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Edited Transcript of COB.U.V earnings conference call or presentation 7-Aug-19 9:00pm GMT

Q2 2019 CohBar Inc Earnings Call

MENLO PARK Aug 20, 2019 (Thomson StreetEvents) -- Edited Transcript of CohBar Inc earnings conference call or presentation Wednesday, August 7, 2019 at 9:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Jeffrey F. Biunno

CohBar, Inc. - CFO, Treasurer & Secretary

* Kenneth C. Cundy

CohBar, Inc. - Chief Scientific Officer

* Steven B. Engle

CohBar, Inc. - CEO & Director

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Conference Call Participants

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* Clay Chase;Torrey Hills Capital;Partner

* Stephen Matthew Dunn

LifeTech Capital, Research Division - President & Senior MD of Research

* Tom Katilius

* Glenn Garmont

LifeSci Advisors, LLC - MD

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Presentation

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Operator [1]

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Good afternoon. My name is Soiree, and I'll be your conference operator for today. At this time, I'd like to welcome everyone to the CohBar's Second Quarter 2019 Financial Results Conference call. (Operator Instructions) As a reminder, this call is being recorded.

Now I'd like to turn the call over to Glenn Garmont of LifeSci Advisors. Please go ahead, sir.

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Glenn Garmont, LifeSci Advisors, LLC - MD [2]

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Thank you, Soiree, and thank you, everyone, for joining Cohort's Second Quarter 2019 Financial Results Conference Call. Joining me on today's call is Steven Engle, CohBar's Chief Executive Officer; Ken Cundy, Chief Scientific Officer; and Jeff Biunno, Chief Financial Officer.

CohBar's financial results press release was issued earlier today and may be downloaded from our website at www.cohbar.com. If you're having issues joining the WebEx, you can access the slide presentation from our homepage.

Jeff will begin with an overview of the second quarter financial results, followed by a business and R&D update from Steve and Ken.

Starting with Slide 3. 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 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, 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, our 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 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.

And now I'd like to turn the call over to Jeff Biunno, CohBar's Chief Financial Officer. Jeff?

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Jeffrey F. Biunno, CohBar, Inc. - CFO, Treasurer & Secretary [3]

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Thank you, Glenn. And thank you, everyone, for joining us this afternoon. I will now provide you with a summary of our financial results for the second quarter ended June 30, 2019 compared to the second quarter ended June 30, 2018. Total operating expenses in Q2 2019 were $2,958,000 as compared to $3,148,000 in Q2 2018, a decrease of approximately $190,000. Operating expenses included noncash expenses of $700,000 for the quarter ended June 30, 2019 and $826,000 for the quarter ended June 30, 2018. Noncash operating expenses include stock-based compensation and depreciation and amortization costs.

Research and development expenses were $1,418,000 in Q2 2019 compared to $1,832,000 in the prior year period. A decrease of approximately $414,000. The decrease in research and development expenses was primarily due to the timing of preclinical and initial clinical costs incurred in the prior year period and a decrease in peptide synthesis services due to the timing of those costs. These decreases were partially offset by an increase in expenses related to our continuing development of peptides. General and administrative expenses were $1,539,000 in Q2 2019 compared to $1,315,000 in the prior year period, an increase of approximately $224,000. The increase in general and administrative expenses for a few of the legal fees, primarily related to the costs associated with the protection of our intellectual property, an increase in recruiting costs related to our CEO search and an increase in director's fees.

For the quarter ended June 30, 2019, CohBar reported a net loss of $3,058,000 or $0.07 per basic and diluted share compared to a net loss for the quarter ended June 30, 2018, of $3,316,000 or $0.08 per basic and diluted share. The net loss included noncash expenses of $805,000 for the quarter ended June 30, 2019 and $925,000 for the quarter ended June 30, 2018.

Moving to the balance sheet. As of June 30, 2019, CohBar had $16.8 million in cash and investments, compared to $22.2 million as of December 31, 2018. The cash burn for the quarter ended June 30, 2019 was approximately $2.9 million. We estimate that, based on our cash and investments balance as of June 30, 2019, we have sufficient capital to finance our operations into the third quarter of 2020.

I'll now turn the call over to Steve.

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Steven B. Engle, CohBar, Inc. - CEO & Director [4]

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Thanks, Jeff. Appreciate that. Next slide. This is our summary on what we'll be talking about for the rest of the day. And just wanted to say up front that I've completed about 2 months with the company. And that in immersing myself in daily and strategic activity of the company, working with the team, the scientists, clinicians and the directors and even with the investors and analysts that I remain excited about the science and the technology and the progress that we're making. The challenges we face are pretty common for a biotech company at our stage, and I am confident we can fully realize the potential of the company.

Next slide. So this is the one-page summary to give you an idea about the company. And if you look at nothing else, this is helpful. I won't go through everything on it, but suffice to say that CohBar mitochondria-based therapeutics are unique set of compounds being designed to treat multiple chronic diseases and to increase healthy life span. The breakthrough discovery behind CohBar's technology is defining that mitochondria do more than generate most of the energy behind most of the functions in our bodies, that would be enough. But in fact, they are signaling for all sorts of processes to start and stop. It is a platform technology, therefore, which we will believe will provide multiple shots on goal. And we believe that CB4211 is the first of a number of candidates that our technology platform will identify for advancement into the clinic.

Next slide. So just a brief summary on the update, we did resume the dosing of subjects in the Phase Ia/b clinical trial of our lead candidate, CB4211, for NASH and obesity, and we did that while continuing to progress on our evaluation of additional novel peptides targeting fibrotic diseases, cancer and type 2 diabetes, which Ken will speak to more in a moment. We also presented a very novel scientific discovery at the American Diabetes Association annual conference, and during this time, we held meetings with multiple pharmaceutical companies at the International BIO 2019 conference. And finally, we hosted a mitochondria-based therapeutics seminar with several of the key opinion leaders, including both our founders and our Chief Science Officer.

Next slide. Ken?

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Kenneth C. Cundy, CohBar, Inc. - Chief Scientific Officer [5]

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All right. Thanks, Steve. I'll now give you an update on our R&D programs, beginning with 4211. So as a reminder, CohBar's lead drug candidate is CB4211, it's a mitochondrial-based therapeutic. It's currently in Phase Ia/Ib clinical testing as a potential treatment for NASH and obesity. The Phase Ia/Ib study resumed in June and is currently ongoing. The Phase Ia part of the study is a conventional single-ascending dose, multiple-ascending dose, assessment of the safety, tolerability and pharmacokinetics of CB4211 in healthy adults. Following this is the Phase Ib part of the study in obese subjects with NAFLD, nonalcoholic fatty liver disease, 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. The study is currently on track to meet the expected time line that we gave on the last call with readout of top line activity data expected somewhere in the second or third quarter of 2020. We're still blinded to the study treatment, and we expect to provide updates on the progress of the study as significant milestones. If the study goes as planned, the next such milestone is expected to be when we start the Phase Ib assessments in obese NAFLD subjects. We will update you on our progress on the next investor call.

We've previously shared the preclinical data for CB4211, which demonstrated efficacy in animal models of both NASH and obesity as CB4211 has a novel mechanism of action involving regulation of fatty acid release from fat cells. And it's that novel mechanism that presents an opportunity for combination of CB4211 with other drugs with different mechanisms. We also previously shared data showing synergy of CB4211 with GLP-1 and PPAR-gamma agonists. These are 2 classes of drugs that are commonly used to treat type 2 diabetes and interestingly, more than 50% of patients with NASH are diabetic.

Next slide, please. Now let's talk about the rest of CohBar's pipeline and our expanded research efforts towards identifying additional mitochondria-based therapeutic candidates and broadening our assessment of their therapeutic potential. We've made significant progress in 3 main areas, and we have shared some of that progress on our last call. The first area I'll cover today is in the setting of fibrotic diseases, where we've shown some promising anti-fibrotic activity from a novel peptide analogue with decreased biomarkers of fibrosis in cultured human cells and also decreased fibrosis in a mouse model of idiopathic pulmonary fibrosis. I'll share some new data from that study that'll show you a corresponding decrease in lung inflammation. The second area of progress is in cancer, where we've identified novel peptide analogues that enhance the ability of human blood cells to kill cancer cells in vitro in what is referred to as an immuno-oncology model. The third area of progress is in the setting of type 2 diabetes research, where we recently identified a novel family of peptides with beneficial effects on glucose regulation in animal models of diabetes. We shared details of this new family of peptides at the American Diabetes Association meeting in June, including our discovery of an important interaction between these peptides and a key cell surface receptor called the apelin receptor.

Next slide, please. So let's start with fibrotic diseases. We've made significant progress in identifying new peptides with anti-fibrotic potential. Now fibrosis is a normal tissue response to injury, but fibrosis also underlines the age and disease-related process of scaring in tissues like liver, lung, kidney and heart, including the progression of NASH and other age-related diseases. We previously showed you that CohBar's peptide MBT #2, produced a significant decrease in key biomarkers of fibrosis and inflammation in a cell-based model of pulmonary fibrosis. Now on this slide, you see, again, some of the in vivo data for MBT #2 in a well-established mouse model of lung fibrosis. In this study, mice were dosed with bleomycin to induce a response that's very similar to the human disease idiopathic pulmonary fibrosis. Animals were then treated for 3 weeks with a vehicle control or a CohBar peptide and then compared to normal animals that did not receive bleomycin. After 21 days, the lungs were examined by microscopy and the lung tissue changes were scored using an objective scale called the Ashcroft scale. Now the Ashcroft score grades the fibrosis based on lung damage and the extent of fibrotic changes. So in the top figure on the left, you can see that, at 21 days, animals that are treated with controlled vehicle had a significant level of fibrosis reaching about 3 on the Ashcroft scale. While those treated with CohBar's peptide once daily had a significantly lower Ashcroft fibrosis score. Now you can also see that effect visually in the photo micrographs of the lungs at the bottom of the slide. So on the far left there, you see lungs of a normal animal that did not receive bleomycin after 21 days. In the middle, you see the effects of bleomycin induction followed by 21 days treatment with a vehicle control. There is significant lung damage with the appearance of fibrous thickening of the issue and formation of many fibrotic notes, some of which are marked here with red arrows. However, in animals exposed to bleomycin and then treated for 21 days with CohBar's peptide, there's clear protection, indicating anti-fibrotic activity. These preliminary data show a direct translation of the in-vitro efficacy signal into efficacy in a disease model. So now we're conducting confirmatory studies, and we will be expanding our evaluation to animal models of other fibrotic diseases, including models of chronic kidney disease and heart failure.

Next slide, please. Now this slide shows some new data from the same study in the mouse lung fibrosis model. In this case, we are looking at lung inflammation based on the number of inflammatory cells in the lung after 21 days of treatment using bronchoalveolar lavage. For normal mice that have not been treated with bleomycin, there are no lymphocytes present in the lavage fluid at 21 days. You see that in the blue dots. When the mice are induced with bleomycin and treated with the vehicle control for 21 days, inflammation is induced and lymphocytes now account for 30% of the cells that are present in the lavage fluid. As you can see in the green, mice induced with bleomycin but treated with our new MBT 2 peptide show a very significant reduction in inflammation, based on the presence of lower numbers of lymphocytes in the lavage fluid representing now less than 10% of the cell. So MBT #2 is still in the process of optimization, but these preliminary data suggests additional opportunities for CohBar's peptides as potential treatments for a range of fibrotic and inflammatory diseases.

Next slide, please. So now we'll turn to our efforts in the area of cancer. In this slide, we're looking at using one of CohBar's novel peptides to enhance the ability of our own blood cells to cure cancer cells, a treatment approach known as cancer immunotherapy or immuno-oncology. Recently, there have been enormous advances in this field using approaches that boost the ability of our own immune cells to recognize and kill invading cancer cells. Now in this slide, we see preliminary data from an in vitro immuno-oncology model that was run by our external CRO partner, PhenoVista Biosciences. In this study, human blood cells called PBMCs or peripheral blood mononuclear cells are grown together with a standard human tumor cell line called SK-Mel-28. This is a human melanoma cell line. The blood cells are then stimulated to induce an immune response. The activated PBMCs will then attack the cancer cells. When we incubate those same cells in the presence of our peptides, we can measure their effect on the number of live cancer cells that remain by microscopy using special stains and imaging techniques. We look for any potential enhancement of the stimulated immune response as reflected in more cancer cell death. So in this specific case, we saw a highly significant increase in killing of the cancer cells in the presence of MBT #3. On the left, you see representative images of the cells at 48 hours using stains designed to specifically show all the cells, which is the blue, or just the cancer cells, which is the green. You can clearly see there was a substantial decrease in the surviving cancer cells when the peptide was present. These are, of course, early data, and we are now moving forward with additional studies as we'll be expanding into animal models of cancer immunotherapy.

Next slide, please. So the third area of progress is our evaluation of the potential of CohBar's novel peptides as treatments for type 2 diabetes. This slide is a brief summary of some of the data we have previously shared and presented at the recent 79th annual Scientific Sessions of the American Diabetes Association meeting in San Francisco. We reported the discovery of a family of novel peptide analogues related to a mitochondrially-encoded peptide, CB5064, discovered by CohBar. This new family of peptides has beneficial effects in diet-induced obese or DIO mice, which is a model of human type 2 diabetes. As you can see on the left of the slide, analogues of CB5064 dosed once daily for 10 days produced a significant body weight loss and a fat mass loss compared to vehicle-treated animals.

In addition, as shown in the plot in the bottom left, these peptides also improved glucose tolerance in this model. Now the ADA poster presented also our discovery of a very selective interaction of these peptides with one specific receptor, the apelin receptor. Apelin is a natural peptide expressed in many different tissues, including adipose tissue, heart, lung, kidney, liver and the brain. The function of apelin and the apelin receptor has been explored by others, and it appears to play a key role in regulating energy metabolism, cardiovascular function, fluid homeostasis and a number of other cellular processes. As shown in the figure on the bottom right, we were able to show that some of our novel CB5064 peptide analogues can produce a maximum response at the apelin receptor, the blue bars, that is similar to the maximum effect of the naturally occurring peptide apelin, the black bar. Now these results open the door to potential utility of this family of novel peptides in type 2 diabetes, but also in other metabolic disease settings.

Next slide, please. So this last slide brings us back to a high-level overview of our current R&D programs for mitochondria-based therapeutics. CB4211, our first clinical candidate, currently in Phase I clinical testing for NASH and obesity, behind that an expanding list of potential indications where new MDP analogues are in the discovery and optimization process. These include areas like type 2 diabetes, fibrotic diseases and cancer. And we're continuing to apply our expanded resources to these new areas of research with the ultimate goal of identifying additional potential MBT drug candidates.

And with that, I'll hand it back to Steve.

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Steven B. Engle, CohBar, Inc. - CEO & Director [6]

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Thank you, Ken. Next slide. So I wanted to talk for a few minutes about the market opportunities, but I wanted to step back up a level. Based on what you saw from Ken's work and his teams' work, what you're seeing is lot of different areas now showing up. And so we wanted to step back and talk for a second about what's really going on here. The research in aging and age-related diseases is increasingly focused on this area of mitochondrial biology or what is sometimes called mitochondrial medicine. We're at the beginning, but it is a major change in direction. It's a change in the allocation of research efforts and represents a watershed moment in medical research.

Next slide. As you can see on this slide with the quotes, one of them is from a leader in the mitochondrial genetic research area for the last 30 or 40 years, Dr. Doug Wallace. And as you can read in the quote, mitochondrial decline and mitochondrial DNA damage are central to the etiology of the age-related metabolic and degenerative diseases, aging and cancer. And so there is a lot of research behind what we're doing that explains and suggests why we're able to have so many different impacts on the human body.

Next. So how broad is it? Here, you can see on this page a list of some of the areas that we're already looking at and a few that are still being on the drawing board, so to speak. In this case, you have to imagine that the mitochondria routinely generate peptides throughout the body that signal changes in processes inside cells and beyond. And then you have to imagine that the research shows that these are affecting metabolic pathways, the cells of the immune system and other processes quite widely. And now you can begin to imagine how we might be able to use them to help treat diseases and that's what we're doing, beginning with NASH, obesity, type 2 diabetes and, as Ken was indicating, in the areas of cancer and fibrotic diseases. Interesting thing is this is such a broad effect. When you look at fibrotic diseases, for example, you actually can see there are multiple potential therapeutic areas that we may be able to apply the technology to.

Next. So speaking briefly about the NASH market opportunity, we wanted to highlight, it's a large market with high unmet need that CohBar's compound can uniquely target. The NASH population is estimated between 12 million and 29 million in the U.S., There are no approved drugs, and the population at risk of NASH is much larger than currently diagnosed. And as earlier diagnosis are made and the methods are validated, the market will expand further. That is why many pharmaceutical companies believe it makes sense to develop a drug in this area. So where are we in this? I'm sure some of you are following the different events going on in the market with other companies. We think the advantage for us is being in an earlier stage, and that's because we stand to benefit from all the successes and failures of those ahead of us. The fate of these later-stage NASH assets helps define the most efficient strategy for CohBar. The clinical and regulatory perspective on NASH is also evolving and particularly at places like the FDA. The FDA will need to support earlier diagnosis and using less invasive indicators of efficacy over time. And all of that has to be agreed to. And at the same time, clinicians are beginning to appreciate the need for a combination therapy in a disease that has many stages and potential targets. We think all of that goes to our advantage.

Next. Now talking about the fibrotic disease area briefly. You have to understand that in many different organ failures that fibrosis is a major contributor to that failure. And we're showing positive results in our initial studies in this area. The major body organs included are pulmonary, kidney, heart and connective tissue. So once again, this has potential to affect many different systems in the body. And many pharma companies have targeted fibrosis and are very interested in licensing in programs from companies like CohBar. As a result, we have seen deals done with biotech companies at early stage than you would otherwise expect.

We're looking at the oncology opportunities right now, and I wanted to indicate that as many of you know, the current cancer therapies have significant limitations, which are generating major unmet needs for us and others. The new breakthroughs are being seen when the immune system is set free by new approved therapies. And what we have seen in our work on the immune system preclinical experiments is positive. So we're very hopeful on being able to move forward with this preclinical program.

Next. So now we'll talk a little bit about going forward plans. And on the clinical side, I think Ken indicated that we expect results in 2Q or Q3 next year. In addition to which, we're moving forward with preclinical peptides. On the partnering side, we continue to expand the companies that we're talking to and educate them up on this area. So I want to take a few minutes to talk about Investor Relations and also in the financing area. We've been meeting with investors in the major biotech investing centers like New York and Boston since I came on board. We are targeting the biotech-focused institutional investors in general as looking for innovative solutions to chronic diseases and aging. But I also wanted you to know that, in September, we will be attending and have meetings at the International Geroscience Summit in Israel, where our founders will be speaking. We also have been invited to speak at the Cantor Fitzgerald Conference in New York on October 2 through 4, exact dates and times we'll be providing a press release on. And we will be presenting at the Bio Investor Forum in San Francisco also in October, around the 21st and 22nd. Once those details are finalized, we'll put out a release. But I think it indicates to you that we're making a major push to become a lot more visible, which I think will be very helpful in terms of the valuation of the company. We're also planning to participate in additional scientific conferences like our recent presentation at the ADA in June and plans to host additional forums on mitochondrial science and medicine, like our top-leading webinar on the mitochondria-based therapeutics in May.

Now I'd like to talk, just for a moment, on the funding area and cash and so forth. And so as we look at it, first of all, I want to talk about some of the efforts. We are having ongoing discussions with several analysts. We can't predict the timing of coverage. But certainly, there's been growing interest in the mitochondrial space, which has been accruing to our advantage, I believe. And in addition to that, I want to talk about future funding plans. As stated, we have enough sufficient funding into Q3 of 2020, and we expect the results from the Phase Ia/b study in the second or third quarter. Now as a public company, we are obviously limited in what we can say about our plans for funding. But I thought it would be helpful if I spoke generally about our overall strategy, which balances several factors, such as the amount and timing, the market conditions both globally and in biotech, the timing of the clinical and preclinical results over the next year, the maintaining of adequate funds to move our clinical and pre-clinical programs forward. The risk factors and the relative cost of money and, of course, dilution. So we're looking at all of these, and using this framework, we regularly evaluate our financing needs. And as we go forward, we'll give you more visibility on those thoughts. The company fundamentals, though, are strong and the management team is quite enthusiastic. As a result, we believe the stock is, of course, substantially undervalued. All these factors are being conveyed in our meetings with potential new investors and they have been well received. In addition, we have seen increasing interest by the investment and analyst communities in mitochondrial and aging companies. So we think the timing is good and we need a bit more visibility, and we're working on that. And as this goes on, we'll come back to you to talk about it.

Next slide. So this is the final slide. And just by way of, again, summarizing the company's goals, platform technology, where we are in clinic as well as with the new peptides that Ken has spoken about. The IP continues to improve. We have 8 issued patents and 65 patent filings. We have an experienced team and Jeff has gone over the numbers. So I feel that we're in a very good position, we just have to execute over the next few months. Next slide.

So now we'd like to move to taking questions from the audience.

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Questions and Answers

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Operator [1]

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(Operator Instructions) We'll take our first question from Stephen Dunn with LifeTech [Agents].

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Stephen Matthew Dunn, LifeTech Capital, Research Division - President & Senior MD of Research [2]

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I have one housekeeping question. You've reinitiated the 4211 trials. Have we seen or heard any new incidents of injection site reactions or do we feel that problem has been solved?

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Kenneth C. Cundy, CohBar, Inc. - Chief Scientific Officer [3]

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So at this point, as I mentioned on the call, Steve, we are in the dose escalation stage, we're in the Phase Ia. So we're obviously got to complete all of that to be able to fully answer that question. As we will be updating you once we start the first subject in the NAFLD cohort. But at this point, we are on track to meet the time line that we announced on the last call.

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Stephen Matthew Dunn, LifeTech Capital, Research Division - President & Senior MD of Research [4]

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Okay. Just one follow-up question in the interests of time. In the past, Ken and the key opinion leaders and your previous calls and meetings, mitochondrial science on the platform is kind of well understood. But from an investor into CohBar's stock, it's a little confusing what is CohBar exactly. Outside of NASH and obesity, we have other preclinical candidates in NASH and obesity. Are those going to cannibalize what's happening now? We have type 2 diabetes with 5064. Is that going to be something separate? Are you fibrotic? You've basically got a field of science, and right now, your pipeline is kind of like a Rubik's cube. So what can investors expect to see on the preclinical pipeline? When would they be seeing things entering into IND-enabling activities or hit some leads or lead selection? Or what can we expect to see going forward, so we get a better feel of what CohBar is actually going to be doing? Because the fact that between this partnership stuff, I'd tell you that you'll obviously at least be IND enabling. So it's a broad question, but it's difficult to I explain to investors what is CohBar?

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Kenneth C. Cundy, CohBar, Inc. - Chief Scientific Officer [5]

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Well, what is the planned quantity -- so we're obviously pushing on a number of areas here. When you see NASH and obesity on the pipeline as well as in our lead program, that just means we have that opportunity because we have other peptides that work in that arena. Obviously, we're excited about the new areas that we're showing activity in like fibrotic disease and immuno-oncology. This is going to be, as it always has been, a continual evaluation of each of these opportunities as we move further through development, which ones are moving fastest, which ones have the best market opportunities, which have the highest probability of success, the best regulatory and clinical path, and that's an equation that we have to look at all the time. So right now, these are areas we're pushing on, and we will be aiming to identify candidates as soon as we can out of any of those areas. And we will definitely update you when we have that.

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Stephen Matthew Dunn, LifeTech Capital, Research Division - President & Senior MD of Research [6]

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Yes, I understand, the question is, when can investors start to some of the prioritization emerge, next year or before year-end, next summer, do you have a field focused? If we look at all your slides, you have different slides from listing the amount of different orders. Some slides have fibrotic and diabetes and cancer. Other slides have cancer, diabetes and fibrotic in different orders. So when can the rest of us get a good feel for what's coming up behind NASH and obesity?

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Steven B. Engle, CohBar, Inc. - CEO & Director [7]

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Right. So the order is nearly the way in which we wanted to present new data. So that was fibrosis ahead, because we had more fibrosis data to talk about. These are all in parallel, right? So what we're looking at here is, we're hoping within the next -- by the end of next year to be in a position where we are embarking on IND studies with our next candidate, that's a goal. So out of any of these programs, that could be the case.

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Operator [8]

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(Operator Instructions) We'll move to Tom Katilius, a private investor.

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Tom Katilius, [9]

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It's Tom Katilius. I would like to first give you an encouraging applause on what seems to be an ever-accelerating validation of CohBar's technology and their technology platform. My question today is a little bit of an extension of a comment that Ken made around milestones. I think it was specifically to CB4211, and my question, I guess, is around those milestones. Can you provide some greater clarity as to what you might be expecting and how those milestones might unfold?

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Kenneth C. Cundy, CohBar, Inc. - Chief Scientific Officer [10]

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Right. So let me try and address that for you. The next milestone that we mentioned would be first dose in an NAFLD subject. So the initiation of the Phase Ib stage of the study. Obviously, when we're done with the dosing, that's another milestone. When we are done analyzing the data out of that study, that's the further milestone. So each of these is a step towards the ultimate piece, which is having a readout on activity. And as we said on the call, and as Steve mentioned, we can't predict exactly a date on which that will happen, but it will be within the second or third quarter of next year to reach the end of that process. But in the interim, we'll keep you advised of these milestones as they happen.

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Steven B. Engle, CohBar, Inc. - CEO & Director [11]

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And Tom, thanks for the compliment. I would just add to that, that when you look back on where the company was a year ago without a clinical candidate and without the preclinical work that Ken and the team have generated, you can see just so much change has occurred. Imagine if we can do that same kind of thing as we march forward in the next 12 to 18 months.

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Tom Katilius, [12]

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I agree. Very exciting, lots of opportunity here.

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Operator [13]

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Next we'll move to [Larry Striglee], a private investor.

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Unidentified Participant, [14]

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Yes. This is [Larry Striglee]. Just a quick question. Steve, you had mentioned towards the end of your presentation -- and by the way, thank you for all the positive information, it's really helpful and insightful to hear all that's going on. But at the end of your presentation, Steve, you had mentioned that you felt the stock was currently undervalued. I'm curious, when and what events do you think will initiate an increase in the stock value?

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Steven B. Engle, CohBar, Inc. - CEO & Director [15]

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Thanks for asking. If I could predict that, I would be in a different business, I think. But without being too facetious, it's always hard to know, but I think what we've got right now is a plate full of events coming along. You can see that we're continuing to run the preclinical programs to come up with additional information. You also heard just a moment ago from Ken about moving forward with the Phase Ia/b study both the movement from one section to the other as well as being able to get the results out of the trial. And then we have hopes of moving on one of the preclinical programs to put it in a pre-IND stage where we can go ahead and move forward with that study for the clinic at some point. So these are a number of factors moving forward. But in parallel, it goes -- kind of what I was saying about the need to become a lot more visible in the market of what we would think that was the standard biotech investors. And our feeling right now is that we've got ways to go there. And so that's very exciting because we think there's a lot of opportunity in meeting with these folks. And of course, my background is I've probably raised over $300 million in my history and with a lot of these very same people. And what I can tell you so far as I've kind of alluded to is there's been a very positive response. And it's at 2 levels, the PhD scientist-types are excited about mitochondria because they know something is going on, and they want to find out who are the leaders and what's being done, what the possibilities are. And then just on the investment side, this represents a fairly nascent area for investors to come into, and we think there are a number of people out there who are already trying to invest in related areas, whether it's the unities or the [cells] or whatever that are in these both mitochondria and age-related areas. So we think when you look at their valuations versus ours, that there's a great opportunity to expand that gap. And one of the ways to do that is simply, in our minds, to make sure the story is being heard on Wall Street and other places. So it's not just that we have events coming up, but it's also that we're working very hard now to raise visibility. And as I indicated, we will be at the BIO Investor Conference and speaking there, and we will also be at the Cantor Fitzgerald Conference and speaking there as well. So it's all a process of making the company just a lot more visible to the rest of the investment community. Does that help?

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Unidentified Participant, [16]

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Yes, that's helps a lot. I appreciate that insight.

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Operator [17]

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Next I'll move to Clay Chase with Torrey Hills Capital.

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Clay Chase;Torrey Hills Capital;Partner, [18]

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Steve, Ken, great update. A lot of new data. My question is around the anti-fibrotic data. We have a pretty good indication of the diseases that you're going after, which are metabolic mitochondria: NASH, obesity, NAFLD. Can you give us some examples of some of the disease indications that you might look to go after with some of your anti-fibrotic activity? Or is it just too early to talk about that?

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Kenneth C. Cundy, CohBar, Inc. - Chief Scientific Officer [19]

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Well, it's a very broad opportunity that you have a true anti-fibrotic agent. And we're starting where, I think, most people start with the signal for anti-fibrosis and that is in the near term, the treatment for idiopathic pulmonary fibrosis. It's a chronic, but very poorly treated disease. There's only 2 drugs on the market for treatment of IPF. And the life expectancy after diagnosis is not very long. So that's an area where you can quickly show you have anti-fibrotic activity and clinically prove it. But we could be pursuing in parallel here cardiac fibrosis, which is obviously very relevant to heart failure. Following myocardial infarction, that kind of setting, and chronic kidney disease, where the buildup of fibrosis in the kidney leads to loss of function and that deteriorates over time. So there's many areas of opportunity. And our first attack on this is to look at these type of diseases in animal models in parallel and see where we have the most effect.

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Steven B. Engle, CohBar, Inc. - CEO & Director [20]

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Sure. And just to add, to get a sense of it. What's interesting is a lot of medicine is set up around organs. And so you kind of get into that mode. But when you deal with something more fundamental like what we're dealing with, fibrosis is one of those processes that is at the end stage of many different diseases. And so again, this is going to be a very interesting situation as we prove out just how broadly the preclinical results are and potentially in these other models. And so I think that will provide us some additional information to talk about over the next year.

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Operator [21]

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And we'll move to [Brian Hardy], a private investor.

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Unidentified Participant, [22]

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I was wondering if you could speak to whether the partnerships that you may pursue in the future with other pharmaceutical companies might focus primarily on assistance in development and testing of CohBar's identified and developed MBT analogues or if there would be an interest as well in opening up CohBar's platform to basically to research by other pharmas to develop their own candidates and identify them that might be licensed and whether that might be an income opportunity.

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Steven B. Engle, CohBar, Inc. - CEO & Director [23]

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Brian, thanks for the question. It's a very good question. We have just really strongly reengaged the pharma companies. So yes, we think that, as we go through and develop these different compounds, that they, themselves, represent product opportunities. And I want to go back to something somebody else asked, which is, in the case type 2 diabetes, although we think 4211 has the kinds of characteristics in terms of its benefits to go into that area, we also have the free-standing family of molecules as well. And someone asked me from one of the pharma companies, "What are you going to do with the second one?" And we said, "Well, we're going to sell that to the next company." So these represent some very, very interesting product opportunities. Your question, I think, is around the idea, would we consider using the platform? And as you may know that, my previous company, we sold antibody libraries. And those libraries allowed the big pharma companies essentially to have a new pond to fish in. And so that's how that business works. It was very profitable. We were doing $30 million a clip as we would start those kinds of deals up. And we still had milestones out as well as royalties. So it's a very interesting alternative model to be done in parallel. What we don't know is where we are in that yet. We need, quite frankly, to find the key people, every one of these big pharma companies has experts on platform technologies. And as you might guess, we're just getting more insight into who those people are and getting to them. I think, once we have those conversations, we'll be able to say a lot more about the possibility. But I can assure you that we will be looking at that as one of the ways to monetize our assets in addition to the idea of licensing some of the drugs. Does that help?

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Unidentified Participant, [24]

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That helps.

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Operator [25]

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Next, we'll move to [Rob Anderson], a private investor.

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Unidentified Participant, [26]

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Steve, I just want to kind of expand a little bit on (inaudible) question. Perhaps, have you kind of compare and contrast. But for -- there's a recent public offering, a company called Akero Therapeutics, currently trading at about $750 million in market cap, who's just recently completed a Phase Ia/b NASH clinical trial, finished it up about 2 months ago. So it's circa a year ahead of CohBar. Can you kind of compare and contrast CohBar as an opportunity that CohBar has versus what Akero. I know Akero has a sublicense from Amgen for their single clinical candidate, they have nothing else. But that might help in giving some perspective on comparable valuations and time frames and opportunities here.

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Steven B. Engle, CohBar, Inc. - CEO & Director [27]

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Sure. Thank you, Rob. The situation that you're referring to with Akero, because they have both a partnership and the results out of the Ia/b. One could understand why they're worth quite a bit more. It's the combination of the two, they're getting validation from the corporate partner as well as they're laying off probably a lot of costs to develop the compound. And I think that's very helpful as well as, of course, the positive results that, that incentivized Amgen to license the compound from them. So there are several steps there, all quite doable. Most important of which is having positive results on the molecule. But we can see where this could end up. Again, you're talking about a tens of billion dollar sized market. And as we know from other areas like the statins, there's a lot of room there for companies to be involved. We think what we have as a company is a unique molecule, that is 4211, because it has, so far, we've demonstrated at a preclinical level these 3 different effects that Ken spoke to. So we think this is a very unique molecule that NASH needs this kind of help. And so for us, it's -- as we think about it compared to the Akero situation is you can see how we have to make these next few steps. But having made them, I don't why we're not going to see the valuation of the company rise quite a bit from where we are right now.

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Operator [28]

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(Operator Instructions) We'll move next to [Steve Karl], a private investor.

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Unidentified Participant, [29]

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Steve, thank you very much for the presentation today, it's very helpful. Just wanted to clarify something with you. You spoke of upcoming events that you're going to be speaking at or attending. You mentioned a BIO Investor Forum, I believe, that's coming up in San Francisco. You also mentioned the Cantor Fitzgerald Conference.

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Steven B. Engle, CohBar, Inc. - CEO & Director [30]

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Yes.

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Unidentified Participant, [31]

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The Cantor Fitzgerald, is that their Life Science Conference?

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Steven B. Engle, CohBar, Inc. - CEO & Director [32]

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Yes, it's the one very first of October in New York.

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Unidentified Participant, [33]

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And is -- and then also, I've noticed on the website, you're talking about an international prospectus on Geroscience, it's going to be in Israel.

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Steven B. Engle, CohBar, Inc. - CEO & Director [34]

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Yes. So we're very excited about this. We've been -- a number of our founders, Nir Barzilai, Hassy Cohen as well as David Sinclair, all extremely well recognized experts in the area of aging and mitochondria and mitochondria-based therapeutics. They're going to be speaking at the conference. And so you can imagine the kind of people that will be attracted to it, both scientists as well as, we expect, investors. And so we will be there as well at the Geroscience Summit. It should be a very exciting time.

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Unidentified Participant, [35]

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The reason I was asking is I'm just trying to get a little clarification and maybe making a recommendation to you. The Cantor Fitzgerald Conference is not listed on the website under upcoming events and each -- and the other 2 are. And I think what would be helpful is that you give a little bit more information on the event as much as you can, obviously, which would be, a, are you speaking or are you just attending? And if so, what are you talking about, if you can give a subject, and who from the company is actually going to be there. I think those -- that would be helpful information to understand what -- how big of a deal is it or how big of a presentation or how timely a presentation or, for that matter, how topical a presentation you're actually making?

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Steven B. Engle, CohBar, Inc. - CEO & Director [36]

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Sure. No, thank you for the suggestion. In the case of the Cantor Fitzgerald Conference, we just found out about it, but I thought it was appropriate to let the people listening to this hear that, that has occurred. And -- but I think it's a great idea. We'll be sure. And as you can imagine, we'd like people to know the kinds of things that we will be speaking at as well as attending.

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Operator [37]

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That does conclude our question-and-answer session at this time. I'll turn the call back over to our presenters for any final or additional comments.

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Steven B. Engle, CohBar, Inc. - CEO & Director [38]

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Well, we appreciate everybody listening today and rest assured that we're going right back to our desks and labs and get work done. So thank you all. Bye now.

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Operator [39]

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That does conclude our conference call for today. We do thank you all for your participation. You may now disconnect.