Yahoo Finance Chimerix, Inc. (NASDAQ:CMRX) Q1 2024 Earnings Call Transcript
Chimerix, Inc. (NASDAQ:CMRX) Q1 2024 Earnings Call Transcript May 1, 2024
Chimerix, Inc. misses on earnings expectations. Reported EPS is $-0.25 EPS, expectations were $-0.21. Chimerix, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
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.
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 Andriole; Chief Medical Officer, Allen Melemed; Chief Operating and Commercial Officer, Tom Riga; Chief Financial Officer, Michelle LaSpaluto; 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 the 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. Of 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, the 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 K27M-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 H3 K27M-mutant glioma. As a result, our team is continuously evaluating registration pathways globally to accelerate commercial access to dordaviprone, also known as ONC201, where possible. As we undertake this effort, we are also aware that having a pivotal Phase 3 study well underway is an important consideration in global regulatory conversations that contemplate accelerated approval and the ongoing maturation of ACTION enrollment enables such discussions. To that end, 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 Ministry of Health inquiring about dordaviprone 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 pre-submission meeting in Australia with the Therapeutic Goods Administration, or TGA, to explore dordaviprone’s eligibility to advance for provisional registration in Australia. That pathway is a three-step process, which begins with a pre-submission evaluation of the current data set 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 advance dordaviprone 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 dordaviprone 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 2 data set does potentially meet their criteria for provisional approval. This along with the status of the Phase 3 ACTION study, supports advancement in the provisional registration process. This example is emblematic of our overall strategy to accelerate global access to dordaviprone, and we’re eager to partner with the TGA in Australia to further advance dordaviprone towards potential provisional registration. Turning to our second generation imipridone ONC206, we have increasing confidence in the safety profile, therapeutic window and potential for novel and differentiated indications from the parent compound dordaviprone.
While 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 Allen to discuss the process and path we’re undertaking in Australia. Allen?
Allen Melemed: Thanks, Mike, and good morning, everyone. As Mike mentioned, our development strategy is to accelerate access to dordaviprone as quickly as possible for patients in need around the world. We expect that the vast majority of the countries will require positive results of our Phase 3 ACTION study, as this is designed to provide a definitive assessment of safety and efficacy in a randomized trial in the frontline setting of H3 K27M-mutant diffuse glioma. That being said, as ACTION enrollment advances, we are exploring options for early approval in the recurrent setting where regulatory pathways allow [ph]. The recent interest from the TGA in Australia was very supportive on moving to the next step in the provision of registration process based on three attributes: one, a high unmet need in H3 K27M-mutant glioma; two, the encouraging Phase 2 data in the recurrent setting and additional supportive data; and three, our current progress in the ACTION study.
We find the outcome of this meeting will validate in to the program and complementary to our broader strategy. The unmet nature is undeniable, and the potential of being this problem to treat the patients sooner is inspiring to me as a pediatric oncologist. We will work collaboratively with the TGA as dordaviprone advances to the next step in the process in the coming months. Once the provisional determination application is submitted, the review process is expected to last about a month. If successful, an application for provisional registration will be submitted, and that review process will take approximately one year. We expect the 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 ACTION study to ensure readiness for early stopping scenarios at upcoming interim efficacy analyses.
The potential to submit [indiscernible] complementary to the regulatory work already in progress. Tom will have much more to say about the specific commercial opportunity and plans as those time lines and activities come to focus later this year. With that, I’ll turn the call over to Josh Allen to discuss our ONC206. Josh?
Josh Allen: Thank you, Allen, and good morning, everyone. In addition to dordaviprone, we are also excited about our earlier stage programs. Regarding Phase 1 evaluation of ONC206, dose escalation remains on track to report preliminary safety and pharmacokinetic finding 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 milligrams 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 model maximized their response to ONC206 at or prior to this duration of exposure.
While dose escalation studies are inherently adaptive with variable time lines, 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 concentration for an adequate amount of time while being adequately safe in humans is the primary aim of Phase 1 evaluation. Establishing this is critical prior to the next step in clinical development, which will be aimed at efficacy evaluations in carefully selected patient population. Non-clinical investigations continue in parallel to Phase 1 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 K27M mutation, but do rely on disease drivers that are directly addressed by the therapeutic mechanism of ONC206.
We are leveraging the dordaviprone 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 and inactivation 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 Michelle for an update on financial results.
Michelle LaSpaluto: Thank you, Josh. Earlier today, we issued a press release containing our financial results for the first quarter of 2024. Chimerix’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 gate 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 2026. 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 or $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. In closing, our primary strategic importance for Chimerix this year is the continued focus and drive of enrollment of 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 dordaviprone for patients with this ultra-rare and lethal disease. More broadly, we’re excited about the profile of ONC206 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, we’ll open the call to questions.
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