Good afternoon. My name is Ariel. I will be your conference operator today. At this time, I would like to welcome everyone to CohBar's Second Quarter 2020 Financial Results Conference Call. [Operator Instructions] I would now like to turn the conference over to Jordyn Tarazi, Director of Investor Relations at CohBar. Please go ahead..

Hi, Ariel and thank you, everyone for joining CohBar's second quarter 2020 financial results conference call. Joining me on today's call is Steve Engle, CohBar's Chief Executive Officer; Ken Cundy, CohBar's Chief Scientific Officer; and Jeff Biunno, CohBar's Chief Financial Officer.

CohBar's 10-Q filing and financial results press release were issued earlier today and may be downloaded from our website at cohbar.com. If you’re having issues joining the WebEx, you can access the slide presentation from the homepage of CohBar's website to follow along.

Jeff will begin with an overview of the second quarter financial results, followed by a business and R&D update from Steve and Ken 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’s plans and expectations for its lead CB4211 drug candidate program, and other programs that therapeutic and commercial potential of the company's lead drug candidate CB4211, and other mitochondria-based therapeutics; statements regarding ongoing and planned research and development activities, potential partnerships and our capital resources and our 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 to differ materially from those anticipated by CohBar.

These risks and uncertainties are described in our registration statements, reports and other filings with the Securities and Exchange Commission and applicable Canadian securities regulators, which are available on our website at cohbar.com, sec.gov and sedar.com, as well as in the Safe Harbor statement included with today’s press release.

You are cautioned that such statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements.

CohBar does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise. Now I’d like to turn the call over to Jeff Biunno, CohBar’s Chief Financial Officer.

Jeff?.

Thank you, Jordyn and thank you everyone for joining us this afternoon. As Jordyn mentioned, if you're having issues with WebEx, the slide presentation is posted on the homepage of the CohBar website. Next slide please. As Jordyn noted, I will begin with a review of the financials followed by a business overview by Steve.

Ken will then review the recent developments in our clinical and preclinical programs and we will conclude with Q&A. Next slide please. I will now provide you with a summary of our financial results for the second quarter ended June 30, 2020 compared to the second quarter ended June 30, 2019.

Total operating expenses in Q2 2020 were $2,936,000 as compared to $2,957,000 in Q2 2019, a decrease of approximately $21,000. Operating expenses included non-cash cost of $693,000 for the quarter ended June 30, 2020, and $700,000 for the quarter-end June 30, 2019.

Net of the non-cash costs, total operating expenses in the current year quarter were $2,243,000, as compared to $2,257,000 in the prior year period, the decrease of approximately $14,000. Non-cash operating expenses include stock-based compensation and depreciation and amortization costs.

Research and Development expenses were $1,545,000 in Q2 2020, compared to $1,418,000 in the prior year period, an increase of approximately $127,000. The increase in research and development expense was primarily due to higher consulting costs and an increase in expenses related to our continuing development of peptides.

General and administrative expenses were $1,391,000 in Q2 2020, compared to $1,539,000 in the prior year period, the decrease of approximately $148,000. The decrease in general administrative expenses was primarily due to lower recruiting and travel costs.

For the quarter ended June 30, 2020, CohBar reported a net loss of $4,103,000, a $0.09 per basic and diluted share, compared to a net loss for the quarter ended June 30, 2019 of $3,058,000 or $0.07 per basic and diluted share. Net loss included non-cash expenses of $1,779,000 for the current year quarter, an $805,000 for the prior year period.

Excluding the non-cash expenses CohBar’s net loss was $2,324,000 for the quarter ended June 30, 2020, as compared to $2,253,000 for the prior year period. The total non-cash expenses include stock-based compensation, depreciation, and amortization costs and equity modification costs.

Moving to the balance sheet as of June 30, 2020, CohBar had $12.3 million in cash, cash equivalents and investments, compared to $12.6 million in cash and cash equivalents as of December 31, 2019. The cash burn for the quarter ended June 30, 2020 was approximately $2.5 million.

During the quarter, we raised approximately $4.5 million using our at the market offering facility. We estimate that based on our cash and investments balance as of June 30, 2020, we have sufficient capital to finance our operations into the third quarter of 2021.

This revised runway guidance is a result of the funds raised in our ATM extending the maturity date of promissory notes, proceeds from option and warrant exercises and delaying certain expenses, which we do not expect to materially affect our R&D programs.

During the quarter-end, the company extended the expiration date of warrants that were issued as part of the company's private offering completed in July 2017. The expiration date of these warrants was extended from June 30, 2020 to September 30, 2021 with the balance of the terms and conditions of the warrants remaining unchanged.

The company incurred a non-cash modification expense charge of approximately $1 million to extend the warrants. Subsequent to the quarter-end, the company entered into amendments with certain holders of its unsecured promissory notes.

The amendments included modifications to the promissory notes such as extending the maturity date from June 30, 2021 to June 30, 2022 and granted participating note holders certain other rights and benefits. For detailed explanation of these amendments please see note 11 to our Form 10-Q that was filed earlier today.

I'll now turn the call over to Steve.

Steve?.

Thanks Jeff. Welcome everyone to our Q2 2020 call. There are three key things that are important for you to know. We have resumed the Phase 1b study and are expecting topline results in the first quarter of 2021.

We announced new preliminary preclinical results in our COVID-19 ARDS program today, and expect to have a [flow] [ph] pre-clinical milestone over the next three to nine months. And for people interested in mitochondria, CohBar remains one of the few vehicles for investing in the therapeutic potential of this new and emerging science. Next slide.

What is the CohBar opportunity? We are the leaders in developing a new class of therapeutics based on our founder's discovery. The mitochondrial peptides regulate multiple systems in the body. Think about that. Prior to 2001 in Dr. Cohen's discovery, people thought the mitochondria were just powerhouses of the cell.

Because it is a new class of therapeutics it represents a large untapped and exciting group of potential compounds over 100 peptides and over 1000 analogs have been discovered and counting. We are targeting a wide range of diseases that are associated with mitochondrial dysfunction.

Mitochondria based therapeutics benefit from over a billion years of evolution and may generate entirely new approaches to disease. We need new and different approaches. The old one may not have worked well. We are taking advantage of the approach that the body has developed itself.

In the last year, the company's portfolio has grown from two programs to five. We are no longer just a NASH focused company and have programs targeting ARDS, fibrosis and oncology. We have a number of expected near term milestones including preclinical results in three programs and the nomination of a new clinical candidate by the end of the year.

The Phase 1b CB4211 clinical study has resumed with results expected in the first quarter of next year. We have a comprehensive IP strategy, and we enjoy a first mover advantage. We are the leaders in the development of mitochondria based therapeutics. Our IP portfolio is significant and continues to expand.

Next slide, the revolutionary discovery behind CohBar’s technology platform is the finding that mitochondria more than the powerhouses the cell that we learned in biology class and generate signals that regulate cells, organs and systems across the body. This was a stunning discovery.

To put that in perspective, it is very rare for a biotechnology company to discover such a large potential group of compounds that have not been discovered or developed previously, not since the discovery of protein sequences in the human genome, or the mRNA proteins from companies like [Madonna] have so many potential compounds been discovered.

We are in the third generation of discoveries. As Dr. Cohen says, we are just entering a new era in the understanding of the complexity of orgazmo processes, whereby micro peptides that are potent biological agents determine human phenotypes alongside large genes.

In fact, micro peptides may encompass an order of magnitude larger array of genes, then large proteins. We believe the size of this opportunity is vast. The results from our programs are showing us that we are actually identifying novel approaches to these diseases, which may provide added benefits.

This is the kind of exciting scientific discovery that holds out great hope for long suffering patients and humankind in general. Next slide, based on the last two decades of research, overcoming mitochondrial dysfunction represents a very large opportunity for CohBar.

We believe CohBar’s peptides may hold the answers for a number of major diseases shown on the right in this picture. This is because mitochondrial dysfunction underlies multiple chronic and age-related diseases. Five of the eight leading causes of death are associated with the impact of mitochondrial dysfunction.

Spending on these diseases represents as much as a $0.5 trillion annually, it will probably not surprise you that mitochondrial dysfunction will turn out to be a large player in the susceptibility to COVID-19. Diseases like diabetes and cardiovascular disease may be improved in parallel due to the underlying mitochondrial dysfunction.

This dysfunction occurs when the mitochondria fail either due to ageing or lifestyle behaviors and other causes. Next slide, our peptides benefit from 1 billion years of evolution. And today I provided novel mechanisms of action, which may provide new approaches to diseases. For example, CB4211 regulates the flow of free fatty acids from adipocytes.

This is a unique approach and the NASH space and is synergistic with existing therapies. Another example is our apelin agonists, which uniquely bind to the apelin receptor and thereby results in a reduction of vascular leakage, fluid accumulation and cytokines, storm kind of the trifecta of COVID disease.

We are encouraged by our preliminary data in ARDS which Ken will share in his section. In a similar faction, our antifibrotic and CXCR4 inhibitor programs have demonstrated unique mechanisms of action, which may provide more effective solutions and diseases with high unmet needs while potentially being better tolerated.

Next slide, here you can see our pipeline has expanded. Note that each one of these compounds represent a different family of peptide structures, they are not the same, and each program is targeting multiple indications. So this is a true portfolio. It provides multiple shots on goal and multiple events.

Of course, with an expanding pipeline, we are regularly evaluating our priority. Currently our program priorities are NASH, antifibrotic peptides or IPF, and apelin agonists for COVID-19 ARDS. Next slide, as CohBar’s founders were the first to discover mitochondrial derived peptides, we have the advantage of being the first mover in the space.

We were first to discover and first to develop. We have 12 issued patents that have issued that cover both composition of matter and methods of use. We identified 100 peptides in the genome and then developed over 1,000 analogs.

These analogs act as picket fence against other companies that might want to work in the same space and we continue to expand our IP portfolio and expect to remain a leader in the space. Next slide, regarding our goals and recent accomplishments, first of all we presumed Phase 1b clinical trial.

Second, we expect to identify our next clinical candidate for preIND studies by end of the year. With finite R&D funds, it is critical that we remain focused on the most important programs. We regularly prioritize our spending based on potential and progress. Currently, our highest priority programs are the antifibrotic and COVID-19 associated ARDS.

In the case of the new COVID-19 ARDS target, we're investigating funding opportunities with the U.S. government agencies such as NIH and BARDA and also looking to see if we can get their help and expediting the research. I also know we were pleased to be added to the Russell.

And we were able to raise 4.5 million aggregate to ensure that our programs continue to be funded appropriately. Our plan remains the same and that we continue to need to fund the programs ourselves until such a time that we can bring in a corporate partner to help develop the assets.

We have resumed the clinical trial which has added more to the project spending. And we've been very successful and expanding our pipeline and now have significantly more opportunities than a year ago. We have continued to be careful and conservative about our spending. And so, we have cash in the bank.

We have been spending approximately the same amount of money per quarter for some time now. But now we have more programs and we have the opportunity to take advantage of their potential by increasing our burn rate, but we only want to do that if we have additional capital.

Besides adding capital to our programs, we're looking to gain biotech focused institutional ownership and research coverage. We see this as an important next step and continuing to fund the company and to reflect the company's value in the marketplace. In the past quarter, Brookline Capital's research analysts initiated coverage on the company.

We also continued to present the key banking conferences. We presented at the Sachs Novel Coronavirus Investment Forum, which was a specialized conference on companies with COVID-19 programs like ours.

Due to the COVID-19 pandemic, the biotech market has enjoyed increased visibility in addition to the important and very visible work being done in COVID vaccines and therapeutics. There have been many positive data readouts across the therapeutic landscape. We see this as a positive for CohBar.

As we continue to increase our visibility within the investment community. We anticipate expanding our efforts to develop partnering activities around CohBar’s technology, particularly after we have the Phase 1a, 1b results. We also were at BIO 2020 in June during this quarter, and had a very good set of meetings.

It's quite obvious that companies that we had met with a year ago in the NASH space are still very interested. And we added a number of addition groups that are interested in both our antifibrotic as well as our oncology programs. As leaders in mitochondrial derived peptide development, we expect continue to expand our IP portfolio.

Next slide, these are the near-term milestones over the next three to six to nine months. We expect to have additional results in ARDS by the end of the third quarter and results from the antifibrotic and CXCR4 programs in the fourth quarter. We expect to nominate a clinical candidate from one of these programs by the end of the year.

And we expect top line results from the Phase 1b study in the first quarter of next year. Our overall goal for the pipeline is to generate programs which lead to multiple clinical studies over the next few years. Now, I will turn it over to Ken.

Ken?.

Okay, thanks, Steve and good afternoon, everyone. I'll now give a brief update on recent progress in our research and development programs. So let's start with the clinical program CB4211 is currently in Phase 1a, 1b clinical testing as a potential treatment for NASH and obesity. The Phase 1a stage of the study is complete.

And we're currently in the 1b part of the study. In March, the Phase 1b stage of the study was paused due to COVID-19. The pause was lifted in early July. And now all four study sites are open for screening and enrollment.

The new sites we've added are sites with extensive experience running NASH studies, and they're running other studies in addition to ours. Now, as a reminder, the Phase 1b stage of the study is a double-blind placebo-controlled evaluation of one dose level of CB4211 given once a day in obese subjects with NAFLD.

This phase is designed to assess the potential effects of CB4211 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 MRI-PDFF, and all subjects must have a minimum of 10% liver fat at baseline.

Now to give you some sense of the process here, once we identify potential subjects from the databases of our clinical sites or through advertising. They must be carefully screened to ensure that they qualify for the study by meeting the extensive list of criteria for participation.

This includes things like not being on any other drug that might affect their liver fat, their body weight, or any of the biomarkers that we're looking at that includes specific ranges for certain lab values like liver function tests to ensure that do not have other health problems.

That long list of requirements is described in detail and the record is posted on ClinicalTrials.gov. If subjects pass all of those required screening tests, they still have to pass the initial MRI scan to show that they have sufficient liver fat.

There's also a fixed window in which all of these tests have to be passed before you have to restart the whole screening process again, only after they pass all the tests within the window can they be enrolled. Now this is an ongoing rolling process until 20 subjects have been enrolled.

And what we mean there by rolling enrollment is that when a subject passes all the tests and qualifies for the study, they can be entered into the study and dosed without waiting for the rest to enroll. So we effectively create a pipeline, with subjects moving through the various steps in the process all the way to their final assessments.

Now when the last of the 20 target subjects receives their last dose, there's still a follow-up period for safety observation to ensure there are no issues. And after all of the necessary data for safety pharmacokinetics liver fat, body weight and biomarkers are collected. The data are then checked for errors and the database is locked.

Then the analysis of the data begins. Now as the study enrolls at the rate we projected before COVID-19 came along, we would be on track to have the top line results in Q1 of 2021. It is possible that the timing of this study going forward will continue to be subject to the effects of an ongoing COVID-19 pandemic.

The true post COVID-19 recruitment rights will become clearer as we enroll further. We expect to update the status once the last subject has had their last assessment. Supporting on this program, we have key opinion leaders like Dr. Rohit Loomba, an internationally recognized expert on NASH KOLs like Dr.

Loomba are recognized experts in the field that helps us design studies and strategize for clinical and regulatory paths forward. They're also thought leaders that analysts follow closely for opinions on new treatment options in development. Next slide, please.

Now I'll give a brief update on new data from our two of our preclinical programs starting with the CB5064 analogs.

These are novel analogs of the mitochondria encoded peptide that have the potential to reduce COVID-19 mortality related to acute respiratory distress syndrome or ARDS by simultaneously blocking many of the processes that lead to global damage. Now, if you look on the right of this slide, you see that COVID-19 is not just a lung disease.

It has global effects that all contribute to increase mortality, including vascular leakage, fluid accumulation, inflammation, sepsis, thrombosis and the cytokine storm. Together, these damaging effects of the virus can lead to respiratory failure, cardiac failure, stroke, and even multi-organ failure.

There are no approved drugs to treat ARDS and even without COVID-19 ARDS affects 3 million people.

Our CB5064 animals work by selectively, activating the apelin receptor, a key adipokine signaling pathway that has a broad protective rebalancing effect on numerous systems, including control of fluid levels, vascular tone, blood clotting, inflammation and cytokine production.

Apelin signaling has been shown to protect animals in models of ARDS, sepsis, thrombosis and stroke.

And we've now generated preliminary in vivo data showing potential efficacy of our CB5064 analogs in an animal model of ARDS, leading to reduce fluid accumulation in the lungs, decreased secretion of pro-inflammatory cytokines and reduced infiltration of inflammatory cells into lung tissue.

I'll show some of the preliminary data in the next couple of slides. We are currently conducting confirmatory studies in ARDS, and exploring options for preclinical testing in actual COVID-19 ARDS models, while moving forward towards candidate selection scale up and initiation of IND-enabling studies. Now supporting us on this program is Dr.

Toby Maher, who is professor of Interstitial Lung Disease at Imperial College, London and now also on the faculty at USC. Next slide, please. In this slide, we present new preliminary data from efficacy studies to CB5064 analogs in a standard mouse model of ARDS using the bacterial lipopolysaccharide or LPS induced acute lung injury model.

Now LPS is a toxin that generates very similar effects on the lungs to those caused by other diseases. Animals received a single dose of our peptide analogs, one hour before the LPS administration, or a second dose six hours after LPS. Now in the slide, we're looking at lung weights at either four hours or 24 hours after the LPS.

The black bar is animals that did not receive the LPS injury. The red bar is animals treated with LPS to induce the acute lung injury and then given vehicle or placebo treatment. You can see the lung weights increased, reflecting accumulation of fluid.

The purple bar is the natural apelin adipokine and the green bars are from one of our CB5064 analogs given here at two different dose levels. You can see that this single dose of our particular analogs in green reduced the increase in lung weight, indicating a decrease in the fluid accumulation.

That protective effect was similar to or better than the effect of apelin itself in this study, and was maintained at 24 hours after the LPS injury. There are preliminary data here and we are now confirming these in additional studies. Next slide please. We’re moving to next there we go. Thank you.

So in this slide, we're showing now some preliminary data from the same studies looking at the effect of our peptides on the levels of key proinflammatory cytokines, things like IL-6, TNF-alpha and others.

This is done by measuring the cytokine levels in the lung fluid, or the bronchoalveolar lavage fluid as it’s called collected by rinsing the lungs at four hours after the LPS injury. Again, animals injured with LPS and treated with placebo shown in the red bars has an increase in all of these cytokines.

We see in the green bars that CB5064 analogs reduce the levels of key pro-inflammatory cytokines in BALF in a dose dependent manner, surpassing the effects of apelin. So once again, these are preliminary data and we're now confirming these and additional studies in comparison to additional analogs. Next slide, please.

A little lag on the slides here, okay. Let's see we should be moving to Slide 21. Okay I'm not seeing a slight change here, Jordyn. I have it changed. You have it changed. Okay, then I'll proceed. So now we'll turn to our antifibrotic peptides.

And these are the CB5138 analogs, the first of which was MBT2 a peptide we've previously shown to have efficacy in preclinical models of idiopathic pulmonary fibrosis or IPF. We've now generating new data demonstrating improved efficacy of additional analogs in this family in the therapeutic mouse model of IPF.

The data were presented in an E-poster of the American Thoracic Society Virtual Annual Meeting just last week.

The poster also included our earlier data on the antifibrotic and antiinflammatory effects of MBT2 in both prophylactic and therapeutic mouse models of IPF involving either immediate treatment without peptide after induction of fibrosis with bleomycin, or treatment one week later after the bleomycin injury.

The new data were generated in the more challenging therapeutic model, and I'll show some of the new results in the next slide. The next steps in this program for us are evaluation of our lead peptides in additional preclinical studies, including addition to the standard of care, with the goal of identifying a candidate for IND enabling studies.

Now supporting us on this program is pulmonary fibrosis expert, Dr. Naftali Kaminski, who is Professor of Internal Medicine and Chief of Pulmonary Critical Care and Sleep Medicine at Yale School of Medicine. Next slide, please.

Okay, I'm showing here some of the new data on the antifibrotic peptides that were just released in the American Thoracic Society Virtual Meeting last week. In addition to the MBT2 also called CB5138-1 to newer analogs of CB5138 were tested in the therapeutic IPF model.

And then compared to vehicle control treatment in the red bars, or to nintedanib in the green bars, which is one of the two currently approved drugs for IPF.

And here you can see consistent antifibrotic and antiinflammatory effects across the board, including reductions in fibrosis, reduced lung weight, reduce inflammation in terms of lymphocytes in lung fluid, reduced levels of collagen both in the lung tissue and secreted into the lung fluid.

Now across these programs, these are the most recent results from our ongoing work and we expect to have additional data on our preclinical programs in the coming months. The goal here is to identify a potential clinical candidate from one of these ongoing programs around the end of the year. And with that, I will return the call to Steve..

Thanks, Ken, great start. Next slide, so obviously NASH is a large unmet medical need. Over 30 million Americans surface for NASH and over 100 million are obese in the U.S. The market is estimated at $35 billion.

In this NASH landscape, the opportunity besides being large and growing, because it's still early, there haven't been any drugs approved recently. It's a bumpy ride for companies who are at a later stage of development. And as a result, the list of these leaders if you will has actually shrunk.

Intercept’s FDA review was delayed, Genfit compound failed. But on the other side again referring to it being bumpy our [Carol's] results look good. And none of this having - nothing has of this has anything to do with us. There have also been two NASH Company IPOs 89Bio and [indiscernible].

So, it appears that so investors are still very interested in the NASH states. Regarding clinical and regulatory development everyone is learning a lot from the successes and failures in this therapeutic space.

This will inform our future clinical studies and regulatory strategy and hopefully allow us to move more effectively and quickly, as well as increase the probability of success. Regarding the competitive landscape, there are a number of companies that are further along in the clinic.

Although they do not have our mechanism of action, and there is a need for a combination treatment of drugs, not just one. There is no direct competitor for our particular mechanism of action. It is hard though for us to compare exactly to the other companies in the space as we're at an earlier stage and the differences in mechanism.

For example, a company like Carol has a repurpose drug. It's already been tested in other indications in a Phase 2 study and as a known mechanism of action. It recently announced positive Phase 2 results. And we believe though, that with a $30 billion potential market, there's plenty of room for other therapies like ours.

Regarding partnering it is a very important part of our strategy to maximize the value of our overall portfolio. We want to use other people's money know how in capability to move multiple programs forward. At my last company, we had over 10 large pharmaceutical companies who are paying us to develop compounds based on our technology.

In each case, we received a large upfront payment milestone payments and royalties. We use the upfront payments to help pay for development of our own products of which we wanted to develop and commercialize ourselves. Based on our experience meeting with partners at BIO 2020, the companies remain very interested in the NASH space.

They are looking for new and different mechanisms. And after the recent failures, there are probably some of the companies who thoughts they had it all worked out who are now looking for new technologies and assets. We again have a unique mechanism of action. There is a need for combination therapy.

Our approach is potentially applicable to all stages of NASH. And it's synergistic with the GLP-1 compounds that are being used as therapy in this area. At this time, we would prefer to sign with a partner that can provide the technical, organizational and financial support for Phase 2 study and beyond.

Our intent would be to use the upfront payments from the deal to cover the cost of other programs. Would we consider going alone? If the Phase 1b results were good enough, the increase in value might allow us to do that, but of course, we don't have those results yet so all of that open ended situation at this point.

I would also note that when Intercept or another company is approved, this will be a breakthrough for all of the companies in the NASH area. And if it's like usual a number of pharmaceutical companies will redouble their efforts to find compounds to develop.

Now let's talk about value inflection, there's a lot of uncertainty about this, but maybe some basics companies which have late stage Phase 2 or early Phase 3 clinical studies underway, and valuations of over $1 billion.

So one hypothetically could draw a line from our current market cap to those numbers and see that there might be one or two value inflection points for our company. We believe also that signing up the first partner will be a major event, as it will validate the technology as well as the program.

In addition, we have the advantage of a larger portfolio and the possibility of those programs moving into clinic or being partnered in the next couple of years.

So, we are more than just a NASH company, we have portfolio with many shots on goal if you look at companies like FibroGen and Kadmon in the IPF space or you look at [ExpoPharma] in CXCR4 arena. The additional valuations can be high.

Adding up the value of the individual programs gives you a much better sense the potential value of the total CohBar portfolio. Next slide, regarding the preclinical program opportunities we note in ARDS there's a high unmet medical need.

You know that COVID besides COVID-19 ARDS in general can be triggered by viral and bacterial pneumonia, sepsis and trauma and other events. There is no safe and effective treatment, and only a 25% survival rate among COVID-19 patients with ARDS.

3 million ARDS patients worldwide plus this new and growing group of patients with COVID ARDS represents the larger number of patients that we're talking about in this area.

And as Ken has indicated, our apelin agonist receptor is actually helping to normalize through the binding to the junction and receptor that results in activating multiple pathways. And then the new data of course in the ARDS model, and we're working to run the next study confirm that.

On the antifibrotic side, we know that fibrotic diseases involved 40% of disease rated are involved in 40% of disease related deaths that occur in lung, kidney, liver and heart. There's a high unmet need an IPF. It's a very difficult disease chronic, progressive, debilitating, and it affects over 100,000 patients in the U.S.

and the approved drugs help slow the disease, but have significant side effects. And then our most recent results, obviously this is a big step forward in this area for us. Regarding the CXCR inhibitors, we would note that they're over expressed the receptors are over expressed in more than 75% of cancers.

It has key pathways, tumor growth, angiogenesis and metastasis and inhibiting this pathway as a number of positive effects including one similar to what we saw on our mouse model which is a synergy which enhances the use of chemotherapy. And so, these invitations potentially include multiple cancer types.

And of course, the results that we showed already and this melanoma model are quite exciting. And finally, although we haven't talked about it really in this particular presentation, we do have a lead in the immunotherapy area, which we're beginning to develop a lead family of compounds.

Next slide, so I've mentioned the near term projected milestones, and so we think we have a pretty good flow of potential events during the next three to nine months. So it's a very exciting time. If you compare it to last year, I think we'll do even better.

And then beginning next year, we look forward to getting these positive top line results we help from the Phase 1b study. And again, our overall goal is that moving these programs forward will transform the company into having clinical trials in multiple indications over the next couple or three years.

So once again in the next slide, if you would Jordan. So we continue to realize the CohBar vision. We have a highly differentiated therapeutics platform with an entirely new class of drug candidates, potentially addressing multiple large indications with high unmet needs.

A clinical trial underway with data expected early next year, a COVID-19 ARDS program, a strong intellectual property position, and an experienced management team, an internationally recognized founders.

CohBar’s vision and strategic opportunity is to make a significant impact on health, medicine and society by addressing the fundamental and impactful diseases, with our technology, and on mitochondrial dysfunction. The profound discoveries that our founders and scientists have pursued have the potential to forever change the health of mankind.

These represent a new frontier for medicine. And the opportunities have become significantly larger as we continue our exploration step by step we are realizing the potential of the CohBar vision. Next slide. Thank you very much. Now I want to turn it over to the operator to open up the line for Q&A..

[Operator Instructions] Our first question comes from Kumar Raja of Brookline Capital Markets. Please go ahead..

Congratulations on all your progress. And thanks for taking my questions.

With regard to the Phase 1b for the 4211, geographically, where are these sites located? So I'm trying to get a sense of if there's a recurrence in COVID-19, what kind of impact that is going to have, and also based on FDA guidance, what kind of protocol deviations you can have in that trial, but still be able to get results there?.

Thanks for joining the call. And good question. The sites we have are located if you have a chance to look at ClinicalTrials.gov record for anybody else that wants to see they're located in Texas and in California. So obviously there is COVID all over the country. It's more a question of how do sites operate in the context of a pandemic.

So there are processes in place at these sites that allow them to continue to operate. And as we said, they're not just operating on our study, they are operating on multiple studies.

So they have processes that allow them to follow our protocol, identify enroll people, bring them into the study where they're sequestered for 30 days as part of this control of their body weight for the obesity part of the study.

So there is - that's the approach they're taking, and it's not something we think that COVID is going to prevent us from doing, but as I said enrollment rate during this period is something we'll learn about as we get further into the - to the enrolling..

And given that the patients are sequester you have complete control over what kind of diet they have?.

Absolutely, that's the reason - main reason for the isolation of the subjects for 30 days was already part of this plan. So, you know, in many ways, they'll be protected from the potential of community transmission of COVID by being within the site for that period..

And with regard to the mouse ARDS models, what do we know in terms of [indiscernible] to get a sense of how it compares with the COVID-19 models?.

Yes, it's a little early, so that I think we - as we said, we're doing the confirmatory studies.

We do like the idea of taking these into a SARS-CoV-2 direct model to look at showing in the most relevant setting we can that if you induce this injury with COVID, you can have the same effects, but this signaling pathway is just generally protective and is potentially independent of the cause of the injury. So it might be COVID-19.

It might be the next Coronavirus. It might even be a bacterial respiratory threats or some kind that this might work in. And so more data to come and we'll definitely share the confirmatory data as it emerges..

And with regard to 5138, what do we know about potential synergistic effects with compounds already approved for IPF?.

That's a great question too, and it's part of what we're doing right now. And that is looking at the potential for add-on to standard-of-care, and as you know, there is only two approved drugs here. So our choice there would be nintedanib being the more reproducible outcome in models of fibrosis.

So we'll be looking at how does this drug perform when added on to that standard-of-care..

Thank you so much..

Absolutely. Thank you, Kumar..

Thank you, Kumar. And I would add that we understand that the government is working on COVID-19 ARDS type models. So we're very interested to do an [incline] [ph] kind of study with them, if they develop [some more] [ph] with others as that becomes available..

Our next question comes from Elemer Piros of ROTH Capital Partners. Please go ahead..

And maybe just beginning - at the end of your previous question on potentially co-developing the IPF drug with existing drugs and looking at synergy. If I understand correctly, those are the side effect profile of those are not exactly pleasant.

So do you plan to once in a clinic, do you plan to investigate your drug in isolation first, and then potentially looking at the combination in order to avoid the toxicity profiles of the currently marketed drugs?.

Yes, thanks for the question. It's a good question. And yes, we would absolutely expect that we would have the efficacy by ourselves as a monotherapy. The question is more, what is the population that will be receiving this drug as a product, and it's likely that they may be on nintedanib. And as you said, nintedanib has its own issues.

It is a multi-kinase inhibitor drug. And for those not familiar with that, it means it's hitting many different targets. And the consequences of that are that not all those targets are necessarily doing good things for you in the setting of fibrosis, and there are other side effects related to that.

In the setting of nintedanib, it's actually anorexia is one of them. But yes, we would expect to look at this as a way to decide how this would be used, rather than trying to get this approved as a combination. This is more to say how it would be used in the ultimate population..

And now turning to CB5064, very encouraging data, if you could please put it in perspective in the ARDS model, that the type of long rate improvement or the decrease of the edema.

The magnitude of changes that you've seen, how does it compare to be broader investigation or compounds that been tested in the same model?.

Right. So as far as head-to-head with other molecules, the only head-to-head we have so far is versus the natural adipokine apelin and you could see in the data we presented that we're surpassing that effect. Now, as far as other head to heads that we could do, that's part of what we would be looking at as we go forward in the confirmatory studies.

But it's also a question of how we give this drug. Right now, these studies were single dose when you saw that first effect on the accumulation, and that's clearly not how these would be used clinically.

If you're going into someone who you think is susceptible to the outcome of severe COVID, you're not going to give him one dose and walk away right, you're going to actually try to treat them over a number of days. So part of what we're doing now in the confirmatory setting as well as looking at the regimen, and how that amplifies the effects..

And in the NASH study - besides a potentially very benign safety profile, what additional information do you think it would be useful for potential partners to decide whether they would like to license the program? What sort of that….

You mean emerging from the 1b?.

Yes..

Yes, I think what we're getting from doing this study is a 4-week study. It's going to be obviously not the same outcome as a 12-week or 16-week NASH study in a biopsy driven readout. But these are the endpoints that should indicate the direction that this drug is capable of going.

So if you're looking at liver fat changes we know, four weeks is long enough to see changes that's been done in the past. Merck had a 4-week study, but also trends in bodyweight trends in the biomarkers. So those are the types of data we expect to get out of this.

And if they're convincing to us of a trend, that's certainly what we'll be discussing with partners..

[Operator Instructions] This concludes the question-and-answer session. I would like to turn the conference back over to Mr. Engle for any closing remarks..

I hope everybody gets the sense of excitement that we've had about the progress we've made in this last quarter. And we're very hopeful as we look over the next quarter or so. So stay tuned. Thank you..

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