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CohBar, Inc.
11/8/2022
good afternoon my name is matt and i will be your conference operator for today at this time i would like to welcome everyone to cobar's third quarter 2022 financial results conference call all lines have been placed on mute to eliminate background noise should you need assistance please signal 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 a touch tone phone to withdraw your question please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Jordan Tarazi, Director of Investor Relations at COBAR. Please go ahead.
Thank you, Operator, and thank you, everyone, for joining COBAR's third quarter 2022 financial results conference call. Joining me on today's call is Dr. Joe Surrett, COBAR's Chief Executive Officer, Jeff B. Uno, COBAR's Chief Financial Officer, and Dr. Kent Grindstaff, Senior Vice President of Research. Following our collective remarks, we will conclude with Q&A, at which time Dr. Nick Vlahakis, COBAR's Acting Chief Medical Officer, will also join us. COBAR's financial results press release was issued earlier today and may be downloaded from our website at cobar.com. Before we begin, I'd like to take a moment to remind listeners that except for statements of historical facts, the remarks on today's conference call may include forward-looking statements within the meaning of the securities laws. 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 COBAR. 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, sec.gov, and cdar.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. COBRA 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. On today's call, after my introductory remarks, Ken will comment on our ongoing preclinical activities for our CD51383 program, and Jeff will then review our Q3 financial performance. COBAR's approach to drug development is rooted in the belief that the mitochondrial genome has the potential to serve as a powerful launching point for the development of a novel class of peptide therapeutics. It is increasingly recognized that the mitochondria play an important role in regulating various biological processes well beyond their traditional function as the powerhouse of the cell. Some of these mitochondrial effects are mediated by peptides encoded in the mitochondrial genome, an area that, prior to COBAR, had been largely overlooked. For example, a recent paper co-authored by Dr. Pincus Cohen, one of COBAR's founders, described a novel mitochondrial peptide termed SHMOOS that may play a role in Alzheimer's disease. While research on this new peptide is still in the early stages, advances such as these contribute to the growing body of research that further supports our underlying hypothesis that the mitochondrial genome is a fruitful source for the development of impactful novel therapeutics. We believe that improved versions of many of these native mitochondrial peptides have the potential to treat a wide range of diseases, and as derivatives of natural peptides, may have a better safety and tolerability profile. COBAR has generated promising data from multiple in vitro and preclinical animal models from several different mitochondrial peptide families in diverse areas, including metabolism, fibrosis, and inflammation. Additionally, we demonstrated clinical proof of concept for our approach with positive data from our initial clinical trial of CB4211 last year. We continue to believe the best way to move that program forward is in the context of a partnership. While we have faced many challenges across several areas of our business, I remain pleased with our team's performance and the progress made on our key priorities. our top priority continues to be the advancement of CB51383 towards the clinic. This product candidate is being developed to treat idiopathic pulmonary fibrosis, or ITF, a devastating progressive lung condition that, despite the availability of two FDA-approved therapies, continues to have significant unmet need with substantial and unacceptably high morbidity and mortality. The current therapies are also quite poorly tolerated, for limiting treatment options for patients and physicians. During the past quarter, we've been particularly focused on two key areas for this program, improving the CB5133 formulation and furthering our understanding of the peptide's target engagement. As a reminder, we previously announced that we observed local skin reactions at the higher dose levels in our earlier toxicology studies in monkeys. These reactions were not inflammatory in nature, but rather appeared to be the result of peptide aggregation or gelling upon injection. This phenomenon is not infrequently seen in the early stages of development of peptide therapeutics, and the team has been working to mitigate this issue by improving the formulation. During our last quarterly update, we mentioned that we had identified several promising formulations based on in vitro data and planned to test those in vivo. This is an important step, since enhanced in vitro stability does not always translate to improved in vivo performance. Unfortunately, that turned out to be true in this case. The formulations we had identified continued to demonstrate evidence of peptide aggregation upon in vivo injection. While disappointing, as we have discussed previously, it was always expected that these reformulation activities would be an iterative process. We have since developed additional formulations that look encouraging in vitro and differentiated from the earlier reformulations based on performance in the presence of physiological stress conditions. We are now in the process of testing these newer formulations in animals, and assuming that these formulations meet our in vivo performance targets, we remain on track to file our IND in the second half of 2023. And in terms of progress on the business front, on September 23rd, we completed a one for 30 reverse stock split and subsequently received confirmation from NASDAQ that Cobra has regained compliance with their $1 minimum bid price requirement. By implementing the reverse split, we have maintained our listing on the NASDAQ exchange, which affords us greater access to capital to further fund our pipeline, improve liquidity for shareholders, and an increased chance of attracting high quality institutional investors and commercial partners. I will now turn things over to Kent to provide additional detail on our CB5138-3 activities during the third quarter. Kent?
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