Yahoo Finance Chimerix Inc (CMRX) Q1 2024 Earnings Call Transcript Highlights: Strategic Developments and ...
Capital Available: $188.2 million as of March 31, 2024
Net Loss: $21.9 million for Q1 2024
Earnings Per Share: -$0.25 for Q1 2024
Research and Development Expenses: $18.8 million for Q1 2024
General and Administrative Expenses: $5.5 million for Q1 2024
Release Date: May 01, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
Chimerix Inc (NASDAQ:CMRX) is actively progressing with the Phase 3 ACTION study, which is on track for its first interim readout next year.
The company is exploring provisional registration in Australia, potentially accelerating commercial access to their drug, doravirine.
Chimerix Inc (NASDAQ:CMRX) has a strong financial position with $188.2 million in capital and no outstanding debt, supporting operations into the fourth quarter of 2026.
The company is preparing for a Phase 2 investment decision by the end of the year for their second-generation drug, ONTO-06, showing confidence in its safety profile and therapeutic potential.
Chimerix Inc (NASDAQ:CMRX) is maintaining a high level of financial discipline, with a burn rate that benchmarks favorably among Phase 3 companies in its peer group.
Negative Points
The company reported a net loss of $21.9 million for the first quarter of 2024, indicating ongoing financial losses.
There are inherent risks and uncertainties in the drug development process that could impact the future success of their clinical trials and drug approvals.
The regulatory approval process, especially for new territories like Australia, can be complex and uncertain, potentially delaying drug availability.
While the company is exploring early approval pathways in various countries, these efforts are contingent upon positive clinical trial outcomes that are yet to be determined.
Chimerix Inc (NASDAQ:CMRX) is dependent on the success of its clinical trials for future growth, which poses significant risks if the trials do not meet their endpoints or fail to demonstrate efficacy.
Q & A Highlights
Q: 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. A: 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.
Q: 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? A: 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.
Q: 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? A: 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.
Q: 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? A: 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.
Q: 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. A: 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.
Q: 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? A: 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?
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
