Jeff Biunno – Chief Financial Officer Simon Allen – Chief Executive Officer Ken Cundy – Chief Scientific Officer.

Analysts:.

Please standby. Good afternoon, my name is Yolanda, and I will be your conference operator today. At this time, I would like to welcome everyone to the CohBar’s Third Quarter 2018 Financial Results Conference Call. All lines have been placed on mute to eliminate background noise. This call is being recorded.

And now I’d like to turn the call over to Jeff Biunno, CohBar’s Chief Financial Officer. Please go ahead, sir..

Thank you, Yolanda. We would like to welcome all of you to CohBar’s third quarter 2018 financial results conference call. Joining me on today’s call is Simon Allen, CohBar’s Chief Executive Officer and Ken Cundy, CohBar’s Chief Scientific Officer.

Our financial results press release was issued earlier today and may be downloaded from our website at cohbar.com. I will begin with an overview of our third quarter financial results, followed by a business update from Simon and Ken.

Before we began, 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 therapeutic and commercial potential of the company’s lead drug candidate CB4211 and other mitochondria based therapeutics, statements regarding the regarding the suspension of the Phase 1 clinical trial for CB4211, and our plans and expectations for resumption of the trial, statements regarding ongoing and planned research and development activities, and statements regarding our potential partnerships, capital resources and ability to fund our 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 statement.

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. I will now provide you with a summary of our financial results for the third quarter ended September 30, 2018 compared to the third quarter ended September 30, 2017.

Total operating expenses in Q3 2018 were $4.5 million as compared to $2.9 million in Q3 2017, an increase of approximately $1.6 million. Research and development expenses were $3.4 million in Q3 2018 compared to $2.3 million in the prior year period, an increase of approximately $1.1 million.

The increase in research and development expenses was primarily due to the costs of our clinical activities and a net increase in the non-cash expense in stock-based compensation related to the investing of performance based stock options, closed by the company’s clinical entry during the quarter.

These increased expenses were offset by the quarterly revaluation of prior equity grants to consultants and by a decrease in costs related to IND enabling activities in the prior year quarter. General and administrative expenses were $1.1 million in Q3 2018 compared to $550,000 in the prior year period, an increase of approximately $550,000.

The increase in general and administrative expenses was due to the increase in stock-based compensation related to the previously mentioned performance based stock options. The cost associated with new option grants made since the prior year period and increases in directors fees and directors and officers insurance premiums.

For the quarter ended September 30 2018, the company reported a net loss of $4.6 million or $0.11 per basic and diluted share compared to a net loss of $2.9 million or $0.07 per basic and diluted share for the quarter ended September 30, 2017.

Moving to the balance sheet, as of September 30 2018, CohBar $24.2 million in cash and investments compared to $8.5 million as of December 31, 2017. We estimate that based on our cash and investments balance as of September 30, 2018, we have sufficient capital to finance our operations into the first half of 2020.

I will now turn the call over to Simon..

Thanks, Jeff. Good afternoon, everyone and thanks for joining our call. We started this quarter with an enormous milestone transitioning to a clinical stage company. And we’re very excited about being in the clinic without first MBT.

We’re also excited about CB4211’s unique mechanism and product profile, which enables strategic opportunities for the potential treatment of NASH and obesity.

We also started this quarter with the largest cash position in the company’s history, enabling us to advance the clinical development of CB4211, while increasing our investment and efforts in advancing our preclinical pipeline with the goal of identifying our next clinical candidate.

As our trial of CB4211 progressed, we saw an unexpected persistence in injection site reactions, which led to the temporary suspension of the trial, which we announced last week. As discussed, we have a plan to address this temporary suspension with the goal of resuming the study as soon as possible.

Ken Cundy, Chief Scientific Officer will continue with review of what was shared on the call last week for those of you who are unable to listen.

Ken?.

Thanks, Simon. For those of you who listened to our call last week, this will be a review. You’ll recall that we initiated this blinded placebo-controlled Phase 1a/1b study in July of 2018 to first assess the safety, tolerability and pharmacokinetics of CB4211 following single and multiple ascending doses in healthy subjects.

The Phase 1b stage of the study which has not yet started, is designed to assess safety, tolerability, and activity in obese subjects with non-alcoholic fatty liver disease or NAFLD. Assessments in those subjects are designed to follow changes in liver fat, measured by MRI-PDFF, body weight, and biomarkers relevant to NASH and obesity.

Now from the beginning of the study, our protocol called for careful monitoring of subjects for adverse effects including possible injection site reactions.

The injection site reactions that we observed in the Phase 1 study as we escalated the dose of generally painless bumps at the injection site that can be felt under the skin, but in most cases would be otherwise undetectable.

Now, it’s not uncommon to experience mild injection site reactions in clinical studies of subcutaneously injected peptide drugs, but for most of those drugs such reactions resolved relatively quickly.

This type of reaction is generally caused by localized sensitivity to the drug under the surface of the skin and in many cases they resolve as the drug dissipates away from the injection site.

Now, we’ve been monitoring the persistence of the reactions in our study and we now believe based on the data accumulated to this point, that some of the administered dose of CB4211 remains localized in the tissue at the injection site, thereby causing these bumps to occur.

And the persistence of these bumps appears to be reflecting a slower dissipation of our drug from the injection site. Our plan going forward is therefore to reduce the risk of that localized drug deposition. Now we’re addressing this issue now at this early-stage of development before proceeding to the Phase 1b stage of the study.

These are exactly the kind of issues that Phase 1 studies are intended to identify, so that they can be addressed before larger numbers of subjects were enrolled in longer efficacy studies. Also, Phase 1 studies are routinely conducted with the knowledge that some aspects of this study may need to be further refined as it progresses.

Protocol amendments are relatively common in Phase 1 studies and that is the approach we’re taking here. So we have a plan to address this issue and that includes refining our study protocol and obtaining regulatory feedback with the goal of resuming the Phase 1a trial as soon as possible.

We are now finalizing our FDA submission and expect to be sending it to the agency very soon. Once we engage with the FDA, we’ll have a better understanding of how that will affect the timeline of the study. And while we’re progressing, 4211 clinical trial and that remains our highest priority.

During this quarter, we also continue to expand our efforts in evaluating the potential of our novel peptides in the preclinical setting across a wide range of modes of age-related diseases with the goal of identifying our next clinical candidate. So with that, I’ll turn the call Simon..

Thanks, Ken. The landscape to NASH continues to evolve as we pursued the development of CB4211. NASH continues to be seen as an enormous unmet medical need in a market opportunity and the tens of billions of dollars, with no approved therapeutics and room for multiple blockbuster drugs and a range of [Audio Dip].

And please stand by. We’ll reconnect our speaker line. Mr. Biunno, one moment. And that line has been reconnected. Please go ahead, sir..

Yolanda, could you let us know where we dropped off? Should I just begin again at my remarks?.

Yes, please..

The landscape to NASH continues to evolve, which we pursue the development of CB4211. NASH continues to be seen as an enormous unmet medical need and the market opportunity and the tens of billions of dollars with no approved therapeutics and room for multiple blockbuster drugs and a range of therapies.

The NASH marketplace and particularly large pharma are increasingly looking towards combination therapy that offers complimentary mechanisms, namely steatosis, inflammation and fibrosis into a single regime. This strategy is being pursued in order to optimize patient outcomes at different stages of the disease.

This landscape is fluid and segmented with multiple programs in various stages of development that have a diverse set of mechanisms targeting different stages of the disease. As we’ve observed in the past, we continue to see a limited number of novel mechanisms and an excess of repurpose drugs trying to find a new home.

We continue to attract potential partnership opportunities to CB4211 as this NASH landscape evolves. And strategic partnering for our pipeline continues to be a fundamental component and objective of our strategy going forward.

We believe that CB4211 is well positioned in the current national landscape with it’s highly differentiated in novel mechanism that involve the insulin receptor and with its unique characteristics that include regulation of fat metabolism, reduction of liver fat, and normalization of body weight.

Normalizing bodyweight is desirable both when treating NASH as the majority of NASH patients are overweight or obese and for treating obesity itself, because when left untreated obesity for medically increases other comorbidities such as Type 2 diabetes, cancer and cardiovascular disease.

Now preclinical studies have also indicated potential synergy of CB4211 in combination with liraglutide, as GLP-1 agonist that is a blockbuster in the diabetes space.

This is a highly desirable characteristic for NASH therapeutic since an estimated 40% of patients with NASH also have Type 2 diabetes as well as for obesity therapeutic, since significant number of obese patients are also diabetic.

Going forward, we are focused in the short term on implementing our plan, getting feedback from the FDA and resuming a CB4211 trial. We will update you on the timeline as soon as we have clarity. At the same time, we are continuing to expand our efforts related to a novel peptides and the therapeutic potential across a range of age-related diseases.

As always, we will carefully manage our operations and have significant funds to take us into the first half of 2020. And with that, I’d like to turn the call over to our operator.

Yolanda’s, Q&A?.

Thank you. [Operator Instructions] And we’ll take a question from [indiscernible] with Clearwater Investments. Please go ahead sir..

Hey, Simon, it’s looks like maybe I’m only one call here. What do I want to say here? I have a question. I have a comment first then a question or at least two questions. I’m not really concerned about the science going long term, but I’m more concerned about the price action being a market technician doing this for 35 years.

I’m very concerned that, you folks who have just not been able to bring in any bind to sustain any upward momentum. Technically, we’ve had three bullish setups in the last, say two months and they’ve all failed because of no follow through. September 25, you partnered with LifeSci Advisors. Stock was for $4.45, and obviously, it was a lower since then.

And getting the suspension, I thought we – that day when that news came out, the stock, handled itself extremely well. And we had another potential to move higher. But once again we failed and obviously today.

So my question to you Simon, the first question is what’s going on with LifeSci and if they’re an IR department or firm, I mean obviously, they’re not obviously promoting very well or you guys are doing your job or something’s going on because this is very frustrated here.

Watching this stock rollover everyday?.

Thanks very much, Graham [ph]. And I think you would just the first one to get to style one. I think there’s like 60 people on the call. That being said..

I just be joking..

Yes, no worries. So look, obviously, we don’t like to see the stock price going down. Nobody does. What we can say is LifeSci has already provided significant input, but there’s only so much input that you can provide in a matter of weeks. And we’re really looking towards clearly on the Q3 call we can outline what we have in store.

But really this is looking towards JPMorgan. This is looking towards doing the very thing that you mentioned which is trying to get as much buying demand into the stock as appropriate at the right time. And we were doing everything that we can. I think you probably saw the IPB was down 2% today as an example.

A lot of the sub billion dollar market cap companies got hit anywhere between obviously, zero and like down 10% and no news. And these are very, very reputable companies. And all I can say is the stock price goes up, the stock price goes down. What we’re focused on here is obviously getting CB4211 on track.

There is no higher priority, but we’re really looking towards this long term growth in building a sustainable company. They can be here for the long term and your comment about having faith in the long term science, if will Graham [ph], that’s absolutely what we’re focused on. We’ve learned a lot with CB4211, we’ll continue to learn a lot.

And that’s it, that’s what we’re focused on..

Well, okay, Simon. But the fact of the matter is, is that, perception is everything. And I mean, I think that that’s what’s troubling is that there hasn’t been any volume.

And obviously, nobody likes to buy a falling stock and it reference the IDB, I mean, it’s of 15% it’s high and almost 5% year to date down where we’re off 70% up or high and 35% percent down in the year. So I don’t think CohBar really kind of flows in the big overall picture. I mean, it’s a different animal onto itself.

And so, I’m just wondering that the story about changing the biotech landscape have so much potential, but for some reason you guys are getting that across to anybody. And so that’s where my frustration is.

So, but anyway, my second question is, your runway, so you’ve got $26 million in the bank here, you’re spending $4.6 million, so it sounds to me like a quarter. So you’ve got above five quarters left. So, I guess down the road you’re going to have to raise some more capital I’m assuming, of course..

Good question, Graham [ph]. As I just indicated, we’ve got cash to that takes us into the second half of 2020, so it fits right into the first half of 2020. I appreciate that. So we’re going to be providing further guidance on our runway as being progressive.

But nothing more to say other than we feel your frustration, biotech is like that from time to time. We had a very robust Q2 with the Russell 2000 raising additional capital and obviously starting our first clinical trial. Where we find ourselves today is having learnt from that clinical trial as it continues to progress.

And Ken I think gave his clear and update as possible about where we stand and as soon as we get greater clarity, we’re looking forward to providing that. And with regards to IR and initiatives to buy – get further buying demand. That is obviously an ongoing initiative and LifeSci and others are there to help us.

And we’ll do everything we can to support that..

Okay, Simon. Thanks for taking my call. Thank you..

Yes. Thanks a lot Graham [ph]..

Thank you. [Operator Instructions] I’m seeing no further questions in our queue. I would like to turn the call back to Simon Allen for any additional or closing comments..

Yes. Thanks very much, Yolanda. I appreciate everybody joining the call. As always, we very much appreciate the ongoing support and we look forward to giving you clarity as soon as we get it. Thank you very much everybody.

Again, that will conclude today’s conference. Thank you all for your participation. And you may now disconnect..