CohBar, Inc.

Good afternoon. My name is Kyle and I will be your conference operator today. At this time, I'd like to welcome everyone to CoBAR's fourth quarter and full year 2021 financial results conference call. All lines have been placed on mute to eliminate background noise. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. Now, I'd like to turn the call over to Jordan Tarazi, Director of Investor Relations at COBAR.

Thank you, Kyle, and thank you, everyone, for joining COBAR's fourth quarter and full year 2021 financial results conference call. Joining me on today's call is Joe Surrett, COBAR's Chief Executive Officer, and Jeff Buno, COBAR's Chief Financial Officer. I would also like to take this opportunity to welcome Dr. Nick Vlahakis, COBAR's newly appointed Chief Medical Officer, who will also be providing remarks today. Following our collective remarks, we will conclude with Q&A, at which time Dr. Kent Greinstaff, SVP of Research, will also join us. COBRA's financial results press release was issued earlier today and may be downloaded from our website at cobra.com. 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, the therapeutic and commercial potential of the company's pipeline product candidates, and other therapeutics from our MITO Plus platform, statements regarding ongoing and planned research and development activities, including planned clinical trials, regular stories, status and strategies, and the timing of announcements and updates relating to our regulatory filings and clinical trials. 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 from those anticipated by COPPA. 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 cobar.com, scc.gov, and cdar.com, as well as in the state-published 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. 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 Surratt, COBAR's Chief Executive Officer. Joe?

Thank you, Jordan, and thank you, everyone, for joining us this afternoon. This past year has been an eventful one for COBAR. We're pleased to have made important advancements in 2021 across all aspects of our business, including our programs, our human capital, and our financial strategy. We announced positive top-line data from our first clinical trial, in the process demonstrating clinical proof of concept for our platform and approach. We nominated our second clinical candidate for clinical development. We continued to develop our MITO Plus platform, and we added key members to the board and leadership team, which strengthened our ability to execute. I'd like to highlight two of those recent appointments, Dr. Kent Greinstaff in the newly created role of Senior Vice President of Research, where he is responsible for overseeing our discovery and preclinical activities, and Dr. Nick Vlahakis as Acting Chief Medical Officer. Kent is a molecular cell biologist and biochemist with extensive experience in drug discovery at several companies in the Bay Area, including COBAR, where he previously served as VP of Biology for six years. As a result, he brings considerable institutional knowledge and familiarity with our MITRE Plus technology platform, which has enabled him to hit the ground running in his new role. Part of the rationale for bringing Kent back to the COBAR family is to increase our discovery activities, which we will discuss in more detail in a few moments. Nick is an accomplished pulmonary and critical care physician who did his training and then served on the faculty at the Mayo Clinic in Minnesota. He subsequently moved into industry and has extensive experience in all phases of clinical development, from first in human trials through phase four studies. Nick has also worked across a wide range of therapeutic areas, from hematology to dermatology to respiratory. Notably, the latter also includes work in idiopathic pulmonary fibrosis, the initial indication we are pursuing for our CB5138-3 program. While Nick has worked at industry leaders such as Genentech, he also has experience at smaller companies like Cobar. Finally, he has expertise in biomarker discovery and the strategy for using biomarkers as clinical predictive or prognostic markers. Given his wealth of experience, we are thrilled to have him as part of the Cobar team. In addition to adding Kent and Nick to the COBAR team, in our press release today, we made several important announcements about the direction and focus for the company in 2022 and beyond. During our remarks today, our goal is to walk you through the thinking and implications of these announcements. I believe that COBAR is beginning 2022 from a position of strength. This will be an important year of execution for us, and we have been working hard to align our development strategy with our resources and the commercial competitiveness of our pipeline. To that end, we have decided to focus on several key areas. We are prioritizing the advancement of our IPF program, CB5138-3, toward the clinic, and we'll be providing some important updates on this program later in the call. We are investing in our novel platform to identify potential new product candidates with compelling scientific advantages. And as part of that process, we have decided to deprioritize our oncology programs. Finally, with clinical proof of concept demonstrated in our CB4211 program, our plan is for the future clinical development of this program to take place in the context of a partnership. Now I'd like to provide some more detail on one of our primary focus areas for 2022. advancing CB5138-3 towards the clinic for IPF, an orphan disease that results in increasing fibrosis or scarring of the lungs and that continues to have a high unmet medical need for new effective therapies. The two FDA-approved drugs to treat IPF have modest clinical effects on the disease and are limited by significant tolerability issues, including gastrointestinal side effects and, in the case of profenadone, photosensitivity issues. Although current standard of care can slow the rate of loss of lung function, it is not improved or stabilized. And patients continue to have high mortality rates and a poor quality of life, with life-altering symptoms. Despite these drawbacks, the currently marketed drugs have done well commercially, with annual sales exceeding $1 billion for profenadone and approximately $3 billion for nintenadib. We think IPF is a significant opportunity where CB5138-3 could make a real difference for patients. The IND-enabling studies for this program continue to progress. The purpose of these studies is to ensure that CB5138-3 can be reliably manufactured and to demonstrate safety in animal models prior to subcutaneous dosing in humans. We have successfully scaled the manufacturing necessary to support the initial clinical study. In terms of safety, We have not seen any notable systemic toxicity to date in our ongoing rodent or non-human primate studies. These results substantially de-risk the program. At the higher dose levels in our monkey studies, we have seen some local skin reactions, which is not uncommon in the early stages of development of peptide therapeutics. For example, injection site reactions were seen in the initial development of many GLP-1 agonists. Additional formulation work enabled this class of peptide therapeutics to become a cornerstone in the treatment of type 2 diabetes, generating sales of approximately $13 billion in 2020. While we have identified several formulations of CB5138-3 with encouraging solubility and stability, after extensive consultations between our team and our expert formulation and toxicology advisors, we have decided that further formulation work is required prior to filing our IND. We believe improved formulations will enable us to not only decrease the risk of local skin reactions in humans, but could also increase the systemic exposure of CB5138-3, which has the potential to translate to better efficacy in IPF patients. Although we are still finalizing the exact implications for our timelines, we now expect to file the IND in the second half of 2023, with our initial human study to start shortly thereafter. This timing was impacted by several important factors, including the additional formulation work, as well as delays in working with our CRO in China related to increased shipment times and the recent disruptions from the spread of COVID-19 in Asia. While we are disappointed in this delay, we believe that taking the time upfront to further improve the formulation mitigates risk and is likely to save us time and money in the long run through reducing the risk of skin reactions, and enabling a broader range of doses in humans, which taken together increases the likelihood of a successful Phase I study and has the potential to enable higher dosing in our subsequent studies in IPF patients. In addition to these activities, our R&D team is working diligently to identify potential biomarkers associated with CB51-38-3 treatment and to further elucidate its molecular target. Nick will discuss the importance of this ongoing work and its implications for our clinical development plan for CB5138-3 in a few minutes. Another area of focus for us is securing a partnership to enable further development of CB4211. In 2021, we recognized a critical milestone in the company's history, the positive top-line data from our first clinical study. With the Phase 1A-1B trial of CB4211, which is under development for the treatment of NASH and obesity, we demonstrated clinical proof of concept, not just for this program, but also for the broader proposition that novel analogs of mitochondrial peptides can have important systemic effects in humans. As you recall, in the 1B portion of the trial, which involved obese subjects with non-alcoholic fatty liver disease, treatment with CB4211 resulted in robust and significant decreases in markers of liver inflammation. which suggests an improvement in liver health compared to placebo, as well as significant reductions in glucose levels, indicating an improvement in metabolic homeostasis. Beyond these exciting efficacy signals, the study met its primary safety endpoint. The clean systemic safety profile of CB4211 validated our hypothesis that analogs of naturally occurring mitochondrial peptides will have fewer off-target effects than drug candidates developed from non-natural sources. And as I mentioned earlier, our work to date in CB5138-3 provides further support for this proposition. This not only decreases the development risk of our product candidates, but also provides the potential for important clinical and commercial advantages. We firmly believe in the potential of CB4211 and are working to secure a partnership to support additional development of this program. Turning towards the remainder of our pipeline, I'm excited to report that we are increasing investment in our MitoPlus platform to identify additional peptide families with significant potential to result in valuable new treatment options for physicians and dramatically improve the lives of patients. In fact, we believe we have only begun to scratch the surface of the potential of our peptide library, and we expect that this additional investment in our discovery efforts will pay dividends in the future. leading to the identification of additional indications where our peptides can bring substantial advantages. Due to this realignment in our strategy, we have decided to pause further investment in our oncology programs. While we continue to believe in the potential of these novel analogs, oncology is a particularly competitive space with multiple approved drugs and a crowded development pipeline. As part of this effort, We are also evaluating where our CB5064 analogs fit into our future development plans. In all cases, our focus is on moving forward those programs with the highest scientific and commercial promise. We look forward to providing updates on our discovery work on future calls. It is my pleasure to now introduce Dr. Nick Vlahakis, our Acting Chief Medical Officer, who will review our current thinking about the clinical development plan for our IPF program in more detail. Nick?