Q1 2020 Earnings Call
Thank you for your patience I thought that you'll be beginning at approximately two minutes, yes, we would like to thank you for your patience.
[music].
Operator assistance during the conference. Please press Star zero on your telephone keypad.
I would like to turn the conference over to Jordan Terrasi director of Investor Relations Echopark. Thank you may begin.
Thank you Gerry and thank you everyone for joining Cobots first quarter 2020 financial results Conference call. Joining me on today's call is Stephen angle Cobra, Chief Executive Officer, Ken can be Cobots, Chief Scientific officer, and just beyond Alcobra, Chief Financial Officer, Cobots 10-Q filing and.
Financial results press release were issued earlier today, and maybe downloaded from our website at <unk> Dot com.
If you're having issues joining the what back you can also accessed the slide presentation on page of coal bars web sites because a lot.
Yes, well begin with an overview of the first quarter financial results, followed by a business and R&D update from Steven Kent.
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 statements regarding the company plans expectations, Brett lead see before due to a loving drug candidates program.
The company's plans and expectations regarding pipeline expansion, the therapeutic and commercial potential of the company's lead drug candidate TV 42 11.
I'll do my declined your based therapeutics statements regarding ongoing and planned research and development activities.
Oh partnership and our capital resources and ability to fund our operations forward looking statements are based on current expectation injections and interpretation that involve a number of risks and uncertainties that could cause actual results could differ materially from those anticipated by cold.
These risks and uncertainties are described in our registration statements reports and other filings with the Securities Exchange Commission and applicable Canadian Securities regulators, which are available on our website I'd Cobra dotcom I see that dogs and see their dotcom.
Well listen 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 a forward looking statement.
It does not undertake any obligation to update publicly 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 Jeff you had all Cobra, she's saying that you called <unk> Chief Financial Officer Yep.
Like the Jordan and thank you everyone for joining us this afternoon.
Jordan mentioned, if you're having issues joining the webex. The slide presentation is posted on the home page of the Cobar website.
Next slide please.
As Jordan noted I will begin with a review of the financial followed by a business overview, but Steve Kim will then review the recent developments in our clinical and preclinical programs.
We will conclude with Q went up.
Looks a lot please.
I will now provide you with a summary of our financial results for the first quarter ended March 31 2020.
Appeared to the first quarter ended March 31 2019.
Total operating expenses in Q1, 2020 were 3.281 million doors as compared to $2.828 million in Q1 2019.
An increase of approximately $453000.
Operating expenses included non cash expenses of $927000.
Quarter ended March 31, 2020.
Appeared to $798000 in the prior year period.
No the non cash expenses total operating expenses in Q1 2020.
Familiar $354000, that's compared to 2 million of $30000 in Q1, 2019, an increase of approximately $324000.
Non cash operating expenses include stock based compensation depreciation and amortization costs.
Research and development expenses were 1 billion $450000 in Q1 2020.
Compared to $1.372 million than the prior year period.
The decrease of approximately $78000.
The increase in research and development expenses was primarily due to an increase in expenses related to our continuing development of peptides, partially offset by a decrease in bonus and stock based compensation costs.
General and administrative expenses were $1.832 million in Q1 2020.
Compared to $1.456 million than the prior year period.
An increase of approximately $376000.
The increase in general administrative expenses was primarily due to an increase in stock based compensation costs.
Director's fees and do you know insurance premiums occurred and the current year period.
During the quarter ended March 31, 2020, Cobar recognize the non cash expense of 800 in $2000 and other expenses.
Which related to the modification of warrants that took place during the quarter.
For the quarter ended March 31, 2020, cobalt reported a net loss of $4.218 million were 10 cents per basic and diluted share.
Compared to a net loss for the quarter ended March 31, 2019 of $2.921 million or seven cents per basic and diluted share.
Net loss included non cash expenses of $1.816 million for the quarter and at March 31, 2020, $903000 for the quarter end of March 31 2019.
Excluding non cash expenses, which include stock based compensation depreciation amortization costs.
And other expenses course, net loss was 2 million forerunner $2000 for the quarter end of March 31 2020.
That's compared to $2.018 million for the prior year period.
Moving to the balance sheet as of March 31, 2020 <unk>.
<unk> 10.2 million a cash cash equivalents.
Fair to $12.6 million in cash cash equivalents as of December 31st 2019.
The cash burn for the quarter ended March 31 2020.
Was approximately $2.5 million.
We estimate that based on our cash and investments balance as of March 31 2020.
We have sufficient capital to finance our operations into the second quarter of 2021.
Subsequent to the quarter and the company extended the expiration date of the remaining warrants 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, with the remaining terms and conditions of the warrants unchanged.
The company has now extended the expiration dates of the warrants to purchase a total of 3.2 million shares what does strike price of $2.25 from the July 2017 private offering.
I'll now turn the call over to Steve Steve.
Thanks, Joe.
Welcome everyone to our Q1 2020 call.
Next slide.
Yeah, I can talk about the new program News, let me review Cobar his vision and the basis for our technology.
This is the cornerstone slide for Cobar summarizing the company and maybe a review for some of you know our story well.
Getting with the first bullet discovery behind Coparts technology is the finding that mitochondria more than the power.
All that be learned in biology class and generate signal that affects cells, Oregon systems across the body.
Based on the last decade research mitochondrial dysfunction underlies multiple chronic and age related diseases like national beat the cancer diabetes and cardiovascular.
Gold bars discovered over 100 peptides encoded in the mitochondria genome and it has generated over a thousand analog.
As a result, we believe we haven't platform technology capable of providing multiple shots on goal.
CB 42, 11 is the first mitochondria based therapeutic to be evaluated clinical study in humans.
I believe that CB 42, 11 is the first of a number of candidates that aren't technology platform all identified for advancement into the clinic.
Chief Science Officer can candidate will discuss further in his section.
In parallel we have generated four preclinical programs.
We plan to nominate one of these programs for R&D, enabling studies in 2020.
Ken will speak to that more in a moment.
We are the leader in the developed kind of mitochondria based therapeutics or I eat portfolio is significant.
And continues to expand.
We haven't experienced management team as well leverage right preclinical and clinical research organization outside medical and other experts and World class founders. This provides strong talent Brett.
On a timely basis with financial efficiency.
As John stated, we had $10.2 million as though the other first quarter.
We have been spending well then about $900000 monk late in the last quarter and expect our runway to take us into Twoq you 2021.
We think it is pretty <unk> plan to maintain our burn rate.
That's the same level until we have raised additional funds, we continue to prioritize our spending on the platform, which we will discuss later.
Next slide please.
We believe mitochondrial Madison is a rapidly evolving science moleeds breakthrough drugs.
He is mitochondrial medicine.
One of your medicine focuses on the broad role mitochondria and mitochondrial dysfunction in People's health aging and to the.
Recent research supports a much broader role and mitochondria, including signaling within.
Between sell and Oregon, and orchestrating multiple biological systems like the metabolic and immune systems.
Mitochondrial dysfunction occurs when the mitochondria failed either due to environmental or genetic causes.
Based on published studies Biocon real dysfunction.
Lead to multiple diseases metabolic diseases, like Nash and neurological diseases like Alzheimer's.
We also know when mitochondria do not function properly disease can become increasingly systemic another aspect of mitochondrial medicine.
Slide.
[noise] cohorts mitochondrial peptides demonstrate attention to address a wide range therapeutic need we've seen evidence of this in our own research and development activities.
Early research from our founders demonstrated therapeutic potential.
Metabolic diseases inflammation and cancer.
Our own CV 42, 11 tied to demonstrate potential to treat Nash.
The both metabolic diseases by targeting the fact that leads to inflammation and fibrosis or recently, we have demonstrated in animal models potential but peptides.
Back to see exceed our or pathway inhibitors anti fibrotic agents and out one agonists as you can see these targeted burst set of diseases. This further supports our belief in the potential of our life.
New York outside to address the therapeutic need a wide range of diseases.
We also believe it continues to position Cobar as a first mover.
And leader in this important new arena, Oh mitochondrial medicine.
Slide.
I am pleased to share with you that since my arrival at Cobar last may we have expanded the number of programs from two to five.
Most recently, we announced that we have a new target for CB 50, 64, Athlon agonist program.
Which is quite a bit 19 associated acute respiratory distress syndrome or cards, a life threatening condition lacks adequate therapies.
We are excited because probably preclinical studies show that athlon can reduce the severity of acute lung injury. We're also excited because we believe its program well have beneficial effects and they are de Oh.
The non <unk> fine where it is estimated Robert 3 million patients around the world annually.
We've already shown that are out when agonists have pausing attacks and they'll be spouse bottle of commonly use model for type two diabetes.
We believe by harnessing the potential of mitochondria really.
Coated peptides AR AP when agonists they represent a unique approach to this potentially deadly condition.
Kim section, we'll focus on this new target.
And then the style order in a brand new program.
We demonstrated that our recently discovered CX your core agonists reduce the growth of tumors in the bottom melanoma when used with chemotherapeutic agent.
Over the use of the agent by itself.
Also made significant progress with our S. I brought a program by generating new results in a therapeutic bottle of idiopathic pulmonary fibrosis.
Finally, like many biotech company, we paused star Phase one be study at National obesity.
Which we hope to continue wants to cope with 19 associated conditions impacting our study sites.
I have improved.
This quarter's accomplishments cobar continues to expand its portfolio of mitochondrial unquote code.
Sides and maintain our leadership in mitochondrial medicine.
So what is the story behind the most recent news.
Given the challenging co bad 19 pandemic, you probably wouldn't be surprised that over the last two months.
I've also been looking for ways to potentially use the unique property.
Our existing mitochondrial upsides to help and the coated fight.
We believe mitochondrial uncoated peptides are key regulators have many functions and the body and mitochondria themselves are found in the thousands and most sells the body which include the immune cells along and other organs.
As a result, we thought we might find the mitochondria based therapeutic and ongoing programs that would affect organs such as belongs.
Further we know the conditions like a rds certain intensified by cellular processes, such as upregulation of inflammatory agents, including cytokine.
We also know that cytokine levels can be affected by pathway downstream from the activity of some of our peptides.
This led us to review the possible impacts of Apple and signaling on downstream processing.
Contribute to both a Arthur yes, and the global effect of Colgate 19 on other organs.
This is a breakthrough.
That expanded our view potential of Athlon agonists peptides, which had already shown promise in affecting both glucose tolerance and back levels in animal model type two diabetes.
As a result, we focused on this family of active Athlon agonists.
That were effective well tolerated in these initial animal studies.
As you also might imagine we have reviewed the science and Heartlands.
With World class medical experts and the fields of lung diseases and they are de.
Based on their support for this approach we decided to move forward.
With targeting the Apple and program at a R&D, yes, and more specifically coated 19 associated Hey, Rds.
We know some people have asked what happened cobalt called bid 19, as Gerard suddenly not likely at this point.
A question we have discussed we believe.
There are kept flights are pausing affects in Cobiz 19, eight rds.
That we would expect to see a positive impact on other types of a rds. We also believe that some of these potential effects of our peptides.
Tact other pockets.
Business had a very productive and been very exciting two months at company. We've not only continued progress on other pre clinical programs, which Campbell summarize.
But we've developed a new indication for an existing compound preclinical programs. We are planning additional preclinical studies now, which we expect will generate more data in the near future.
With this quarter's accomplishments Hobart continues to expand its portfolio.
It has all been a very productive time, ensuring our study or story with investors both major conferences like JP, Morgan and bio CEO as well and has been one on one meetings in New York, Boston and San Francisco.
It is important to note since the shelter in place crosses started.
We really have not slowed down and holding conversations with both investors and analysts.
Before they can speak on our clinical and preclinical programs I would like to thing John Stern.
The long term.
Exactly that we're stepping down from his day to day management role.
As noted in the press release issued earlier, John it's been a critical player in helping the company grow.
From a small early stage research company to where it is today.
We appreciate all of his contribution Cobar and we look forward to continuing our close working relationship with him as a director.
Thanks, John.
With that I'll turn it over to Ken Ken.
Thanks, Steve.
I'll now give a brief update on your R&D programs, beginning with our C.D. 42, 11 clinical program next slide please.
Maybe 42 11 is a novel enhanced analog and must see naturally occurring mitochondrion coded peptide discovered by our co founder Dr. Hussey Cowen and his colleagues.
Maybe 42 11 is currently in phase one they wouldn't be clinical testing as a potential treatment for Nash and obesity. The phase one day stage of the study is complete and involved a double blind placebo controlled single ascending dose multiple ascending dose assessment of safety, Tolerability and pharmacokinetics and healthy adults to some.
The most appropriate dose for the phase one be stage.
No significant safety or Tolerability issues were observed in the phase one night after we starting to study.
The phase one be part of the study is a double blind placebo controlled evaluation of one dose level to see before you 11, given once daily it'll be subjects with and they F.L.D.
This phase is designed to assess the potential effects to see before you 11 on liver fat body weight and various biomarkers that are relevant to Nash obesity and metabolic disease.
Changes in liver fat will be assessed by Android Pdfs, and all subjects must have a minimum of 10% liver fat a baseline.
As we announced in March the phase one be stage of the study is currently pause due to covert 19. The sports is not unique to Cobar. That's more of a thousand clinical studies have been affected globally by the pandemic and many of them have paused enrollment.
As we mentioned on the last quarterly call. We added three new clinical sites to the study earlier this year in order to accelerate enrollment we're continuing to monitor the situation and expect to provide an update once there's a change in status, but as previously stated we will not be providing subject by subject details on enrollment as a result of the covert 19.
Pause well able to provide guidance on the timeline for availability of topline activity data at this time.
In the event that the covert 19 pauses lifted the timing of this study will be a function of the post covert 19 enrollment right.
We'll have more clarity on that when the study result, we plan to update on the progress on the next Investor call next slide please.
Turning to the rest about pipeline, we expect additional data from several programs over the next three to six months on the last quarterly call. We shared information on four programs in the preclinical peptide optimization stage.
First of these was announced in January and B T flight and logs for cancer and other indications.
And B T. Five analogs are family of peptides that are highly potent and selective inhibitors of the CXC chemo kind receptor type four or six CR for a key chemo kind receptor that regulates the gross and metastasis of tumors as what does the localization of immune cells within the bone marrow.
On the last call we shared data on the in vitro activity of this family peptides and cell based assays and successful translation. So the invivo setting in a mouse model of aggressive melanoma, where it M. B T five analog and hence the efficacy of chemotherapy.
We plan to advance this program now into additional preclinical models, including potentially models of Hematological cancer stem cell mobilization with the goal of identifying a candidate for advancement.
The second program is a and B T. Two analog peptides full flight product diseases. We previously shared data on the efficacy of NBT two in prophylactic and therapeutic mouse models of idiopathic pulmonary fibrosis or I P. S.
In April we announced acceptance of our late breaking abstract on this program at the American Thoracic Society H.T.S. National meeting.
DHS in person meeting originally planned for me was eventually canceled due to concerns around covert 19, but the abstract has been published by Ats. There now considering a virtual meeting later this year. This family peptides has been further expanded and we're now running additional studies with the goal of identifying a candidate for advanced.
Went towards R&D, enabling studies.
The third program also discussed on previous calls is the M. B T. Three family of peptide analogs with potential for cancer immunotherapy.
Sensing the killing of cancer cells by human immune cells in vitro.
Program will be advancing into Invivo studies to look a translation of these in vitro effects.
The final program on the list is the CD 50 64.
There's a family of novel Apple in agonists that have already shown positive results in a mouse model of type two diabetes. This program has now been expanded to include a new target indication acute respiratory distress syndrome, or a rds, including specifically a rds associated with Covidien 19.
On today's call I will focus on this newest indications next slide please.
So this is a new target for FCB 50, 64, analogs, the acute respiratory distress syndrome, or a or D.S. and specifically.
Told that 19 associated.
Next slide please.
Well, let's start with a understanding what a rds is so LDS is a much bigger problem and just what we're now seeing in this setting of covert 19.
Oh, yes can be triggered by a variety of injuries to the lungs, such as viral and bacterial infection, including influenza viral infections sepsis traumatic injury installation of smoke or chemicals and other sources.
Oh, Yes presents most commonly as a sudden shortness of breath accompanied by rapid breathing a fast heart rate mental confusion low blood oxygen and extreme tiredness as shown on the right of the slide.
Yes involves damage to the thin lining of the lungs separates the capillary blood flow from the L. yellow light or air Sachs, where the exchange of oxygen and carbon dioxide occurs.
Well, that's Finley I've long cells is damaged there was a leakage of fluid blood cells and proteins from the blood the gradually fills the air sex and blocks the ability of the lungs to absorb oxygen.
Blood cells entering the damage Stelvio life send out a cascade of signals that started an intense inflammatory response.
No LDS is a major cause of morbidity and mortality among patients who were hospitalized for other reasons and usually occurs within about seven to 10 days of the initial injury.
There are no effective drugs for prevention or management, the they already yes, and instead, LDS patience with low blood oxygen levels are treated with mechanical ventilation and supportive care in attempt to support breathing reduce infection reduce inflammation pain and anxiety.
The resulting need for intensive care convalescence and rehabilitation Lisa long hospital stays that are a major contributor too expensive and rising healthcare costs. There was a huge unmet need for a safe and effective treatment to reduce time spent on ventilators reduce mortality and to improve the quality.
You have life.
Even without Cobiz 19, a rds is a major unmet medical need affecting about 3 million people globally next slide please.
In the setting of covert 19.
Yes has emerged as one of the most LIFO consequences of the Corona virus infection and this is why so many people end up on ventilators in severe cases, the virus infects the cells lining the lungs, leading to pneumonia inflammation cellular destruction, resulting in that loss of the thing capillary LDL and then brain to separate.
The blood from the air spaces, the local damage lease the vascular leakage an accumulation of fluid in the L.D.O. life as a long still with fluid the blood cannot absorb enough oxygen and the heartless pump harder to force blood through the saturated lungs.
Another potentially devastating effect to the virus is a dysregulated release of inflammatory signals quota cytokine storm. This results in intense local installation, but the storm also riches other organs like the heart the kidneys, the liver and the brain where inflammation in cellular damaged can eventually result in multi organ failure.
Next slide please.
Now recent evidence shows that metabolic dysfunction is a major underlying factor contributing to the severity of covert 19.
The presence of co motive morbidities like obesity, hypotension diabetes or increase the chances of severe disease and liesl consequences.
That's an example, a recent publication took a retrospective look at the fate of 7000 patients with totaled 19.
The presence of type two diabetes prior to infection increased the overall need for medical intervention, including ventilation and had a significant impacts on overall survival in fact, 7.8% of covert patience with diabetes died while only 2.7% of those without this co morbidity diet.
And looking just at the sub population of patients with diabetes as shown in the diagram on the left those with poor glucose control had a much greater chance of dying, 11% first is closer to 1% for those who had well controlled glucose levels next slide please.
Now, let's look at how April in signaling figures into this picture.
No one is a naturally occurring it typically and it's a cell signaling peptide secreted by fat cells or a different sites to regulate a variety of biological functions, including fluid homeostasis metabolic homeostasis cardiovascular function inflammation and other processes.
It works by activating a cell surface receptor called the Apple in receptor or a P.J. sounds broadly in most tissues, but particularly abundance in long and hard.
On the right of this slide you see a stimulation of the receptor on the surface upsells leads to activation of several different intra cellular signaling pathways that in turn regulate the expression and control of other proteins. These include pathways involving important regulators like Ras and PK.
Eric wanting to enormous and others.
Apple and is therefore, a key regulator of multiple regulatory pathways, leading supplier tropic abroad system effects.
Apple in has been shown to have brought protective effects in animal models of a rds, including prevention of the pulmonary edina or fluid accumulation in rodent models of acute lung injury and reduction of acute lung damage caused by chemical insults like lake acid or bacterial toxins like life appellate probably second.
Our Lps.
Importantly, Apple in Siglin also decreases pro inflammatory cytokine levels in these and <unk>.
In these cells and protects other organs such as the liver from similar damage.
[noise] Apple in has also shown beneficial metabolic effects by decreasing body weight and fat deposits in obese mice.
However, Apple in itself is rapidly metabolized and the Invivo half life is only about eight minutes. So this is too short for effective use of the peptide itself in the clinic next slide please.
Now Cobots CB 50, 64 analogs are a family of novel peptides based on a natural pets human peptide encoded within the mitochondrial genome. We've confirmed in the number of them display agonist activity at the ethylene receptor in vitro using different assay formats.
In some cases stimulating a signal of the same magnitude as that produced by Apple in itself.
Metabolic stability of these peptides has also been demonstrated in human plasma in vitro. We previously shared data for this family of novel Aplin agonists in this setting of type two diabetes at the American Diabetes Association meeting last year.
In that poster presentation, we showed that administration of CB 50, 64 analogs to obese mice led to improved glucose tolerance in diet induced obese mice and reduced body weight and fat mass.
No safety issues have been observed to date in multiple tend to 14 day rodent studies of these molecules.
Based on their ability to engage the Apple in signaling pathway, we don't beliefs that the CB 50, 64 analogs could potentially have similar effects to apple in on acute lung injury.
Let's go to the next slide.
So the rationale for potentially using a C. B 50, 64 analog to treat a rds associated with Covance 19 lies in the demonstrated the ability of the Apple is signaling pathway in animals to regulate many of the damaging processes that are also induced by Covidien 19 injury.
On the left here you see Tobin 19, Corona virus infection, producing the same array of damaging effects that we've already described pneumonia Vasco leakage fluid accumulation low blood oxygen and the cytokine storm leading to multi organ failure.
Next slide please.
And there you see the effect that a C. B 50, 64 analog could potentially have by engaging the ethylene receptor initiating a series of protective events to potentially block. Many of the damaging process is shown here by decreasing fluid accumulation and Vasco leakage I see be 50 64.
Hello can potentially reduce fluid accumulation and improve oxygen absorption raise the levels of oxygen in the blood by blocking the cytokine storm peptides could potentially protect other organs from failure and thereby reduce mortality and the long term health consequences asked a recovery from covert 19.
Since the effects of ethylene signaling or independent of the cause of the lung injury. This approach could equally be applicable to other forms that they are D.S., including even a rds, resulting from infections by future novel strains of viruses old bacteria.
So now let's look at some of the underlying data that support this approach next slide please.
And this slide we see just one example of the published data on the protective effects of stimulating the Apple in receptor in the setting of acute lung injury.
In this case in animals injured by introducing a bacterial toxins into the lungs.
Apple in injection reduced the infiltration of inflammatory cells into lung tissue and preserve the loan structure as you can see in the figure a way.
Aplin also reduce the accumulation of fluid in the lungs as measured by the difference in the water content in figure B.
Capillary leakage was also decreased by Apple in based on the measurement of protein leaking into the Bronco Lv old all the vonage fluid and figure seat.
And finally in the bottom three figures Apple in also reduce the secretion of pro inflammatory cytokine such as TNF Alpha aisle six an idle one beta important components of the cytokine storm.
Next slide please.
In this slide we summarize published results of studies of stimulating the Apple in signaling pathway in obese mice here injection of Apple in had multiple beneficial effects on metabolic dysfunction, increasing glucose uptake in stores into muscle reducing circulating level.
<unk> insulin triglycerides and fatty acids. These effects also led to a reduction in body weight and fat deposits.
So in this animal model.
Apple is signaling had clear protective effects on what is a significant co morbidity of a Rds next slide please.
So now let's look at the data we have previously shared for co bars own novel Apple in agonists CB 50, 64 analogs are radio post during 2019 included data on the mechanism of action to this new family of peptides exploration of the interaction between seat CB 50 60.
And the logs and a broad range of cell surface receptors revealed a very selective activation of one specific receptor the apple in receptor or a P.J. as shown in the figure on the left some of our novel CB 56 people and logs produced a maximum response at the ethylene receptor the blue bars that was similar to the.
Excellent effect of the natural peptide and the Black bar.
On the right we see it a second let's say that CB 50, 64 analogs decreased the production of cyclic N P and sells over expressing the A.P.J. receptor a characteristic of Apple in signally.
Next slide please.
Now, let's see be 50, 64, and logs were also shown to have beneficial effects in vivo indict induced obese or D.O. mice model of human type two diabetes.
As shown on the left here at the top analog CCB 50, 64 dosed once daily for 10 days produce significant body weight loss and reduced fatness compared to vehicle treated animals below that the administration of several CB 50, 64 peptide and logs in another study it'll be small is also read.
Do the decrease and decrease the peak glucose levels. Following a challenge with a glucose bolus injection, indicating an improved glucose tolerance now that effect was also reflected in significantly lower blood glucose levels two hours. After the glucose challenge shown on the bottom right. So these results demonstrate.
<unk> similar effects it obese mice to those produced by Apple in injection next slide please.
So now let's cycle back to summarize how we believe CB 50, 64, and looks could have the potential to treat a rds and more specifically I already yes in the setting of covert 19 here. Once again is the array of damaging processes. The koby 19 produces.
And let's go next slide please.
And here is the potential impact of CB 50, 64 analog engaging the apple in receptor and shutting down these damaging effects other drugs now being evaluate <unk> in covert 19 target individual sidecars or only a subset of these issues we now.
No that Apple in signaling can protect animals from acute lung injury, whether the injuries caused by chemical bacterial viral or other insults, we know ethylene signaling reduces the fluid accumulation and the vascular leakage as cytokine release in animal models. So based on these observations co bars.
Levels CB 50, 64, Apple in agonists could potentially block the same range of damaging effect seen with Covidien 19 associated Hey, Rds.
It's important to note that this signaling pathway is completely independent of the source of the injury. So CB 50, 64 analogs could have potential utility in covert 19 associated a rds and other forms of they odious.
And this could include future viral and bacterial infections.
We're now moving forward with evaluation of the F.C.D. 50, 64 and logs in preclinical models are they rds.
Let's move to the next slide.
This final slide shows a high level overview of our current R&D programs.
From for mitochondria based Therapeutics CV 42, 11, <unk> first clinical candidate currently in phase one be clinical testing for potential use in treating national obesity. The study is currently paused awaiting the resolution of the coated 19 related delay.
We have four preclinical programs moving forward in various animal models of cancer idiopathic pulmonary fibrosis and acute respiratory distress syndrome with a goal of identifying and next clinical candidate this year for advancement to I, Indeed, enabling activities, we expect to see additional preclinical data emerging on these.
Programs in the next three to six months and we plan to provide an update on your next call and with that I'll return the call back to Steve.
Thanks, Ken already moved to the next slide let me.
Summarize all this a little bit I'd want to make sure you understand.
First of all we're extremely excited to have these.
New targets.
And you can see why now because we're talking about affecting multiple downstream pathways that are causing multiple problems.
And you know began to get a sense <unk> power.
The mitochondrial derived.
Sides, but.
But I wanted to say we believe.
We have a very large platform.
We're working on.
We have over 100.
Oh, the peptides encoded that are within the DNA.
And it's like they're up on the wall and pulling them down one of the time.
Hi, Keith and looking for what walks they open.
But it's a very large platform.
And it's also targeting and I'm very large well known opportunities.
Most of you already know virtually everything in terms of the disease areas, whether its oncology or some of the others. We all know these are very.
Large areas and with high unmet need.
Any one of which would be enough to make a big difference a boat with patients and with the company itself.
And we are the leader in this area.
Our <unk>.
Patents are already filed and be filed.
Creating a huge hedge.
Around the original discoveries.
And we believe we have multiple shots on goal.
When you think about what that means that one drug that happens to work in five different indications.
We wanted the preclinical programs and the clinical program.
Different compounds and families who compound.
So this is a very solid situation that one gets in trouble be others are still pretty to move forward.
So that greatly diminishes the risk and increases the potential.
Oh the programs.
So I think with that we could move forward, but I want you to understand we really think there are quite a few opportunities here.
And then at some point run into an inflection point.
Much like some of the other companies the biotech do and we think as.
As a result that this is a great time to be involved with the company.
Next slide.
So here are the goal or 2020.
Obviously, we're moving forward with the national Besides the clinical program.
But it has been placed on pause and we'll continue to move forward as soon as the sites themselves are able to operate a that we expect will be I want to to push the program or and we'll give you more update on that.
As we get to that point.
On the preclinical programs keep her this year is to identify the next clinical Canada.
In addition, with who want to continue to make progress on our preclinical programs and we can certainly say based on the re targeting the program toward say Rds and also.
The I've been a new programs here CR or an oncology area.
We are making significant progress in that particular goal.
And then it's always they're continuing to evaluate our options both in the financing area.
And as we do that we're looking in a number factors.
And are doing that monitoring the market for you can imagine we've been very closely monitoring what's going on.
And then parallel we're also continued to expand the relationships with the Investor community.
And we we've been having you know two or three meeting today, even under the conditions, we've been on recently with the shelter in place.
Regarding partnering wanted to make sure it's clear that.
We continue to look for ways to move that Congress goes conversations forward you may remember right. After I joined last year, we write the bio 29, T. meeting, we had 10 meetings with corporate partners very large pharmaceutical companies mostly.
And we're about to hit that same point again, a bio 2020 meeting is coming up.
First week June and we will be.
There are there that's kind of course it virtual book will be every meeting.
Folks and expect to again keep moving forward in this area and finally AMNIOEXCEL property area you know as leaders in mitochondrial drive peptide development, we will continue to expand our IP portfolio maintain our leadership.
Next slide.
So we continue to realize.
The Cobar vision.
Recent academic research on mitochondria continues to expand the lift of impacts.
Mitochondrial dysfunction on multiple systems in the body, that's just the immune system and the metabolic systems.
Further new researches illuminating the bulk connections between the mitochondria and these systems.
They're showing that mitochondrial drive peptides are a key component.
Regulation and modulation.
And we believe Cobar is uniquely positioned to capitalize on these new scientific findings.
In the last year Cobar it made substantial progress increasing our clinical preclinical programs from two to five showing the therapeutic breath and potential the peptides and the potential the platform generate multiple shots on goal.
Cobar technology and opportunity has been well received.
The company's fundamentals have strengthened significantly in the management team is increasingly enthusiastic about its prospects and you can see walk.
We continued to be on the front lines of mitochondrial medicine.
And step by step we're realizing the potential.
Cobar vision.
Thank you.
We'd like to go to you in a now.
Thank you if he would like to ask a question. Please press star one on your telephone keypad a confirmation tell indicate your line is in the question. Kim You May Press Star tell if he would like to remove your question friendly killed and for participants using speaker equipment and they'd be necessary to pick up your head.
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Our first question is from Edward dashed with Canaccord Genuity. Please proceed.
Well, Steve Kennen, Jeff that's about a month, Robert how do we hope all of we hope you and your families are doing well then healthy just a few questions Ross stuff first off Ken. Thank you very much for that great description provided in your prepared remarks regarding a rds and CB 56, before maybe I missed this but could you expand on the time.
Line for CB 50, 64, how many additional preclinical studies do you need to be need to be completed two Baptists program and what other additional information we get out of these trial and I have another follow up.
Right. Thank said so the question and let me give you some some feeling on that obviously worse just getting into now preclinical studies in the setting of a rds. These are cute lung injury models [laughter] and we'll be looking at the data emerging from those in the next three to six months that those data or what's going to define.
How much additional work there needs to be done in this setting or it may be a case that we don't have too much more to do before selecting a candidate and moving rapidly to R&D, enabling work and you know that will be something we'll know more about as soon as we see the data emerging from these studies.
Yeah that makes no no yeah before you go for can I, just add things on to that.
One thing you will understand is that it's good to talk with you again.
You will understand these are acute indications.
So although you still have set up the studies for the preclinical work. The reality is the time it actually takes to evaluate to conduct the experiment and evaluate it is much shorter than it might be for chronic.
Hi disease, so as compared with some of the other areas that we're working in this is a very different situation in terms of.
Time, it might take to actually run the experiments themselves.
And the second thing about this is.
You know, we're very fortunate we know some of our friends other biotech companies that are struggling with the fact that they are in the clinic or trying to get into the clinic and their stock and we certainly understand and and misery, but in our case, we expect these pro.
Grams continue to provide.
Additional results news flow over the next six to nine months. So I know your focus mostly on the one program, but I did want to point out that we expect to see additional results coming out of several of these programs and we're fortunate in the sense.
Our.
Clinical research partners people like Charles river's and so forth are still very much open and running so we plan to a continued to move forward.
In that direction.
Yeah, that's great here and I'm going to pivot now it's one of those Ah that other indicates about you're probably referring to work with Nash. So I saw that you stated you're adding a phase one be study in diabetic population not a GLP one EGEN. If you have allergies evaluate synergy and so the results. So CB 42 11.
Hi, good Todd could you speculate on why there might be a synergy that synergistic effect there.
Yeah, the synergy you're referring to is actually information we shared earlier from preclinical studies clearly showing that if you add a small amount of al peptides gbpforty to 11 onto a liraglutide treatment in the other piece animal you greatly increase the potency of the combination to.
<unk> decreased liver fat to decrease body weight as well so that synergy is a you know established in in a in a preclinical study now. The reason is l. mechanism is a very different from a GLP one agonists, which is obviously acting very specifically at one receptor regulating the the management of.
Glucose our mechanism involves an enhancement of the way that instilling itself interacts with the insulin receptor and the downstream said <unk> singling effects of that on life policies in the setting of a dip a sites regulating how much free fatty acid is flowing into the portal circulation and accumulating in the liver. So these are two different mechanism.
Sums that by definition or attacking different components of Nash. So it's not really a big surprise that there's an opportunity there that the two together are greater than the individual parts. We also see that with other mechanisms. So like P. park and or a combination without there's two different mechanisms going on there very different mechanism.
So I hope that answers your question.
Yeah, no and if I could.
Yeah, sorry, just one more at all [laughter] sorry about that.
But I think what things several things here and what Ken's pointing out one is that the m. away is different from virtually from anybody else and we believe that match you probably due to be treated eventually.
The combination of compounds and so we know right now that intercept is going to be reviewed a both at the AD com level and and core approval by the UK.
Probably by the end of June based on what they've said and you know you just have to understand from our point of view that's great because it means it's a and I'm sure you feel the same way its validation that you can actually get a drug approved but in addition to that we see it as you know even people like intercept will make.
Become people, who need companies who need.
To fill out the pipeline nor to treat patients and because we're working upstream in the process not only a mechanism different but the the reduction in fatty acids going in liver should result in a reduction in the problems downstream obvious.
The wrapped around the studies and so forth. So you know we've got a unique and my way. We think it makes sense in terms of combination as Ken said, well GLP ones and so we're so you can imagine the companies that might be interested and then its upstream from what people are doing and I think that most people believe.
This will be a situation where more than one drug will be used to treat these patients. So for all those reasons from a partnering point of view.
We think that it's a it's a very good candidates or a number of potential partners.
And unique in the way that its position.
That's great. Thank you for taking my question.
Absolutely. Thank you for being on today.
As a reminder to starwood on your telephone keypad. It seems like asking a question. Our next question is from Steve for exactly WBB Securities. Please proceed.
Hey, Thank you for taking just one quick question.
In your in your approach to Ards, you're you're showing in your explaining how you're shutting down the cytokine cascade.
But I'd like to know in terms of from how you're approaching it because obviously, what's what's coming out a lot now on the corporate side is that this is a global attack on the body. So what can you tell us in a much colors you can get on what you would look out in terms of being able to stop that a hyper expression.
And maybe a hyper inflammatory expression throughout the body because.
I'd like to know how that would be viewed and and they'll just hop back in the here after that thank you.
Yeah. Thanks, Thanks for thanks for the questions I forget and on the call. The that these effects that you're gonna have if you're able to decrease cytokine expression in the level of the long is that circulation from there to other organs, which is what's going on in the cytokine storm a is going to be also.
Decrease so you kind of have direct effects in each Oregon by the Apple in signaling 'cause that's already been shown pre clinically to you couldn't going directly into her liver and protect it without pulling signaling you could you could also theoretically block decided kinds from ever being able to circulate and reach the liver and Lee.
So the information so there's multiple ways in which Apple is signaling could be effective here. A you know I think it's important to also compare this the what other approaches our if you go and you block something like a single cytokine, a you're really just allowing other side. It kinda has to do the job right. So you want something that's gonna down regulate generally.
Sorry to try and levels, but also be applicable in organs elsewhere. So if you give an apple in agonist like ours systemically potentially you will directly protect organs. In addition to reducing the long production of the cytokine.
[noise] over and very much appreciated the clarity on that front, obviously, you're looking for to your next process and.
With your announcement thank you.
All right. Thanks, a lot Stacey thank.
Thank you Steve.
We have reached the had never question answer session I would like to turn the conference back over theme for closing remarks.
Thanks, everyone for listening today.
You know I think 10, it's really done a great job of lining up so for us. So that we can understand it I realized for some of US it's a lot of scientific one.
But as we presented it to some of the World class.
Outside expert and one disease and particularly on the RBS area, we've gotten very positive responses.
In addition, as we've talked to our own.
Founders and other medical and Sciences.
On the board and so forth similar kinds of responses. So I think it's a very exciting new program.
And when you combine it with you others I think again you get the sense of just what's possible.
So we're very excited and well look forward to talking to you on the next call.
Thank you.
Thank you. This does conclude today's conference you may disconnect. Your lines at this time and thank you for your participation.
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