CohBar, Inc.

Good afternoon. My name is Chuck, and I'll be your conference operator today. At this time, I would like to welcome everyone to COBAR's third quarter 2021 financial results conference call. All lines have been placed on mute to eliminate background noise. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad, and to withdraw your question, please press star then two. Please know this event is being recorded. I would now like to turn the conference over to Ms. Jordan Tarazi, Director of Investor Relations at Cobar. Please go ahead.

Thank you, Chuck, and thank you, everyone, for joining Cobar's third quarter 2021 financial results conference call. Joining me on today's call is Joe Surrett, Cobar's Chief Executive Officer, Ken Cundy, Cobar's Chief Scientific Officer, and Jeff Buno, Cobar's Chief Financial Officer. COBAR's financial results press release was issued earlier today and may be downloaded from our website at cobar.com. Joe will begin with an introduction, followed by an update on our CB5138-3 program from Ken. Jeff will then provide an overview of the third quarter financial results. We will conclude with Q&A. Before we begin, I'd like to take a moment to remind listeners that the remarks on today's conference call may include forward-looking statements within the meaning of the securities laws. These forward-looking statements include but are not limited to statements regarding the company's business and financial strategies, plans and expectations for its pipeline product candidates, including its lead CB4211 drug candidate program, the therapeutic and commercial potential of the company's pipeline product candidates, including its lead drug candidate CB4211 and other mitochondria-based therapeutics, statements about the company's ability to provide patent protection for its program, and the potential listing of the CB40-11 patents in the FDA's Orange Book. Statements regarding ongoing and planned research and development activities, including ongoing and planned clinical trials and regulatory status and strategies, and the timing of announcements and updates relating to our clinical trials and related data. Potential partnerships and our capital resources, financial and operating performance, 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 than those anticipated by COBAR. These risks and uncertainties are described in our registration statements, reports, and other filings at the Securities and Exchange Commission and applicable Canadian securities regulators, which are available on our website at cobar.com, sec.gov, and cedar.com. as well as in the Safe Harbor Statement included with today's press release. We are cautioned that such statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements. COBAR does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events, or otherwise. Now I'd like to turn the call over to Joe Surrett, COBAR's Chief Executive Officer. Joe?

Thank you, Jordan, and thank you, everyone, for joining us this afternoon. The last quarter for COBAR was quite eventful. We made significant advancements across many areas of our business, including the achievement of a major milestone with a positive data readout from our first human study. We also strengthened our human capital with the addition of two new board members, Carol Nast and Dr. Joanne Young. They each bring a wealth of relevant industry expertise, and we are fortunate to have them as part of the COBAR team. Welcome, Carol and Joanne, to COBAR. In addition, we recently completed a financing that extends our operational runway and allows us to continue to advance our pipeline. We believe that the fundamentals of our story have never been better, and we're excited for what lies ahead. COBAR is a leader in harnessing the power of the mitochondrial genome to develop novel peptide therapeutics. Although people tend to think of mitochondria primarily in terms of energy production and They also play a much broader role in the regulation of a variety of biological pathways. As part of this process, many of the peptides encoded in the mitochondrial genome are secreted outside of the cell and enter the systemic circulation, where they have important impacts on other organs and tissues. We believe that our approach of tapping into the tremendous power of the mitochondria has the potential to provide valuable new treatment options for physicians and dramatically improve the lives of patients. Our pipeline is focused on chronic conditions with significant unmet medical need, and our most advanced programs are CB40-11, under development for the treatment of non-alcoholic steatohepatitis, or NASH, as well as obesity, and CB51-38-3, which we believe has the potential to treat a variety of fibrotic diseases with an initial indication of idiopathic pulmonary fibrosis, or IPF. With that background, I'd like to discuss each of these programs in more detail. In August, we announced positive top-line data from a multi-centered, randomized, double-blind, placebo-controlled Phase 1A-1B trial of CB4211. While we reviewed the results in detail during our last quarterly call, I think it's worth reiterating the key takeaways from the 1B portion of the study. First, the study met its primary endpoints of safety and tolerability, with no adverse events occurring in more than one subject in the CB4211 group, other than transient injection site reactions. This clean tolerability profile is not only an important de-risking outcome for this program, but it is also a validation of our broader hypothesis that analogs of naturally occurring mitochondrial peptides will have fewer off-target effects than drug candidates developed from non-natural sources. In terms of efficacy, we saw robust and significant improvements in both ALT and AST, which are markers of liver damage, in subjects treated with CB4211 compared to placebo. Reductions in these key biomarkers are reflective of decreased liver inflammation and improved liver health. The 25% reduction in ALT seen with CB4211 treatment versus placebo compares favorably not only when compared to other four-week studies of potential NASH products, but also when compared to similar time points from longer studies of assets currently in Phase III development for NASH. In fact, the level of ALT reduction seen in 27% of the subjects treated with CB4211 had reached a level of reduction that is predictive of potential NASH resolution, a very encouraging result after just four weeks of treatment with CB42-11. We also demonstrated a significant decrease in glucose in the CB42-11 group compared to placebo, even though only one of the 20 subjects in the trial was diabetic. We believe that this result, combined with our preclinical data on improved insulin signaling, is particularly promising in light of the fact that almost 50% of NASH patients have diabetes as a comorbidity. Additionally, subjects treated with CB42-11 exhibited a trend towards weight reduction. Finally, we saw substantial reductions in liver fat content in both the active and placebo groups. We believe a similar level of liver fat reduction in the placebo group is due to the fact that subjects were confined for the duration of the trial and were provided a healthier diet than they were eating prior to enrolling in the study. Keep in mind that it is the slowing and reversing of the liver damage related to inflammation and fibrosis not decreasing liver fat in and of itself, that is the ultimate objective in treating NASH patients. Notably, despite the similar reductions in liver fat between the two groups, only the CB4211 arm demonstrated the improvements in markers of liver inflammation and glucose metabolism that I mentioned earlier. After we announced these results, we were selected for a late-breaker poster presentation at the American Association for the Study of Liver Diseases, or AASLD, which was held last week. The lead author on the poster was Dr. Rahit Limbaugh, one of the leading key opinion leaders in the NASH field, and the poster provided additional data and context for the study. Finally, our CB40211 program gained additional momentum on the IP front due to the issuance in September of a foundational U.S. patent covering the composition of matter of our peptide and related peptides, as well as methods of use, including the use to treat NASH. The term of this new patent extends to at least 2037. In the event that CB4211 is approved as a therapeutic in the U.S., the new patent would be eligible for listing in the FDA Orange Book, which is an important further barrier to generic entry. There are also foreign counterparts of this patent that are currently in the patent prosecution stage in multiple countries throughout the world. Taken together, these developments reflect significant advancement in our NASH program. We believe that the study results clearly demonstrate that CB4211 has a meaningful impact on disease, and shows great promise in the treatment of patients with NASH. We have been meeting with key opinion leaders and other experts to determine the most appropriate design for a longer-duration Phase IIa study in an outpatient setting, though we have additional formulation and preparatory work to do before such a study could begin. Given the large expense and long timelines associated with developing assets for the treatment of NASH, our preferred path forward with this program would be in the context of a partnership, and we have been discussing our recent clinical data with potential partners. NASH represents a very large opportunity for COVAR and is estimated to impact up to 30 million people in the U.S. alone, with a potential market size in the tens of billions of dollars. While no drugs have been approved to date, many expect that combination therapy is likely to become commonplace due to the complexity of the disease. We believe CB4211 is well positioned for use in combination regimens due to its unique mechanism of action and demonstrated synergistic effects in preclinical models with other potential classes of NASH drugs, including GLP-1 agonists. I'd now like to turn to our second clinical candidate, CB5138-3, which is a peptide with broad antifibrotic and anti-inflammatory properties that we are initially developing for IPF. IPF is a progressive respiratory disease of unknown cause that generally impacts adults over the age of 50 and is more common in men. Initial symptoms typically include a persistent cough, shortness of breath, and fatigue. While the course of disease varies considerably between individuals, the mean survival after diagnosis is only two to three years, which is worse than most cancers. Unlike NASH, there are two currently approved drugs to treat IPF, but many patients are unable to tolerate them due to gastrointestinal and photosensitivity side effects. While current treatment can delay some of the loss of lung function, outcomes remain poor, and patients continue to experience significant morbidity and mortality, so there is a pressing need for novel therapeutics with better efficacy and an improved safety profile. Despite the limitations of the drugs currently on the market, each has annual sales exceeding $1 billion per year. Ken will say more about our CB5138-3 program in a moment, but we believe that this peptide has the potential to address the significant unmet needs that IPF patients currently face. Given the tremendous promise of both of our clinical candidates, we recently completed a $15 million public offering, which added much needed capital to our balance sheet to enable us to continue to advance our pipeline. Our recent positive clinical data from CB4211 gives us even more confidence in the power of the approach that we are taking to novel drug development. With the additional funds combined with our previous cash balance, we are now well positioned to continue to progress our pipeline and are particularly excited about our plans to initiate our first in-human study for CB5138-3 next year. I'll now hand it over to Ken, who will review our IPF program, including an update on our current thinking regarding the potential study design. Ken?