CohBar, Inc. (NASDAQ:CWBR) Q4 2021 Earnings Conference Call March 29, 2022 5:00 PM ET
Company Participants
Jordyn Tarazi – Director of IR
Joe Sarret – CEO and Director
Nick Vlahakis – Chief Medical Officer
Jeff Biunno – CFO
Kent Grindstaff – SVP, Research
Conference Call Participants
Kristen Kluska – Cantor Fitzgerald
Kumar Raja – Brookline Capital Markets
Operator
Good afternoon. My name is Kyle. And will be your conference operator today. At this time, I’d like to welcome everyone to CohBar’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. [Operator Instructions] Please note this conference is being recorded.
Now I’d like to turn the call over to Jordyn Tarazi, Director of Investor Relations at CohBar.
Jordyn Tarazi
Thank you, Kyle. And thank you, everyone, for joining CohBar’s fourth quarter and full year 2021 financial results Conference Call. Joining me on today’s call is Joe Sarret CohBar’s Chief Executive Officer; and Jeff Biunno, CohBar’s Chief Financial Officer. I would also like to take this opportunity to welcome Dr. Nick Vlahakis, CohBar’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 Grindstaff, SVP of Research, will also join us.
CohBar’s financial results press release was issued earlier today and may be downloaded from our website at cohbar.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+ platform, statements regarding ongoing and planned research and development activities, including planned clinical trials, regulatory 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 CohBar. 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 cohbar.com, fcc.gov and sedar.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. CohBar 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 Sarret, CohBar’s Chief Executive Officer. Joe?
Joe Sarret
Thank you, Jordyn. And thank you, everyone, for joining us this afternoon. This past year has been an eventful one for CohBar. 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 continue to develop our Mito+ platform, and we added key members to the Board and leadership team, which strengthen our ability to execute.
I’d like to highlight two of those recent appointments, Dr. Kent Grindstaff, in a 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 biochemists with extensive experience in drug discovery at several companies in the Bay Area, including CohBar, where he previously served as VP of Biology for 6 years. As a result, he brings considerable institutional knowledge and familiarity with our Mito+ 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 CohBar 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 4 studies. Nick has also worked across a wide range of therapeutic areas from hematology to dermatology, 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 CohBar. 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 CohBar team.
In addition to adding Kent and Nick to the CohBar 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 CohBar is beginning 2022 from a position of strength. This will be a 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 pirfenidone, photosensitivity issues.
Although current standard of care can slow the rate of loss of lung function, it has 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 pirfenidone and approximately $3 billion for Nintedanib.
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 nonhuman primate studies. These results substantially derisked 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 stage 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 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 advisers, 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. We are still finalizing the exact implications for our time lines. 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 1 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 CB5138-3 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 to carrying 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 involves 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 motochondrial 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 risk — 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 Mito+ 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?
Nick Vlahakis
Thanks, Joe, and good afternoon, everyone. I’m very excited to be joining the CohBar team and help with realizing the therapeutic promise of this portfolio of novel mitochondrial peptides. Our growing understanding of the role of mitochondria has clearly shown, it’s not just the engine of the cell, but also plays important roles in critical biologic disease pathways such as fibrosis.
As Joe mentioned, I’m a pulmonologist. And over the years, have taken care of many people with lung fibrosis, both in the clinic and intensive care unit. And I’m intimately familiar with the devastating burden of disease and unmet need for these patients.
I’m looking forward to helping move CB5138-3 into human studies, molecule that has the potential to provide a novel and effective class of therapeutics to IPF patients who still need new medicines that will improve their lung function, prolong their lives and improve their quality of life.
As a reminder, CB5138-3 is a member of the family of peptides, that have shown broad antifibrotic properties in multiple in vitro and in vivo models of IPF. Based on studies conducted in cultured human lung cells these peptides appear to work by reducing the production of key proteins involved in fibrosis and by inhibiting the pathological fibrotic process of cell transformation from healthy lung cells to fibrotic cells.
Additionally, in a therapeutic mouse model of IPF, we showed that treatment of animals beginning one week after the induction of fibrosis with bleomycin had positive effects on all study outcomes, reducing the level of lung fibrosis measured by the Ashcroft score and lung weight as well as the levels of collagen secretion and deposition.
CB5138-3 also has the potential for an improved safety and tolerability profile, which could provide important clinical and commercial advantages over current standard of care. The antifibrotic effects of CB5138-3 in the rodent bleomycin model of lung fibrosis is highly encouraging and provides us a strong rationale to move forward with human studies in patients with IPF and potentially expanding from this initial opportunity into other fibrotic conditions.
To build effectively on these encouraging in vivo findings and to optimize the probability of success for our first in IPF patient study, near term development of CB5138-3 will focus on expanding our core understanding of the molecule and its effects in two key strategic areas. First, through Kent and his team’s ongoing efforts we will further refine the depth and fidelity of our molecular understanding of CB5138-3s, relevant biologic effects, which in turn, we expect will support the additional build-out of our biomarker and pharmacodynamic approach in the clinic for the IPF studies.
Second, we plan to clearly define CB5138-3s, safety, tolerability and pharmacokinetic properties in initial human studies across a broad range of dose exposures. This will enable a well-informed approach to dose-ranging in IPF patients.
We believe the learnings from these two strategic areas of drug development are foundational for effective study design for our IPF program and will optimize the balance of probability of success against resource and time considerations.
To most effectively and efficiently achieve this, following the submission and clearance of our IND clinical development of CB5138-3 will begin with a Phase 1 single ascending dose and multiple ascending dose study in healthy volunteers at a Phase 1 clinical research unit. We plan to quickly follow this study with a multicenter Phase 2 study in IPF patients.
While CohBar had previously discussed conducting a planned Phase 1/2a study under a single study protocol, we believe our current approach carries a number of advantages. From an operational perspective, having two separate protocols is a more efficient way to move forward without significantly impacting the overall development time line.
By utilizing a dedicated Phase 1 clinical unit we expect that recruitment of this Phase I study will be accelerated and enable the intensive monitoring required to generate the necessary PK, safety and tolerability data from this study.
In addition, this approach also affords us optionality for the Phase 2 study and decouple it from the IND filing. By separating the Phase 1 and Phase 2 studies, the design of our first study in IPF patients can be optimized on the foundation of accumulating CB5138-3 clinical and biologic data and ongoing input from our close collaboration with leaders in the fields of IPF biology and clinical trial design.
Altogether, this will help inform key designments of the Phase 2 trial such as study duration, dose levels and the most appropriate proof-of-concept endpoints beyond safety, tolerability and PK.
Overall, we believe this approach increases the chances of a successful and data rich Phase 2 IPF study. And as I mentioned earlier, is not expected to result in an impactful delay to study initiation. We are continuing to work closely with pulmonary leaders in the field of IPF as we build toward our Phase 1 study in healthy volunteers and our Phase 2 in IPS. As Joe stated, the Phase I study will start shortly after our IND filing.
And with that, I’ll return the call to Joe. Joe?
Joe Sarret
Thanks, Nick. I’d now like to ask our CFO, Jeff Biunno, to walk you through our fourth quarter financial performance. Jeff?
Jeff Biunno
Thank you, Joe. And thank you, everyone, for joining us this afternoon. Total operating expenses in Q4 2021 were $2.8 million as compared to $4.4 million in Q4 2020, which is a decrease of approximately $1.6 million. Research and development expenses, which included a vendor credit of approximately $173,000, were $800,000 in Q4 2021 compared to $2.7 million in the prior year period, a decrease of approximately $1.9 million. The decrease in research and development expenses was primarily due to lower clinical trial and preclinical costs due to the timing of those expenses.
In terms of G&A, our general and administrative expenses were $2 million in Q4 2021 compared to $1.7 million in the prior year period. An increase though was primarily due to higher stock-based compensation costs.
For the quarter ended December 31, 2021, CohBar reported a net loss of $2.8 million or $0.04 per basic and diluted share compared to a net loss for the quarter ended December 31, 2020, of $4.7 million or $0.08 per basic and diluted share. Net loss included non-cash expenses of approximately $600,000 for the quarter ended December 31, 2021, and $600,000 for the quarter ended December 31, 2020. Excluding the non-cash expenses, CohBar’s net loss was $2.2 million for the quarter ended December 31, 2021, as compared to $4.1 million for the prior year period.
As we begin 2022, we’re in a solid financial position with $26.2 million in cash and investments as of December 31, 2021. As previously announced in the fourth quarter of 2021, we executed on an equity financing amidst a difficult market backdrop in biotechnology, bringing in gross proceeds to the company of $15 million. Subsequent to the quarter end, we repaid the last remaining promissory note, totaling approximately $500,000 in principal and interest. As a result, we currently have no outstanding debt.
The cash burn for the quarter ended December 31, 2021, was approximately $3 million. We continue to estimate that we have sufficient capital to finance our operations into the second half 2023.
And now I’ll turn things back over to Joe. Joe?
Joe Sarret
Thanks, Jeff. Before we take your questions, I’d like to reiterate our key focus areas for 2022. First, we are continuing to complete the necessary studies to enable us to file our IND for CB5138-3, while also proactively exploring formulation improvements to increase our probability of success as we move into the clinic.
We now expect to file our IND for this program in the second half of 2023, with our first-in-human study to shortly follow that filing. In parallel, Kent and his team are working to further define the mechanism of action of this peptide analog and to identify relevant biomarkers that could be useful as exploratory endpoints in the subsequent Phase 2 study.
We are also increasing our efforts to further characterize our extensive library of peptides derived from the mitochondrial genome, to identify those peptide families that show the most promise for the development.
In addition to the scientific data, we will be conducting a thorough commercial analysis to identify opportunities where our peptides can provide meaningful value to patients and physicians. Finally, we are seeking potential partners for CB4211, since we believe that is the best way to move this asset forward.
In summary, 2021 was an important year for CohBar. We gained additional confidence in our Mito+ platform to clinical proof of concept CB4211 and the strong preclinical antifibrosis data for CB5138-3, while also making significant improvements to our team. I’d like to take the opportunity to thank our company’s founders Dr. Cohen, Barzilai and Amatruda, who have transitioned from our Board of Directors to our Scientific Advisory Board where we continue to access their guidance and expertise.
Looking ahead, we are extremely optimistic about the future. And we are focused on execution in 2022 to achieve our goals and continue to advance our programs.
I would like to thank our shareholders for their continued support, which is an essential component of both our prior and future successes.
Kyle, can you please open the line for questions?
Question-and-Answer Session
Operator
At this time, we’ll be conducting a question-and-answer session. [Operator Instructions] Our first question is from Kristen Kluska with Cantor Fitzgerald. Please proceed with your question.
Kristen Kluska
Hi, good afternoon, everybody. Thanks for taking my questions. First one that I had for you is what do you think is pharma’s broad view on the NASH space right now, considering you’re looking to secure partner here for CB4211? Specifically, what do you think that these larger companies are looking for in a drug as well as understanding around the regulatory space?
Joe Sarret
Yeah. Thanks, Kristen. I appreciate the question. So obviously, there’s been a lot of companies that have been focused on the NASH space for development of new assets, given a very large market opportunity that, that represents. And we’ve been out talking to the usual suspects in terms of the types of companies that are interested in continuing to pursue NASH.
And I think that the pharma companies broadly — it’s hard to generalize because I think each company takes a slightly different view deeding on how they view, one, the NASH opportunity; and two, how well that either fits or doesn’t fit with their broader strategic objectives and sort of the rest of their pipeline and portfolio.
So there’s some companies, I think, that are taking a wait-and-see approach to see what happens. But there are also definitely a significant number of the companies that are continuing to evaluate the space that they believe it’s a very large opportunity, and they want to make sure that they have a seat at the table and a way to participate in that potential opportunity.
And so they’re looking at a variety of different factors, including the stage of development, what’s your mechanism of action, how that either is synergistic with or different than what other companies are doing. They certainly want to look at the safety profile given some of the sort of later-stage issues there. So I think it’s a complex assessment that they are undertaking. But I think we’ve been encouraged that the companies are continuing to evaluate NASH assets. And we’ve been — like I said, been in discussions with lots of them.
So in terms of the regulatory path, I think that there is some ongoing sort of tension, I guess, between sort of the way the regulators in — at least in the U.S. and Europe are looking at. Approval and endpoints, and that does create some additional complexity in terms of thinking about sort of global — commercializing a product on a global basis. But I think, yeah, this is the first time that’s happened, and I think big pharma is used to those kinds of challenges and working through them.
Kristen Kluska
Okay. Thanks. And then part of your prepared remarks highlighted plans to develop additional novel peptide families with the Mito+ platform and then also to deprioritize some of the earlier work in oncology. So maybe I could ask broadly which therapeutic areas you’re considering giving some of the preclinical work that you’ve conducted here is really focused on metabolic effects across a number of signaling pathways that might be relevant for all different types of conditions, frankly.
Joe Sarret
Yeah. Great question. I appreciate that. I might use opportunity to let Dr. Kent Grindstaff, speak to that since he’s leading that charge.
Kent Grindstaff
Yeah. Thank you, Joe. Thank you, Kristen for the question. Obviously, you touched on the point where we feel we’ve established significant expertise around metabolism, fibrosis and inflammation. And obviously, continue to use those formats to interrogate our Mito+ platform. But we’re also exploring undisclosed disease areas at this time. And as we gain information or we gain additional data along these lines to provide updates.
But the goal for research continues to be to identify novel peptide with potentially novel MOAs. And we feel this establishes a strong scientific rationale for the utility of these peptides to treat specific diseases as well as providing the scientific justification for advancing new programs into development with the hope then that we’ll further diversify our pipeline to address a wide range indications.
And we’re very encouraged by the continued publications in the field, the growing body of evidence in the literature on MDPs. And we feel this provides further proof of concept, both physiological importance as well as the potential utility of the use of these peptides as therapeutics.
So again, we’re leveraging the expertise that we have before also developing additional formats in order to interrogate and we’ll provide updates as that work progresses. Does that answer your question?
Kristen Kluska
Yes, it does. And maybe the last one I have kind of goes off of this a little bit. And maybe it’s a more longer-term question for the company. But you talk about diversifying the assets and the indications you’re going after. But how should we also be thinking about potential synergies within one asset? So for example, 5138, the preclinical effects that you saw across a number of pro-inflammatory cytokines, do you think something like this could also have effect elsewhere? Or are you really just kind of looking to diversify all the assets collectively in unique indications? Thanks again.
Joe Sarret
Sure. Thanks, Kristen and that’s a great question as well. So the way that we’re thinking about it, we have discussed in the past, we’ve been very impressed by the broad antifibrotic and anti-inflammatory effects that we see with the 5138 family of peptides. And so while our initial indication with 5138-3 is IPF, as we’ve discussed, we have also been in parallel looking at other antifibrotic models to look for further potential indications for that peptide.
And so the work that we’re doing now in terms of all the IND-enabling work and getting into the clinic and establishing sort of all the important parameters that Nick discussed around the Phase 1 study would be informative and helpful, not just for IPF, but could also then provide a solid foundation for them moving into additional indications for that particular peptide.
And so when we’re looking — and we fund these peptide families that have these broad sorts of features. We do — currently do and we plan to continue in the future for additional peptide families, look at potential synergies and other add-on indications, and that’s certainly been our plan with 5138 is to start with IPF and then look at potential indications beyond that.
Kristen Kluska
Thank you.
Joe Sarret
Thank you.
Operator
Our next question is from Kumar Raja with Brookline Capital Markets. Please proceed with your question.
Kumar Raja
Thanks for taking my questions. With regard to the formulation improvement work, is it more related to like inhalation or nanoparticle based? Or what kind of additional work is being done in that front?
Joe Sarret
Thanks, Kumar. So what we’re really doing here, as we mentioned in the prepared remarks, we’re seeing some local skin reactions, which is not an uncommon feature in peptide therapeutics. But our work on the formulation here is really about improving the formulation in a way that would allow us to continue with subcutaneous dosing. So our plan here is to still deliver the peptide subcutaneously, which we think makes the sense for this particular peptide.
And Nick, maybe if there’s more, maybe you want to comment on our thinking there.
Nick Vlahakis
Yeah, I think that’s right, Joe, regarding the subcutaneous. The ultimate goal, as I had mentioned earlier, was that the perfect setup for our IPF program is to be able to have a broad dose-ranging approach in the Phase 1. And so we really would like to have the formulation optimized to have this broader range of dosing as we can manage in the Phase 1 characterize our PK very carefully and the safety so that in the Phase 2 IPF study, we’re able to likewise, those broadly and give ourselves every opportunity to show the changes in lung function and outcomes that we’re hoping for.
Kumar Raja
Okay. And you guys mentioned that you’ve already scaled manufacturing that product could be used for the store [ph] formulation?
Joe Sarret
That’s correct. Yeah, we’ve already done some scale-up work, and we’re planning to use that. That’s all GMP material that we can then use in subsequent studies. So we’re confident on the manufacturing process.
Kumar Raja
Okay. And you also talked about further evaluation of mechanism of actions and what would that involve? And any thoughts on that? Thank you.
Joe Sarret
Sure. So I think I’ll ask maybe Ken to talk about a little bit about what we’re doing. And then, Nick, maybe if you want to follow that up with sort of how MOA is relevant for IPF. But Ken, do you want to start there?
Kent Grindstaff
Yeah, that would be great. Thanks, Joe. Thanks, Kumar, for the question. As we touched on, obviously, we’ve got some impressive data involvement both in fibrosis readouts as well as anti-inflammatory aspects for the 5138-3. Our focus really is — has been ongoing right now to develop both in vitro and in vivo models that we feel are translatable that we can use to really interrogate both the fibrotic aspects as well as the inflammatory aspects. The latter focusing on things like cytokines and chemokines.
And looking at readout for activity, where we announced effects of the 5138-3. So these are kind of the classic type of models. I’m sure you’re familiar with, Kumar, that we’ll continue to interrogate and look for positive activities there that we can not only expand, as Nick mentioned, our [indiscernible] and hopefully potential demarkers that we’ll be able to use in our Phase 2 clinical studies, but also to use those to walk backwards and cover our molecular interactions that occur in vitro systems and hopefully identify a stable MOA for this class of peptides.
Nick Vlahakis
Thanks Kent. And maybe just to build on a couple of points that you made. I think a couple of things. As Kent and I worked closely together to think through markers that would be relevant for IPF and talking with a number of the field leaders in the biomarker world.
It’s clear that there are a couple of approaches to take both looking at biomarkers as an indicator of PD, or pharmacodynamic effect, both generally as it relates to fibrosis in the lung, but also specific mechanism-related biomarkers. And that’s where a lot of the focus will be.
I think it’s also really important to understand that the program is not going to be dependent on absolutely nailing down these MOA and PD markers. I think there’s a lot of examples, not least of which within IPF, where moving drugs forward based on in vivo findings and high-level effects that we know occur with the molecule can still lead to success. And both pirfenidone and nintedanib are good examples of that, that have been effective.
There’s still room to move and improve on those. But the clarity around the MOA and pharmacodynamic markers in those molecules were not clear. So we feel generally that the forward momentum for the clinical program is in good shape. There’s work to be done, and we think we can really build with Kent to put together a good program. But it certainly is not a prerequisite to get into the clinic and ultimately IPF.
Kumar Raja
Great. Thank you so much.
Joe Sarret
Thanks, Kumar.
Operator
We have reached the end of the question-and-answer session. And I will now turn the call over to Joe Sarret for closing remarks.
Joe Sarret
Well, thank you, everyone, for joining us this afternoon. We look forward to updating you on our continued progress throughout the year. Kyle, would you please conclude the conference call?
Operator
This concludes today’s conference. And you may disconnect your lines at this time. Thank you for your participation.
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