Q3 2024 Chimerix Inc Earnings Call
Good morning, ladies and gentlemen, and welcome to the Chimerics 3rd Quarter 2024 Earnings Conference Call. I would now like to introduce you to your host for today's call, Will O'Connor from Sturm Investor Relations. Please proceed.
Will O'Connor: Thank you, Operator. Good morning, everyone, and welcome to the Chimeric Third Quarter 2024 Financial and Operating Results Conference Call. This morning, we issued a press release related to our third quarter operating update. You can access the press release in our Investors section of the website.
With me on today's call are President and Chief Executive Officer Mike Andriole, Chief Scientific Officer Josh Allen, Chief Financial Officer Michelle LaSpaluto, Chief Medical Officer Allen Melemed, and Chief Operating and Commercial Officer Tom Riga for questions.
Speaker Change: Thank you, Will. Good morning, everyone, and thanks for joining us.
The third quarter was marked by continued execution across our pipeline including continued enrollment in our global phase 3 action study of dorgabaprone, and we are nearing complete enrollment of our phase 1 dose escalation studies for our second generation imiprodone ONC-206.
Speaker Change: The Phase III Action Study is active in 15 countries worldwide, and our first interim data readout is potentially less than a year away.
Speaker Change: During this past quarter, we received confirmation from the pre-specified Interim Safety Review undertaken by the study's Independent Data Monitoring Committee, which recommended the action study continue as is, with no change to study conduct.
Speaker Change: This is always welcome news, but even more so in the case of the ACTION study, where we have two treatment arms.
Speaker Change: One at the phase two 625 milligram dose administered once per week and a second treatment arm administering 625 milligrams twice per week on consecutive days or essentially a double dose of the phase two schedule
Speaker Change: Last month, we participated in the European Association for Neuro-Oncology Annual Meeting in Glasgow, Scotland. It was evident that the enthusiasm across the European community for this program and the degree of support from so many investigators who recognize the very high unmet need in this patient population only continues to strengthen with time.
Speaker Change: We view our partnership with the S.N.O.W. organizers and engagement at this pivotal conference as important to the success of our programs.
Speaker Change: Not only will we have presentations for DoorDataProne, but we'll also showcase ONC 206. Abstracts for that conference will release next week, so please stay tuned for more details. For those attending, we're looking forward to seeing many of you and our investigators in person.
Speaker Change: We continue to make progress with the Therapeutic Goods Administration, or TGA, to file for provisional approval in Australia. While this was not on our radar last year, we were agile when an opportunity arose earlier this year, and we're now in a position to file an NDA for provisional approval around year-end.
Speaker Change: Having the NDA document ready for submission in Australia also aids our capacity and timelines should we have a positive interim overall survival outcome for action next year.
Speaker Change: To that end, we are judiciously preparing the company and the market for Dordavapron's potential commercialization, as we may be within a year from the first interim readout.
Speaker Change: With our Phase III Action Study and our expanded access programs in the U.S. and Europe, we now have a well-laid foundation with hospitals and physicians who have ongoing treatment experience with dordabiphrone.
Speaker Change: Recall, there are no approved therapies specific to this patient population, and we consequently expect a rapid uptake upon potential commercialization, forecasting a potential global market opportunity over $750 million.
Turning to our second generation of Mifridone ARM 206.
Speaker Change: Our objective for the year is to gather safety and PK data in an unselected CNS patient population and to evaluate lead indications for the program. I'm happy to report the phase one dose escalation is nearing completion and the lab has been working diligently on non-clinical studies to inform the next step for the program.
Speaker Change: We continue to see ONC-206 as well tolerated in adult and pediatric patients as we near completion of the dose escalation studies. As we review the incoming clinical and preclinical data, we plan to announce next steps for the program in the coming months.
Speaker Change: Before I turn the call over to Michelle for a review of the financials, I'd like to take a brief moment to recognize the recent promotion of Josh Allen as our Chief Scientific Officer.
Since joining Chimerics in 2021 with the acquisition of Oncosutex,
Speaker Change: Josh has been an integral team leader and a trusted colleague to many across the company and has continually advanced the research and development of the Omiprodone class of compounds from academic discovery to the lead registration phase program. Please join me in congratulating Josh on this well-deserved promotion.
Speaker Change: For that, I'll turn the call over to Michelle for a brief review of our financials.
Michelle LaSpaluto: Thank you, Mike. Earlier today, we issued a press release containing our financial results for the third quarter of 2024.
Michelle LaSpaluto: For the third quarter of 2024, we reported a net loss of $22.9 million compared to a net loss of $24 million in the third quarter of 2023.
Michelle LaSpaluto: Research and Development Expenses increased to $19.6 million for the third quarter of 2024 compared to $17.4 million for the same period of 2023. This was primarily driven by increased spending in the Action Study.
Michelle LaSpaluto: General and administrative expenses decreased to $5.2 million for the third quarter of 2024 compared to $9.3 million for the same period in 2023. This decrease is due to a one-time non-cash expense related to historical grants recognized during the same period in 2023.
Michelle LaSpaluto: We ended the third quarter with just over $152 million in cash and cash equivalents. As anticipated, our cash burn rate did experience a modest increase this quarter.
Speaker Change: As in preparation for the commercialization of door dapper prone, we are committed to sensible cash management. Currently, we have a cash runway extending into the fourth quarter of 2026.
Speaker Change: With that, I will turn the call back over to Mike for closing remarks.
Mike Andriole: Thanks, Michelle. We've continued to execute our plan as expected in the third quarter with a focus on bringing Dordabaprone to patients as soon as possible. We're beginning to prepare our organization to launch Dordabaprone and are excited about the promise to further broaden our pipeline in the future by advancing ARC-206 or through business development initiatives.
With that, Leonardo, we'll open the call to questions.
and Michael Andriole. Thank you.
Speaker Change: Thank you. We will now begin the question and answer session. At this time, I would like to remind everyone in order to ask a question, press the star and then the number one in your telephone keypad.
Speaker Change: If you are called upon to ask your question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. Now we will pause for a moment to compile the question and answer roster.
Speaker Change: Your first question comes from the line of Maury Raycroft. Please go ahead.
Maury Raycroft: Can you talk about how you're preparing the submission of the NDA for Australia and a potential launch by the end of 2025? How are you using these commercialization efforts to potentially scale the organization for a potential U.S. launch too? Do you plan to leverage that NDA submission to dovetail into conversations with other regulatory agencies for accelerated approval paths as well?
Speaker Change: between that backbone and what might be needed or expected in other markets around the world. So we see synergy there in having this ready. Of course, the efficacy component for this application will be predicated on the phase two response rate data that we've previously announced.
Speaker Change: In terms of where we might utilize that in other markets around the world, we continue to look at the action study as the first opportunity for registration in other markets around the world. But should that change, we'll update the market accordingly. Tom, do you want to comment on?
Speaker Change: Great. Thanks for the clarity. And just another quick follow-up. So EBS announced the execution of contract options for $67.4 million to acquire Tempexa for national preparedness efforts.
Speaker Change: And they also announced yesterday that they'll conduct clinical trials with Timbexa for a monkeypox in Africa.
Speaker Change: So how much of that total contract value would Chimerix be eligible to receive and what will be the timing for receiving that milestone? Do you have any insight into how the monkeypox outbreak has affected the U.S. government's initiative to stockpile Temvexa for smallpox?
Speaker Change: Thanks for the question. Let me take the monkey pox part of that question and then I'll ask Michelle to answer the first part on the partial CLIN exercise.
From a MonkeyPox perspective, yes, Immersion did announce participation.
Speaker Change: in a randomized monkeypox study at the end of business yesterday. They're best positioned to answer questions on that. That is an ongoing new study to explore Tembex's utility in that population. We'll see how that unfolds in the coming years. That could lead to potential royalties to Chimerix when and if there could be international sales associated with that indication. But of course, they're at the very beginning of that process now.
Michelle comments on the milestone.
Michelle LaSpaluto: And with that option, we are due approximately $2.7 million related to that exercise. However, due to accounting rules, we have to wait until the cash is received for that to be recorded.
Speaker Change: So hopefully next quarter, we'll have a little bit more information on that. Yeah, that and that exercise, I think goes out to 2027, Michelle. So it's a multi-year.
Speaker Change: exercise of a CLIN that's about, or an option that's I think just over half of the value of that next option. That is correct.
Great. Thank you so much for taking my questions.
Speaker Change: Again, if you would like to ask a question, press star and then the number 1 on your telephone keypad.
The End
and Michelle LaSpaluto. Thank you.
Speaker Change: All right, that concludes our question and answer session. I will now turn the conference back over to Mike Andriole for closing remarks.
Mike Andriole: Thanks Leonardo. Thank you everyone for your time this morning and we look forward to updating you in the coming months.