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CohBar, Inc.
8/16/2022
Good afternoon. My name is Ryan, and I will be your conference operator for today. At this time, I would like to welcome everyone to COBAR's second quarter 2022 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. As a reminder, this conference is being recorded. Now, I would like to turn the call over to Ms. Jordan Tarazi, Director of Investor Relations at Cobar. Please go ahead.
Thank you, Ryan, and thank you, everyone, for joining Cobar's second quarter 2022 financial results conference call. Joining me on today's call is Dr. Joe Surrett, Cobar's Chief Executive Officer, Jeff Beuno, Cobar's Chief Financial Officer, Dr. Nick Vlahakis, COBAR's Acting Chief Medical Officer, and Dr. Kent Greinstaff, Senior Vice President of Research. Following our collective remarks, we will conclude with Q&A. 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 calls 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. 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, COBRA'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, Kent will review our ongoing preclinical activities for CB5138-3, our novel peptide for the treatment of idiopathic pulmonary fibrosis, or IPF, as well as our ongoing discovery efforts. Nick will then provide some additional context about the approach to our initial clinical trials, for our IPF program, and Jeff will review our Q2 2022 financials. Cobar is a leader in harnessing the power of the mitochondrial genome to develop a novel class of peptide therapeutics. While people tend to think of mitochondria primarily in terms of energy production, in fact, they also play an important role in the regulation of a variety of biological pathways. This regulation is partially mediated through the systemic effects of certain peptides encoded in the mitochondrial genome. that are secreted and have distal effects on other cells, tissues, or organs. We believe that tapping into the intrinsic activities of these mitochondrial peptides has the potential to lead to powerful new therapies to treat a wide range of conditions. Additionally, by focusing our development on analogs of naturally occurring peptides, we expect our product candidates to have fewer off-target effects, ideally translating to improved safety and tolerability profiles that can provide further benefits to patients and physicians. we have already demonstrated clinical proof of concept for our approach with the release last year of positive top-line data from our first clinical trial. As we have discussed previously, 2022 is a year of execution for the company, and in the second quarter, we made further progress in our key areas of focus. One of our primary objectives for the year is to advance CB51383 towards the clinic, and we remain on track to file our IND for this program in the second half of next year. Our ongoing IND enabling studies continue to show that this peptide is well tolerated, and we have not seen any notable systemic toxicity in animal testing. We've also made significant progress in developing improved formulations for CB5138-3, and Kent and the team have identified some promising new approaches that we hope may provide further clarity on target engagement for this peptide, which, while not essential for moving the program forward, may help inform biomarker selection for our clinical studies. Based on the significant antifibrotic effects of CB5138-3 in preclinical animal models of IPF, we believe this product candidate has the potential to offer significant value to patients. While current standard of care can slow the rate of loss of lung function, there continues to be significant unmet medical need in this patient population. IPF remains a devastating disease with substantial morbidity. Patients experience chronic and increasing shortness of breath, frequently requiring supplemental oxygen, and quality of life is poor. Mortality rates also remain unacceptably high. Additionally, the available therapeutics are not well tolerated due to frequent gastrointestinal side effects and, in the case of prophenidone, photosensitivity issues. In fact, in our discussion with pulmonologists, a common theme is that tolerability issues have a significant impact on their ability to effectively treat this patient population. Despite the limitations of the available IPF therapies, both FDA-approved drugs have done well commercially, with combined annual sales in 2021 exceeding $3.5 billion. While the broader capital markets for biotech remain challenging, recent activity shows that positive clinical data in IPF, even relatively early Phase II data, has translated into substantial enthusiasm from investors. Additionally, Multiple big pharma companies have prioritized fibrosis generally, and IPF specifically, as an area of focus, reinforcing our view that IPF and the broader fibrosis and inflammation market are attractive commercial opportunities for COBAR. Looking beyond our IPF program, we continue to seek to advance the development of CB4211 through a potential partnership. I will now turn things over to Kent Greinstaff, our Senior Vice President of Research, to provide some additional color on our preclinical and discovery activities. Kent?
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