Good afternoon. My name is Justin and I will be your conference operator today. At this time, I would like to welcome everyone to CohBar’s Fourth Quarter 2018 Financial Results Conference Call. All lines have been placed on mute to eliminate background noise.

[Operator Instructions] Now I would like to turn the conference over to Glenn Garmont of LifeSci Advisors. Please go ahead, sir..

Thank you, Justin and thank you everybody for joining CohBar’s fourth quarter 2018 financial results conference call. Joining me on today’s call is Philippe Calais, CohBar’s Interim Chief Executive Officer; Ken Cundy, CohBar’s Chief Scientific Officer; and Jeff Biunno, Chief Financial Officer.

Our financial results press release was issued earlier today and maybe downloaded from the website, www.cohbar.com. If you are 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 fourth quarter financial results, followed by a business and R&D update from Philippe and Ken. But before we begin, I would 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 towards its lead CB4211 drug candidate program, the therapeutic and commercial potential of the company’s lead drug candidate and other mitochondria-based therapeutics, statements regarding ongoing and planned research and development activities, potential partnerships, and capital resources to fund the company’s operations.

Forward-looking statements are based on current expectations, estimates and projections 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 would like to turn the call over to Jeff Biunno, CohBar’s Chief Financial Officer.

Jeff?.

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 fourth quarter ended December 31, 2018 compared to the fourth quarter ended December 31, 2017.

Total operating expenses in Q4 2018 were $4.95 million as compared to $2.851 million in Q4 2017, an increase of approximately $1.244 million. Operating expenses for the quarter ended December 31, 2018 included non-cash expenses of $944,000. Non-cash operating expenses includes stock-based compensation and depreciation and amortization costs.

Research and development expenses were $2.85 million in Q4 2018 compared to $1.791 million in the prior year period, an increase of approximately $294,000.

The increase in research and development expenses was primarily due to the transition of CB4211 from a preclinical to clinical stage resulting in an increase in clinical activity costs incurred in the current year quarter partially offset by a decrease in cost of preclinical activities that were incurred in the prior year quarter.

General and administrative expenses were $2.10 million in Q4 2018 compared to $1.60 million in the prior year period, an increase of approximately $950,000.

The increase in general and administrative expenses included a severance and non-cash acceleration cost of stock options related to the termination of our former Chief Executive Officer, an increase in the recruiting costs related to our CEO search, increases in directors’ fees associated with new and existing directors.

These increases were partially offset by a decrease in compliance costs due to the timing of certain NASDAQ and regulatory registration fees that were incurred in the prior year quarter.

For the quarter ended December 31, 2018, the company reported net loss of $4.190 million or $0.10 per basic and diluted share compared to a net loss of $2.833 million or $0.07 per basic and diluted share for the quarter ended December 31, 2017.

Moving to the balance sheet as of December 31, 2018, CohBar had $22.2 million in cash and investments compared to $8.5 million as of December 31, 2017. For the year, we averaged approximately $2.9 million in quarterly cash burn. We expect our average quarterly cash burn to increase modestly in 2019 to a range of $3.1 million to $3.6 million.

We estimate that based on our cash and investments balance as of December 31, 2018, we have sufficient capital to finance our operations into the third quarter of 2020. I will now turn the call over to Philippe.

Philippe?.

Thank you, Jeff and my thanks for joining us this afternoon.

I will begin with a review of our strategic plan before turning the call over to Ken Cundy, our Chief Scientific Officer, to review our clinical trial status and our exciting progress in evaluating our new peptides for future potential clinical candidates and expanding our portfolio of MDPs.

Next slide, many of you may have seen this slide before, as you know in the past 4 years, we have been building on our founders’ research and discoveries of new genes encoding peptides in the mitochondrial genome that we call mitochondrial-derived peptides or MDPs.

These MDPs have demonstrated regulatory and protective effects on metabolism and have the potential to lead the novel mitochondria-based therapeutics to treat a broad range of age-related diseases. At the high-level, we have been focused on two primary R&D objectives.

The first one has been to develop our lead MOTS-c MDP into the first novel and improved mitochondria-based therapeutic with the potential for treating NASH and obesity, two major age-related diseases. Our work with our clinical stage lead drug candidates CB4211 is targeted at this goal.

Our second objective at the most strategic level has been to own the MDP space by identifying and obtaining intellectual property rights to as many of the other undiscovered genes encoded in the mitochondria as possible.

Determining the safety potential and developing a significant pipeline of additional therapeutic candidates with similar or even greater therapeutic potential for treating age-related diseases. Let’s talk for a few minutes about how our proprietary platform technology enabled these objectives. Next slide.

This slide illustrates the conceptual level that what we have done to advance CB4211 to the clinic. We created many novel analogs of the naturally encoded MOTS-c peptide, identified and quantified their therapeutic potential and optimize them for NASH and obesity disease targets.

As you can imagine, the actual process to optimize the naturally expressed protein into a highly efficacious therapeutics with the right drug-like properties is a complex one requiring many cycles of analog engineering and evaluation by our highly skilled experts and that’s just for one MDP clinical candidate.

As you know, as part of our strategy to own the MBT space, we have completed a genome mining process last year that discovered over 100 peptides in the mitochondrial genome with varying degrees of biological activity and we have been evaluating novel analogs of those MDPs for therapeutic potential across multiple diseases.

One of our fundamental challenges has been to identify the best new candidates to develop among very wide range of therapeutic possibilities enabled by the new genes and the next slide shows at the high level how we have been addressing the challenge. So next slide please.

Since we completed our genome mining activity, we have been further optimizing and evaluating novel analogs of the most promising MDPs with a variety of methods and techniques.

As you can see from this slide, it’s a lot more complex than the process for developing a single peptide like MOTS-c for specific diseases like NASH and obesity, which we saw in the previous slide, because we have so many peptides and possible diseases and our goal is to identify the most advantageous combination of therapeutic potential, unmet medical need, development and regulatory pathways and commercial opportunities for our next candidates.

While we have previously shared some data of the few analogs in the earlier stages of optimization and evaluation, we have recently been able to make even more progress by applying additional resources enabled by our successful funding activities last June. Next slide.

In this slide, you can see our CB4211 clinical program in the center of the age-related disease landscape, together with several other disease areas, on which we are currently focusing our optimization and evaluation, some of those such as Type 2 diabetes, cancer and Alzheimer’s disease that we have discussed before and others that we have more recently identified.

Ken will be providing further data on the recent progress we have made in these areas, which has opened up some new potential opportunities for addressable diseases and is enabling us to further refine our prioritization of possible clinical candidates.

There are some things that we can’t talk about right now for a variety of reasons, intellectual property protection being a major one, but Ken will show you enough to hopefully give you a better idea of the significant progress we have made and where we are headed.

We believe that the progress that we are making and the new opportunities that we are uncovering with our novel peptides provide additional evidence of the integral roles that a number of those MDPs play in metabolic and energetic regulation and protection and additional support for our strategic goals and our plan to use our portfolio of discovered peptides to develop a significant pipeline of additional therapeutic candidates to treat age-related diseases and increase healthy lifespan.

Ken, the stage is yours now..

Okay, thank you Philippe. Let’s go to the next slide please. Let’s start with an update on the CB4211 clinical program. As mentioned in the press release, we continue to focus on getting CB4211 back into the clinic as soon as possible and as a reminder, this slide showed the design of our clinical study.

It starts with an initial Phase 1A stage which is a dose-range finding study in healthy volunteers to establish the safety, tolerability and pharmacokinetics of CB4211. This will be followed by the 4-week Phase 1b stage in obese NFALD subjects with the goal of assessing activity of CB4211 against endpoints that are relevant to NASH and obesity.

Now as we have discussed on previous calls, the study was suspended to address the mild, but unexpectedly persistent indurations or bumps that were observed at the injection site during the dose escalation phase of the study. We also announced on our December investor call that we have submitted to FDA a clinical plan intended to mitigate the issue.

So, let’s talk about the status of that process. Next slide please. Now, as you may know, the timeline for FDA to respond to request for comment is related to the urgency of the situation and therefore situations involving serious adverse effects have a higher priority.

So recall that we are not on an FDA imposed clinical hold here and although we were hoping for some quick feedback, we are seeing a slower response timeline from the agency, which is of course subject to the internal and external factors.

Now on March 7, CohBar finally had its first opportunity to discuss with FDA, our plan for resuming the clinical study, but in parallel to awaiting FDA feedback, we have also been discussing our plan with several prominent clinical and regulatory experts with the goal of expediting the lengthy FDA process. Let’s go to our next slide please.

So, among these advisers is Dr. James Leyden, MD, who is emeritus professor of Dermatology at the University of Pennsylvania. Now, Dr. Leyden has been an adviser to U.S. and European regulatory agencies has been involved in more than 40 years of preclinical safety studies as well as Phase 2 and Phase 3 trials.

He has reviewed our clinical data in detail and has concluded that there is no significant safety issue. He also concurs with our assessment that these bumps observed in the study are due to a localized depot of drug that is slow to dissipate, but otherwise does not represent a safety concern. Now, Dr.

Leyden also participated on our recent call with FDA. Let’s go to the next slide. So, let’s talk about the next steps here. As follow-on to that recent discussion with FDA, we are now submitting some additional information to them that we have on hand.

We plan to resume the study following regulatory clearance and that begins by resuming enrollment of healthy subjects to complete the remaining steps of the Phase 1a dose finding. Following dose selection, we would enroll the obese, NFALD subjects and initiate the Phase 1b stage.

Now, although we cannot be certain when the process with FDA will be concluded, we are poised to resume the study and hope to get back into the clinic as soon as possible. We expect to provide updated timelines once we have clarity and we also expect to post the final study design on a clinicaltrials.gov.

Though we have talked about the status of 4211 development, but there is obviously a lot more going on at CohBar external attention to the rest of CohBar’s pipeline.

Following the successful financing in the middle of last year, we began to expand our research efforts with an enhanced focus on the design synthesis, evaluation and optimization of additional novel peptide analogs that related to our broader portfolio of mitochondrially-encoded peptides.

That expanded research effort has included adding additional cell-based biological assay capabilities to our growing internal research repertoire in the CohBar lab.

We have added new state-of-the-art analytical capability in-house to aid in characterizing peptide physical properties and metabolism and we are harnessing a number of external broad activity screens to look for new leads in new target areas. That external screening effort has included the use of two different approaches.

The first approach on this slide involves target-based screening of activity as cell surface receptors with known functionality. Now, as a reminder, these cell receptors are composed of proteins that sit on the surface of cells and act as receivers from messages carried by other molecules.

Once they are activated, they send signals into the cell that may regulate cellular processes or change the levels of other signaling molecules.

The screening process itself uses human cell-based receptor assays, so cells that are separately expressing a very broad spectrum of known cell surface receptors are placed in a high throughput format and we look for an interaction that alters the downstream signaling process within the cell.

This type of assay is able to identify both peptides that directly activate the receptor leading to enhanced cellular signal and those that can inhibit the action of the natural activator thereby blocking the cellular signal.

We can use this approach to look at the activity of individual peptide analogs or to compare within related analog families to tease apart the effects of structural changes on their activity. The peptides can be screened simultaneously against the entire list of receptors.

The goal here is to find a selective signal at a specific target receptor as shown in the example on the left of this slide.

When we a selective effect like this, the identified target can be specifically started in depth and knowing the target of our peptides helps uncover their mechanism of action and can further unlock potential additional opportunities in new therapeutic indications. Next slide please.

The second type of screening we employ externally is what we call phenotypic screening, where we are looking more at the effect of the peptide on the cell rather than its interaction with the target. So, in these wide-ranging phenotypic screens, we can be looking at things like changes in protein levels in a broad range of human cell-based systems.

The changes in these clinically relevant biomarkers maybe related to a wide range of disease processes, for example, inflammation, fibrosis and other cellular processes. In the example shown in this slide, we see a peptide analog that induces very significant increases in certain specific protein biomarkers with known clinical relevance.

So, again, identifying the specific biomarkers that are affected by our peptides helps to uncover their mechanism of action and potentially reveals additional opportunities for new therapeutic areas. Go to the next slide, please.

Now we’re applying these external screens and continue to see new and unexpected activity among our novel mitochondrial peptide analogs.

For example, in the arena of type 2 diabetes, we’re actively optimizing a family of peptide analogs that are completely unrelated to CB4211 that have so far demonstrated beneficial effects on glycemic control in animal models of diabetes and using the types of screening that I’ve described, we’ve already significantly advanced their understanding of the mechanism of action of this new peptide class.

By exploring their activity in the cell surface receptor target screens, we have seen activity at one key receptor currently the subject of intense research in other pharma and academic labs that appears to play a key role in a number of age-related diseases.

So, this discovery potentially unlocks the possibility of an entirely new class of peptide agents that engage this important receptor. Now, as a result of this recent breakthrough, we have submitted an abstract on our findings for presentation at a major scientific meeting that is scheduled for later this year. Next slide, please.

So, beyond the type 2 diabetes arena, we are prioritizing our research activities based on what we are seeing.

For example, in the field of oncology, we’re expanding on our earlier discovery of mitochondrially encoded peptides with broad antiproliferative activity to look for the most potent and druggable peptide analogs for further evaluation in animal models of specific cancers.

Behind that, we’re extending our early stage research from initial leads that we uncover in our broad screening activities towards more rigorous assessment in animal disease models. An example here is in the fibrosis area. In such cases, we are looking for the fastest path to a proof-of-concept.

Obviously, there are many more potential opportunities here at CohBar than we can hope to explore entirely with internal resources. So, we will continue to use external CROs for support and also look for opportunities to partner some of these early stage examples under a research collaboration. And with that, I’ll return the stage to Philippe..

Thank you very much, Ken. I know that you and your team are really doing everything you can to get CB4211 back into clinic as soon as possible and at the same time making such exciting progress on the new peptides and identifying new potential therapeutic opportunities.

I’d like to focus on how we take all of these progress and turn it into a new MBT drug candidate. Next slide. We believe that our new peptides contain many potential opportunities many more than we have resources to explore.

So, we have to be very selective and efficient in our choices and focus on a handful of the most promising opportunities and find the best ones to take forward into the clinic. When selecting a new MBT drug candidate, there are a number of things that we have to consider and compare among our potential candidates.

We look for reproducible biological activity in disease models and explore the potency of the analog to support subcutaneous administration. A novel mechanism of action is expected and we look for an analog’s potential to exert a synergistic effect when combined with other drugs leading to a differentiated profile.

We also need to ensure that we can secure strong patent protection for the analog and its potential indications. In choosing the most appropriate indication for an analog, we need to verify that there is indeed an unmet medical need in an addressable population that is accessible.

It’s important that there are reliable preclinical disease models that mimic the target disease as not all disease have such models. The clinical and regulatory paths need to be clear and affordable with an acceptable study design.

And the market and competitive space for an analog’s indication must be determined with market research and competitive intelligence to assess the compound’s market potential and evaluate the pharma appetites for partnering opportunities.

So, the process we had to go through to prioritize our next clinical candidate is an extremely complex one of alignment between scientific research and business opportunities. But I can assure you that this process allows us to pick the best drug candidate and it’s very important to realize the most value for our portfolio of peptides. Next slide.

Let’s briefly talk about some of our other activities. We’ve continued to focus on expanding the investment community’s awareness of the company particularly among institutional investors. We presented at the BIO Investor Forum and met with investors, bankers and analysts during the JPMorgan Healthcare Conference in January.

We presented at the BIO CEO and Investor Conference in February, where I was featured on the panel entitled Attacking Biological Mechanisms of Aging to Extend Healthspan. And I’m actually calling you today from the ROTH conference where I just participated on the panel led by ROTH’s leading research analyst with 6 other companies focusing on NASH.

We plan to continue developing relationships with research analysts and investment banks. We’re also evaluating the timing for non-deal roadshows and for a key opinion leader scientific event.

Partnering continues to be a fundamental element of our strategy that we believe will provide validation of our technology and also generate non-dilutive financing.

We are planning to resume our partnering discussion for CB4211, once we have reached a value inflection point with the results of our Phase 1a/1b, we are continuing to work with our partnering advisor in anticipation of these efforts.

As we continue to make steady progress with our new MBT candidate, we are evaluating the potential for possible collaborations with prospective pharma partners that could contribute to accelerating and expanding our research efforts. Our vision is that a research collaboration could lead to a development partnership.

To add on a personal note, I’ve been acting as the company’s CEO for the last 4 months and I must say that I’m more excited than ever. My first few months have strengthened my belief in our unique science, our extraordinary team and in our opportunities to increase healthy lifespan while at the same time creating value for our shareholders.

The journey is at the same time exciting and intense. I’m proud to lead the team fully dedicated and focused to succeed. Finally, I’d like to thank you for your continued support and believe in our mission at CohBar. Next slide. So, thank you for joining us. And we now revert to the operator to take your questions.

Justin?.

Well, thank you. [Operator Instructions] Our first question will come from Stephen Dunn with LifeTech Capital..

Good afternoon, and thanks for taking my questions guys.

Can you hear me okay?.

Yes, I can hear you, Steve. Please go ahead..

Yes, Stephen. Very good..

Okay, great. I’m not sure this is a Philippe question or a Ken question.

We love to ask, I understand if you can’t answer, but with respect – even though you’re not under a clinical hold for your injection site reaction, I was wondering if you can give a little clarity on do you think the injection site reaction are related to the MOTS-c or the peptide or the analogs of it or should we – you expect to see it in your other drug candidates that you’re working on the hit to leads, in other words, do you think this is just rather specific analog or do you expect to see –.

Yes, let me take that question, Steve, I’ll answer that one for you. So, we don’t believe this is reflective of other peptides within our portfolio. We think it’s a specific property of the structure that we have within the MOTS-c related peptides here.

And what we believe is going on as we’ve discussed before is that the peptide is just producing a deposit, a local depot at the site of injection in many ways like a depot drug lift, where the drug just resides there and slowly dissipates only – it’s not dissipating fast enough in this setting for us to make that useful.

So, the goal as we have previously described is making that not happen in the first place, so getting away from the deposition of the drug and thereby allowing it to reach the area where it needs to be effective. So, we don’t expect that to carry over to other peptides that have totally different structures..

Okay, that’s an important point to emphasize. Alright, so, we don’t expect to see that in the other drug candidates.

Now, is it correct my understanding that your next programs will be type 2 diabetes? And if so, are you still on hit to lead or you would lead optimization or where are you in that program?.

So, as I mentioned, the furthest along in terms of data that we are sharing would be the type 2 diabetes arena, where we’re now submitting an abstract around the mechanism of action of this class that we are focused on. So that’s a very, I would say high area of research for us. There are other areas that could surprise us and move faster.

It’s hard to predict when we would get a candidate out of these programs. But clearly, we’ve got a lot of data around the type 2 diabetes opportunity here, but we’re doing our best to generate data around many indications here.

And we’ve mentioned cancer, but opening other doors with our external screening, some of those could be a faster route to a candidate..

Okay, last question and I’ll hop back in the queue.

On the abstract to the type 2 diabetes, would we be expecting to see CohBar at the ADA meeting in Orlando in a couple of months or something later on?.

Yes, I wouldn’t want to give specifics right now until we haven’t accepted abstract. So, it’s been submitted for a meeting and as soon as we have confirmation of acceptance, we’ll let you know which meeting.

And as you know once you submit to a major meeting of this type, you really can’t talk about the specifics of the content of the abstract until the embargo is lifted, but that’s a process we’re familiar with, so we would definitely be giving an update once we pass those hurdles..

Okay. So, the takeaway that I’m getting then is the issue we have of the injection site reactions even though it’s limited and minor are not expected to be seen in the other work that you’re doing in the other analogs to the peptide, and in type 2 diabetes, I guess research what we’re seeing some kind of poster sometime this year.

Is that correct?.

That’s correct. Yes, I’d – I’d go further on the issue of the injection site reactions clearly going forward as well. It’s the goal for us to have mechanisms by which we ensure the possibility of future deposition of drug is not going to be an issue for us..

Alright, thanks so much, Ken, and thanks Philippe, and keep up the good work..

Sure. Thanks, Steve..

Thank you, Stephen..

[Operator Instructions] And we’ll go next to Brian McAllister, a Private Investor..

Hello, thanks for taking my call. I guess this question is for Ken.

Ken, when you restart the trial, will you need to go back to the beginning or where do you actually start the trial?.

Right, right, Brian. So, yes, let me give you a little color on that. So, as we mentioned earlier, once we clear the regulatory clearance and we begin to resume the study, the first step is to resume enrollment of the Phase 1a, so that’s the healthy subjects to finish the remaining part of that. So, we’re not restarting here.

We’re concluding the dose range finding activity that then tells us what the appropriate doses for the Phase 1b, and as soon as we have that information, we’re then actively enrolling the subjects for the 4-week Phase 1b study. So, those are the steps involved.

So, as I said, we’ll provide more detail on that design once it’s finalized then we can actually update and put it on the clinicaltrials.gov website..

Okay, thank you very much..

Sure..

And next will be Blair Stribley, a Private Investor..

Hi, thanks for taking my question. My question is related to Brian, I’m just curious once you guys do get approval to go back into the clinical trials, it sounds like Phase 1b is a 4-week process.

I’m curious about what’s the entire length of the process would take, is that several months or until you’re in a position to be able to announce the results in the clinic? Thanks..

Right. Thanks for the question. Yes. So, we can’t predict right now the full timeline. First, we have to finish the process with FDA. As I said, we are poised to resume as soon as we’re through that process.

And as I mentioned, we’ve got to finish the Phase 1a enroll and complete the Phase 1b, and bear in mind, the Phase 1b is 4 weeks for treatment, right? So, there is a length of process associated with enrolling those subjects and then also the other end of the study where you have to do all the data analysis.

So, we’ll give a more update on that expected timeline when we have clarity on the conclusion of the FDA process and we’re sharing the design publicly as well at that point on clinicaltrials.gov..

Alright, thank you..

Sure, thank you..

[Operator Instructions] And at this time, there are no further questions. I’ll now turn the conference back over to you. Actually, we just got a question come in from Rob Anderson, a Private Investor..

Yes. I think this question is directed at Jeff. So, Jeff, can you talk about where we are as far as cash and cash runway and this kind of maybe dovetails into Blair’s question as well.

Can you give any kind of hypothesis or assumptions about where you are clinically come mid-year next year or third quarter of next year?.

So, Rob, I don’t understand the question. Can you rephrase it..

Yes, let me – so, the process for clinical trials with Phase 1a, Phase 1b and then into Phase 2 design into Phase 2.

Where does the cash take you in that process do you think?.

So, as I mentioned earlier in my comments, our runway takes us into the third quarter of 2020. Now that cash runway that includes the Phase 1a/1b expenses and it does include some Phase 2 prep cost.

Some of the Phase 1a cost obviously because of the temporary suspension has been deferred a bit, but will still be caught in this runway between now and the end of –into I’m sorry, into Q3 2020..

Great. So, what I’m hearing you’re saying that Jeff, correct me if I’m wrong that there’s the Phase 2 design work is going to be funded by our current cash position and it’s possibility that give or take that we may be ready to move into Phase 2 at that point in time as well. Is that a good conclusion or –.

There’s Phase 2 preparation cost that are part of this cash runway and it depends how far along we get into through the Phase 1b and into the Phase 2 and that’s something that we will monitor and address at the time. But we do have some Phase 2 prep cost as part of the runway and we’ll finish with the Phase 1a/1b within this runway..

Great, thank you, Jeff..

Absolutely. Thanks Rob..

And at this time, there are no further questions. I’ll now turn the conference back over to you for any additional remarks..

Well, thank you very much for participating to our call today. We certainly appreciate the interest and the quality, the depth of the question we had and we look forward to our next interaction. So thank you very much everyone and goodbye..

Well, thank you. That does conclude today’s conference. We do thank you for your participation and have a wonderful day..