until such time that we can bring in a corporate partner to help develop the assets.
We have resumed the clinical trial, which is added board to the project spending and we've been very successful in expanding our pipeline and now have significantly more opportunities than a year ago.
We have continued to be careful and conservative about our spending.
And so we have cash in the bank.
We have been spending approximately the same amount of money per quarter for some time now.
And now we have more programs and we have the opportunity to take advantage of their potential by increasing our burn rate, but we only want to do that if we have additional capital.
Besides adding capital our programs, we're looking to gain biotech focus institutional ownership and research coverage. We see this is an important next step and continuing to fund the company into reflect the company's value in the marketplace.
In the past quarter Brookline Capitals research analyst initiated coverage on the company.
We also continued to present the key banking conferences, we presented at the Sachs novel Corona virus investment Forum.
Which was a specialized conference on companies with Cobiz 19 programs like ours.
There's a cobiz 19 pandemic the biotech market has enjoyed.
Increased visibility in addition to the important in very visible work being done in cold bid vaccines and therapeutics there have been many positive data readouts across the therapeutic landscape.
We see this is the pause be for Cobar as we continue to increase our visibility within the investment community.
We anticipate expanding our efforts to develop partnering activities.
Around Cobar technology.
Particularly after we have the phase one a one be results.
We also were at bio 2020 in June during this quarter and had a very good set of meetings, it's quite obvious that companies that we met with a year ago and the Nash space are still very interested and we added a number of addition groups that are interested in both our anti.
Hi, broadly as well as our oncology programs.
As leaders in body Unreal drive peptide development, we expect continued to expand our IP portfolio.
Next slide.
These are the near term milestones over the next three to six now.
To nine months, we expect to have additional results dennard by the end of the third quarter and results from the anti fibrotic can see I see our core programs in the fourth quarter, we expect to nominate a clinical candidate from one of these programs by the ended the year and we expect topline results from the phase one piece.
Study and the first quarter of next year, our overall goal for the pipeline.
It's a generate programs, which lead to multiple clinical studies over the next few years.
Now I will turn it over to Ken Ken.
Okay. Thanks, Steve.
And good afternoon, everyone will now give a brief update on recent progress in a research and development programs.
So let's start with a clinical program CB 42, 11 is currently in phase one a one be clinical testing as a potential treatment for Nash in obesity. The phase one they stage of the study is complete we're currently in the one will be part of the study.
In March the phase one be stage of this study was pause to chew to covert 19. The post was lifted in early July and now all four study sites are open for screening and enrollment.
[music] sites was added or sites with extensive experience running Nash studies and they're running other studies in addition to us.
Now as a reminder, the phase one be stage of this study is a double blind placebo controlled evaluation of one dose level of CV 42, 11, given once a day it'll be subjects with NFL D.
This phase is designed to assess the potential effects to see before he to 11 or liver fat body weight and various biomarkers that are relevant to Nash obesity and metabolic disease.
Changes in liver fat will be assessed by an MRI pdfs and all subjects must have a minimal the 10% liver fat at baseline.
Now to give you some sense of the process here once we identified potential subjects from the databases that our clinical sites or through advertising they must be carefully screen to ensure that they qualify for the study.
Leading the extensive list the criteria for participation.
This includes things like not being on any other drug that might affect their liver fat that body weight or any of the biomarkers that we're looking at it includes specific ranges for certain lab values like liver function tests to ensure they do not have other health problems.
That long list of requirements as described in detail in the record is posted on clinical trials Dot Gov.
If subjects pass all of those required screening tests, they still have to pass the initial MRV scared to show that they have sufficient liver fat.
There's also a fixed window in which all of these tests have to be passed before you have to restart the whole screening process again only after the pass all the test within the window can they be enrolled now. This is an ongoing rolling process until 20 subjects have been enrolled and what we mean there by rolling enrollment is that when it.
Subject passes all the tests and qualifies for the study they can be entered into the study and dose without waiting for the rest to enroll.
So we effectively create a pipeline with subjects moving through the various steps in the process all the way to their final assessments.
No in the last of the 20 targets subjects received their last dose there's still a follow up period for safety observation to ensure their or no issues.
After all of the necessary data for safety pharmacokinetics liver fat body weight and Biomarkers are collected data then checked for errors and the database is locked.
In the analysis of the data begins.
Now at the study in roles at the rate we projected before Cobiz 19 came along we would be on track to have the topline results in Q1 of 2021.
It is possible that the timing of this study going forward, we'll continue to be subject to the effects of an ongoing covidien 19 pandemic.
The true post Koby 19 recruitment right well become clearer as we enroll further.
We expect to update the status once the last subject has had their last assessment.
Supporting on this program, we have key opinion leaders like Dr. role he loomba an internationally recognized expert on Nash.
Well, it's like Dr. Loomba, a recognized experts in the field, but help US designed studies and strategize for clinical and regulatory paths forward.
There are also thought leaders that endless follow closely for opinions on new treatment auctions in development.
Next slide please.
Now I'll give a brief update on new data from out to about preclinical programs starting with the CB 50, 64, and a logs. These are novel analog sort of might have culturally encoded peptide that have the potential to reduce cobot 19 mortality related to acute.
Respiratory distress syndrome or a rds.
Simultaneously blocking many of the processes that lead to global damage.
Now if you look on the right of this slide you see that covert 19 is not just a lung disease. It has global effects that all contribute to increased mortality, including vascular leakage fluid accumulation inflammation sepsis thrombosis and the cytokine storm.
Together these damaging effects of the virus can lead to respiratory failure cardiac failure stroke, and even multi organ failure.
There are no approved drugs to treat a rds and even without coated 19, I already s. effects 3 million people.
Oh, CB 50, 64 analogs work by selectively activating the Apple in receptor a key a dip a kind signaling pathway that has a broad protective rebalancing effect on numerous systems, including control of fluid levels vascular tone blood clotting inflammation and cytokine production.
[noise] Apple in signaling has been shown to protect animals in models at a rds sepsis thrombosis and stroke.
And we've now generated preliminary invivo data showing potential efficacy of our CB 50, 64 analogs in an animal model of a already yes, leading to reduce fluid accumulation in the lungs decreased secretion of pro inflammatory cytokines and reduced infiltration of inflammatory cells into loan.
Tissue all show some of the preliminary data in the next couple of slides. We are currently conducting confirmatory studies in a rds and exploring options for preclinical testing.
In actual coded 19, a or D. S models, while moving forward towards candidate selection scale up and initiation of Alain de enabling studies.
Now supporting US on this program is Dr. Toby Mayor, there's professor interstitial lung disease that Imperial College, London and now also on the faculty at U.S.C.
Next slide please.
And this slide we present, new preliminary data from efficacy studies is CB 50, 64 analogs in a standard mouse model of a rds using the bacterial life of polysaccharide or L.P.S. induced acute lung injury model.
No P. S is a talks and the generates very similar effects on loans to those caused by other diseases.
Animals received a single dose about peptide and logs one hour before the L.P.S. administration or a second dose six hours after L.P.S.
Now in this slide we're looking at low rates at either four hours or 24 hours after the L.P.S.
The Black bar is animals that did not receive the L.P.S. injury, the red bars animals treated with L.P.S. to induce the acute lung injury, and then given vehicle or placebo treatment.
You can see the long waits increased reflecting accumulation of fluid.
The purple bar is the natural Apple in a typical in and the green bars are for one of the L.C.D. 50, 64 analogs given here at two different dose levels.
You can see that this single dose of that particular analog in green reduce the increase in long wait, indicating a decrease in the fluid accumulation.
That protective effect was similar to or better than the effect of Apple itself. In this study and was maintained at 24 hours after the L.P.S. injury.
There are preliminary data here and we're now confirming these in additional studies.
Next slide please.
Moving to the extent we go thank you.
So in this slide we're showing now some preliminary data from the same studies looking at the effects of our peptides on the levels of key pro inflammatory cytokines things like I O six TNF alpha and others.
This is done by measuring the cytokine levels in the long fluid or the Bronco LDL levels fluid as it's called collected by reducing the lungs at four hours after the L.P.S. injury.
Okay animals engine with L.P.S. and treated with placebo shown in the Red bars has an increase in all of these side to Collins.
We see in the Green bars that CB 50, 64 analogs reduce the levels of key pro inflammatory cytokine is involved in.
No dose dependent mehta, surpassing the effects of ethylene. So once again these are preliminary data and we're now confirming these an additional studies in comparison to additional analogs.
Next slide please.
Okay leg on the slides here.
Okay.
Let's see we should be moving to slide 21.
So I'm not seeing a slight change here Jordan.
I haven't changed.
You have to chase. Okay, then obviously so.
Now, let's turn to our anti fibrotic peptides.
And these are the CB 50, 138 and logs.
First of which was NBT to peptide. We've previously shown to have efficacy in preclinical models of idiopathic pulmonary fibrosis or I P. S.
Well now generating new data demonstrating improved efficacy of additional analog in this family in the therapeutic mouse model of I P. S.
The data were presented in an E post Oh, the Americans thoracic Society virtual annual meeting just last week.
The post the also included our early data on the unless you fight brought it could anti inflammatory effects of the N. B T. Two in boasts a prophylactic and therapeutic mouse models of I P. S involving either immediate treatment without peptide after induction of fibrosis would be a myself or treatment. One week later after the <unk> Liam.
Listen injury.
The new data, we generated in the more challenging therapeutic model and all show some of the new results in the next slide.
The next steps in this program for us or evaluation of our lead peptides and additional preclinical studies, including addition to the standard of care with the goal of identifying a candidate for R&D, enabling studies.
Yes, the putting us on this program is pulmonary fibrosis expert dr. enough totally kalinsky, whose professor of internal medicine, and chief of pulmonary critical care and sleep medicine at Yale School of Medicine.
Next slide please.
Okay, I'm not showing here some of the new data on the anti fibrotic peptides that would just released in the Americas Cirrhotic Society Virtual meeting last week. In addition to the N B T.
Two also called CB 50, 138 dash one to newer analogs of CB 50, 138 were tested in the therapeutic I P. S model and then compared to vehicle could treatment in the red bars or to Nintedanib in the green bars, which is one of the two currently approved drugs for IP, yes.
And here you can see consistent anti fibrotic anti inflammatory effects across the board, including reductions in fibrosis reduce long waits reduced inflammation in terms of lymphocytes in long fluid reduced levels of college and both in the lung tissue and secreted into the long fluid.
Now across these programs. These are the most recent results from our ongoing work and we expect to have additional data on their preclinical programs in the coming months. The goal here is to identify potential clinical candidate from one of these ongoing programs around the edge of the year with that I will return the call to Steve.
Thanks, Ken Great stuff next time.
So obviously Nash is a large unmet medical need.
Over 30 million Americans are at risk for Nash in over 100 million.
Our obese and the U.S. the market has made it a $35 billion in this national landscape the opportunity besides being large and growing.
Because it's still early there haven't been or any drugs approved recently, it's a bumpy ride for companies were at a later stage of development.
And as a result, the list of these leaders if you will it has actually shrunk.
Hi, intercepts, if the a review was delayed gen pits compound failed.
But on the other side again, referring to it being bumpy Carol's results look good.
And none of this having nothing has of this has anything to do with us.
There I've also been to Nash company IPO was 89 bio and inventive up so it appears the so investors are still very interested in the Nash space.
Regarding clinical regulatory developments, everyone is learning a lot.
On the successes and failures in this therapeutic space.
This will inform our future clinical studies and regulatory strategy and hopefully allow us to move more effectively and quickly as well as increased the probability of success.
Regarding the competitive landscape there are a number of companies that are further along in the clinic.
Although they do not have our mechanism of action and there isn't need or a combination treatment of drugs not just one.
There is no direct competitor or our particular mechanism of action.
It is hard though for us to compare exactly to the other companies in the space as we're at an earlier stage and the differences in mechanism.
For example, a company like Taro has they re purpose drug that's already been tested and other indications in a phase two study and as a known mechanism of action. It recently announced positive phase two results.
And we believe though.
That with a 30 billion dollar potential market, there's plenty of room for other therapies like ours.
Regarding pardon me.
Very important part of our strategy to maximize the value of our overall portfolio, we want to use other people's money no howling capability to move multiple programs forward.
My last company, we had over 10 large pharmaceutical companies, who are paying us to develop compounds based on our technology.
In each case, we received a large upfront payment milestone payments and royalty.
We use the upfront payments to help pay for development.
Oh, our own products of which we wanted to develop and commercialize ourselves.
Based on experience meeting with partners Bio 2020, the Companys remained very interested the Nash space.
They are looking for new and different mechanisms.
And after the recent failures or there are probably some of the company's thought they had it all worked out who are now looking or new technologies and assets.
We again have a unique mechanism of action there is a need for combination therapy.
Our approach is potentially a little too all stages of batch and synergistic with the GLP one call compounds that are being used to therapy in this area.
At this time, we would prefer to sign partner that can provide the technical.
Organizational and financial support for Phase two study and beyond.
Our intent would be to use the upfront payments on the deal to cover the cost of other programs.
What we consider going alone.
Yes, the phase one be results were good enough the increase in value might allow us to do that but of course, we don't have those results yet. So all of that's an open ended situation at this point.
I would also note that when intercept or another company is a true this will be a break through for all of the companies in the Nash area.
And if it's like usual a number of pharmaceutical companies well redoubled their efforts to find compounds to develop.
Now, let's talk about value inflection, there's there's a lot of uncertainty about this but maybe some basics companies, which have late stage phase two results.
Early phase three clinical studies underway and valuations of over $1 billion.
So one hypothetically could draw us lying from our current market cap to those numbers and see that there might be one or two value inflection points.
For our company.
We believe also that signing up the first partner will be a major a bad as it will validate the technology as well as the program.
In addition, we have the advantage of a larger portfolio and the possibility of those programs moving into the clinic or being partnered in the next couple of years.
So we are more than just the Nash company, where portfolio with many shots on goal. If you look at companies like Fibrogen and Kadmon in the <unk> Yep space or you look at export pharma in the six year for arena.
The additional valuations can be hot.
Adding up the value of the individual programs. It gives you a much better sense the potential value of the total cobar portfolio.
Next slide.
Regarding the preclinical program opportunities, we know dennard, there's a high unmet medical need.
You know that that co bid besides co bed 19, Ards in general can be triggered by viral and bacterial pneumonia sepsis and trauma. Another events. There is no safe and effective treatment and only a 25% survival rate among coded 19 patients with cards.
3 million Ards patients worldwide.
Plus this new and growing group of patients with Cobot Ards.
Represent the larger number of patients that were talking about in this area.
And as Ken has indicated our Apple and agonists receptor is actually helping to normalize through the binding to the junction and receptor that results and activating multiple pathways.
And then the new data of course, and the Arts model and we're working to run the next study confirmed that I.
Let me add if I brought upside we note that I'd roddick diseases involve 40% of disease rated are involved in 40% of disease related deaths.
Her and long kidney liver and heart.
There's a high unmet need and yeah.
It's a very difficult disease, chronic progressive debilitating effects of over 100000 patients the U.S. and the approved drugs, Oh slows the disease, but have significant side effects and.
And then our most recent results. Obviously this is a big step forward in.
In this area for us.
Regarding the sexier inhibitors, we would note that there are over expressed a the receptors overexpressed in more than 75% of cancers. It has I can't it's a key pathway in tumor growth.
Angio, Genesis and metastasis and inhibiting this pathway as a number of positive effects, including one similar to what we saw on our mouse model, which is a synergy which enhances the use of chemotherapy.
And so these indications potentially include multiple cancer types.
And of course, the results that we showed already and that's melanoma model are quite exciting.
And finally, although we haven't talked about really in this particular presentation. We do have a lead in the immuno therapy area, which we're beginning to develop a lead family of compounds next slide.
Well I've mentioned in the near term projected milestones and so we think we have a pretty good flow of potential events. During the next three to nine months. So it's a very exciting time, if you compared to last year I think we'll do even better.
And then beginning next year, we look forward to getting these positive topline results, we hope from the phase one be study.
Again, our overall goal is that moving these programs Ford will transform the company and having a clinical trials in multiple indications over the next couple of three years.
So once again in the next slide if you would Jordan.
So we continue to realize the Cobar vision.
We have a highly differentiated.
Therapeutic platform.
With an entirely new class of drug candidates.
Potentially addressing multiple large indications with high unmet needs.
Hey, clinical trial underway with data expected early next year.
Cobiz 19 Arts program.
Strong intellectual property position.
And then experienced management team and internationally recognized founders.
So far as vision and strategic opportunity is to make a significant impact on Hell medicine in society by addressing the fundamental impactful diseases.
With our technology and on mitochondrial dysfunction.
Profound discoveries that our founders inside pursued.
The potential.
Super ever change that help band fine.
These represent a new frontier for medicine.
And the opportunities that become significantly larger as we continue our exploration.
Step by step we are realizing the potential of.
Nicobar vision.
Next slide.
Thank you very much now I wanted to turn it over to the operator to open up the line for Q1 day.
Thank you we will now begin the question and answer session to join the question Q You May Press Star then one on your telephone keypad, you'll hear a tone acknowledging your request. If you are using a speakerphone. Please pick up your handset before pressing any keys to withdraw your question. Please press Star then too.
Two during the question can you. Please press Star then one now.
Our first question comes from Kumar, Russia of Brooklyn Capital markets. Please go ahead.
Thank you congratulations on all your progress and thanks for taking my question.
Regardless of the phase one be part of the or the one one.
Oh.
Geographically where are the site located pared back so I'm trying to get it that's about it.
That said he got anything Colby 19, how what kind of impact that is going to Ohio.
And also based on that guidance.
Well I end up protocol deviations you can have in the prior but there would be able to get to that.
Hi, Good tomorrow, thanks for joining the call and a good question. The a the sites. We have are located if you. If you have a chance to look a clinical trial start governor code for anybody else that wants to see a they're located in Texas and in California, or so obviously, there's there's covert all over the country. It's a it's more a question of how do.
Sites operates in the context of a pandemic. So there are processes in place at these sites that allow them to continue to operate.
And as we said, they're not just operating on our study they were all operating on multiple studies. So they have thought processes that allow them to follow out protocol or identify enroll people bring them into the study where their sequestered for Ah for 30 days as part of this control of their body weight for the obese.
City part of the study so there's a you know that's that's the approach they're taking a and it's not a it's something we think that cove. It is going to prevent us from doing it but as I said enrollment rate. During this period is something we're learn about as we get further into the to the enrolling.
And given that debate here in south sequence data you you how complete control over it enough what I know for diet.
Absolutely. That's the reason main reason for the Oh isolation of the subjects for 30 days was already part of this plan. So you know in many ways they'll be protected from the potential of Ah community transmission of covert by being within the site for that period.
Oh and with regard to the mouse a ought to be more those ward movie knowing.
It's 81.
All right too.
So that.
I get a sense I, probably come back with the core we'd 19 Martins.
Yeah, It's a little early for that I think we as we said we're doing the confirmatory studies, we do like the idea of taking these into a Sars koby to direct model to look at a you know showing.
In the most relevant setting we can that a few induce this injury. We've covered a you can have the same effects, but this signaling pathways just generally protective and is potentially independent of the cause of the of the injury. So it might be covert 19, it might be the next kuroda virus it might even be it back.
Serial respiratory.
Threats of some kind that this might work and so you know more data to come ahead, we'll definitely share a the confirmatory data as that emerges.
And with regard to fly 138 won but we know about that potential to let just pick up actually components already up we'll cut IPO. That's a great question soon as part of what we're doing right now and that is looking at the potential for add on to standard of care.
And as you know there's only two approved drugs here. So oh choice there would be a nintedanib being the more reproducible outcome in a in models of Ah of fibrosis. So we'll be looking at how does this drug perform when added on to that standard of care.
Thank you so much.
Absolutely I used to work.
Thanks Tomorrow.
And I would add that we understand that the.
Government is working on Cobot 19, Ards type models. So we're very interested to do and then kind kind of study with them.
If they develop a more with others as that becomes available.
Operator.
Our next question comes from Elemer Piros of Roth Capital Partners. Please go ahead.
Good afternoon, gentlemen, thank you for taking my questions and maybe just a beginning at the end of your previous question on that.
Potentially co developing <unk> B.I.P.S. drug red.
Our existing drugs and looking at synergy if I understand correctly those are.
The side effect profile of those are not exactly pleasant.
So do you plan to once in the clinic do you plan to investigate Youre drug in isolation first and then potentially looking at the combination in order to.
Avoid that toxic pro toxicity profile or or or group currently marketed drugs.
Thanks for the question if it is a good question, yes, we would absolutely expects that we would have efficacy by ourselves as a monotherapy or the question is more you know what is the population that will be receiving this drug.
As a product.
And it's likely that they may be on Nintedanib, but as you said intended it has its own issues is a multi kinase inhibitor drug and for those they'll familiar with a it means it's hitting many different targets on the consequences of that are that not all those targets a necessarily doing good things for.
For you in this setting of fibrosis and there are other side effects related to that you know in the setting of Ah Nintedanib, it's actually kinda rexy or is one of them, but yeah. We would expect to look at this as a way to decide how this would be used rather than try.
Turning to get this approved as a combination Oh. This is more to say how it would be used in the and the ultimate population.
Okay. Thank you and now turning to see be 506 for a very encouraging data. If you could please put in perspective in video idea small that b type of a long rate improvement or decrease of DEMA the magnitude of change.
You have seen how does that compare to bid gotta investigational compounds that being tested in the same model.
Right, so as far as head to head with other molecules. The only head to head. We have so far is sources the natural a difficult in Apple in and you could see in the in the data we presented that were surpassing that effect I'm at now as far as other head to heads that we could do that's part of what will we be looking out as we go forward.
In the confirmatory studies, but.
Yeah. It's also a question of.
How we give this drug right now these studies were single dose when you saw that first effect on the accumulation Oh, that's clearly not how these would be used clinically.
If you're going into someone who you think is is susceptible to the outcome of Ah of severe cove. It a you're not going to give them one <unk> dose and walk away right, you're going to actually tried to treat them over a number of day. So part of what we're doing now in the confirmatory setting as well is looking at the regimen and how that and play.
Oh I see effects.
Okay. Okay. Thank you [noise].
And in the Nash study.
[noise] it besides a potentially very benign.
Safety profile what additional.
Information do you think it would be useful for potential partners to decide whether they would like to license that program. What's right you mean, a emerging from the one the yes.
Yeah, I think you know what we're getting from doing this study. It's a four week study, it's going to be obviously not the same al comes a 12 week or 16 week Nash study or in a biopsy driven read out but these are the endpoints that ER should indicates the direction that this drug is capable of going so if you're looking at.
Liberal wait <unk> liver fat changes, we know four weeks is long enough to see changes that's been done in the past Merck had a four week study, but also trends in body weight trends into biomarkers. So those are the types of data, we expect to get out of this and if they're convincing to us of a trend that's certainly what will be discussing.
Partners.
Okay. Thank you so much for taking my questions sure absolutely. Thanks.
Thank you Elemer operating.
Once again, if you have a question. Please press Star then one.
This concludes the question and answer session I would like to turn the conference back over to Mr. angle for any closing remarks.
Well I hope everybody gets the sense of excitement that we've had about the progress we've made in this last quarter and we're very hopeful as we look over the next quarter or so so stay tuned. Thank you.
This concludes today's conference call you may disconnect your lines.
Thanks for participating and have a pleasant day.
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