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spk05: 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.
spk03: 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.
spk06: 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?
spk07: Thank you, Joe. As Joe mentioned, this quarter we continue to make progress on our preclinical development for CB5138-3, focusing on formulation work and elucidating its molecular target. As we have previously discussed, our initial formulation work focused on enhancing our understanding of the key physical properties of the peptide. This led to the selection of interim formulations with favorable in vitro profiles for further in vivo assessment. Based on in vitro analysis, we identified several interim formulations that support solubility of CB5138-3 at projected clinically relevant doses, provided favorable extended stability profiles, and exhibited reduced aggregation compared to the formulation we used in our prior toxicology studies. We've since tested these formulations in vivo and disappointingly discovered that there was significant deposition of the peptide at the injection site due to persistent aggregation or gelling with these interim formulations. As Joe mentioned, formulation development is an iterative process, often requiring multiple rounds of in vitro and in vivo work to identify compositions that are both compatible with the physical properties of the drug substance and the route of administration. To this end, we've recently completed the in vitro phase of new formulation work for CV5138-3. The in vitro profiles for these most recent formulations show a reduced propensity for aggregation following physiological stress. We are now preparing to test these formulations in animals with the objective of identifying a formulation with performance characteristics that support a clinically relevant range of doses for our IPF program. We expect to have clarity in the near term regarding whether our novel formulations have sufficiently de-risked the injection site reactions to enable submission of the IMD in the second half of 2023 as planned. On the discovery side, we're continuing to evaluate CB5138-3's mechanism of action, including further clarifying the relevant molecular pathways. In an effort to identify direct target engagement, We're in the process of completing a broad cell surface receptor screen with CB5138-3 and expect to have preliminary data in the near future. Now I'll turn the call over to Jeff to discuss our Q3 financial performance.
spk02: Jeff? Thank you, Kent. We ended Q3 2022 with $18.3 million in cash and investments at a quarterly burn rate of approximately $1.9 million, and we have no debt. Research and development expenses were $1 million in Q3 2022, compared to $1.6 million in the prior year period, a decrease of approximately $600,000. The decrease in research and development expenses was primarily due to the timing of the expenses incurred for our research programs. General administrative expenses were $1.4 million in Q3 2022, compared to $1.8 million in the prior year period. a decrease that was primarily due to lower stock-based compensation costs. For the quarter ended September 30, 2022, COBAR reported a net loss of $2.4 million, or $0.82 per basic and diluted share on a post-split basis, compared to a net loss for the quarter ended September 30, 2021 of $3.4 million, or $1.61 per basic and diluted share on a post-split basis. That loss included non-cash expenses of approximately $400,000 for the quarter ended September 30, 2022, and approximately $700,000 for the quarter ended September 30, 2021. Overall, we are pleased with our financial performance, and we estimate that we have sufficient capital to finance our operations through the fourth quarter of 2023. I'll now turn things back over to Joe. Joe?
spk06: Thanks, Jeff. This past year has been a challenging one for COBAR, especially given the turbulence in the capital markets, which has had a disproportionate impact on microcap biotech companies. I'm pleased with the way our team has remained focused on continuing to advance our programs and our science. And we continue to believe in the power of the mitochondrial genome to deliver therapeutics to address underserved conditions that represent significant market opportunities, such as IPF and NASH. Throughout this year, we have made progress on advancing CB5138-3 towards IND filing, as well as refining our clinical development program for this product candidate. At the same time, as Jeff highlighted, we continue to be prudent financially, closely monitoring our cash spend, while prioritizing activities that are expected to de-risk key aspects of our IPF program, such as enhancing our understanding of target engagement and developing improved formulations to mitigate against injection site reactions and improve drug exposure. After many months of effort, we now expect data on both of those fronts in the near future, and we look forward to updating you on the outcome of those studies in subsequent calls. Operator, can you now please open the line for questions?
spk05: Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2.
spk01: At this time, we will pause momentarily to assemble our roster. And our first question will come from Kemp Dolliver with Brookline Capital Markets.
spk05: Please go ahead.
spk04: Great. Thank you. First, apologies for the voice. So I have two questions. First, you mentioned you will have data available in the near future. Can you put more specificity on that? Is it possible we will see this data by year end or sometime in 23?
spk06: Hi, Kemp. Thanks for the question. Yeah, you know, it's difficult to say the exact timing of data because certain things are dependent upon you know our contract research partners so we're you know hoping to have that data by year end but not not 100 sure when the timing of that will be okay very good thank you second question is you know given that you're in the midst of an inner process in
spk04: getting the formulation and the target engagement questions answered, how many times can you iterate and still stay on track to file in your IND in the second half of next year? Yeah.
spk06: So the answer to that really depends on, you know, sort of what the data we get back next. Our hope is that we think we've, based on the recent in vitro data that Kent was describing, that these, you know, newest formulations will meet our final performance targets. And as I mentioned, assuming that they do, then we're on track. If further work is required, it really is going to depend on what does that data show us. you know, what is the performance that we're seeing and sort of how do we then figure out where we go from there. And so whether that, you know, further work required there would have an impact on the timelines really will depend on what does the data show and how close or far are we from where we feel like we need to be. And so it's a difficult to answer without actually seeing the data first. And sort of what the data shows will sort of lead us to the subsequent answer on next steps and possible impacts on timing.
spk04: Okay. Fair enough. Thank you. That's all my questions.
spk06: Sure. Thank you.
spk05: This concludes our question and answer session. I would like to turn the conference back over to Joe Surratt, CEO, for any closing remarks.
spk06: Thank you, everyone, for joining us this afternoon. I would like to thank our shareholders for their continued support, and we look forward to keeping you updated on our future progress. Matt, would you please conclude the conference call?
spk05: Thank you. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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