CohBar Inc (CWBR) 2021 Q1 法說會逐字稿

Good afternoon. My name is Hillary, and I will be your conference operator today. At this time, I would like to welcome everyone to CohBar's First Quarter 2021 Financial Results Conference Call. (Operator Instructions)

Now I would like to turn the call over to Jordyn Tarazi, Director of Investor Relations at CohBar.

Thank you, Hillary, and thank you, everyone, for joining CohBar's First Quarter 2021 Financial Results Conference Call. Joining me on today's call is Joe Sarret, CohBar's Chief Executive Officer; Ken Cundy, CohBar's Chief Scientific Officer; and Jeff Biunno, CohBar's Chief Financial Officer.

CohBar's 10-Q filing and financial results press release were issued earlier today and may be downloaded from our website at cohbar.com. This quarter, we will not be hosting a slide presentation.

Joe will begin with a business update followed by an R&D update from Ken. Jeff will then provide an overview of the first quarter financial results.

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, including its lead CB4211 drug candidate program, the therapeutic and commercial potential of the company's pipeline product candidates, including its lead drug candidate CB4211 and other mitochondria-based therapeutics, statements regarding ongoing and planned research and development activities, including ongoing and planned clinical trials and regulatory status and strategies and the timing of announcements and updates relating to our clinical trials and related data. 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, sec.gov and sedar.com as well as in the safe 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?

Thank you, Jordyn, and thank you, everyone, for joining us this afternoon. I'm delighted to be joining you on the first quarterly earnings call since my recent appointment as CEO of the company.

Before I provide an update on the business, I wanted to take a few minutes to introduce myself and tell you about the main reasons I decided to join the CohBar team. Why CohBar, quite simply because I am a firm believer that CohBar's strategy of identifying micropeptides that are encoded in the mitochondrial DNA has the potential to lead to the development of multiple therapeutic products that could revolutionize the way we treat patients.

As you know, drug companies have spent significant time, money and energy mining our nuclear DNA. But until CohBar, the mitochondrial DNA has been largely ignored, primarily since the role of mitochondria was historically believed to be relatively narrow and limited to functions related to energy production.

What CohBar's founders appreciated, and the company is in the process of proving out, is that peptides encoded by mitochondria have important roles to play beyond just ensuring normal mitochondrial function and that those roles extend to many essential processes throughout the body. This is a key and potentially underappreciated point.

Although CohBar is focused on developing peptides that originate in the mitochondria, we are not just targeting mitochondrial disease. Instead, we are focusing on diseases that are impacted by changes in these mitochondrial-derived peptides, many of which may impact aspects of biology with little or no relation to what we have traditionally thought of as mitochondrial function.

I think a useful analogy is insulin, a peptide produced by pancreatic cells. Although this important peptide is produced by the pancreas, we don't typically think of abnormalities in the level of or sensitivity to insulin as primarily a disease of the pancreas. Rather, insulin dysregulation results in a systemic condition that impacts multiple organ systems, even though normal insulin production is a function of the pancreas.

We believe that many other conditions follow the same basic pattern that involve peptides that originate in the mitochondria rather than a particular organ, such as the pancreas. These peptides play significant roles in maintaining normal function imbalance in many critical biological pathways. As a result, changes in the plasma levels of these peptides could lead to or worsen now adopted physiological responses, resulting in or exacerbating certain diseases.

For example, these peptides may impact normal regulatory pathways to restore homeostasis, the goal in our CB4211 program, or they may block overregulated signaling pathways as we are setting in our CXCR4 oncology program. In fact, in many cases, they may work through both mechanisms.

Additionally, studies suggest certain mitochondrial peptides may have the potential to be used as therapeutics to slow or even reverse certain aspects of the aging process. Given the large number of mitochondrial-derived peptides that the CohBar team has identified, over 100, we believe that there are a wide range of diseases across many different therapeutic areas that could potentially benefit from the CohBar approach. Further, by being a first mover in this space, CohBar has been able to carve out an attractive IP position with 12 issued patents and more than 65 patent filings.

Additionally, since CohBar is focused on developing analogs of naturally occurring peptides, we expect that these peptides will have an improved safety profile relative to completely novel drugs, significantly reducing the development risk. It is this remarkable potential to unlock the power of mitochondria-based therapeutics to treat a wide variety of important diseases and possibly to ultimately impact the aging process itself that drew me to the company.

I was also impressed by the quality of the team, from the founders, including Drs. Cohen and Barzilai, whose early insights into the promise of exploring the mitochondrial genome form the basis for the company to the world-class scientists that the company has attracted as advisers. And although I've only been on the ground for a couple of weeks, I've been uniformly impressed by the hard-working and dedicated employees of the company, including Ken, Jeff and Jordyn, who are joining me on the call today.

I also believe that I bring relevant skills and experience that will help CohBar achieve its potential, including a track record of success in leadership roles at both private and public companies. And importantly, I started my career as a practicing physician, focusing on the treatment of HIV and AIDS. Having worked in the clinical setting, I have first-hand familiarity with the decision-making process that physicians undertake when evaluating novel therapeutic agents and whether and how to fit them into their existing treatment paradigms.

I also have extensive experience negotiating complex licensing and partnering arrangements, and a real passion for business development. Additionally, beyond putting the deals in place, I have been responsible for actually implementing and living with those agreements, which is critical in transforming a deal on paper into a long-term productive relationship.

As CohBar's pipeline continues to develop and we evaluate various partnering opportunities, I believe that expertise will help us make sure that we select the right partner or partners and set up any partnership in a way that will align incentives and maximize long-term success.

Finally, I have been involved in raising approximately $250 million in equity issuances while at prior companies, including approximately $65 million in equity investments from strategic partners with the remainder related to financing transactions. That experience will be invaluable as we work to ensure that CohBar is appropriately funded moving forward.

With that background, I'd now like to provide an overview of the key corporate developments during the first quarter. First, and perhaps most importantly, we completed enrollment of the last patient in our ongoing Phase Ib clinical study of CB4211 for NASH and obesity. Additionally, we announced last month that the last subject had completed their final visit. As a result, the study remains on track, and we are planning to release top line data from the trial in early July.

Second, we announced the selection of CB5138-3 as our next clinical candidate for the potential treatment of idiopathic pulmonary fibrosis, or IPF, and other fibrotic diseases. Ken and his team have now initiated the work to conduct the IND-enabling studies for this promising new product candidate.

And finally, we announced an exciting new relationship with the National Institute of Allergy and Infectious Diseases, or NIAID, to evaluate the potential of CB5064 analogs for the treatment of COVID-19-associated acute respiratory distress syndrome, or ARDS. The relationship with NIAID will enable our analogs to be tested in validated preclinical models of ARDS associated with COVID-19.

As I mentioned earlier, a large part of the appeal in my decision to join CohBar related to the promise that mitochondria-based therapeutics could impact a wide range of different therapeutic areas, and a review of our current pipeline confirms this. We have 5 current programs which are targeting multiple disease areas. Since our team has identified over 100 different peptides, in many ways, our current pipeline is just the tip of the iceberg.

Having said that, we are focusing on our efforts on our lead programs in NASH, obesity and fibrosis, and we will confine our further remarks to those programs. I'd now like to turn the call over to our Chief Science Officer, Ken Cundy, to highlight some of the more technical details of these programs, including the ongoing CB4211 trials. Ken?

Thanks, Joe. I'll now give a brief update on our most advanced research and development programs, starting with the 4211 clinical program for NASH and obesity.

We're currently in the final stages of the Phase Ia/Ib clinical study. As a reminder, the Phase Ia part of the study was a single ascending dose, multiple ascending dose study conducted in 65 healthy subjects to define the appropriate dose. The Phase Ib part was then a double-blind, placebo-controlled comparison of active versus placebo in obese subjects with nonalcoholic fatty liver disease, or NAFLD. The Phase Ib used 1 dose level of CB4211 once a day by subcutaneous injection for 4 weeks. This stage of the study targeted a total of 20 subjects.

We enrolled the last subject in the Phase Ib part in March, and last month, we announced that the last subject had also completed their final safety follow-up visit. In total, we enrolled 23 obese NAFLD subjects in the Phase Ib stage. We increased the target enrollment to 23 in order to ensure that we would have 20 subjects with end-of-treatment data replacing 3 that had dropped out before completion of their final MRIs.

The Phase Ib stage of the study is designed to assess the potential effects of CB4211 on liver fat, body weight and a list of biomarkers that are relevant to NASH, obesity and metabolic disease. Changes in liver fat are assessed by MRI-PDFF, which is currently the most predictive noninvasive measure of NASH, and all subjects were required to have a minimum of 10% liver fat at baseline during screening.

Since this is only a short 4-week Ib study and not a pivotal 12- or 16-week Phase II study, this study is not statistically powered and we will instead be looking at the data for possible trends in these various measures of activity. As soon as we completed the last subject safety follow-up visit, the study immediately shifted to the next stage of completing all final data entry and continuing the process of cleaning the data by checking for entry errors and systematically resolving any open queries. When this process is complete, the database will be locked. Then the data will finally be unblinded and the analysis of the data will begin.

We currently expect to release the top line data from the study in early July, subject, of course, to any unexpected delays. As discussed on the last quarterly call, there are multiple possible outcomes for a short-term study of this design. The primary endpoints of the study are the safety and tolerability. The secondary end point will be the pharmacokinetics. But the exploratory endpoints include the changes in liver fat, body weight and biomarkers after 4 weeks of dosing that we'll be analyzing for possible trends.

Moving now to CohBar's second clinical candidate. In March, we announced the selection of CB5138-3 as a potential therapeutic for treatment of IPF and other fibrotic diseases. This novel peptide is a member of a family of peptides that have shown strong antifibrotic and anti-inflammatory 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. We discovered several of these improved analogs that have demonstrated clear antifibrotic and anti-inflammatory effects in vivo in prophylactic or therapeutic animal models of IPF.

In the therapeutic mouse model, we showed that treatment of animals beginning 1 week after induction of fibrosis with bleomycin had positive effects on all study outcomes, reducing the lung fibrosis, the levels of collagen, cytokine secretion and inflammation. A number of these effects were greater than the effects seen on those parameters with nintedanib, one of the 2 approved drugs for IPF.

Following the selection of the new clinical candidate, we immediately initiated IND-enabling activities with the goal of filing an IND and starting a clinical study in 2022. The initial indication will be IPF. But the broad antifibrotic and anti-inflammatory effects of CB5138 analogs also suggest these peptides may have potential for use in treating other fibrotic diseases. We're currently exploring that potential in a number of preclinical models such as NASH, systemic sclerosis and kidney fibrosis.

The next step for CB5138-3 will be to complete all of the necessary IND-enabling activities and the IND submission to FDA that will potentially support a first in human study. And with that, I'll return the call to Joe.

Thanks, Ken. That was a great overview. I'd now like to ask our CEO, Jeff Biunno, to walk you through our financial performance last quarter. Jeff?

Thanks, Joe. I will now provide you with a summary of our financial results for the first quarter ended March 31, 2021, compared to the first quarter ended March 31, 2020. Total operating expenses in Q1 2021 were $4.013 million as compared to $3.281 million in Q1 2020, an increase of approximately $732,000. Operating expenses included noncash expenses of $357,000 for the quarter ended March 31, 2021, and $927,000 for the quarter ended March 31, 2020.

Net of the noncash expenses, total operating expenses in Q1 2021 were $3.656 million as compared to $2.354 million in Q1 2020, an increase of approximately $1.302 million. Noncash operating expenses include stock-based compensation and depreciation and amortization costs. Research and development expenses were $2.655 million in Q1 2021 compared to $1.450 million in the prior year period, an increase of approximately $1.205 million. The increase in research and development expenses was primarily due to the timing of the costs incurred related to our clinical trial and the continuing development of our peptides. Those increases were partially offset by a decrease in stock-based compensation costs.

General and administrative expenses were $1.359 million in Q1 2021 compared to $1.832 million in the prior year period, a decrease of approximately $473,000. The decrease in general and administrative expenses was primarily due to lower stock-based compensation costs in the current year period.

For the quarter ended March 31, 2021, CohBar reported a net loss of $4.038 million or $0.07 per basic and diluted share compared to a net loss for the quarter ended March 31, 2020, of $4.218 million or $0.10 per basic and diluted share. Net loss included noncash expenses of $371,000 for the quarter ended March 31, 2021, and $1.816 million for the quarter ended March 31, 2020. Excluding the noncash expenses, CohBar's net loss was $3.657 million for the quarter ended March 31, 2021, as compared to $2.402 million for the prior year period.

Moving to the balance sheet. As of March 31, 2021, CohBar had $17.8 million in cash and investments compared to $21 million as of December 31, 2020. The cash burn for the quarter ended March 31, 2021, was approximately $4.2 million. During the quarter ended March 31, 2021, CohBar received proceeds of approximately $1 million for option and warrant exercises.

We estimate that based on our cash and investments balance as of March 31, 2021, we have sufficient capital to finance our operations through the first quarter of 2022. I'll now turn things back over to Joe. Joe?

Thanks, Jeff. I'd now like to highlight some key upcoming milestones and events to watch out for during the remainder of 2021. First, as we've mentioned, we expect top line data from our Phase Ib trial of CB4211 in NASH and obesity in early July. Once we've had the opportunity to analyze those data, we will be able to finalize plans for the next phase of development for 4211, including the necessary activities to enable a Phase II study. A key part of that process, assuming positive data, will be to secure additional funding, including through stepping up our partnering efforts.

Second, we will continue our ongoing work to complete the IND-enabling studies for CB5138-3 for idiopathic pulmonary fibrosis. Our goal is to be able to file an IND in 2022, providing us with a second clinical stage program. And finally, assuming adequate funding, by the end of the year, we also plan to select a third clinical candidate to progress towards IND-enabling studies.

As I mentioned throughout my remarks, we believe that CohBar has just scratched the surface of its potential. While we are well on our way to developing a robust pipeline of peptides, our focus now is ensuring that we have the necessary capital to enable continued execution that can turn that tremendous potential into reality. As a result, we continue to evaluate the range of financing options available to us, including nondilutive funding opportunities.

Before opening up to questions, I would like to reiterate how excited I am to be joining CohBar. In my short tenure with the company, I've been extremely impressed by the dedication and commitment of the CohBar team. I would also like to thank our shareholders for their continued support, and I look forward to the opportunity to meet with you over the coming weeks and months.

Operator, can you please open the line for questions?

(Operator Instructions) Our first question is from Kumar Raja of Brookline Capital Markets.

With regard to CB4211, once you have the data in July, What would be the time line to start a Phase II trial? Are you guys thinking about a 12-week or a 16-week trial? And also, are you guys planning to include a GLP-1 agonist combination in the Phase II trial?

Right. I'll take that question. Kumar, good to hear from you. This is Ken. Yes. So our plans obviously depend on the outcome of the Phase Ib study with respect to the results. So we will be looking at those analyzing the trends. Preparation for Phase II will depend on the outcome of that study and on completing other activities required to prep for Phase II. Part of that as well, of course, is securing additional funding, whether that's through partnerships or through another means of fundraising. But our goal would be to complete the prep activities to support a Phase II study to start the Phase II study in 2022.

As far as your second question about design, yes, I think it's likely of the choices between 12 and 16 weeks that a 12-week study would probably be sufficient. But again, we would not settle on that design until we have data. And I've had a chance to discuss that as well with our advisers in designing the next study.

It's very likely, I would say that we would want to include diabetic subjects that are on a GLP-1 agonist in that study as it does take advantage of the known synergy between CB4211 and that class of drugs. But again, that's a design question that will obviously be answered once we have the data and get into that further discussion. I hope that answered your question, Kumar.

Yes. And with regard to IPF, can you directly go to the IPF patients? Or how much of healthy volunteer data would you need before moving to the IPF patients? And how are you guys thinking about dosing there based on the animal models?

Yes, that's a good question, Kumar. So for IPF, there are options here. So again, we're in discussions now with our advisers around the best designs for an early proof of concept. One approach, you may be familiar with some of the other drugs out there in the IPF space, has been to do an adaptive study where you begin in healthy subjects and then move to IPF subjects fairly early on with the intent of demonstrating a change in biomarkers as some proof of activity rather than a longer-term change in lung function.

So those are all factors we're taking into consideration here. We do not yet have a final say on the design for that first clinical study, but it's something we're currently discussing with our advisers.

Our next question is from Jason McCarthy of Maxim Group.

It's Adheip on the line for Jason. And Joe, congratulations on your appointment as Chief Executive Officer. Just wanted to see if you plan expanding any of the clinical trial sites to outside the U.S. or if you have any intention of meeting with ex U.S. regulators?

Yes. With respect to 4211, if that was your question, for the next clinical study, I think we would definitely be considering broadening the locations to do a large enough 12-week study in the setting of NASH. We'll be pushing resources out beyond just the few U.S. sites that we might engage. So I think that is clearly a consideration. But again, we have not decided yet on the clinical study design for Phase II. And so the number of sites would be part of that equation.

Great. And regarding -- this is a little down the time line here. But regarding a future potential Phase II study, could you maybe shed any color on what potential endpoints of those would be, if you have maybe exploratory endpoints that you could briefly go over?

Again, I think it's a little early to give you full details on what the plan is there because we're still developing that. But the obvious inclusions would be at a minimum, what is required by FDA for pivotal studies just because we want to know in a Phase II setting if we are likely to have a predictable outcome as we move into Phase III. So histopathology, biopsy-driven NASH would be a key component.

I think MRI-PDFF is gaining ground as far as its acceptance of being a predictable measure of likely NASH outcome. But as far as the biomarkers, that really will depend on what we see out of the Phase Ib study as to whether we think any of those could also be argued to be predictive. So a little early yet in that process. The data, I think, are critical to that discussion.

Our next question is from Steve Brozak of WBB.

And I'm specific on more color as to -- everything we're looking at for the long hauler side shows not one fibrotic event but multiple fibrotic events. Can you give as much color and specificity as to what you would look at as far as potential peptides and what the answers would be that CohBar might present in dealing with each of these specific [insights] and as much detail as you can give would be really appreciated.

Yes. Thanks, Steve, for the question. So now this really is a big question, right, because this is a new emerging population here with COVID long haulers that are now manifesting with not just the expected consequences of a short-term acute respiratory distress induced by a virus, but they are developing prolonged fibrotic events, thrombotic events, things that are only now becoming known.

I think we have an opportunity here because COVID is a disease of many different outcomes in terms of the sequelae. And if those include fibrosis, we have peptides that we know have strong antifibrotic activity. So there's an opportunity there where these might be used in the setting of COVID long haulers.

There's also the question of whether you can preempt a lot of that damage in the early stages if you're treating around the time of the infection to prevent the downstream effects of the damaging signaling caused by the cytokine storm and inducing thrombosis at that stage. And that's where our apelin agonist peptides, the 5064 analogs, are interesting and potentially useful. So that's why that's important that we continue to pursue that program for ARDS in general, but are also very much interested in working with NIAID to get that into the realm of testing for COVID as well. So I think there's many possibilities there across our programs that could have an impact on the long haulers. Does that address your question there, Steve?

Yes. No, no. Thank you very much. Very much appreciate that, and thanks again for taking the question.

Our next question is from Nathan Weinstein of Aegis Capital.

We've been excited about how many MDPs, you stated over 100 of them, I guess how many of them would you say are well characterized enough to the point where you could see them sort of in a preclinical stage or start to move towards IND studies.

Yes. That's a great question, Nathan. Thanks for the question. So what we have effectively is a large library of MDPs and a very large library of analogs that we have discovered and patented around those sequences. As far as what we know about them, as Joe mentioned in the call, right, we're scratching the surface here. So once we put resources into a program, we uncover things we did not expect about their potential utility disease indications that they might be useful for. So that really is exemplified by the recent discoveries, right, around the apelin agonist program, the inhibitors of CXCR4.

We believe there are many other opportunities like this in the portfolio, and it's a question of time and resources to dig deep enough to find those. So I think it's difficult to say how many we think out of 100 are going to translate into preclinical opportunities. But I think you can see from what we have so far that it's going to be not just a few. There will be more. And the more resources we have, the more we can obviously identify those additional ones.

Great. That makes sense. And I just have one follow-up question on sort of the other side of things. On the business development side, really when you think about just philosophically on partnerships, at what time in the development cycle do you think you might be willing to engage with a potential partner?

Yes. Thanks for that question. This is Joe. That's a key thing that we're always sort of evaluating when looking at different programs is what's the right timing. We think that it's important to start discussions early to get potential partners familiar with our programs, and the company has certainly done that so far. And the answer really depends, I think, to a certain degree on a program-by-program basis.

We're certainly, as Ken referenced, and as I think I mentioned also in my earlier remarks, on 4211, now that we've -- we'll soon have completed the Phase Ib study. We think that's a good time to engage more seriously with partners about potentially forming a partnership to further progress that program.

With other programs, there's certainly been interest in some of the earlier stage programs, including the fibrosis program. And there, we're kind of evaluating sort of the pros and cons of continuing to progress that on our own, derisking the program and getting ideally better terms at a future date versus taking that early partnership now.

And so that really depends to a certain degree on sort of the tenor of those discussions, but that's sort of the calculus that we're going through. But we think that in the near term, 4211 is, again, assuming good data in July, is our nearest term sort of partnering opportunity.

Got it. Looking forward to the Ib results and all the other updates from CohBar through the balance of the year.

Our next question is from Michael Morabito of Chardan Capital Markets.

First, I just want to ask since you had the update that you enrolled 23 subjects because 3 had dropped out, are you able to provide any color on why those 3 patients have dropped out, if it's a safety concern or if it's just a lost follow-up? And also, we have the top line data coming in July, but do you know when we can expect the full data if that will be at AASLD this year or later?

Michael, thanks for the question. Yes, on the first one, so the 3 dropouts, 2 of those were actually tested positive with COVID-19 in the middle of the study. So they had to be discharged from the study regardless of anything else, just from having a positive COVID. The third one, actually, withdrew consent early in the study for personal reasons. So these are not safety-related dropouts. These are just the subjects we lost in the process and therefore made steps to replace them to have enough for the original target of 20.

Now with respect to the expectations for top line data, we'll have, in the July time frame, the safety and activity data. It may be a little bit later that we'll have pharmacokinetic information. As far as digging deeper, it depends really what those data look like and what we might be presenting at AASLD or elsewhere later in the year. So too early to kind of parse that out. But I think as soon as we see the data, we'll have a good sense then of what else there is to dig deeper into and what our timing will be for release of additional information.

Okay. And a follow-up on 5138-3, you've made a point to mention other fibrotic diseases in addition to IPF. So beyond IPF, what would be the plans next indication after IPF? And how soon after starting an IPF clinical trial do you think you can make a second indication move into the clinic?

Yes. Good question. The first step in that is providing ourselves proof of concept in the preclinical setting for the program working in various fibrotic settings. So as I mentioned, we have the plan here to generate data in the NASH setting, in the systemic sclerosis setting and also in the kidney fibrosis setting. Now which of those might be prioritized as we go deeper, I think, will depend on what data we see, what else has to be done to move those to an IND stage as far as being ready to support an initial clinical study in a new indication.

So I think we'll be able to tell you more about that as the data emerge. Clearly, there's a lot of opportunity here in the fibrotic settings and not just the 3 that I mentioned there, but others we're also considering. So I'd say that's going to be data driven, and we'll update you as we go.

Okay. Great. And just one last question. I'm sorry, my screen just scrolled at me. So with the NAFLD study ending and IPF moving towards IND, this quarterly cash burn was $4.2 million cash through first quarter of next year, but how to model the cash burn ebbs and flows throughout the year as one study winds down and another move toward the clinic. Should we expect it to be roughly flat across the year? Or do you think that we'll see hills and valleys?

So Michael, thanks for the question. It's Jeff. You probably want to see a front-loaded cash -- use of cash in the first -- in the next couple of quarters. And then it will tail off a bit because we got some increased costs coming up from the trial in the next quarter. So you probably want to model it a little higher in the next 2 quarters, a little lower on the back end. But overall, if you ever wanted to, you could just straight line it and then add back some noncash expenses if you want to get back to an accrual basis.

We have reached the end of the question-and-answer session. I will now turn the call back over to Joe Sarret for closing remarks.

Thank you for everyone for joining us this afternoon. We look forward to updating you on our continued progress on our next call. For those of you who will be attending the virtual BIO Conference in June, we look forward to seeing you there.

Operator, would you please conclude the call?

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation, and have a great day.