Q3 2020 CohBar Inc Earnings Call
[music].
Good afternoon, My name is Rob and I'll be your conference operator today and.
This time I would like to welcome everyone to cope <unk> third quarter 2020 financial results Conference call.
All lines have been placed on mute to eliminate background noise.
A question and answer session will follow the formal presentation.
If anyone today should require operator assistance during the conference. Please press star zero from your telephone keypad. Please.
Please note this conference is being recorded.
Now I would like to turn the call over to Jordan Terrasi director of Investor Relations Echopark.
Thank you Rob and thank you everyone for joining Cobank third quarter 2020 financial results Conference call. Joining me on today's call is Steve angle Colbert, Chief Executive Officer, Ken on the Colbert, Chief Scientific Officer, and Jeff Do you and also buys Chief financial Officer called.
Oh, sorry, 10-Q filing and financial results press release issued earlier today and may be downloaded from our website at <unk> Dot com and you're having is she joined in a while back you can access the slide presentation and the home page of Cobos website for follow along Jeff.
Jeff will begin with an overview of the second quarter financial results, followed by a business and R&D update some Steve and Ken.
Before we begin I'd like to pick a momentum of remind listeners that the run Mark and 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 for its elite CB 42, 11 drug candidate programs the therapy.
Dick and commercial potential other companies the lead drug candidate CB 42 11.
And other might a current year based therapeutics.
And just regarding ongoing and planned research and development activities potential partnerships and our cash capital resources and ability to fund our operations forward looking statements are based on current expectations projections and interpretations that involve a number of risks and uncertainties that could cause actual results could differ materially from those instances.
Weighted by call Bye.
These risks and uncertainties are described in our registration statement for reports and other filings with the Securities and Exchange Commission and applicable Canadian Securities regulators, which are available on our website at <unk> Dot com and you see that GAAP and Si dot com as well as and the Safe Harbor statement included with today's press release.
And you are cautioned that such statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward looking statements Cobar 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 and.
And I'd like to turn the call over to Jeff You know Cobots Chief Financial Officer John.
But Jordan and take your word for joining us this afternoon.
As Jordan mentioned, if you are having issues with Webex slide presentation is posted on the home page of the Cobar website.
Next slide please.
[noise] as Jordan noted I'll begin with a review of the financials, followed by a business overview, but Steve and will then review the recent developments in our clinical and preclinical programs and will conclude with Q and a.
Excellent.
I will now provide you with a summary of our financial results for the third quarter ended September 32020, compared to the third quarter and at September 32019.
Total operating expenses in Q3, 2020 were $2.618 million as compared to $3.228 million and Q3 2019.
Decrease of approximately $610000.
Operating expenses included non cash cost of $407000 for the quarter and September 32020 assets.
Compared to $621000 for the quarter and at September 32019.
Net of non cash costs total operating expenses and Q3 2020.
Familiar and $211000 as compared to $2.607 million and Q3 2019.
Decrease of approximately $396000.
Non cash operating expenses include stock based compensation and depreciation and amortization costs.
Research and development expenses were $1.246 million and Q3 2020 compare.
Compared to $1.944 million and the prior year period and decrease of approximately $698000.
Decrease in research and development expenses was primarily due to lower clinical trial costs.
Resulting from the timing of those expenses and lower stock based compensation costs, which were partially offset by an increase and consulting expenses.
General administrative expenses were 1 million and $372000 and Q3 2020.
Compared to $1.284 million and the prior year period and.
An increase of approximately $88000.
The increase in general administrative expenses was primarily due to professional fees related to protecting our intellectual property.
For the quarter ended September 32020, cobalt reported a net loss for $3.237 million or six cents per basic and diluted share compared.
Compared to a net loss for the quarter and September 32019, a $3.349 million or eight cents per basic and diluted share.
Net loss included non cash expenses of $947000 for the quarter ended September 32027.
$726000 for the quarter and at September 32019.
Excluding the non cash expenses cobots net losses $2.290 million for the quarter and at September 32020.
As compared to $2.623 million for the prior year period.
Total non cash expenses include stock based compensation, depreciation and amortization and equity modification costs.
Moving to the balance sheet as of September 32020, cobalt had $23.4 million and cash cash equivalents and investments.
Compared to $12.6 million and cash and cash equivalents as of December 30, Onest 2019.
During the quarter, we completed a public offering in order to finance, our clinical and preclinical programs and raised approximately $15 million for commissions and expenses.
Cobar issued 12.3 million units at a price for $1.22 per unit with each unit consisting of one share of the company's common stock and one warrant to purchase point 75 of a share of common stock and a per share exercise price of $1.44.
The cash burn for the quarter ended September 32020, with approximately $2.9 million.
We estimate that based on our cash and investments balance as of September 32020, we have sufficient capital to finance our operations into the first quarter of 2022.
During the quarter ended September 32020, the company entered into amendments with certain holders of its unsecured promissory notes, which.
Which extended the due date of these notes from June 32021 to June 32022.
Amendments also included the issuance of warrants to those holders that extended the due date of their notes.
I will now turn the call over to Steve Steve.
Thanks, Jeff.
Good day, everyone to our call.
We believe credit bar represents a rare opportunity and biotech.
And that mitochondria based therapeutics represent a treasure trove of potential therapeutic agents for multiple diseases.
We are elucidating the function of the peptides defined by sequences and the human mitochondrial genome.
We are reading the language and the mitochondria speaking.
For the rest of the body.
Based on our progress today.
Expense this will enable us.
To develop key therapies and multiple chronic and age related diseases.
Let's start and I review quarterly free he points.
And the phase one B study after the plan subject and reach the end of their treatment.
We made significant progress with our preclinical projects.
For example, we announced new and.
Clinical data showing enhanced the facts and our anti fibrotic peptide is combined with a commonly prescribed drugs.
Drugs.
And third based on continued progress in the anti Fibrotic program, we plan to nominate a second clinical candidate in the first quarter of 2021 based on leading several research task.
Next slide.
What is the Cobar opportunity, we believe that we are the leaders.
And developing a new class and therapeutics.
Based on our founders discovery and mitochondrial peptides regulate multiple systems and the body.
Take about their price.
Prior to 2001, and doctors Cohen and bars and wise discovery.
People thought mitochondria were just the power houses of the cell and not a key player and regulating some the bodies key functions.
Because this is a new class of drugs, we believe mitochondria based therapeutics represent a large untapped and exciting group of.
Total therapeutic.
Amazingly, our Chief Science officer, and and the interest scientists.
And I've discovered over 100 peptide and the mitochondrial genes.
Genome and developed over a thousand analogs.
It is like we have 100 keys on the wall and we're taking them down one by one to discover which biological clock or luck day open.
Based on our research results.
We believe that some fees may actually open multiple locks such as Nash and obesity.
We are targeting a wide range of diseases that are associated with mitochondrial dysfunction.
And because we're targeting the problem and the cellular level we.
We believe mitochondrial peptides for work on the cars.
Rather than just the symptoms.
Mitochondria based therapeutic benefit from over a billion years evolution and may generate entirely new approaches to treating diseases, we need new and different approaches.
And doing so we are taking advantage of the mitochondrial driven system peptides that the body has evolved.
And developing our compounds we are searching on the wave of the evolutionary biology behind mitochondrial peptides we've.
We believe that they represent a better starting point for developing therapeutic agents.
As a result for our peptide medicine may have a higher probability of technical success compared to the traditional discovery approach.
And the last year, the company's portfolios growth two to five programs. We are no longer just for Nash focused company and now have programs targeting a R&D and fibrosis and oncology.
It is an exciting time, we continue to learn new things about this class of potential therapeutics new indication.
New targeted Oregon's new mechanisms of action and new approaches to helping patients.
We expect to have a number of near term milestones.
And finally as the leader in the developed and mitochondrial based therapeutics, we are committed to strengthening our comprehensive intellectual property position.
We have benefited greatly from a first mover advantage next.
Next slide.
Based on the last two decades and research mitochondrial dysfunction is a primary problem underlying many chronic and age related diseases.
We believe cobar as peptides may hold the answers for a number of the major diseases shown on the right.
Spending on these diseases represent as much as the half trillion dollars at the inpatient level annually.
Importantly, five of the eight leading causes of death are associated with the impact of mitochondrial dysfunction.
And as we are targeting the cellular processes. We believe this approach may be disease, modifying rather than just ameliorating the symptoms.
In addition, some mitochondrial peptide key and actually opened multiple walks.
Next slide.
We have achieved two key milestones and the development of our portfolio. One is the initiation and first clinical study evaluating mitochondria based therapeutic that is CB 42 11.
Second is a significant expansion and the number of programs supporting the portfolio like nature of our platform.
Which we accomplished this year.
Note that each one of these compounds represents a different family.
GAAP type structures, they are not the same and.
And each program is targeting multiple indications.
So this is a true portfolio. It has the potential to provide multiple shots on goal.
And if one program is delayed the others can move forward next.
Next slide.
[noise] before we discuss progress and the last quarter, let's take a step back and look at the body of data that Copart has generated over the last few years.
We have come a long way we've.
We've identified over 100 peptide sequences and developed over a thousand analogs.
We have successfully tested a number of those peptides and multiple indications and preclinical studies.
We have shown that a number of the peptides can generate a consistent therapeutic impact on the targeted organs and preclinical models of key human diseases.
And based on their natural origin.
MBT may have the potential for improved safety compared to synthetic small molecule.
Today, we are pleased to announce that half of the plan subjects have reached the end of their treatment and the phase one b stage clinical study evaluating CB 42 11.
We are moving our guidance to expect topline results and the second quarter of 2021 due to the impacts of co bid on the enrollment and the study.
Which Ken will speak more about in his section.
Of course, many companies are experiencing delays associated with.
With the COVID-19 pandemic.
And our anti Fibrotic program recent preclinical data demonstrates the combination of one of our analog swim intend and demand for.
Produce enhance affects compared either treatment alone.
Suggesting potential utility for combination therapy and IPO.
And our Apple and agonist program, we generated initial positive results and a preclinical model of a rds and are moving the program forward to a candidate identification.
We did this and.
Only a few months after announcing the program.
In order to finance, our pipeline, we significantly strengthened our finances, which I will speak more about the next slide.
And we continue to educating both pharmaceutical companies and investors about our mitochondria base.
Outside platform and portfolio net.
Sorry.
As Jeff noted, we expect our current cash to take us into first quarter 2022, we.
We raised 15 million to advance our expanded pipeline.
Added biotech focused institutional investors and gained additional research analyst coverage, bringing the total to three analysts.
We look forward and continuing to develop our biotech institutional investor and Beth base and provide additional visibility for the company.
Next slide.
The company presented and ate industry and healthcare bank conferences.
Net obesity conference focused on metabolic dysfunction.
Which reflects the growing interest and developing therapies to target this area.
Thomas Seo and the team and Contactless Institute put on one of the best all around conferences of the year.
Two conferences focused on new therapies for COVID-19, one hosted by Roth Capital Partners and one by Sachs No surprise that the interest and this area.
A key part of our strategy is to collaborate on R&D with pharmaceutical companies and leading academic medical centers around the world.
A few weeks ago, we attended the bio Europe conference, where we continued to build on our partnering efforts.
Next slide.
Now I will turn the call over to Ken.
All right. Thank you Steve I'll now give a brief update on recent progress and our research and development programs next slide please.
So let's start with the clinical program CB 42, 11 is currently in phase one day, one be clinical testing and the potential treatment for Nash and obesity as a reminder, the phase one b stages. This study is a double blind placebo controlled evaluation of one dose level of CD 42 11.
And once a day in obese subjects with and they FLT.
This phase is designed to assess the potential effects of CB, 42, 11, or liver fat body weight and various biomarkers that are relevant to last obesity and metabolic disease changed.
Changes and liver fat will be assessed by and large pdfs and all subjects must have a minimum of 10% never set a baseline during screening.
This is a short study not a pivotal phase two study so we will be looking for trends and the data.
And we've been actively enrolling and dosing subjects and currently have for the target number of 20 subjects have already reached the end of their treatment with laid the significant progress. Despite total big 19 related issues, which have included the initial pause slower enrollment and more recently dropouts due to positive.
Vic 19 test at one of our sites.
With appropriate safety precautions that site continues to dose already enrolled subjects onsite flow enrolling new subjects.
These types of issues and not unique to us. Many other companies are experiencing similar COVID-19 related issues with their ongoing clinical studies.
We currently expect to have the topline results in the second quarter, a 2021 and if the study continues to progress for the current rate.
Which may change due to the unpredictable nature of the COVID-19 pandemic and other factors such as the availability of subjects over the holidays.
We expect to update the status of the study was the last subject has completed their follow up thanks.
Next slide please.
So as we discussed on the last call.
The clinical trial process for this study involves a rolling enrollment as shown in the simplified diagram.
This is a continuous process starting for each individual subject as soon as they're able to enter the study.
Each subject has to be enrolled dose and followed up for safety. This.
This process continues until the last subject is completed the final study follow up so.
So the process of recruiting and screening is also continuous we identify potential subjects and the database and our clinical sites or through advertising they must consent to be tested and and then they are carefully screened to ensure that they qualify for the study by meeting the extensive list of criteria for participation.
Including the initial and Laura skin to show that they have sufficient liver fat.
For the subject passes all the tests and qualifies for the study they can be enrolled or entered into the study and then dose without waiting for the rest of the subjects to enroll.
When each subject receives their last dose theres still a follow up period for safety observation to ensure there are no issues. So subjects into the study at different times, and we effectively create a pipeline or rolling process with subjects moving through the various steps in the process and a staggered manner all the way to the flow.
And I'll follow up.
[noise] data collected throughout this entire process and entered into a database at this stage all the data are blinded, meaning we do not know yet who received CB 42, 11, and who received placebo.
When all subjects have completed the final follow up and ask the all required data for safety pharmacokinetics liver fat body weight and biomarker levels of all being collected the data other than checks for errors. The average to systematically result, and then the database is locked and then the date or a finally unblinded and the analysis and.
The day to begin.
So as we say that half of the target subjects and they're completed the dosing and we will update when the last subject completes their last final follow up.
Next slide please.
Now moving to our preclinical programs and focused today on two programs, where we've made significant progress during the last quarter start.
Starting with her and she fibroid peptides for CB 50, 138, and a logs. This is a family of novel molecules related to a mitochondria and coated peptide that have strong anti fibrotic and anti inflammatory properties and multiple in vitro and in vivo models of idiopathic pulmonary fibrosis for IP assets.
Now based on studies conducted and culture human cells. These peptides work by reducing the production of key proteins involved and fibrosis and by inhibiting the pathological fibrek process of cell transformation from healthy low sales to fiber optic sales.
We've built on those initial discoveries by demonstrating clear anti fibrotic and anti inflammatory effects in animal models of IP, yes.
And the first prophylactic IP EPS model in which Blair mice and is used to induce fibrosis. We showed that immediate treatment for the animals without peptides reduce the extent of fibrosis and installation and the loans 21 days later.
Then in the therapeutic model, we showed the treatment of animals, beginning one week after induction of fibrosis, we agree and license assets.
Positive effects on all study outcomes, reducing the low fibrosis for.
Reducing the levels of college, and the cytokine secretion and inflammation.
We further demonstrated the efficacy of multiple CB 50, 138 and logs in the same therapeutic model.
Now most recently using this therapeutic model, we have shown that a combination other CB 50, 138, and along with Nintedanib. One of the two approved IP EPS drugs and the current standard of care produce greater effects and dosing with Nintedanib alone this points to a potential for use of cash.
C. B 50 was 38 and logs on top of current therapy and IP, yes.
We tell and we expect to complete the necessary activities required to support identification other clinical candidates early in the first quarter of 2021 subject to the successful outcome of those remaining activities and.
And then to initiate and de enabling activities with a goal of potentially funding and 90 around the end of 2021.
At the same time and the broad anti fibrotic and anti inflammatory effects of CB 50, 138, and logs suggest theres potential for their use and treating other fiber optic diseases and we're exploring that potential in preclinical models, such as scleroderma kidney fibrosis and Nash next slide please.
So on this slide we see some of the data that were released this summer at the American Thoracic Society virtual annual meeting looking.
Looking here at potential for monotherapy using the mouse therapeutic model of IP assets.
In addition to the first CD 50, 138, and a previously cold and the T. too and the most were treated with two newer and logs alone and then compared to placebo vehicle treatment and the red bars for Nintedanib and the green bars.
Now and internally as one of the two approved I P. S drugs, it's a tyrosine kinase inhibitor the block several different targets, leading to a slowing the progression of I.P.S.
And then Ted and it also has significant off target effects, including nausea, vomiting and diarrhea.
Here you see we have consistent anti fibrotic and anti inflammatory effects across the board, including reductions and fibrosis reduced low weight reduced inflammation in terms of lymphocytes and the low fluid reduced levels of college and both in the lung tissue and secreted into the low fluid.
Next slide please.
So moving now to the most recent data released just three weeks ago. This was a study designed to look at the potential for combination and now CD 31, 38, and along with the standard of care and this case nintedanib.
The study was a gain conducted in the therapeutic mouse model of IP and where treatment was initiated seven days after the bleomycin induction of fibrosis.
The treatments included CD 50, 138 dashed to alone Nintedanib alone and the combination of both drugs together.
And he you can see the effects of these treatment the dark blue bars. Other combination of CB 50, 138 does too with nintedanib compared to the green bars for Nintedanib alone.
You can see there was a greater reduction and lung fibrosis, low weight and levels of college and for the combination.
And that positive combination effect also carried over to the other slides I'll just study endpoints on the next slides next slide please.
Okay. So and the same experiment, we see here the levels of pro inflammatory cytokine secreted into the low fluid.
This includes key cytokine such as aisle, one beta TNF Alpha and iOS six as well as other key chemo kinds involved and the inflammatory response such.
Such as the monocyte chemo attractive protein and CP, one and the macrophage inflammatory protein NIPT, one alpha and.
In all cases, the combination of the CB 50, 138 analog with Nintendo and Ted and it was much more effective at reducing these pro inflammatory cytokine then nintedanib alone.
Next slide please.
So and this last day decide here, we're looking at the infiltration and the inflammatory cells into the low flow it [noise].
You can see that the combination and the CD 50, 138, and oil with Nintedanib and the dark Blue bar was again more effective and reducing the infiltration and macrophages lymphocytes and new truck sales when compared with treatment with Nintedanib alone and the green bars.
Next slide please.
Now a key advisor on this fibrosis program is Dr. Toby Mayor is the professor of clinical medicine at the Keck School of Medicine for the University of Southern California, and also professor of interstitial lung disease, and the National Heart and lung Institute for the Imperial College, London.
Net dot and there has been involved and more than 50 trials and fiber optic lung diseases from phase one b two phase for including five P.F. studies.
And our recent key opinion leader coal docs and I gave a compelling clinical perspective on the devastating impact of I.P.S. and the continuing unmet need for new treatments.
Moving to talk to me a future treatment of I.P.S. will likely move towards combinations of new mechanisms with the current standard of care.
And he believes that co bars preclinical data for CB, 50, 138, and logs in combination with net incentive or a step towards that goal.
Next slide please.
Moving now to our CB 50, 64 and logs. This is a different family a peptide and logs that have the potential to reduce the mortality in acute respiratory distress syndrome, or rds and and COVID-19 related they are yes.
By simultaneously blocking many other processes that lead to global damage.
No and the right you can see that totaled 19 is more than a lung disease and severe cases, it's and cause fluid accumulations asking for leakage sepsis inflammation and thrombosis and even a cytokine storm that can lead to multi organ failure. So together these damaging effects of the virus can lead.
And to respiratory failure cardiac failure stroke, and even multi organ failure.
There are no approved drugs to treat rds.
And even without coded 1980, s. affects 3 million people.
Oh, CB 50, 64, and logs work by selectively activating the Apple and receptor a key a difficult and signaling pathway that has brought protected rebalancing effect on numerous systems, including the control of fluid levels, that's still a tone blood clotting inflammation and cytokine.
And production.
Apple and signaling has been shown to protect animals and models of a rds.
Sepsis thrombosis and stroke selling.
And engaging the ethylene receptor has the potential to block many of these damaging effects of COVID-19, we.
We have previously share excuse me in vivo data showing efficacy of our CV 50, 64, and logs and an animal model of a rds leading to reduced fluid accumulation in the lows day.
Decreased accretion of pro inflammatory cytokines.
And now we're currently conducting confirmatory studies and the a rds model and moving forward towards potential candidate selection scale up and the initiation of I., India and enabling studies.
And with that I'll return the call to Steve.
Thanks, Ken next side.
So briefly we wanted to make sure the opportunity was clear as you know with and Nash situation. It's a large unmet medical need there is no approved treatment for Nash and over 30 million.
Patients are at risk for Nash and the United States and.
In terms of landscape and it's a large and growing population yeah.
He has been a bumpy ride for certain later stage company and.
For this has very little to do with us.
Because we have a unique mechanism of action.
We do learn a lot and we believe watching some of the companies are and later stage helped us design.
Better future studies and regulatory strategy.
Regarding the competitive landscape, it's a very large opportunity at $30 billion as estimated so there's plenty of room for multiple therapies and.
Physicians believe there is a need for combination therapy again, there is no direct competitor for our mechanism of action and previously we've explained that there are synergies for the existing compounds like the GLP ones.
Pardon me as an important part of our strategy and we think that our unique mboe a day is potentially applicable to all stages of Nash and again synergistic with the GLP ones.
As we know the later stage companies have valuations over a billion dollars, we believe clinical results and and partnering will be future derived drivers on our value.
And then we also believe that Cobar and other programs will add to the overall value.
And expense.
And I like to focus and a little bit on idiopathic pulmonary fibrosis, one of the targets and our preclinical anti fibrosis program.
And 29 team. They are about 187000 cases worldwide, it's expected to grow to 20 by 2028 day.
These onset often occurs and.
After 65.
There is a high unmet medical need.
One percentage of the death of the U.S. are caused by IPO.
Unfortunately, only 50% of the patients live to three years.
And only 10% survive for five years, you current and prove drugs slow progression and disease, but do not repurchase fibrosis.
There is a clear need for combination therapies.
You can see the global market numbers, but the real issue and the current therapies.
Have gastrointestinal and other problems like skin problems or.
They're not well tolerated.
And as a result, many patients either cannot say on him or find themselves and living in a very difficult situation.
Particularly when drugs for combined.
And our case as Ken indicated.
Shown its ability to combine win with Nintendo and net and show and enhanced effect.
Next slide.
And then as far as the opportunity and our other programs clearly there is a high unmet need the Rds area as Ken has talked about there is no safe and effective treatment.
And the survival rate is only 25% amongst COVID-19 patients with a rds.
And of course, our program targets potentially the other 3 million a rds patients worldwide as well as patients with a co. Good.
Generated a R&D yes.
And we have shown as Ken said, some pretty interesting results. The one other preclinical program.
He is our CFO CR for inhibitors for cancer and orphan diseases and.
See our for and receptor is over expressed and more and 75% of cancers.
Therefore, we and others believe that the indications for a compound and this category include multiple cancer types stem cell mobilization and genetic defects.
And there we have already shown that our inhibitors reduce mean tumor volume and and melanoma model by 61% and combination get temozolomide and chemotherapy drug versus 38%.
And temozolomide issues by itself.
Next time.
These are the near term milestones for us over the next six to nine months, we expect to have additional results and they are the EPS in this quarter. We also plan to nominate a clinical candidate for one of these programs and Q1 2021.
We are also expecting topline results from the phase one b and the second quarter of 2021 subject to the impact of COVID-19.
And our overall goal for the pipeline is continuing generating programs, which could lead to multiple clinical studies over the next few years next side.
To close then I'd like to be about why we are so excited about our development products and what they can do for patients.
Let's start with our innovative endpoint enhancing CB 42, 11 compound again, there are no approved products and the morbidity and mortality caused by Nash can be devastating.
With a unique mechanism and need for combination drug treatment and Nash our novel molecule has potential to be an important compound in the future treatment of Nash.
We also believe that the problems at different stages of Nash can be treated with therapeutics like ours.
We have shown co bars, and bts have unique mechanisms.
And we originally had shown this with the Nash compound and now we see the same combined.
Effect with our anti fibrosis peptides with and tend to net and IPO.
Our priority now or to generate topline results other case lumpy trial too.
Execute on our preclinical pipeline and I am pleased with progress across the board, so far and 2020, especially with preclinical data from our idea and a rds programs.
And finally to nominate a new clinical candidate and the first quarter.
In summary, we are pleased with the pace of progress the key highlights from this quarter or the exciting preclinical results, which further demonstrates the depth and breadth for the program.
We know that we have a special opportunity for quite a country based therapeutics, we remain committed to delivering on the promise of our science to bring forward and new class of medicines for patients.
Next slide.
Now I will turn the line over to Rob to open up for the Q and AG.
Thank you.
Well now be conducting a question and answer session if you'd like to ask a question today. Please press star one for your telephone keypad and a confirmation total indicate your line is and the question Q.
You mean for star to feel free to move your question from the Q.
For participants are using speaker equipment, and maybe necessary to pick up for handset before pressing the star keys.
One moment. Please so we poll for questions.
Thank you.
For personal and we assemble the queue.
Thank you.
Our first question is coming for the line of and.
And one or how should we Elmer terrace and it was always capital partners. Please proceed with your question.
Sure.
And and gentlemen, thank you very much for the comprehensive updates I only have a handful of questions.
Ken you alluded to that half of the patients and the 42 11 have been completed their treatment phase and you described the continue and.
And the pipeline and this trial.
Are there any other patients and at the beginning of the screening phase for how Syria and this continue that are being contemplated.
Contemplated now.
Yeah without getting into a you know a patient by patient de sales were still in the recruiting screening and enrolling phase. So we're bringing in patients continually and they're exiting continue and that's the way I'd describe it.
Okay and.
And with regards to 61 38, the anti fibrotic peptides and the follow on and that use and we'll announce.
It's not going to be a replacement did I understand correctly to 61 38, but for a potentially.
And additional and pipe hydraulic indication.
That's right, it's would be potentially adding to the breadth of possible uses for the lead.
That we choose as a clinical candidate for I T. F. In other words have the opportunity to also pursue it for other fiber Arctic indications and on the list as you heard a.
Just as a start exploring.
Exploring scleroderma, preclinically kidney fibrosis and potentially net.
Okay, and then last question I had a real obviously for the good news on the vaccine current not from Swedish and companies.
What would a highly effective let's assume that it remains as a sector as it was announced today and the weeks ago, a vaccine means for the RMBS market and specialty the current relate to the air and D. S.
Right well you know to the first question, which is to the Rds market in general even a very effective COVID-19 vaccine is not going to diminish the unmet need of those existing threemillion that didnt get there a rds as a result for the Covidien sex and that's a huge.
[noise], continuing unmet need but for cobot itself I think it's too early to really concludes that a you know the vaccines currently and development are good enough over the last long enough and we'll have a you know effects in the severely affected subjects, which is the key here the one.
Consider or are there suffering from a rds and have a high risk and mortality.
Or a subset of the population and it's really important to understand how they are protected regardless of that and people who recover already from Cove and infection are going to have longer term consequences Oh.
And we think there are other molecules within their portfolios as well that could be applicable to those longer term downstream total sequences of a severe cold in Texas.
Okay. Thank you so much.
Sure. Thanks Ella.
Thank you for Elemer.
Your next question comes from the line of Kumar for Russia was for client capital. Please proceed with your question.
Hi, good off and loan and thanks for taking my quick and yeah.
Yeah, I would like to continue with regard to the net grouping and screening.
Can you give us a sense like you know what proportion outreach and I end up and being door stocking and the recruiting and screening.
And also with regard for the phase one walk kind of playing a income from Oh, and the U.S. price back for a net body weight and other biomarkers.
Do you guys think we'd be operating model.
Okay, two or two good questions there Colin thanks for the question the for the first as far as recruiting and screening as I said, it's an ongoing continuous process. If you are asking more about you know whats the screen failure rate here. So how many people do we have to screen to find a you know successfully qualified subject.
That's a you know a common thing across studies that there will be a screen failure number and because you have a long list of criteria. So you know we're looking at finding a lot more subjects and that actually ends for the study, but that's just part of this process and you know we've been.
And successful and getting halfway through it so for despite the cove. It oh issues that arise says they have arisen with many clinical studies right now so yeah, that's about as much detail because as I can give you and screening so it.
For your second question you know what trends are we expecting to see other this study will it give you a kind of a a perspective on this there were several recent results released in the space for Nash studies and a full week setting. One example, being direct that put out their day to recently.
And they were happy to report and their case or something and nailed it too when you look at the data around a 7% reduction and liver fat and that translated to you know obviously to the suspicion that there is a good efficacy in that period. So I'm not saying, that's what we are targeting but I'm, saying, we're going to need.
To look at the day to carefully to.
To judge what a predictive trend is as to how that translates to a 12 week study Europe for phase two study and that's just the liver fat. So then we'll also be looking at body weight and it's a long list of Biomarkers and that's less clear going into it as to what constitutes a a you know.
As you said optimal outcome and we'll probably be looking across multiple biomarkers for an indication of Ah I continue and if you like other effects that are related to last for obesity or events and metabolic disease.
Okay and that in preclinical studies, we have seen synergistic EPS with that GLP, one and so how do you think that we find out for heating Bill how are you guys thinking pounds, how for future studies.
That's a good question because you know it is a consideration and designing a follow on study the Poland studies, the phase two and 12.
12 week or 16 week study and the Nash population it may be a better to do that study in the setting of diabetic Nash subjects, because 50% and less subject to our diabetic.
In particular, those that les already be on a stable regimen and other GLP one agonists because we do have this evidence that the mechanism of our drug is synergistic complementary to a GLP one mechanism.
And that may be true of other mechanisms to so I'd say, you know that factors very significantly into our thinking around what the next study might be in this program.
Okay, and you touched about expanding into scleroderma, Maki day fibrosis, and non cash Lord that preclinical data or do you have index frying and that gives you confidence and thought on this is something that studies and it could be done in the future.
The other studies are initiated and ongoing in some cases and about to be ongoing. So we will have these data.
Probably in the next few months on those parallel indications. So this will be new preclinical data will be generating with our lead and logs and the C.D. 50 138 or so.
Setting so that by the time, we are in a position to select the candidate for I.P.S. and will be a <unk> have a good understanding of its utility for those other indications.
Indications as well.
And finally with regard for the CXC and putting he'd be test when can we expect that next topic on dark. Thank you.
Yes, sure that program is continuing and now preclinical studies right now and progressing and kind of on the schedule. We plan. So we're expecting to update on that program at the next call you know hopefully with some some new data to to demonstrate their utility there as we said we're exploring.
Utility and the setting and things like stem cell localization and we'll we'll give an update on the next call.
So mark Thank you very much.
The next question comes from the line of Steve for exact with WBB. Please proceed with your question.
[laughter] good afternoon, gentlemen, thanks for taking the questions I only have one I'm keeping most of think things have been asked and answered and it goes back to one of your earlier questions and it's specific to the co goods to qualify that you know is now becoming very well documented and unfortunately.
Morning.
Oh Untreatable can you can you go back and cover what you were saying originally about the potential for your platform to treat these these issues that exist long after the patients have left for hospital and rehabilitation. Please.
Sure, Yes, thanks, Steve let's talk about that so the immediate use of our CV 50, 60 for analog see Apple in AG and then in the setting of coated or a rds for this related to covered or not is addressing the acute injury. So its an acute injury phase.
And when there's a lot of damage going on and the loans and the other tissues and that's where we think that program will have immediate utility obviously, if you're reducing those that damage. You are also going to reduce the downstream secondly is that the.
The downstream consequences of the damage that could translate you know in the longer term into things like more lung fibrosis, you know for a kidney failures floor or you know.
Chronic morbidity related to the Dan and she caused in other tissues, but having said that we've also got a portfolio of peptides here. So we have other peptides and an example, being anti fibrotic peptides that you could potentially directly used to treat the type of fibrosis that might be developing now and these subjects and head of sales.
For the year, Covidien section and had Dell and slows and and now looking at you know dealing with this chronic.
Situation that is just emerging now and she said becoming very clear.
And in terms of the mechanism, which you'd be looking at it would be a leap of faith at all to to be able to go out there and utilize that mechanism to deal with with these issues that as you put it were once acute and our chronic and sent a is that a good way of looking yeah. I think that's true you know it.
No.
Not really.
A stretch for the imagination to say, that's something that you've already shown directly can improve flow fibrosis when its induced by an injury.
There are some who would argue that the bleomycin model is actually a model of a covert related injury as well because of the downstream affects other similar so I would say, yes. There is there's a good likelihood that anti fibrotic peptides lights have utility and.
And in a setting like the downstream consequences of Cove it.
Great well again, thank you for taking the questions I'll hop back in the queue.
Thanks, a lot thanks, Steve.
Thank you and your minor you mean for star one to ask a question.
[noise].
Thank you.
At this time.
And then Oh, Pos and moment.
Our next question will come from the line of Andre Safra private investor.
Hi.
And just separately for EMEA over for questions.
Oh, sorry price accident.
And im interpreting that impact and cushion.
Oh, thank you.
At this time I will turn for back to Steve and go for closing comments.
Thanks, Rob and.
And everybody I hope you get a sense very excited we are making now pass pathway Mark with the study.
For CB 42, 11, and also that we just continue to make progress that adds to not only in the knowledge about specific programs, but about peptides and general.
So we look forward to sharing more with you and the next call and.
And look forward to that at that time, thanks, very much for joining us today.
Thank you everyone. This will conclude today's conference you may disconnect. Your lines at this time. Thank you for your participation.