Q2 2024 Chimerix Inc Earnings Call

August 13, 2024

Speaker Change: Good morning, ladies and gentlemen, and welcome to the Chimeric Second Quarter 2024 Earnings Conference Call.

Operator: I would now like to introduce you to your host for today's call, Will O'Connor of Stern Investor Relations. Please proceed.

Speaker Change: I would now like to turn, I mean, I would now like to introduce to you your host for today's call, Will O'Connor of Stern Investor Relations. Please proceed.

Will OConnor: Thank you, Operator. Good morning, everyone, and welcome to the Chimerix Second Quarter 2024 Financial and Operating Results Conference Call. This morning, we issued a press release related to our Second Quarter Operating Update. You can access the press release in the Investors section of the Chimerix website. With me today on today's call are President and Chief Executive Officer Mike Andriole, Chief Financial Officer Michelle LaSpaluto, and Chief Technology Officer Josh Allen.

Will OConnor: Thank you, Operator. Good morning, everyone, and welcome to the Chimerix Second Quarter 2024 Financial and Operating Results Conference Call. This morning, we issued a press release related to our Second Quarter Operating Update. You can access the press release in the Investors section of the Chimerix website. With me today on today's call are President and Chief Executive Officer, Mike Andriole, Chief Financial Officer, Michelle LaSpaluto, and Chief Technology Officer, Josh Allen.

Will O'Connor: Thank you, Operator. Good morning, everyone, and welcome to the Chimeric Second Quarter 2024 Financial and Operating Results Conference Call. This morning, we issued a press release related to our Second Quarter Operating Update. You can access the press release in the Investors section of the Chimeric's website.

Speaker Change: With me on today's call are President and Chief Executive Officer, Mike Andriole, Chief Financial Officer, Michelle LaSpaluto, and Chief Technology Officer, Josh Allen.

Speaker Change: We also have Allen Melemed, our Chief Medical Officer, and Tom Riga, our Chief Operating and Commercial Officer, for questions.

Will OConnor: We also have Allen Melamed, our Chief Medical Officer, and Tom Riga, our Chief Operating and Commercial Officer, for questions. Before we begin, I'd like to remind you that the statements made on today's call 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.

Will OConnor: We also have Allen Melemed, our Chief Medical Officer, and Tom Riga, our Chief Operating and Commercial Officer, for questions. Before we begin, I'd like to remind you that the statements made on today's call 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 statement. 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.

Speaker Change: Before we begin, I'd like to remind you that the statements made on today's call 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.

Speaker Change: These risks and uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements

Speaker Change: Please refer to our filings with the SEC for more complete disclosure of these risks and uncertainties.

Will OConnor: Please refer to our filings with the SEC for 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. Thanks, Will. Good morning, everyone, and thank you for joining us.

Speaker Change: At this time, I'll now turn the call over to Chimeric's President and Chief Executive Officer, Mike Andriole.

Michael Andriole: Thanks, Will. Good morning, everyone, and thank you for joining us. It's been a busy summer at Chimerix, and we continue to make meaningful progress across our clinical program. Starting with our lead program, Dordavaprone, our team continues to be laser focused on the execution and enrollment of the phase three action study, which is on track for the first interim overall survival readout in the third quarter of next year. We're executing with urgency, as there remains a significant need for patients battling this lethal disease. With no approved treatment options available that have proven clinical benefit beyond radiation therapy, we're keenly aware of the importance of speed in addressing this unmet need.

Michael Andriole: It's been a busy summer at Chimerix, and we continue to make meaningful progress across our clinical program. Starting with our lead program, Dordavaprone, our team continues to be laser focused on the execution and enrollment of the phase three action study, which is on track for the first interim overall survival readout in the third quarter of next year. We're executing with urgency, as there remains a significant need for patients battling this lethal disease.

Mike Andriole: Thanks Will. Good morning everyone and thank you for joining us. It's been a busy summer at Chimerics and we continue to make meaningful progress across our clinical programs.

Mike Andriole: Starting with our lead program, Dordavaprone.

Mike Andriole: Our team continues to be laser-focused on the execution and enrollment of the Phase 3 Action Study, which is on track for the first interim overall survival readout in the third quarter of next year. We're executing with urgency as there remains a significant need for patients battling this lethal disease.

Michael Andriole: With no approved treatment options available that have proven clinical benefit beyond radiation therapy, we're keenly aware of the importance of speed in addressing this unmet need. It's because of this need that we continuously evaluate registration pathways globally to accelerate commercial access to Dordavapro where possible. Earlier this year, we initiated the evaluation process for DiverProne to be considered for provisional registration in Australia. Provisional registration is a three-step process that begins with a pre-submission meeting to evaluate current data, the status of pivotal studies, and other program plans.

Mike Andriole: With no approved treatment options available that have proven clinical benefit beyond radiation therapy, we're keenly aware of the importance of speed in addressing this unmet need.

Michael Andriole: It's because of this need that we continuously evaluate registration pathways globally to accelerate commercial access to DoorDava Pro and, where possible, to where it is already registered. Earlier this year, we initiated the evaluation process for DiverProne to be considered for provisional registration in Australia. Provisional registration is a three-step process that begins with a pre-submission meeting to evaluate current data, the status of pivotal studies, and other program pieces. Following a supportive pre-submission meeting earlier in the year, our team recently initiated the second step in this process, the filing of a provisional determination application. Should the regulators in Australia approve this application, the final step is to apply for provisional registration.

Mike Andriole: It's because of this need that we continuously evaluate registration pathways globally to accelerate commercial access to DoorDava Pro and where possible.

Mike Andriole: Earlier this year, we initiated the evaluation process for DiverProne to be considered for provisional registration in Australia. Provisional registration is a three-step process that begins with a pre-submission meeting to evaluate current data, the status of pivotal studies, and other program features.

Michael Andriole: Following a supportive pre-submission meeting earlier in the year, our team recently initiated the second step in this process, the filing of a provisional determination application. Should the regulators in Australia approve this application, the final step is to apply for provisional registration.

Mike Andriole: Following a supportive pre-submission meeting earlier in the year, our team recently initiated the second step in this process, the filing of a provisional determination application.

Mike Andriole: Should the regulators in Australia approve this application, the final step is to apply for provisional registration. If we proceed to this final step, it's expected that an NDA filing could occur as early as year-end 2024, with possible commercial availability in early 2026.

Michael Andriole: If we proceed to this final step, it's expected that an NDA filing could occur as early as year-end 2024, with possible commercial availability in early 2026. This morning, we're also excited to provide a safety and PK update from our other clinical program, the second generation Omicrodona 206. We're making great strides advancing this program through Phase I studies, which recently began dosing within an expected therapeutic range, and we are now enrolling the first of two remaining dose cohorts.

Mike Andriole: This morning, we're also excited to provide a safety and PK update from our other clinical program, the second generation Omicrodonoff 206.

Mike Andriole: We're making great strides advancing this program through Phase I studies, which recently began dosing within an expected therapeutic range, and we are now enrolling the first of two remaining dose cohorts.

Michael Andriole: As we escalate and intensify the dose within this range, we're encouraged by ongoing pharmacokinetic data that is in line with modeled expectations for delivering dose-proportionate exposures for extended duration. Importantly, these exposures have not been associated with dose-limiting toxicities thus far. With these data, we have increasing confidence in the safety profile and therapeutic window for ARNC-206, and we look forward to completing enrollment in our dose escalation trials by the end of the year. I'll now turn the call over to Josh for a more detailed discussion on the ARC-206 data we announced this morning.

Mike Andriole: As we escalate and intensify the dose within this range, we're encouraged by ongoing pharmacokinetic data that is in line with modeled expectations for delivering dose-proportionate exposures for extended durations.

Mike Andriole: Importantly, these exposures have not been associated with dose-limiting toxicities thus far. With these data, we have increasing confidence in the safety profile and therapeutic window for ARNC-206, and we look forward to completing enrollment in our dose escalation trials by the end of the year.

Michael Andriole: With these data, we have increasing confidence in the safety profile and therapeutic window for ARNC-206, and we look forward to completing enrollment in our dose escalation trials by the end of the year. I'll now turn the call over to Josh for a more detailed discussion on the AHRQ 206 data we announced this morning. Thank you, Mike, and good morning, everyone.

Mike Andriole: I'll now turn the call over to Josh for a more detailed discussion on the ANC 206 data we announced this morning. Josh?

Joshua Allen: Thank you, Mike, and good morning, everyone. I'm delighted to provide an update on the program for our next generation product, OCT206, which is being evaluated in ongoing phase 1 clinical trials. I'll start with a reminder that this is a small molecule that shares the novel ClpT and DRD2 binding targets with its parent compound, dordaviprone, and exhibits a tenfold increase in potency while retaining favorable safety and oral administration attributes. It also has the relatively rare ability to penetrate the blood-brain barrier and has shown encouraging activity in non-clinical studies of specific forms of cancer, both within and outside of the central nervous system.

Joshua Allen: I'm delighted to provide an update on the program for our next generation product, OCT-206, that is being evaluated in ongoing Phase I clinical trials. I'll start with a reminder that this is a small molecule that shares the novel ClpP and DRD2 binding targets with its parent compound, dordaviprone, and exhibits a tenfold increase in potency while retaining favorable safety and oral administration attributes. It also has the relatively rare ability to penetrate the blood-brain barrier and has shown encouraging activity in non-clinical studies of specific forms of cancer, both within and outside of the central nervous system.

Josh Allen: Thank you, Mike, and good morning, everyone.

Josh Allen: I'm delighted to provide an update on the program for our next generation product, OCT-206, that is being evaluated in ongoing Phase I clinical trials.

Josh Allen: I'll start with a reminder that this is a small molecule that shares the novel ClpT and DRD2 binding targets with its parent compound, dordabiprone, and exhibits a tenfold increase in potency while retaining favorable safety and oral administration attributes.

Josh Allen: It also maintains the relatively rare ability to penetrate the blood-brain barrier and has shown encouraging activity in non-clinical studies of specific forms of cancer, both within and outside of the central nervous system.

Joshua Allen: In the ongoing Phase I trials for pediatric and adult CNS tumors, we have previously completed dose escalation on a once-per-week administration schedule at doses reaching up to 350 milligrams. That experience demonstrated the desired peak plasma concentrations and safety in patients that we expected based on our non-clinical model. In parallel to the clinical evaluation of this dose schedule, non-clinical studies suggested that the anti-cancer activity of this compound could be enhanced by prolonging the duration of time that tumor cells are exposed to biologically active concentrations.

Joshua Allen: In the ongoing Phase 1 trials for pediatric and adult CNS2, we have previously completed dose escalation on a once-per-week administration schedule at doses reaching up to 350 mg. That experience demonstrated the desired peak plasma concentrations and safety in patients that we expected based on our non-clinical models. In parallel to the clinical evaluation of this dose schedule, non-clinical studies suggested that the anti-cancer activity of this compound could be enhanced by prolonging the duration of time that tumor cells are exposed to biologically active concentrations.

Josh Allen: In the ongoing Phase 1 trials for pediatric and adult CNS tumors, we have previously completed dose escalation on a once-per-week administration schedule at doses reaching up to 350 milligrams.

Josh Allen: That experience demonstrated the desired peak plasma concentrations and safety in patients that we expected based on our non-clinical models.

Josh Allen: In parallel to the clinical evaluation of this dose schedule, non-clinical studies suggested that the anti-cancer activity of this compound could be enhanced by prolonging the duration of time that tumor cells are exposed to biologically active concentrations.

Joshua Allen: This appeared to potentially be achievable through dosing on a twice per day for three consecutive days per week administration schedule based on our modeling, and we have been busy testing this in the clinic this year. We have now generated human data for safety and pharmacokinetics, or PK for short, at doses reaching up to 100 milligrams at this intensified administration schedule. We are happy to report that the tolerability of the compound continues to be favorable as we continue dose intensification, with no meaningful changes in the overall adverse event profile as the dosing has either escalated or become more frequent. The most frequent treatment-related adverse events are fatigue, vomiting, and lymphopenia, which have occurred in a minority of patients and are largely low-grade.

Joshua Allen: This appeared to potentially be achievable through dosing on a twice per day for three consecutive days per week administration schedule based on our modeling, and we have been busy testing this in the clinic. We have now generated human data for safety in pharmacokinetics, or PK for short, at doses reaching up to 100 milligrams at this intensified administration schedule. We are happy to report that the tolerability of the compound continues to be favorable as we continue dose intensification, with no meaningful changes in the overall adverse event profile as the dosing has either escalated or become more. The most frequent treatment-related adverse events are fatigue, vomiting, and lymphopenia, which have occurred in a minority of patients and are largely low risk.

Josh Allen: This appeared to potentially be achievable through dosing on a twice per day for three consecutive days per week administration schedule based on our modeling, and we have been busy testing this in the clinic this year.

Josh Allen: We have now generated human data for safety and pharmacokinetics, or PK for short, at doses reaching up to 100 milligrams at this intensified administration schedule.

Josh Allen: We are happy to report that the tolerability of the compound continues to be favorable as we continue dose intensification with no meaningful changes in the overall adverse event profile as the dosing has either escalated up or become more frequent.

Josh Allen: The most frequent treatment-related adverse events are fatigue, vomiting, and lymphopenia that have occurred in a minority of patients and are largely low-grade.

Joshua Allen: With respect to PK results, our goal was to sustain biologically active concentrations for a prolonged duration of time, and that is indeed what we have accomplished with the intensified dose schedule. At 100 milligrams twice a day for three days per week, the human PK results showed that biologically active concentrations of OCT2O6 were sustained for beyond 24 hours in plasma, and that peak plasma concentrations are well in excess of the compound's IC50 in vitro, as well as exposures associated with in vivo efficacy in oncology models.

Joshua Allen: With respect to PK results, our goal was to sustain biologically active concentrations for a prolonged duration of time, and that is indeed what we have accomplished with the intensified dose schedule. At 100 milligrams twice a day for three days per week, the human PK results show that biologically active concentrations of OCT2O6 were sustained for beyond 24 hours in plasma, and that peak plasma concentrations are well in excess of the compound's IC50 in vitro, as well as exposures associated with in vivo efficacy in oncology models.

Josh Allen: With respect to PK results, our goal was to sustain biologically active concentrations for a prolonged duration of time and that is indeed what we have accomplished with the intensified dose schedule.

Josh Allen: at 100 milligrams twice a day for three days per week.

Josh Allen: The human PK results showed that biologically active concentrations of OCT2O6 were sustained for beyond 24 hours in plasma, and that peak plasma concentrations are well in excess of the compound's IC50 in vitro, as well as exposures associated with in vivo efficacy in oncology models.

Joshua Allen: Keep in mind that this is all based on plasma concentrations and that many target tissues are expected to have even higher exposure based on prior distribution studies in rodents. For example, brain tissue showed a two-fold higher drug concentration relative to plasma. And that's before considering disruptions to vasculature in the tumor microenvironment that are expected to further augment drug delivery.

Josh Allen: Keep in mind that this is all based on plasma concentrations and that many target tissues are expected to have even higher exposure based on prior distribution studies in rodents.

Josh Allen: For example, brain tissue showed a two-fold higher drug concentration relative to plasma, and that's before considering disruptions to vasculature in the tumor microenvironment that are expected to further augment drug delivery.

Joshua Allen: And that's before considering disruptions to vasculature in the tumor microenvironment that are expected to further augment drug delivery. While that is already promising at the current dose, our modeling suggests that we may be able to push the dose up even a bit further to fully optimize the pharmacologic activity of the compound. We therefore have two more dose levels to enroll that we expect to top out at 200 milligrams twice a day for three consecutive days per week by the end of the year.

Joshua Allen: While that is already promising at the current dose, our modeling suggests that we may be able to push the dose up even a bit further to fully optimize the pharmacologic activity of the compound. We therefore have two more dose levels to enroll that we expect to top out at 200 milligrams twice a day for three consecutive days per week by the end of the year. This enrollment is on top of the more than 75 patients dosed to date that have provided a robust safety and PK data set.

Josh Allen: While that is already promising at the current dose, our modeling suggests that we may be able to push the dose up even a bit further to fully optimize the pharmacologic activity of the compound.

Josh Allen: We therefore have two more dose levels to enroll that we expect to top out at 200 milligrams twice a day for three consecutive days per week by the end of the year.

Joshua Allen: This enrollment is on top of the more than 75 patients dosed to date that have provided a robust safety and PK data set. Following this, we will make a determination of how to best advance the compound into efficacy studies in selected populations. Establishing safety and PK are the primary goals of these studies.

Josh Allen: This enrollment is on top of the more than 75 patients dose to date that have provided a robust safety and PK data set. Following this, we will make a determination of how to best advance the compound into efficacy studies in selected populations.

Joshua Allen: Following this, we will make a determination of how to best advance the compound into efficacy studies in selected populations. Establishing safety and PK are the primary goals of these studies. However, we are all, of course, keen to look for objective responses whenever possible, and we have an eye on this in the current and future cohorts. These are phase one trials that enroll patients at various doses with many different forms of CNS cancer and at different time points in their disease journeys that often involve surgery, radiotherapy, and chemotherapy. Therefore, the assessment of response needs to be handled very carefully to avoid misinterpretation.

Josh Allen: Establishing safety and PK are the primary goals of these studies. However, we are all, of course, keen to look for objective responses whenever possible, and we have an eye on this in the current and future cohorts.

Joshua Allen: However, we are all, of course, keen to look for objective responses whenever possible, and we have an eye on this in the current and future COAP. These are phase one trials that enroll patients at various doses with many different forms of CNS cancer and at different time points in their disease journeys that often involve surgery, radiotherapy, and chemotherapy. Therefore, assessment of response needs to be handled very carefully to avoid misinterpretation.

Josh Allen: These are phase one trials that enroll patients at various doses with many different forms of CNS cancer and at different time points in their disease journey that often involves surgery, radiotherapy, and chemotherapies.

Josh Allen: Therefore, assessment of response needs to be handled very carefully to avoid misinterpretation.

Joshua Allen: Response assessment may be appropriate in the subset of patients who meet certain criteria, including those who have a CNS tumor that has progressed on prior therapy, received monotherapy ONC-206 without concurr or very recent anti-cancer interventions, are naive to imiprodone treatment, have achieved adequate exposure to ONC-206, and have disease characteristics that are invaluable by conventional response criteria for CNS tumors such as Raynaud. The ongoing trials have recently begun enrolling patients who meet these specific criteria, and we expect some patients enrolled in the two remaining dose cohorts may also meet these criteria for appropriateness to evaluate objective results. This is an exciting opportunity to get an initial glimpse into the potential of OCT206 to treat CNS tumors.

Joshua Allen: And we expect some patients enrolled in the two remaining dose cohorts may also meet these criteria for appropriateness to evaluate objective response. This is an exciting opportunity to get an initial glimpse into the potential of OCT206 to treat CNS tumors. And we are carefully monitoring these patients in these higher-dosing cohorts, in particular those who are starting to stay on study beyond the typical window of time for DLT assessment when we would otherwise expect further disease progression.

Josh Allen: Response assessment may be appropriate in the subset of patients who meet certain criteria.

Josh Allen: including those who have a CNS tumor that has progressed on priority therapy.

Josh Allen: Received monotherapy on 206 without concurrence or very recent indicator interventions, are naive to a Mepardone treatment, have achieved adequate exposure to on 206, and have disease characteristics that are valuable by conventional response criteria for CNS tumors, such as Reino.

Josh Allen: The ongoing trials have recently begun enrolling patients who meet these specific criteria, and we expect some patients enrolled in the two remaining dose cohorts may also meet these criteria for appropriateness to evaluate objective response.

Josh Allen: This is an exciting opportunity to get an initial glimpse into the potential of Oct06 to treat CNS tumors.

Joshua Allen: And we are carefully monitoring these patients in these higher-dosing cohorts, in particular those who are starting to stay on study beyond the typical window of time for DLT assessment when we would otherwise expect further disease progression. Given the need to confirm responses and the importance of characterizing their durability, initial readout of objective response is expected to occur in the first half of 2025. We're very excited about the current stage of the study, where OCTU6 is now safely achieving sustained biologically active concentrations in patients, some of whom have forms of CNS cancer that are expected to be responsive to OCTU-L6 based on preclinical models, and some of whom have never been tested before in the clinic with either OCTU-L6 or even OCTU-L1. An example of that is medulloblastoma, where OCTU-06 has consistently shown compelling in vivo efficacy as a monotherapy in mouse models, and we have just enrolled our first patient with this tumor.

Josh Allen: And we are carefully monitoring these patients in these higher dosing cohorts, in particular those who are starting to stand that he's beyond the typical window of time for DLT assessment, when we would otherwise expect further disease progression.

Joshua Allen: Given the need to confirm responses and the importance of characterizing their durability, initial readout of objective response is expected to occur in the first half of 2025. We're very excited about the current stage of the study, where OCTO6 is now safely achieving sustained biologically active concentrations in patients, some of whom have forms of CNS cancer that are expected to be responsive to OCT206 based on preclinical models, and some of whom have never been tested before in the clinic with either OCT206 or even OCT201.

Josh Allen: Given the need to confirm responses and the importance of characterizing their durability, initial readout of objective response is expected to occur in the first half of 2025.

Speaker Change: We're very excited about the current stage of the study where October 6 is now safely achieving sustained biologically active concentrations in patients.

Speaker Change: Some of which have forms of CNS cancer that are expected to be responsive to OCT-206 based on preclinical models, and some of which have never been tested before in the clinic with either OCT-206 or even OCT-201.

Joshua Allen: An example of that is medulloblastoma, where OCTU-06 has consistently shown compelling in vivo efficacy as a monotherapy in mouse models, and we have just enrolled our first patient with this tumor. We look forward to updating you more on this program in the future that is evaluating the potential of ONC-206 in indications beyond that of Dordabapro. With that, I will turn the call over to Michelle for an update on the finances. Thank you, Josh.

Speaker Change: An example of that is Mediolo Blastoma, where onto a six has consistently shown compelling and bevel efficacy as a monotherapy in mouse models and we have just enrolled our first patient with this tumor type.

Joshua Allen: We look forward to updating you more on this program in the future that is evaluating the potential of ONC-206 in indications beyond that of the door DAB approach. With that, I will turn the call over to Michelle for an update on financials. Thank you, Josh. We continue a balanced approach of investing in R&D while keeping a tight control on G&A expenses, which have essentially been flat year on year.

Speaker Change: We look forward to updating you more on this program in the future that is evaluating the potential of Ong206 and indications beyond that of Dordabapro. With that, I will turn the call over to Michelle for an update on financial results.

Michelle LaSpaluto: Thank you, Josh. We continue a balanced approach of investing in R&D while keeping a tight control on G&A expenses, which have essentially been flat year-on-year. This discipline has allowed us to maintain an average burn rate for the past six months of about $16 million a quarter. We expect this rate to increase modestly in the quarters to come as we begin to make investments in launch readiness in advance of the interim OS assessment next year. As always, we remain confident in our ability to make smart investment decisions as we approach upcoming catalysts.

Michelle LaSpaluto: Thank you, Josh.

Michelle LaSpaluto: We continue a balanced approach of investing in R&D while keeping a tight control on DNA expenses.

Michelle LaSpaluto: This discipline has allowed us to maintain an average burn rate for the past six months of about $16 million a quarter. We expect this rate to increase modestly in the quarters to come as we begin to make investments in launch readiness in advance of the interim OS assessment next year. As always, we remain confident in our ability to make smart investment decisions as we approach upcoming catalysts. Now, turning to the financial results for the quarter.

Michelle LaSpaluto: Which has essentially been flat year on year. This discipline has allowed us to maintain an average burn for the past six months of about 16 million a quarter.

Michelle LaSpaluto: We expect this rate to increase modestly in the quarters to come as we begin to make investments in launch readiness in advance of the interim OS assessment next year. As always, we remain confident in our ability to make smart investment decisions as we approach upcoming catalysts.

Michelle LaSpaluto: Now, turning to the financial results for the quarter, earlier today we issued a press release containing our financial results for the second quarter of 2024. For the second quarter of 2024, we reported a net loss of $20.7 million compared to a net loss of $18.6 million in the second quarter of 2023. Research and Development Expenses increased to $18.4 million for the second quarter of 2024, compared to $16.9 million for the same period in 2023. This was driven primarily by increases in spending in the Action Study.

Michelle LaSpaluto: Earlier today, we issued a press release containing our financial results for the second quarter of 2024. For the second quarter of 2024, we reported a net loss of $20.7 million compared to a net loss of $18.6 million in the same period in the second quarter of 2023. Research and Development Expenses increased to $18.4 million for the second quarter of 2024 compared to $16.9 million for the same period in 2023. This was driven primarily by increases in spending in the Action Study. General and administrative expenses remained essentially flat at $4.5 million for the second quarter of 2024, compared to $4.4 million for the same period in 2023.

Speaker Change: Now, turning to the financial results for the quarter. Earlier today, we used to depress release, containing our financial results for 2nd quarter of 2024.

Speaker Change: The second quarter of 2024, we reported a net loss of $20.7 million, compared to a net loss of $18.6 million in the second quarter of 2023.

Speaker Change: Research and development expenses increased to $18.4 million for the second quarter of 2024, compared to $16.9 million for the same period in 2023. This was driven primarily by increases in spending in the action study.

Michelle LaSpaluto: General and administrative expenses remained essentially flat at $4.5 million for the second quarter of 2024, compared to $4.4 million for the same period in 2023. We ended the second quarter with just over $171 million in cash and cash equivalents. Under our current operational plan, we expect to have cash in 4Q of 2026. With that, I will now turn the call back over to Mike.

Speaker Change: General and administrative expenses remained essentially flat at $4.5 million for the second quarter of 2024 compared to $4.4 million for the same period in 2023.

Michael Andriole: We ended the second quarter with just over $171 million in cash and cash equivalents. Under our current operational plan, we expect to have cash into the fourth quarter of 2026. With that, I will now turn the call back over to Mike. Thanks, Michelle. Throughout the remainder of 2024, we will continue to focus on the execution and enrollment of the Phase III Action Study to accelerate this potentially life-altering drug to patients as quickly as possible, and we'll continue to advance our discussions with regulators in Australia and hope to reach agreement on filing for provisional registration before year end.

Speaker Change: We ended the second quarter with just over $171 million in cash and cash equivalents. Under our current operational plan, we expect to have cash into 4Q of 2026.

Speaker Change: With that, I will now turn the call back over to Mike.

Michael Andriole: Throughout the remainder of 2024, we will continue to focus on the execution and enrollment of the Phase III Action Study to accelerate this potentially life-altering drug to patients as quickly as possible, and we'll continue to advance our discussions with regulators in Australia and hope to reach agreement on filing for provisional registration before year end. The safety and PK progress we reported today from the ONC-206 program furthers our conviction in the potential for second-generation imicrodone, and we look forward to enrolling the remaining two-dose cohorts later this year.

Mike Andriole: Thanks, Michelle.

Mike Andriole: Throughout the remainder of 2024, we will continue to focus on the execution and enrollment of the phase 3 action study to accelerate this potentially life-altering drug to patients as quickly as possible. And we'll continue to advance our discussions with regulators in Australia and hope to reach agreement on filing for provision or registration before years end.

Michael Andriole: The safety and PK progress we reported today from the ONC-206 program furthers our conviction in the potential for the second generation omicrodone, and we look forward to enrolling the remaining two-dose cohorts this year. Lastly, as we move past the midpoint of the year, I'd like to take a brief moment to thank all of my fellow employees at Chimerix who are working tirelessly to bring this pipeline to fruition. Thank you for your dedication to our mission. It's this shared sense of purpose that drives our continued progress now and into the future.

Mike Andriole: The safety and PK progress we reported today from the ONC-206 program furthers our conviction in the potential for the second-generation imiprodone, and we look forward to enrolling the remaining two-dose cohorts yet this year.

Michael Andriole: Lastly, as we move past the midpoint of the year, I'd like to take a brief moment to thank all of my fellow employees at Chimerix who are working tirelessly to bring this pipeline to fruition. Thank you for your dedication to our mission. It's this shared sense of purpose that drives our continued progress now and into the future. With that, Dustin, we'll open the call to questions.

Mike Andriole: Lastly, as we move past the midpoint of the year, I'd like to take a brief moment to thank all of my fellow employees at Chimerics who are working tirelessly to bring this pipeline to fruition. Thank you for your dedication to our mission. It's this shared sense of purpose that drives our continued progress now and into the future.

Operator: With that, Dustin, we'll open the call to questions. Thank you, sir. As a reminder, if you'd like to ask a question, please press star and the number one on your telephone keypad. We will begin the question and answer session. Our first question for today comes from the line of Maurice Raycroft from Jefferies. The line is open.

Mike Andriole: With that, Dustin, we'll open the call to questions.

Operator: Thank you, sir. As a reminder, if you'd like to ask a question, please press star and the number one on your telephone keypad. We will begin the question and answer session. Our first question for today comes from the line of Maurice Raycroft from Jefferies.

Dustin: Thank you, sir. As a reminder, if you'd like to ask a question, please press star and the number one on your telephone keypad.

Speaker Change: We will begin the question and answer session.

Maurice Raycroft: Hi, good morning. Congratulations on the progress, and thanks for taking the time to answer my questions. Maybe I'll start with 206. So for the higher dose cohorts of 206, could you potentially backfill any of those cohorts? And maybe talk more about the first half of 2025 update. Can you talk about the number of patients that you could report on, the amount of follow-up goals that you have, and just how you plan on doing that disclosure as well? Yeah, thanks, Maury, for the question. I'm gonna turn that over to Josh to answer both of those. Josh?

Speaker Change: Our first question for today comes from the line of Maury Raycroft from Jefferies. The line is open.

Maurice Raycroft: Hi, good morning. Congratulations on the progress and thanks for taking the time to answer my questions. Maybe I'll start with 206. So for the higher dose cohorts for 206, could you potentially backfill any of those cohorts and maybe talk more about the first half of 2025 update? Can you talk about the number of patients that you could report on, the number of follow-up goals that you have, and just how you plan on doing that disclosure as well?

Maury Raycroft: Hi, good morning. Congrats on the progress and thanks for taking my questions.

Maury Raycroft: Maybe I'll start with 206. So, for the higher dose cohorts for 206, could you potentially backfill any of those cohorts?

Speaker Change: And maybe talk more about the first half of the 20, 25 update, can you talk about a number of patients that you could report on the amount of follow-up goals that you have and just how you plan on doing that disclosure as well.

Michael Andriole: Yeah, thanks, Maury, for the question. I'm going to turn that over to Josh to answer both of those. Josh?

Josh Allen: Thanks, Maury, for the question. I'm going to turn that over to Josh to answer both of those.

Joshua Allen: Yeah, happy to do that, Maury. Good to hear from you. In terms of backfilling cohorts for the remaining couple that we're going through, we'll be looking at treatment nave patients. I mean, there's the opportunity in the pediatric trial for some intrapatient dose escalation after treatment nave patients have completed their DLT window. So by and large, we're looking really to load in patients that are in the treatment nave setting. In terms of how many patients and how much follow-up we're looking at, in general, these are, especially as we get into the final cohorts of the study, tend to follow more of the 3 plus 3 kind of paradigm.

Joshua Allen: Yeah, happy to do that. Maury, good to hear from you. In terms of backfilling cohorts for the remaining couple that we're going through, we'll be looking at treatment-naive patients. I mean, there's the opportunity in the pediatric trial for some intrapatient dose escalation after naive patients have completed their DLT window. So by and large, we're looking really to load in patients that are in the treatment-naive setting. In terms of how many patients and how much follow-up we're looking at, in general, these are, especially as we get into the final cohorts of the study, tend to follow more of the three plus three kind of paradigm. And keep in mind, there are two different trials, two different enrollment settings for pediatrics.

Joshua Allen: So we should have an experience that follows somewhere in that range with about three cohorts following roughly a three plus three design. In terms of the amount of follow-up, the DLT window, keeping in mind safety, the primary goal of this study, lands at around a month. So that's what you need sort of for safety.

Josh Allen: Yeah, happy to do that. Mario, good to hear from you. In terms of backfilling cohorts for the remaining couple that we're going through, we'll be looking at treatment naïve patients. I mean, there's the opportunity.

Josh Allen: on the pediatric trial for some intrapatient dose escalation after naive patients have completed their DLT window. So, by and large, we're looking really to load in patients that are in the treatment naive setting. In terms of, you know, how many patients and how much follow-up we're looking at, in general, these are, especially as we get into the final cohorts of the study, tend to follow more of the three plus three kind of paradigm. And keep in mind, there's two different trials, two different enrollment settings for pediatrics. So, you know, we should have an experience that follows somewhere in that range with about three cohorts following roughly a three plus three design. In terms of the amount of follow-up, you know, the DLT window, keeping in mind safety is the primary goal of this study, lands it around.

Joshua Allen: And keep in mind, there are two different trials, two different enrollment settings for pediatrics. So we should have an experience that falls somewhere in that range with about three cohorts following roughly a 3 plus 3 design. In terms of the amount of follow-up, you know, the DLT window, keeping in mind safety is the primary goal of this study, lands at around a month. So that's what you need sort of for safety. Response assessment, like I mentioned in my prepared remarks, takes a little more time to confirm and characterize durability. So we're looking more at the first half of 2025 when we look at how long we need to follow some of those patients out in these final cohorts for an initial look at response.

Joshua Allen: Response assessment, like I mentioned in my prepared remarks, takes a little more time to confirm and characterize durability. So we're looking more at the first half of 2025 when we look at how long we need to follow some of those patients out in these final cohorts for an initial look at response. Got it. Okay. And anything more you're saying about the types of tumors that could be in that update, any baseline trends that you're seeing that you can comment on? Not too much to say other than, you know, I mentioned the medulloblastoma example there. I'll just note that ONC 201 within CNS tumors was largely limited in its exploration to glioblastoma and H3K27M mutant glioma.

Josh Allen: That's what you need sort of for safety. Response assessment, like I mentioned in my prepared remarks, takes a little more time to confirm and characterize durability. So we're looking more at the first half of 2025 when we look at how long we need to follow some of those patients out in these final cohorts for initial look at response.

Joshua Allen: Got it. Okay. Anything more you're saying about the types of tumors that could be in that update, any baseline trends that you're seeing that you can comment on?

Speaker Change: Got it. Okay. And anything more you're saying about the types of tumors that could be in that update? Any baseline trends that you're seeing that you can comment on?

Joshua Allen: Not too much to say other than, you know, I mentioned the medulloblastoma example there. I'll just note that ONC 201 within CNS tumors was largely limited in its exploration to glioblastoma and H3K27M mutant glioma given, you know, some of the initial stages of escalation with 206 when it started in its program at a time when action wasn't There was, you know, a variety of tumors that may have come into that initial experience, but we really think there are a lot of other CNS tumors that have never been tested before with either ONC 206 or ONC 201 that could make sense based on the mechanism and non-clinical data.

Speaker Change: Um, not not too much to say other than, you know, I mentioned that the Metro low blast domain example there, um, I'll just note that on to a one within CNS tumors was largely limited in its exploration to glial blastoma, an H3K27M muting glialoma, um, given, you know, some of the initial stages of escalation with 206 when it started in its program, at a time action, was an open, there was, um, you know, a variety of tumors that may have came into that initial experience, but we really think there's a lot of other CNS tumors. That have never been tested before with either October 6 or October 1.

Joshua Allen: Given, you know, some of the initial stages of escalation with 206 when it started in its program at a time when action wasn't open, there were, you know, a variety of tumors that may have come into that initial experience, but we really think there are a lot of other CNS tumors that have never been tested before with either ONC 206 or ONC 201 that could make sense based on the mechanism and non- So, we're really excited in these final cohorts to get into some of these tumor types that we think could make sense that we've never tested before. Metriloblastoma is just one example of that I mentioned there, and I look forward to seeing if we get more patients that fit that profile and updating on them in the future.

Joshua Allen: So we're really excited in these final cohorts to get into some of these tumor types that we think could make sense that we've never tested before. Medulloblastoma is just one example of that, and I look forward to seeing if we get more patients that fit that profile and updating on them in the future.

Speaker Change: that could make sense based on the mechanism and non-clinical data. So we're really excited in these final cohorts to get into some of these tumor types that we think could make sense that we've never tested before. Metriloblastoma is just one example of that I mentioned there and look forward to seeing if we get more patients that fit that profile and updating on them in the future.

Michael Andriole: Got it. Okay, and maybe I'll ask one question on 201 and hop back in the queue. Just for the new guidance for the interim overall survival data in the third quarter of 2025, are you seeing event rates stabilize, or is there anything else on clinical metrics that you can comment on that you're seeing in the study? Yeah, thanks, Maury, for the question. Certainly, enrollment rates are consistent, stable, and predictable at this point. Event rates, blinded event rates, are just now beginning to come in, so I'd say it is still early days on blinded event rates, but stay tuned in the coming quarters for updates there.

Speaker Change: Got it. Okay, and maybe I'll ask one question on 201 and hop back in the queue. Just for the new guidance for the interim overall survival data in third quarter of 2025, are you seeing

Speaker Change: Event rates stabilize or is there anything else on clinical metrics that you can comment on that you're seeing in the study?

Michael Andriole: Yeah, thanks, Maury, for the question. I'm certainly seeing enrollment rates are consistent, stable, and predictable at this point. Event rates, blinded event rates, are just now beginning to come in, so I'd say it's still early days on blinded event rates, but stay tuned in the coming quarters for updates there. We have enough confidence to project out about a year when we expect that first interim OS, but more to follow on blinded event rates and observed event rates as we get into the next quarter. I think it'll be instructive. Got it. Okay.

Speaker Change: Yeah, thanks, Maury, for the question. Certainly seeing enrollment rates.

Speaker Change: are consistent, stable, and predictable at this point. Event rates.

Speaker Change: Blinded Event Rates are just now beginning to come in, so I'd say it's still early days on blinded event rates, but stay tuned in the coming quarters for updates there.

Michael Andriole: We have enough confidence to project out about a year when we expect that first interim OS, but more to follow on blinded event rates and observed event rates as we get into the next quarter. I think that will be instructive.

Speaker Change: Enough confidence to project out about a year when we expect that first interim OS, but more to follow on blinded event rates and observed event rates as we get into the next quarter. I think it'll be instructive.

Michael Andriole: Got it. Okay. Thanks for doing my part.

Maurice Raycroft: Okay. Thanks for doing my questions. Thank you. Our next question comes from the line of Soumit Roy from Jones Research. The line is open.

Speaker Change: Got it. Okay, thanks for doing my questions.

Operator: Thank you. Our next question comes from the line of Soumit Roy from Jones Research. The line is open.

Speaker Change: Thank you.

Speaker Change: Our next question comes from the line of Schmidt-Roy from Jones Research.

Soumit Roy: Good morning, everyone, and congrats on all the progress. Sorry, I missed the comment on the last question. Did you provide any color on the enrollment status, like how far along is it that the Phase 3 action trial is enrolled, and will you be providing any baseline characteristics in a blinded fashion well ahead of the data? Thank you. Thank you. Thank you.

Soumit Roy: Good morning everyone and congrats on all the progress. Sorry I missed the comment on the last question. Did you provide any color on the enrollment status, like how far along is it that the phase 3 action trial is enrolled, and will you be providing any baseline characteristics in a blinded fashion ahead of well ahead of the data?

Will OConnor: I would now like to introduce to you your host for today's call, Will OConnor for Stern Investor Relations. Please proceed. Thank you operator.

Schmidt-Roy: The line is open. Good morning, everyone, and congrats on all the progress. Sorry I missed the comment on the last question. Did you provide any color on the enrollment status?

Schmidt-Roy: How far along is it that Phase 3 Action Trial is enrolled and will you be providing any baseline characteristics in a blinded fashion well ahead of the data?

Will OConnor: Good morning everyone and welcome to the Chimerix Second Quarter 2024 Financial and Operating Results Conference call. This morning we issued a press release related to our second quarter operating update. You can access the press release in the Investor section of the Chimerix website.

Michael Andriole: Yeah, hey, Soumit, thank you for the question. Yeah, enrollment, we continue to be excited about the level of engagement from investigators around the world, not just in the U.S., but really, a really balanced enrollment between the U.S., Europe, and Asia, and really proportional. So, the progress continues to be very encouraging. We're seeing meaningful contributions geographically around the world. We haven't provided exact guidance on where we are with enrollment, but we're on track to meet that first interim OS assessment in Q3 of next year. With respect to early disclosures of patient characteristics, we're not planning to do that. That will be part of the final data readout.

Michael Andriole: Yeah, enrollment. We continue to be excited about the level of engagement from investigators around the world, not just in the U.S., but really a really balanced enrollment between the U.S., Europe, and Asia, and really proportional. So it continues to be very encouraging. We're seeing meaningful contributions geographically around the world. We haven't provided exact guidance on where we are with enrollment, but we're on track to meet that first interim OS assessment in Q3 of next year. With respect to early disclosures of patient characteristics, we're not planning to do that.

Soumit Roy: One last question, would you be providing any color on... screen failure rate? Is it matching up with your prior experience, or if anything changed by geographic location or any other metrics?

Schmidt-Roy: Yeah, hey, Shumit, thank you for the question. Yeah, enrollment, we continue to be excited about the level of engagement from investigators around the world, not just in the U.S., but really, a really balanced enrollment between the U.S., Europe, and Asia, and really proportional. So, continues to be very encouraging. We're seeing meaningful contributions geographically around the world. We haven't provided exact guidance on where we are with enrollment, but we're on track to meet that first interim O.S. assessment in Q3 of 2020.

Michael Andriole: That will be part of the final data. Okay. One last question. Would you be providing any color on the screen failure rate?

Will OConnor: With me today, with me on today's call are President and Chief Executive Officer Mike Andriole, Chief Financial Officer Michelle LaSpaluto, and Chief Technology Officer Josh Allen.

Will OConnor: We also have Allen Melemed, our Chief Medical Officer, and Tom Riga, our Chief Operating and Commercial Officer for Questions.

Will OConnor: Before we begin, I'd like to remind you that today that the statements made on today's call include forward-looking statements within the meaning of the Security Private Security's 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.

Schmidt-Roy: of next year. With respect to early disclosures of patient characteristics, we're not planning to do that. That will be part of, that'll be part of the final data readout.

Allen Melemed: Is it matching up with your prior experience, or has anything changed by geographic location or any other metric? Thanks, Shuman. I'll turn that over to Allen for comment. Our screen failure rate is as we've been expecting it to be. Now, these are hard patients to get as it is a rare patient population, and our enrollment does have specific criteria that are necessary to show activity, but our screen failure rate has been consistent throughout the study at this point.

Speaker Change: One last question, would you be providing any color on...

Speaker Change: Screen failure rate, is it matching up with your prior experience or if anything changed by geographic location or any other metrics?

Michael Andriole: At this time, I'll now turn a call over to Chimerix President and Chief Executive Officer Mike Andriole. Thanks Will. Good morning everyone and thank you for joining us. It's been a busy summer at Chimerix and we continue to make meaningful progress across our clinical programs. Starting with our lead program, Dordava Prone, our team continues to be laser-focused on the execution and enrollment of the Phase III Action Study, which is on track for the first interim overall survival readout in the third quarter of next year.

Michael Andriole: Thanks, Shuman. I'll turn that over to Allen for comment. Allen

Allen Melemed: Our screen failure rate is as we've been expecting it to be. These are hard patients to get as it is a rare patient population, and our enrollment does have specific criteria that is necessary to show activity, but our screen failure rate has been consistent throughout the study at this point. Yeah, and it's pretty much in line with what we expected at the start of the study.

Allen Melemed: Thanks, Shuman. I'll turn that over to Allen for comment.

Allen Melemed: Our screen failure rate is as we've been expecting it to. These are hard patients to get, as it is a rare patient population, and our enrollment does have specific criteria that is necessary to show activity. But our screen failure rate has been consistent throughout the study.

Allen Melemed: And this is pretty much in line with what we expected at the start of the study.

Allen Melemed: Yeah, and it's pretty much in line with what we expected at the start of the study. Great. Thank you so much.

Allen Melemed: at this point. And it's pretty much in line with what we expected at the start of the study. Correct.

Michael Andriole: We're executing with urgency as there remains a significant need for patients battling in this lethal disease. With no approved treatment options available that have proven clinical benefit beyond radiation therapy, we're keenly aware of the importance of speed in addressing this unmet need. It's because of this need that we continuously evaluate registration pathways globally to accelerate commercial access to Dordava Prone where possible. Earlier this year, we initiated the evaluation process for Dordava Prone to be considered for provisional registration in Australia.

Speaker Change: Great. Thank you so much. Sure.

Operator: Thank you. Our next question comes from the line of Ed Hoyt from H.C. Wainwright. The line's open.

Soumit Roy: Thank you. Our next question comes from the line of Ed Hoyt from H.C. Wainwright. The line's open. Good morning.

Speaker Change: Thank you. Our next question comes from the line of Ed Hoyt from H.C. Wainwright.

Ed Hoyt: Good morning. Thanks for taking my questions. Just to follow up on the 206 study, you had mentioned that the response data could be available in the first half of 2025. What about the further PK, final PK, and safety data? Would that be available before that, and would you disclose that before that, or just wait until you get the response rate data?

Ed Hoyt: Thanks for taking my questions. Just to follow up on the 206 study, you had mentioned that the response data could be available in the first half of 2025. What about further PK, final PK, and safety data?

Speaker Change: The line is open.

Ed Hoyt: Good morning. Thanks for taking my questions. Just to follow up on the 206 study you had mentioned,

Joshua Allen: Would that be available before that, and would you disclose it before that, or just wait until you get the response rate data? Thanks, Ed, for the question. I'll turn that over to Josh.

Michael Andriole: Provisional registration is a three-step process that begins with a pre-submission meeting to evaluate current data, the status of pivotal studies, and other program features. Following a supportive pre-submission meeting earlier in the year, our team recently initiated the second step in this process, the filing of a provisional determination application. So the regulators in Australia approved this application, the final step is to apply for provisional registration. If we proceed to this final step, it's expected that an NDA filing could occur as early as year-end 2024 with possible commercial availability in early 2026.

Ed Hoyt: that the response.

Ed Hoyt: Data could be...

Ed Hoyt: available in the first half of 25. What about the, you know, further PK, final PK and safety data? Would that be available before that? And if you would disclose before that or just wait until you get the response rate data?

Joshua Allen: Thanks, Ed, for the question. I'll turn that over to Josh. Josh? Yeah, Ed, nice to hear from you.

Joshua Allen: Yeah, Ed. Nice to hear from you. Thanks for the question. You know, the safety experience really requires, you know, about a month's DLT window, right?

Ed Hoyt: Thanks, Ed, for the question. I'll turn that over to Josh. Josh? Yeah, Ed. Nice to hear from you. Thanks for the question. You know, the safety experience really requires, you know, about a month.

Joshua Allen: So I mentioned that we planned to round out the rest of the dose escalation cohorts by the end of the year, and so I would expect safety data and PK data to follow in, you know, the months to come afterward. Okay, thanks. And just on Dordapheprone...

Josh Allen: month DLT window, right? So I mentioned that we plan to round out the rest of the dose escalation cohorts by the end of the year. So I would expect safety data and PK data to follow in, you know, the months to come after that.

Joshua Allen: This morning, we're also excited to provide a safety and PK update from our other clinical program, the second generation of Miprodon-Oc 206. We're making great strides advancing this program through phase one studies, which recently began dosing within unexpected therapeutic range, and we are now enrolling the first of two remaining dose cohorts. As we escalate and intensify the dose within this range, we're encouraged by ongoing pharmacokinetic data that is in line with modeled expectations for delivering dose proportionate exposures for extended duration.

Ed Hoyt: Okay, thanks. And just on Dordevaprone,

Michael Andriole: If you could just discuss your strategy outside of the US, in particular Australia, I think you had mentioned prior that you were looking to get a distribution agreement for Australia. Are you making any progress there or any progress outside of the US? Yeah, thanks, Ed. We've been studying that commercial model outside of the US for some time. I'm going to ask Tom Riga to comment on our status there. Hey, Ed, nice to hear from you. Yeah, we're doing a lot of work on that. I think the first step here is to work through the TGA process and, subsequently, the HTA process for reimbursement.

Speaker Change: If you could just discuss your ex-U.S. strategy, in particular, Australia. I think you had mentioned prior that you were looking to get a distribution agreement for Australia. Are you making any progress there or any progress outside of the U.S.?

Tom Riga: Thanks, Ed. We've been studying that commercial model outside of the U.S. for some time. I'm going to ask Tom Riga to comment on our status there. Hey, Ed. Nice to hear from you. Yeah, we're doing a lot of work on that. I think the first step here is to work through the TGA process and subsequently

Joshua Allen: You know, the safety experience really requires, you know, about a month DLT window, right? So I mentioned that we've planned to round out the rest of the dose escalation cohorts by the end of the year. And I would expect safety data and PK data to follow in the months to come after that.

Joshua Allen: Yeah, Ed, nice to hear from you. Thanks for the question.

Ed Hoyt: Okay, thanks. And just on Dordevaprone, if you could just discuss your ex-US strategy, in particular Australia, I think you had mentioned prior that you were looking to get a distribution agreement for Australia. Are you making any progress there or any progress outside of the US?

Thomas Riga: But we are looking at a lean commercial model that could include distribution partners and other strategies that will minimize the expense here at Chimerix but enable us to provide commercial availability. So more to follow as we progress through the regulatory process, but we are actively engaged in studying that business case. Okay, thanks, Tom. And my last question is just for Michelle.

Tom Riga: The HTA process for reimbursement, but we are looking at a lean commercial model that could include distribution partners and other strategies that will minimize the expense here at Chimerics, but enable us to provide commercial availability.

Michael Andriole: Thanks, Ed. We've been studying that commercial model outside of the U.S. for some time. I'm going to ask Tom Riga to comment on our status there. Hey, Ed. Nice to hear from you.

Thomas Riga: Hey Ed, nice to hear from you. Yeah, we're doing a lot of work on that. I think the first step here is to work through the TGA process and, subsequently, the HTA process for reimbursement, but we are looking at a lean commercial model that could include distribution partners and other strategies that will minimize the expense here at Chimerix but enable us to provide commercial availability. More to follow as we progress through the regulatory process, but we are actively engaged in studying that business case.

Joshua Allen: Thank you, Mike, and good morning, everyone. I'm delighted to provide an update on the program for our next generation product, O206, that is being evaluated in ongoing Phase I clinical trials. I'll start with a reminder that this is a small molecule that shares the novel clip P and D-2 binding targets with its parent compound or dava prone, and exhibits a tenfold increase in potency while retaining favorable safety and oral administration attributes.

Tom Riga: So more to follow as we progress through the regulatory process, but we are actively engaged in studying that business case.

Thomas Riga: Okay. Thanks, Tom. And my last question is just for Michelle.

Tom Riga: Thanks, Tom. My last question is just for Michelle. You had mentioned that

Michelle LaSpaluto: You mentioned that you are making investments in the launch and expect to see operating expenses increase modestly. What kind of investments have been made towards the launch so far? And, you know, are these, should we be thinking mostly about 2025? Or will some of these expenses impact the back half of this year?

Ed Hoyt: You mentioned that you are making investments in the launch and expect to see operating expenses increase modestly. What kind of investments have been made towards the launch so far? And, you know, are these, should we be thinking mostly about 2025, or will some of these expenses impact the back half of this year?

Speaker Change: You are making investments in the launch and expect to see operating expenses increase modestly. What kind of investments have been made towards the launch so far? And, you know, are these.

Joshua Allen: It also maintains the relatively rare ability to penetrate the blood brain barrier and has shown encouraging activity in non-clinical studies of specific forms of cancer both within and outside of the central nervous system. In the ongoing Phase I trials for pediatric and adult CNS tumors, we have previously completed dose escalation on a once per week administration schedule at doses reaching up to 350 milligrams. That experience demonstrated the desired peak plasma concentrations and safety in patients that we expected based on our non-clinical models.

Speaker Change: Should we be thinking mostly for 2025 or will some of these expenses impact the back half of this year?

Michelle LaSpaluto: Yeah, thanks. So we have seen, we've made a little bit of investment this year, obviously with Tom coming on board. And I do expect that, as I mentioned, to increase a little bit more this year, but obviously a little bit more as we continue into 2025. So, Tom, would you maybe elaborate a little bit on some of the early investment?

Michelle LaSpaluto: Yeah, thanks. So we have seen, we've made a little bit of investment this year, obviously with Tom coming on board. And I do expect that, as I mentioned, to increase a little bit more this year, but obviously a little bit more as we continue into 2025. So, Tom, would you maybe want to maybe elaborate a little bit on some of the early investments?

Speaker Change: Yeah, thanks.

Speaker Change: So we have seen, we've made a little bit of investment in this year, obviously with Tom coming on board, and I do expect that, as I mentioned, to increase a little bit more this year, but obviously a little bit more as we continue into 2025.

Joshua Allen: In parallel to the clinical evaluation of this dose schedule, non-clinical studies suggested that the anti-cancer activity of this compound could be enhanced by prolonging the duration of time that tumor cells are exposed to biologically active concentrations. Disappeared to potentially be achievable through dosing on a twice per day for three consecutive days per week administration schedule based on our modeling, and we have been busy testing this in the clinic this year. We have now generated human data for safety and pharmacokinetics or PK for short at doses reaching up to 100 milligrams at this intensified administration schedule.

Speaker Change: Um...

Tom Riga: So, Tom, did you want to maybe elaborate a little bit on some of the early, some of the early investment? Yeah. And we're going to, we're taking a gated approach to our spend on launch that lines up to our development milestones. So in the early days, we're engaging key stakeholders, obviously the investigators and the customer base through action, as well as patient advocacy. And the third stakeholder here is the payer and starting to engage and have early conversations there. So I think what you can expect from a burn standpoint in the back half of this year is modest. That work will involve both Salesforce size, structure, forecasting work to round out our early efforts in that regard, but it won't involve substantial.

Thomas Riga: Yeah, Ed, we're taking a gated approach to our spend on launch that lines up to our development milestones. So, in the early days, we're engaging key stakeholders, obviously the investigators and the customer base through action, as well as patient advocacy, and the third stakeholder here is the payer, and starting to engage and have early conversations there. So, I think what you can expect from a burn standpoint in the back half of this year is modest. The work will involve both Salesforce size, structure, and forecasting work to round out our early efforts in that regard, but it won't involve a substantial increase in head count and others. So, we're going to take a measured approach here to make sure that we're ready for the first interim here in Q3 of next year. Thank you.

Thomas Riga: And we're taking a gated approach to our spend on launch that lines up to our development milestones. So, in the early days, we're engaging key stakeholders, obviously, the investigators and the customer base through action, as well as patient advocacy. And the third stakeholder here is the payer, and they are starting to engage and have early conversations there. So, I think what you can expect from a burn standpoint in the back half of this year is modest.

Thomas Riga: That work will involve both Salesforce size, structure, and forecasting work to round out our early efforts in that regard, but it won't involve a substantial increase in headcount and others. So, we're going to take a measured approach here to make sure that we're ready for the first interim here in Q3 of next year. Okay, thanks for taking my question. Thank you. Our next question comes from the line of Troy Langford from T.D.

Joshua Allen: We are happy to report that the tolerability of the compound continues to be favorable as we continue dose intensification with no meaningful changes in the overall adverse event profile as the dosing has either escalated up or become more frequent. The most frequent treatment related adverse events are fatigue, vomiting, and lymphopenia that have occurred in a minority of patients in our largely low grade. With respect to PK results, our goal was to sustain biologically active concentrations for a prolonged duration of time and that is indeed what we have accomplished with the intensified dose schedule.

Tom Riga: and others, so we're going to take a measured approach here to make sure that we're ready for the first interim here in Q3 of next year.

Operator: Okay, thanks for taking my question.

Speaker Change: Okay, thanks for taking my question.

Ed Hoyt: Sure Ed, thanks.

Operator: Our next question comes from the line of Troy Langford from T.D. Cullen.

Speaker Change: Thank you. Our next question comes from the line of Troy Lanford from TD Coleman.

Joshua Allen: At 100 milligrams, twice a day for three days per week, the human PK results show that biologically active concentrations of onto a six were sustained for beyond 24 hours in plasma, and that peak plasma concentrations are well on excess of the compound IC50 and B-TRO, as well as exposures associated with in vivo efficacy and oncology models. Keep in mind that this is all based on plasma concentrations and that many target tissues are expected to have even higher exposure based on prior distribution studies and rodents.

Troy Langford: The line's open. Hi, congratulations on all the progress this quarter, and thanks for taking our questions. I just have two questions, both on 3rd Avapron.

Troy Langford: Hi, congratulations on all the progress this quarter, and thanks for taking our questions. I just have two questions, both on 3rd Avapron. First, can you all just remind us how large you think the commercial opportunity for 3rd Avapron in Australia could be relative to that of the US and EU? And then, related to that, do you think the TGA will want to see that first interim OS data from the action study before they issue an approval?

Speaker Change: The line is open.

Troy Lanford: Hi, congrats on all the progress this quarter and thanks for taking our questions.

Troy Langford: First, can you all just remind us how large you think the commercial opportunity for 3rd Avapron in Australia could be relative to that of the US and EU? And then, related to that, do you think the TGA will want to see that first interim OS data from the action study before they issue an approval? Yeah, thanks, Troy, and Mike. I'll start with that first question.

Troy Lanford: I just have two questions, both on 3rd Avapron. First, can you all just remind us how large you think the commercial opportunity for 3rd Avapron in Australia could be relative to that of the U.S. and EU? And then related to that, do you think the TGA will want to see that first interim OS data from the action study before they issue an approval?

Michael Andriole: Yeah, thanks Troy, it's Mike. I'll start with that first question. I'll ask Tom to comment on the size of the commercial opportunity in Australia, but with respect to our interactions with TGA to date, it's been focused on the Phase 2 50 patient registration cohort that we did the BICR on some time ago and the output of that. So there is certainly within that window the potential for that interim OS to read out, and yet that's not the basis of our discussions with regulators in Australia, it's really on the Phase Tom, you want to talk about the commercial opportunity? Yeah, commercial opportunity.

Troy Lanford: Thanks, Troy. Mike, I'll start with...

Michael Andriole: I'll ask Tom to comment on the size of the commercial opportunity in Australia, but with respect to our interactions with TGA to date, it's been focused on the phase two 50 patient registration cohort that we did the BICR on some time ago and the output of that. So there is... Certainly within that window, the potential for that interim OS to read out, and yet that's not the basis of our discussions with regulators in Australia. It's really on the phase two response rate data. Tom, do you want to talk about the commercial opportunity? Yeah, commercial opportunity in Australia is small relative to Europe and the U.S., obviously based on population.

Mike Andriole: That first question, I'll ask Tom to comment on the size of the commercial opportunity in Australia, but with respect to our interactions with TGA to date, it's been focused on the phase two 50 patient registration cohort that we did the BICR on some time ago and the output of that, so.

Joshua Allen: For example, brain tissues show the twofold higher drug concentrations relative to plasma, and that's before considering disruptions to vascular and the tumor microenvironment that are expected to further augment drug delivery. Well, that is already promising at the current dose. Our modeling suggests that we may be able to push the dose up even a bit further to fully optimize the pharmacologic activity of the compound. We therefore have two more dose level to enroll that we expect to top out at 200 milligrams twice a day for three consecutive days per week by the end of the year.

Speaker Change: There is

Speaker Change: Certainly within that window the potential for that interim OS to read out and yet the that's not the the basis of our discussions with regulators in Australia it's really on the the phase two response rate data.

Thomas Riga: Yeah, the commercial opportunity in Australia is small relative to Europe and the US, obviously, based on population. I think that proof of concept is important both for gaining first regulatory approval, as well as providing commercial access for patients in need. So that could be a business that is interesting if managed in a lean fashion from an overall operating expense, and we are looking forward to that potential opportunity. Thanks for all.

Speaker Change: Tom, you wanna talk about the commercial opportunity? Yeah, commercial opportunity in Australia is small relative to Europe and U.S., obviously, based on population. I think that proof of concept, I think, is important both for gaining first regulatory approval as well as providing commercial access for patients in need. So that could be a business that is interesting if managed in a lean fashion from an overall operating expense, and we are looking forward to that potential opportunity.

Thomas Riga: I think that proof of concept is important both for gaining first regulatory approval as well as providing commercial access for patients in need. So that could be a business that is interesting if managed in a lean fashion from an overall operating expense, and we are looking forward to that potential opportunity. Great. Thanks for all the color. Thank you. Seeing as there are no more questions in the queue, that concludes our question and answer session.

Joshua Allen: This enrollment is on top of the more than 75 patients dose today that have provided a robust safety and PK data set. Following this, we will make a determination of how to best advance the compound into efficacy studies in selected populations, establishing safety and PK are the primary goals of these studies. However, we are all, of course, keen to look for objective responses whenever possible and we have an eye on this in the current and future cohorts.

Troy Langford: Great. Thanks for all the color.

Speaker Change: Great. Thanks for all the color.

Operator: Seeing as there are no more questions in the queue, that concludes our question and answer session. I will now turn the call back over to Mike Andriole for closing remarks. Thanks, Dustin, and thank you, everyone, for your...

Speaker Change: Michael Andriole Michael Andriole Joshua Allen Allen Melemed Michael Andriole

Speaker Change: Thank you.

Joshua Allen: These are phase one trials that enroll patients at various doses with many different forms of CNS cancer. And at different time points in their disease journey that often involves surgery, radiotherapy and chemotherapies. Therefore, assessment of response needs to be handled very carefully to avoid misinterpretation. Response assessment may be appropriate in the subset of patients who meet certain criteria, including those who have a CNS tumor that has progressed on prior therapy, received monotherapy on 206 without concurrence or very recent anti-cancer interventions.

Speaker Change: Seeing as there are no more questions in the queue, that concludes our question and answer session. I will now turn the call back over to Mike Andriole for closing remarks.

Thomas Riga: I will now turn the call back over to Mike Andriole for closing remarks. Thanks, Dustin. And thank you, everyone, for your time this morning. We look forward to updating you in the coming months. Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

Michael Andriole: Thanks, Dustin. And thank you, everyone, for your time this morning. We look forward to updating you in the coming months.

Mike Andriole: Thanks, Dustin, and thank you, everyone, for your time this morning. We look forward to updating you in the coming months.

Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining us. You may now disconnect.

Speaker Change: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

Joshua Allen: Our naive to a meppardone treatment have achieved adequate exposure to off to a six and have disease characteristics that are available by conventional response criteria for CNS tumors such as rain out. The ongoing trials have recently begun in rolling patients who meet these specific criteria and we expect some patients enrolled in the two remaining dose cohorts may also meet these criteria for appropriateness to evaluate objective response. This is an exciting opportunity to get an initial glimpse into the potential of on 206 to treat CNS tumors and we are carefully monitoring these patients in these higher dose cohorts, in particular those who are starting to stand steady beyond the typical window of time for DLT assessment when we would otherwise expect further disease progression.

Joshua Allen: Given the need to confirm responses and the importance of characterizing their durability, initial readout of objective response is expected to occur in the first half of 2025. We are very excited about the current stage of the study where octo-6 is now safely achieving sustained biologically active concentrations in patients, some of which have forms of CNS cancers that are expected to be responsive to octo-6 based on preclinical models. And some of which have never been tested before in the clinic with either on 206 or even on 201. An example of that is Medjalo Blasoma where on 206 has consistently shown compelling and beable efficacy as a monotherapy and mouse models and we have just enrolled our first patient with this tumor type.

Joshua Allen: We look forward to updating you more on this program in the future that is evaluating the potential of on 206 in indications beyond that up to or down from.

Michelle LaSpaluto: With that, I will turn the call over to Michelle for an update on financial results. Thank you Josh. We continue a balanced approach of investing in R&D while keeping a tight control on DNA expenses, which has essentially been flat year on year. This discipline has allowed us to maintain an average burn for the past six months of about 16 million a quarter. We expect this rate to increase modestly in the quarters to come as we begin to make investments in launch readiness in advance of the interim OS assessment next year. As always, we remain confident in our ability to make smart investment decisions as we approach upcoming cattle.

Michelle LaSpaluto: Now, turning to the financial results for the quarter earlier today, we use you to press release containing our financial results for second quarter of 2024. The second quarter of 2024, we reported a net loss of 20.7 million compared to a net loss of 18.6 million in the second quarter of 2023. Research and development expenses increased to 18.4 million for the second quarter of 2024 compared to 16.9 million for the same period in 2023.

Michelle LaSpaluto: This was driven primarily by increases in spending in the action study. General and administrative expenses remained essentially flat at 4.5 million for the second quarter of 2024 compared to 4.4 million for the same period in 2023.

Michelle LaSpaluto: We ended the second quarter with just over 171 million in cash and in cash equivalent. Under our current operational plan, we expect to have cash into 4Q of 2026.

Michael Andriole: With that, I will now turn the call back over to Mike. Thanks, Michelle. Throughout the remainder of 2024, we will continue to focus on the execution and enrollment of the Phase III Action Study to accelerate this potentially life altering drug to patients as quickly as possible. And we'll continue to advance our discussions with regulators in Australia and hope to reach agreement on filing for provisional registration before years end. The Safety and PK progress we reported today from the Onc 206 program furthers our conviction and the potential for the second generation of microdome and we look forward to enrolling the remaining two dose cohorts yet this year.

Dustin: With that, Dustin, we'll open the call to questions. Thank you, sir. As a reminder, if you'd like to ask a question, please press star and the number one on your telephone keypad. We will begin the question and answer session.

Molly Raycroft: Our first question for today comes from the line of Molly Raycroft from Jeffries. The line's open. Hi, good morning. Congrats on the progress and thanks for taking my questions. Maybe I'll start with the 206. So for the higher dose cohorts for 206, could you potentially backfill any of those cohorts and maybe talk more about the first half of 2025 update? Can you talk about a number of patients that you could report on the amount of follow-up goals that you have and just how you plan on doing that disclosure as well?

Molly Raycroft: Thanks, Molly, for the question. I'm going to turn that over to Josh to answer both of those. Yeah, happy to do that. Molly, good to hear from you. In terms of backfilling cohorts for the remaining couple that we're going through, we'll be looking at treatment naive patients. I mean, there's the opportunity on the pediatric trial for some interpatient dose escalation after naive patients have completed their DLT window. So by and large, we're looking really to load in patients that are in the treatment naive setting.

Molly Raycroft: In terms of how many patients and how much follow-up we're looking at, in general, these are especially as we get into the final cohorts of the study, tend to follow more of the three plus three kind of paradigm and keep in mind there's two different trials, two different enrollment settings for pediatric. So, you know, we should have an experience that follows somewhere in that range with about three cohorts following roughly a three plus three design.

Molly Raycroft: In terms of the amount of follow-up, you know, the DLT window, keeping in mind safety is the primary goal of this study, lands it around a month. So, that's what you need sort of for safety response assessment. Like I mentioned in my prepared remarks, takes a little more time to confirm and characterize durability. So, we're looking more at the first half of 2025 when we look at how long we need to follow some of those patients out in these final cohorts for initial look at response.

Molly Raycroft: Got it. Okay. And anything more you're saying about the types of tumors that could be in that update, any baseline trends that you're seeing that you can comment on? Not too much to say, other than, you know, I mentioned the Metrolobe Blastoma example there. I'll just note that on 201 within CNS tumors was largely limited in its exploration to glioblastoma in H3K27L mutin glioma. Given, you know, some of the initial stages of escalation with 206 when it started in its program at a time action wasn't open.

Molly Raycroft: There was, you know, a variety of tumors that may have came into that initial experience, but I really think there's a lot of other CNS tumors that have never been tested before with either on 206 or on 201 that could make sense based on the mechanism and non-clinical data. So we're really excited in these final cohorts to get into some of these tumor types that we think could make sense that we've never tested before. Metrolobe Blastoma is just one example of that. I mentioned there and look forward to seeing if we get more patients that fit that profile and updating on them in the future. Got it. Okay.

Molly Raycroft: And maybe I'll ask one question. I want to hop back in the queue just for the new guidance for the interim overall survival data in 3rd quarter of this year of 2025. Are you seeing event rates stabilized or is there anything else on clinical metrics that you can comment on that you're seeing in the study? Yeah, thanks, Mary, for the question. Certainly seeing enrollment rates are consistent, stable, and predictable at this point.

Molly Raycroft: Event rates, blinded event rates are just now beginning to come in. So I'd say still early days on blinded event rates, but stay tuned in the coming quarters for updates there. We have enough confidence to project out about a year when we expect that that first interim OS, but more to follow on blinded event rates and observed event rates as we get into the next quarter. I think it'll be instructive. Got it. Okay. Thanks for hearing my questions. Sure. Thank you.

Soumit Roy: Our next question comes from the line of unit Roy from Jones Research. The line is open. Good morning everyone and congrats on all the progress. So you missed the comment on the last question. Did you provide any color on the indicators like how far along is it that phase 3 action trial is enrolled and will you be providing any baseline characteristics in a blinded fashion ahead of well ahead of the data?

Soumit Roy: Yeah, hey, Stuart, Stuart, thank you for the question. Yeah, enrollment, we continue to be excited about the level of engagement from investigators around the world, not just in the US, but really a really balanced enrollment between the US, Europe, and Asia, and really proportional. So it continues to be very encouraging. We're seeing meaningful contributions geographically around around the world. We haven't provided exact items on where we are within enrollment, but we're on track to meet that first interim OS assessment in Q3 of next year.

Soumit Roy: With respect to early disclosures of patient characteristics, we're not planning to do that. That will be part of, that will be part of the final date. One last question, would you be providing any color on screen failure rate? Is it matching up with your prior experience or if anything changed by geographic location or any other metrics? Thank you, Shimmer.

Allen Melemed: I'll turn that over to Alan for comment, Alan. Our screen failure rate is as we've been expecting it to. These are our patients to get as it is a rare patient population and our role that has specific criteria that is necessary to show our activities. But our screen failure rate has been consistent throughout the study at this point. Yeah, and then it's pretty much in line with what we expected at the start of the study. Correct, yeah. Great, thank you so much. Sure.

Unknown Executive: Thank you.

Ed White: Our next question comes from the line of Ed White from H.C. Winwright. The line's open.

Ed White: Good morning. Thanks for taking my questions. Just to follow on the 206 study you had mentioned that the response data could be available in the first half of 25. What about the further PK final PK and safety data? Was that the available before that and if you were disclosed before that or just wait until you get the response rate data? Yeah, thanks. Thanks for the question.

Joshua Allen: I'll turn that over to Josh. Yeah. Nice to hear from you. Thanks for the question. You know, the safety experience really requires, you know, about a month, a month deal T window. Right, so I mentioned that we planned around out the rescue to the dose escalation cohorts by the end of the year. So I would expect safety data and PK data to follow in, you know, the month to come after that. Okay, thanks.

Thomas Riga: And just on door Devaprone, you know, if you could just discuss your XUS strategy in particular, Australia, I think you had mentioned prior that you were looking to get a distribution agreement for Australia. Are you making any progress there or any progress outside of the US? Yeah, thanks. Thanks, Ed. We've been studying that commercial model outside of the US for some time. We're going to ask Tom, Tom Rigat to comment on our status there.

Michelle LaSpaluto: Hey, nice to hear from you. Yeah, we're doing a lot of work on that. I think the first step here is to work through the TGA process and subsequently the HTA process for reimbursement. But we are looking at a lean commercial model that could include distribution partners and other strategies that will minimize the expense here at Chimerix, but enable us to provide commercial availability. So more to follow as we progress through the regulatory process, but we are actively engaged in studying that business case.

Michelle LaSpaluto: Okay, thanks Tom. And my last question is just for Michelle, you had mentioned that you are making investments in the launch and expect to see operating expenses increased modestly. What kind of investments have been made towards the launch so far? And, you know, are these should we be thinking mostly for 2025 or will some of these expenses impact the back half of this year? Yeah, thanks. So we have seen, we've made a little bit of investment in this year, obviously with Tom coming on board.

Michelle LaSpaluto: And I do expect that, as I mentioned, to increase a little bit more this year, but obviously a little bit more as we continue into 2025. So Tom, did you want to maybe elaborate a little bit on some of the early investments? Yeah, and we're going to, we're taking a gated approach to our spend on launch that lines up to our development milestones. So in the early days, we're engaging key stakeholders, obviously the investigators in the customer base through action, as well as patient advocacy.

Michelle LaSpaluto: And the third stakeholder here is the payer and starting to engage in early conversations there. So I think what you can expect from a burn standpoint and the back half of this year is modest that work will involve both Salesforce size, structure, forecasting work to round out our early efforts in that regard, but it won't involve substantial increase in headcount and others. So we're going to take a measured approach here to make sure that we're ready for the first interim here in Q3 of next year. Okay, thanks for taking my question. All right, thanks. Thank you.

Troy Langford: Our next question comes from the line of Troy Landford from TD Cohen. The line's open. Hi, you can go through all the progress with quarter and thanks for taking our questions.

Michael Andriole: I just have two questions, both on Third Avaporn. First, can you all just remind us how large you think the commercial opportunity for Third Avaporn in Australia could be relative to that of the US and EU, and then relate to that. Do you think the TGA will want to see that first interim OS data from the action study before they issue an approval? Yeah, that'll be all thanks, Troy. Mike, I'll start with that first question.

Michael Andriole: And then I'll ask Tom to comment on the size of the commercial opportunity in Australia. But with respect to our interactions with TGA today, it's been focused on the phase two 50 patient registration cohort that we did the BICR on some time ago in the output of that. So there is certainly within that window the potential for that interim OS to read out. And yet, that's not the basis of our discussions with regulators in Australia, it's really on the phase two response rate data.

Michael Andriole: Tom, want to talk about the commercial opportunity? Yeah, commercial opportunity in Australia is small relative to Europe and US, obviously based on population. I think that proof of concept I think is important both for gaining first regulatory approval as well as providing commercial access for patients in need. So that could be a business that is interesting if managed in a lean fashion from an overall operating expense and we are looking forward to that potential opportunity.

Thomas Riga: Great. Thanks for all the color. Thank you.

Dustin: Seeing as there are no more questions in the queue, that concludes our question and answer session.

Michael Andriole: I will now turn the call back over to Mike Andriole for closing remarks. Thanks, Dustin. And thank you everyone for your time this morning. We look forward to updating you in the coming months.

Will OConnor: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

Unknown Executive: Thank you.

Q2 2024 Chimerix Inc Earnings Call

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