Advertisement
Canada markets closed
  • S&P/TSX

    22,320.87
    +120.07 (+0.54%)
     
  • S&P 500

    5,304.72
    +36.88 (+0.70%)
     
  • DOW

    39,069.59
    +4.29 (+0.01%)
     
  • CAD/USD

    0.7317
    -0.0004 (-0.05%)
     
  • CRUDE OIL

    77.80
    +0.08 (+0.10%)
     
  • Bitcoin CAD

    93,642.98
    -1,036.31 (-1.09%)
     
  • CMC Crypto 200

    1,480.93
    +12.83 (+0.87%)
     
  • GOLD FUTURES

    2,339.30
    +4.80 (+0.21%)
     
  • RUSSELL 2000

    2,069.67
    +21.26 (+1.04%)
     
  • 10-Yr Bond

    4.4670
    -0.0080 (-0.18%)
     
  • NASDAQ

    16,920.79
    +184.79 (+1.10%)
     
  • VOLATILITY

    11.93
    -0.84 (-6.58%)
     
  • FTSE

    8,317.59
    -21.64 (-0.26%)
     
  • NIKKEI 225

    38,646.11
    -457.09 (-1.17%)
     
  • CAD/EUR

    0.6742
    -0.0002 (-0.03%)
     

Q1 2024 Chimerix Inc Earnings Call

Participants

Will O'Connor; IR; Stern Investor Relations

Mike Andriole; President & CEO; Chimerix Inc

Allen Melemed; Chief Medical Officer; Chimerix Inc

Joshua Allen; CTO; Chimerix Inc

Michelle LaSpaluto; Chief Financial Officer; Chimerix Inc

Thomas Riga; Chief Operating Officer, Chief Commercial Officer; Chimerix Inc

Maury Raycroft; Analyst; Jefferies

Naureen Quibria; Analyst; Capital One Securities Inc

Soumit Roy; Analyst; Jones Trading

Troy Langford; Analyst; TD Cowen

Presentation

Operator

Good morning, ladies and gentlemen, and welcome to the Chimerix first quarter 2024 earnings conference call. I would now like to introduce you to your host for today's call, Will O'Connor of Stern Investor Relations. Please proceed.

ADVERTISEMENT

Will O'Connor

Thank you, operator. Good morning, everyone, and welcome to the Chimerix First Quarter 2024 financial and operating results conference call. This morning, we issued a press release related to our first quarter operating update. You can access the press release in our Investors section of the website. With me on today's call are President and Chief Executive Officer, Mike NGL, Chief Medical Officer, Alan Melman, Chief Operating and Commercial Officer, Tom Riga, Chief Financial Officer, Michel OSB, Ludo, and Chief Technology Officer, Josh Allen.
Before we begin I'd like to remind you that the statements made on today's call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties and other factors. These risks and uncertainties and other factors could cause actual results to differ materially from those referred to in our forward-looking statements. Please refer to our filings with the SEC for a more complete disclosure of these risks and uncertainties.
At this time, I'll now turn the call over to Chimerix President and Chief Executive Officer, Mike Andriole.

Mike Andriole

Thanks, Will, and good morning, everyone, and thank you for joining us. I'm pleased to be joined this morning by other members of our senior leadership team to share an update on a productive quarter across several key initiatives. A primary strategic importance to Chimerix this year is the continued focus and drive of enrollment in the Phase 3 ACTION study for which the team continued to execute at a high level during the first quarter.
The study remains on track for first interim readout next year and is reaching steady-state accrual. The success of the action study, which is the most advanced trial in H3 K. 27 M. mutant glioma is central to our strategy as a positive outcome likely represents approval of the first medicine to treat this specific disease. As the organization drives action enrollment, we are keenly aware of the significant unmet need for patients with this disease.
As there are no approved treatment options available that have proven a clinical benefit beyond radiation therapy in H. three K. 27 M. mutant glioma. As a result, our team is continuously evaluating registration pathways globally to accelerate commercial access to door diver prone, also known as off to a one where possible as we undertake this effort, we are also aware that having a pivotal Phase 3 study well underway is an important consideration and global regulatory conversations that contemplate accelerated approval and the ongoing maturation of action enrollment enables such discussions to that. And I want to share a set of experiences that have been complementary to our strategy and underscore the magnitude of the unmet need. We see every day with this lethal disease.
Late last year, I received a communication from the Australian Minister of Health inquiring about the word out of prone for patients in need within his country during this interaction, the topic of provisional approval in Australia was raised, which is similar to the accelerated approval pathway in the United States. This interaction was the catalyst to our recent presubmission meeting in Australia with the Therapeutic Goods Administration or TGA to explore data phones eligibility to advance for provisional registration in Australia.
That pathway is a three-step process, which begins with a pre-submission evaluation at the current dataset in recurrent disease as well as other program features, including the status of pivotal studies. We're pleased with the outcome from this meeting and intend to advanced would have a prone to the second step in the process, the provisional determination application. I'll let Allen provide more details on the process going forward.
To be clear, we recognize that or to have a prone remains early in the provisional registration process. However, we are sharing the outcome of this meeting now as we are encouraged by TGA.'s review of the program to date and their conclusion that the Phase two data set does potentially meet their criteria for provisional approval. This, along with the status of the Phase 3 action study supports advancement into provisional registration process. This example is emblematic of our overall strategy to accelerate global access to our data prone. And we're eager to partner with the TGA in Australia to further advance, stood out and prone towards potential provisional registration.
Turning to our second generation of methadone onto oh six, we have increasing confidence in the safety profile, therapeutic window and potential for novel and differentiated indications from the parent compound or data from our Phase 1 safety studies are not yet complete. We are nevertheless preparing development strategies for this program that we expect to share before the end of the year as we near a Phase 2 investment decision. I'll let Josh frame this process further as we look into the second half of 2024.
Finally, financially, the company remains on strong footing, and we continue to execute with financial discipline. Michelle will provide a full summary of our financial performance in the first quarter and insights into cash runway.
I'll now turn the call over to Alan to discuss the process and path we're undertaking in Australia. Alan?

Allen Melemed

Thanks, Mike, and good morning, everyone. As Mike mentioned, our development strategy is to accelerate exports of Gabon as quickly as possible for patients in need around the world. We expect that the vast majority of countries will require positive results of our phase the AXIS study as this is designed to provide a definitive assessment of safety and efficacy in a randomized trial in the frontline setting of HDK. to seven Nugent diffuse glioma. That being said, as action enrollment advances, we are exploring options for early approval in recurrent setting where regulatory pathways allow. The recent interaction with the TGA in Australia was very supportive of a move to the next step in the provisional registration process based on three attributes.
One is a high unmet need and H. the K2 seven M. mutant glioma to the encouraging Phase two data in the recurrent setting and additional supportive data and three, our current progress in the ACTION study, we find that often this meaningful validating to the program and complementary to our broader strategy. The unmet need here is undeniable and the potential to bring this constituted the patient sooner is inspiring to me as a pediatric oncologist.
We work collaboratively with the TGA. That's a data or the data to the next step in the process of the coming months. Once the provisional determination application is submitted, the review process is expected to last about a month is successful and an application for provisional registration will be submitted and that review process will take approximately one year. We expect a filing could be submitted by the end of 2024 with potential commercial availability in 2026.
Our organization is preparing an NDA submission in parallel to the execution of the asset study to ensure readiness for early stopping scenario of the upcoming interim efficacy analyses. The test is submit strategic and complementary to the regulatory work already in progress. Tom will have much more to say about the specific commercial opportunity and plan to those timelines and activities come into focus later this year.
With that, I'll turn the call over to Josh to discuss our two assets. Josh?

Joshua Allen

Thank you, Alan, and good morning, everyone. In addition to door down prone, we are also excited about our earlier stage programs regarding Phase one evaluation of our tools, six dose escalation remains on track to report preliminary safety and pharmacokinetic findings this summer.
As a reminder, the compound is being evaluated in pediatric and adult patients with advanced CNS tumors, dose escalation on a once per week basis with doses ranging from 50 to 350 milligrams has completed without limiting safety signals and is now being evaluated on an intensified dose schedule of twice per day for three consecutive days per week.
This intensified dose schedule was selected based on observations that the majority of advanced cancer, and I'll maximize their response to October sixth at or prior to this duration of exposure was dose escalation studies are inherently adaptive with variable timelines. We remain on track to report preliminary safety and exposure data.
This summer at dose levels anticipated to be within the therapeutic range, ensuring that a potential new treatment is present at therapeutic concentrations for an adequate amount of time while being adequately safe in humans is the primary aim of Phase 1 evaluations establishing this is critical prior to the next step in clinical development, which will be aimed at efficacy evaluations in carefully selected patient populations. Non-clinical investigations continue in parallel to phase one to identify and prioritize opportunities for future clinical efficacy evaluation.
These include tumors that occur both within and outside of the central nervous system that do not harbor the H3 K. 27 M. mutation, but we do rely on disease drivers that are directly addressed by the therapeutic mechanism among two of six we are leveraging the door data from clinical experience as well as the vast knowledge of the multidimensional mechanism of our compounds that impact critical aspects of tumor biology.
These include reversal of epigenetic disease drivers, degradation of specific oncogenic proteins in activation of a central Pro survival signaling pathways. We are delighted that some of these concepts are showing promise in the lab and we look forward to providing more details in the context of a Phase 2 investment decision anticipated by the end of the year. In view of the totality of the program
With that, I will now turn the call over to Michel for an update on financial results.

Michelle LaSpaluto

U-gas earlier today, we issued a press release containing our financial results for the first quarter of 2024. Chimera's balance sheet at March 31, 2024 included $188.2 million of capital available to fund operations and no outstanding debt. We remain highly disciplined in the financial management of the company. Our rolling four-quarter burn rate of [$58 million] at the end of Q1 2024 benchmarks us among the most capital efficient Phase 3 companies in our peer group.
Our approach is to retain strong discipline and gain investment as we evaluate commercial models in the different territories we continue to expect our cash balance to be sufficient to support operations into 4Q 2020.
Turning to our results for the first quarter of 2024, the company reported a net loss of $21.9 million or $0.25 per basic and diluted share compared to a net loss of $21.4 million were $0.24 per basic and diluted share in the first quarter of 2023. Research and development expenses of $18.8 million were flat compared to the same period in 2023.
General and administrative expenses decreased to $5.5 million for the first quarter of 2024 compared to $5.7 million for the same period in 2023.
With that, I will now turn the call back over to Mike for closing remarks.

Mike Andriole

Thanks, Michelle. And closing a primary strategic importance for Chimerix this year is the continued focus and drive of enrollment in the Phase 3 action study for which the team continues to execute at a high level. Additionally, we continue to explore pathways, which may accelerate access to door to have a problem for patients with this ultra-rare lethal disease. More broadly, we're excited about the profile of onto a six that is potentially emerging and look forward to reporting preliminary safety and PK data later this summer.
At Chimerix, we're devoted to filling gaps in the treatment paradigm in oncology, despite advances in the field of genetically defined tumors. There remains a significant unmet need, particularly in neuro oncology, and we're focused on bringing potential new medicines to these patients in need.
I'd like to take this opportunity to thank our dedicated team at Chimerix as well as the doctors patients, patient advocates and caregivers for their unwavering commitment. As we move closer to bringing life-altering new medicines to the patients, we serve.
With that, John will open the call to questions.

Question and Answer Session

Operator

(Operator Instructions)
Maury Raycroft from Jefferies. Please go ahead.

Maury Raycroft

Hi, good morning. Congrats on the progress and thanks for taking my questions. I was going to start off with Dom just enrollment for the Phase three on seeing that you added five additional sites since your fourth quarter update. Does that include some of the higher volume ex US sites and geographies and can you provide perspective on whether you're seeing a meaningful change in the enrollment ended, but event rates in this study? Or do you think you'll require more sites for further optimism for to further optimize enrollment.

Mike Andriole

Hi, Maury, it's Mike. I appreciate the question. Yes, the additional five sites that have been added recently were sort of part of the initial tranche of sites. So not including the additional sites that we talked about last quarter, and that's probably going to be less than 10 in any event. It's really strategic for for markets where we're seeing patients travel great distances. So those aren't necessary to achieve our enrollment projections, and we continue to expect first interim OS in 2025.

Maury Raycroft

Got it. Okay. That's helpful. And then I'm forgetting your app, your filing applications submitted to the Australia TGA. I've got a couple of questions. Are I guess what are the gating factors for the application and submission when and how often do you plan on meeting with the TGA prior to the filing? And what do you anticipate the TGA. will want to see as it relates to progress in the Phase three action study? Or is it just the status of Phase 3 enrollment? Or do you expect that the approval will be contingent on the interim OS data that you get in 2025?

Mike Andriole

Yes. Great. Great question, Maury. Yes. So in terms of in terms of what's needed for the application or ongoing interactions like the next step in the process is a preliminary determination application. It will initiate that here over the summer and then they'll evaluate that assuming that we move to the final step in the process, the provisional application will resemble a traditional new drug application.
So the overlap between the work we're already doing within the company for creating that document and the submission in Australia. As Alan alluded to earlier, there's a lot of overlap between those two things in terms of progress and enrollment. Their their key consideration is making sure that they'll have definitive safety and efficacy data during the provisional registration period. I think we've already seen enough to feel comfortable with that. And so continued trajectory on the trajectory we're on is I think assumed. And of course, we expect there's going to be additional tailwinds to that, which we've which we've already talked about.
Some other parts of your question, but I missed under certainly, yes.

Maury Raycroft

Just some how often you plan on meeting with TGA arm prior to filing and when those meetings could take place? And will you provide updates to the public after those meetings?

Mike Andriole

Yes, certainly there is ongoing collaborative interactions with TGA, particularly as we move through this next, the second phase of the process, the preliminary determination application. And then we expect to meet with some degree of frequency heading into the third step in the process, assuming that we get that far. And so Alan, I don't know if there's any additional regulatory interactions that you would you would comment there, but I think I think that covers it.

Allen Melemed

And the only thing I'll add this is Alan, is that the submission is not contingent on the Phase three trial data to ensure that the trial is well underway at the time of approval from them to make a decision gotten.

Maury Raycroft

Understood. Okay. Would Thanks for taking my questions. I'll hop back in the queue.

Operator

The next question comes from the line of Florian Korea from Capital One. Please go ahead.

Naureen Quibria

I'm Hi, good morning. Congrats on the progress and thanks for taking my questions. And I guess sort of following up on what Maury, more just asked regarding the A.M. Well, sort of on the accelerated approval in Australia, the potential for that. I'm just curious what the commercial opportunity might be in Australia. And also if you could talk a bit more about other territories that you might be considering along the same lines?

Mike Andriole

Yes. So thanks. Thanks, Darren, for the call for the questions. I will I'll take the second first and then I'll ask Tom Regan to comment on the commercial potential in Australia.
So look, the in terms of other countries, we're focused on the ACTION study. First and foremost, as I as I mentioned, is our is our key strategic priority. We are evaluating a handful of other countries that have a pathway.
As you can imagine, strategically, the time line of when we could potentially submit there is an important variable as we think about that because we're just around the corner from a potential first interim analysis on the ACTION study next year. So and if we intend to evaluate or pursue a pathway that we're evaluating. We'll update the market at that time.
Tom comments on commercial potential in Australia.

Thomas Riga

Yes. Hey, Noreen, Tom Riga. I think first, we're excited about the proposition of submission here by the end of the year. And along with that process and it runs in sequence and potentially in parallel is the process with the Australian regulators for pricing access and reimbursement, the HTA process. So that market is more analogous to those in Southern Europe and very much different than US prices are lower. But as we have studied this particular market. There is some room for optimism when we evaluate the criteria for how those evaluations are conducted.
And we see attributes of up to one that could be potentially very interesting from a commercial perspective, I think those issues are one of first in class product in an area of high unmet medical need. I think second is a ultra rare disease and third, and I think of significant importance is that there is not an anchor product that's currently approved to treat this area of illness so early, but we do see some optimism from a commercial standpoint.
I think that coupled with the high unaided awareness that exists in country today within our action sites, along with the efficient network that exists in the neuro oncology community in Australia could make for a very lean and efficient commercial model. We do not foresee a significant investment from a human capital perspective. On behalf of Chimerix, we would be looking for in-country collaborations, and we'll have much more to say about that as we as we progress in the process.

Naureen Quibria

No, that is helpful. Thank you. I guess one more from me on onto oh six, the dose escalation trials. I know you're not commenting on what stage of that, but, you know, let's say in terms of both the trials are they moving at the same pace? You know, for instance, if you have a data, no PV and the pediatric is incomplete, will you still report data from one trial if the other is incomplete in that timeframe.

Mike Andriole

Thanks, Doreen. Josh, would you like to answer that?

Joshua Allen

Yes. Thanks for the question, Noreen. I mean, both both trials in adult and pediatrics are proceeding in parallel, there's some nuances in the exact design and kind of how they play out in different ways. But at the end of the day, I think what you can expect to see on the next quarter is us provide an update on key safety and pharmacokinetic information from both of the studies I think are across the different dose levels and cohorts, et cetera.
I think we we would expect to have an experience that's around 75 patients. It's going to be a little pediatric skewed, I'd say about two thirds of that aggregate population just because the pediatric trial has enrolled in a couple of settings in contrast to the adult study. So you can expect to see some safety and PK information represented from both.

Naureen Quibria

Okay, terrific. Thanks.
Thanks for taking my questions.

Operator

The next question comes from the line of Sumit Roy from Jones Research. Please go ahead.

Soumit Roy

Good morning, everyone, and congratulations again on progress on that front. A quick question on up with the approval of the wants to revenue, or is there any overlap between H. three K. 27 and PDF alteration? Or are you expecting any change in enrollment pace across both four to six a two one.

Mike Andriole

Great. Great question, Sumit and contemporary one, I'll ask Josh to comment on that specifically. But but before I do, I just want to pause and congratulate day one on that approval is a meaningful milestone for the field of neuro oncology. I think by our account. That's the third genetically defined approval in the field in the last several years and after a dearth of innovation over the last quarter century, that's a really significant milestone and are quite quite meaningful for pediatric patients with low-grade glioma. So congratulations to that team, and we're excited for the future. Josh, do you want to talk about the overlap between HDK. 27 M. and BRAP.

Joshua Allen

Yes. Thanks, Mike. And I think well said that the congratulations for day one on. Yes, I think first and foremost, the thing to point out is that H. three K. 27 M. doesn't doesn't really cause occur with other actionable mutations, and that includes the D-Ram fusions and V. 600 E. population. So these are these are populations of patients that really don't overlap. On.
The final thing I would point out that it is just that in the unlikely event that you do have a patient that has coal occurred. So I would just highlight that the accelerated approval for TiVo rapid out was in the relapse or recurrent setting and our Phase three trial is focused in the front-line setting. So again, coal currents would be exceedingly rare based on the available evidence that there are there's actually an opportunity to sequence therapy following the actually.

Soumit Roy

And the other thing is, I don't know if you can provide any color on as you are expanding globally is the percent of H. three K. nonsense mutation is still according to your initial market survey of 8% to 9% to 10% or is it changing depending on US versus ex-US?
And the second one is, are you seeing in ex-US territories any difference in prior treatment or how patients are being handled? Last time you mentioned ex U.S. patients have more temozolomide usage or anything else you're seeing that could affect the action expected results?

Mike Andriole

Yes. Thanks, Sumit, for the question. I'll take the first one on just the XUS. percent of the mutation, and I'll ask Alan to talk about what we're seeing in terms of different standards of care, if any, broadly speaking geographically, on your first one, Sumit and the percentage with H. three K. 27 M. in terms of incidence.
We have no reason to conclude that it's different country to country or within different races. In fact, our proportion of enrollment relative to where we have sites is almost uniform globally, and it's kind of consistent with that conclusion. So no reason to expect any geographic differences in terms of the mutation.
Alan, would you like to comment on on the standards of care.

Allen Melemed

And thank you for the question, Sumit. In general, the standard of care worldwide is still radiation therapy for these patients. There's a slight difference that you may see in the US. Some patients are receiving proton beam radiation. But as us as a whole, it's still radiation as the mainstay. Some there are some patients who are due are receiving temozolomide is typically more in the adult setting. Pediatric patients globally do not, but there is a little higher instance of Pyratine dolomite, even in pediatric patients come in and globally.

Soumit Roy

Thank you.
And congratulations again.

Operator

Joel Beatty, Baird.

Probably this is Ben calling, China fertility. Thanks for taking the question on the future development path of on to oh six on, would it be possible to give us a sense of what's being contemplated? Is that a monotherapy? Is that a combination therapy potentially with Tumor Treating Fields? Or is that maybe not seeing a solid tumors affect?

Mike Andriole

Thanks, Ben, for the question. Josh, would you like to comments, sir?

Joshua Allen

Thanks for the question. I mean, I think the short answer to the question is private prioritization is given the opportunities for monotherapy development, at least initially that focuses on solid tumors that don't harbor the H3 K. 27 M. mutation and the opportunities are inclusive of but not restricted to CNS tumors. So I wouldn't I wouldn't pigeonhole because these this drug to the specific combination that you just mentioned there and I'll highlight there is in line with this if you're looking for more specificity.
Great. There's several positive in vivo studies with monotherapy onto a six in histologically defined indications that are published and summarized in our corporate deck. Those examples include GBM, medulloblastoma, uterine cancer, breast cancer and certain kinds of neuroendocrine tumors such as paraganglioma.
As I mentioned in my prepared remarks, some of the specific mechanistic considerations that we're using to guide some of these monotherapy activity potentials and how we identify and prioritize them. And really the goal of that is to further refine those opportunities for indications that are either defined by or enrich for specific biomarkers of October sixth that we think could represent meaningful opportunities for us for clinical development.

Great. Thank you.

Operator

The last question comes from the line of Troy Langford from PD Towbin. Please go ahead.

Troy Langford

Hey, congrats on the progress and thanks for taking our question. So just with respect to the next steps or onto a fixed, do you believe any of these do you believe any of these future study for the program program? Could constitute pivotal studies in the selected patient populations? Or do you think you all know more likely to do smaller single-arm Phase two studies?
First of all, by a larger controlled Phase 3 study similar to what you did with did have a problem?

Mike Andriole

Sure. I think thanks for the question. I'll let Josh speak to that. I think in short, it may well depend on the direction of the program and the indication pursued that, Josh, would you like to comment further?

Joshua Allen

That's exactly right. Our goal in the near term is going to be to have to make sure that the drug is able to get into humans at adequate therapeutic concentrations for an adequate amount of time to be well-tolerated. We think if we can achieve that and update everyone on this in the middle of the year that that's going to be sufficient to open up a lot of additional opportunities for further development.
We intend to take that decision, the totality of the program and the exact nature of that sort of registration opportunity, like Mike said, the trial design, what the exact next steps are and the exact endpoints are very much something that we're thinking about right now and are tailored to the specific opportunity. But but obviously, we're going to be focused on identifying clear monotherapy signals in the most efficient path and two approval possible for that disease if we see confirmation of that activity.

Troy Langford

Great. Thanks for that color.

Operator

As there are no further questions at the queue at this time. I would like to turn the call over back to Mike Andriole.

Mike Andriole

Thanks, John. Thank you, everyone, for your time this morning, and we look forward to updating you in the coming months.

Operator

This concludes today's conference call. Thank you for your participation. You may now disconnect.