Chimerix, Inc.

Good morning, ladies and gentlemen, and welcome to the Chimerics Third 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.

Thank you, operator. Good morning, everyone, and welcome to the Chimerics 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 investor section of the website. With me today on today's call are President and Chief Executive Officer Mike Andreol, Chief Scientific Officer Josh Allen, Chief Financial Officer Michelle Laspaludo, Chief Medical Officer Alan Melamed, and Chief Operating and Commercial Officer Tom Riga 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. 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 President and Chief Executive Officer Mike Andreol.

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 III action study of Dorgaviprone, and we are nearing complete enrollment of our Phase I dose escalation studies for our second generation of Mipridone Onc206. The Phase III action study is active in 15 countries worldwide, and our first interim data readout is potentially less than a year away. 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. This is always welcome news, but even more so in the case of the action study, where we have two treatment arms, one at the Phase II 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 at the Phase II schedule. Passing this IDMC safety review with no change to study conduct to any arm is a meaningful milestone and underscores the well-documented safety profile of Dorgaviprone that makes it both a promising profile as a potential monotherapy, but also an ideal candidate as a potential backbone therapy. 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. Turning a little closer to home, the Annual Meeting for the Society for Neuro-Oncology, also known as SNO, will occur in Houston, Texas later this month where we're planning a large presence. We view our partnership with the SNO organizers and engagement at this pivotal conference as important to the success of our programs. Not only will we have presentations for Dorgaviprone, but we'll also showcase Onc206. 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. 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 your end. 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. To that end, we are judiciously preparing the company and the market for Dorgaviprone's potential commercialization as we may be within a year from the first interim readout. 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 Dorgaviprone. 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 Mifredone, Onc206. 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 I dose escalation is nearing completion and the lab has been working diligently on non-clinical studies to inform the next step for the program. We continue to see Onc206 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. 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 Onc206, 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 amypridone class of compounds from academic discovery to the lead registration phase program. Please join me in congratulating Josh on this well-deserved promotion. With that, I'll turn the call over to Michelle for a brief review of our financials.

Thank you, Mike. Earlier today, we issued a press release containing our financial results for the third quarter of 2024. For the third quarter of 2024, we reported a net loss of $22.9 million compared to a 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. 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. 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. As in preparation for the commercialization of door-dabber prone, we are committed to sensible cash management. Currently, we have a cash runway extending into the fourth quarter of 2026. With that, I will turn the call back over to Mike for closing remarks.

Thanks, Michelle. We continue to execute our plan as expected in the third quarter with a focus on bringing door-dabber prone to patients as soon as possible. We are beginning to prepare our organization to launch door-dabber prone and are excited about the promise to further broaden our pipeline in the future by advancing on 206 or through business development initiatives. With that, Leonardo, we will open the call to questions.

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. If you are called upon to ask your question and are listening by a 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 post for

an amendment to compile the question and answer roster. Your first question comes from the line of Maurie Raycroft. Please go ahead.

Can you talk about how you are 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 US launch to? Do you plan to leverage that NDA submission to dovetail into conversations with other regulatory agencies for accelerated approval paths as well?

Thanks for the question. There are probably two parts to that question. There is a regulatory component and a commercial component. I will ask Tom Riga to comment on the commercial side. On the regulatory side, having the backbone of the new drug application complete for Australia has great utility. In other markets around the world, there is a lot of overlap between that backbone and the new drug application. We see synergy there in having this ready. The efficacy component for this application will be predicated on the phase 2 response rate data that we have previously announced. 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. Should that change, we will update the market accordingly. Tom, do you want to comment on commercial?

We are enthusiastic to be inside of a year of first potential data from the action study. I think as we approach the market, our MetaFairs team is up and running and in full force. The early commercialization efforts are focused around payer engagement, forecast confirmation, some of the commercial build and internal infrastructure. We are taking a very gated spend. I think you can see in our SG&A line, we are going to be conservative and gated as we get more data within the program. We will make sure that we are ready for the market as we are enthusiastic about the opportunity.

Great. Thanks for the clarity. Just another quick follow-up. EBS announced the execution of contract options for $67.4 million to acquire Tempexa for national preparedness efforts. They also announced yesterday that they will conduct clinical trials of Tempexa for monkeypox in Africa. How much of that total contract value would Chimerics be eligible to receive? 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 Tempexa for smallpox?

Thanks for the question. Let me take the monkeypox part of that question and then I will ask Michelle to answer the first part on the partial clinic exercise of $67 million. From a monkeypox perspective, yes, eMERGEAN did announce participation in a randomized monkeypox study at the end of business yesterday. They are best positioned to answer questions on that. That is an ongoing new study to explore Tempexa's utility in that population. We will see how that unfolds in the coming years. That could lead to potential royalties to Chimerics when and if there could be international sales associated with that indication. Of course, they are at the very beginning of that process now. Michelle, comments on the milestone?

Yes. BARDA did exercise a partial exercise with eMERGEAN for Tempexa which was just over $67 million. 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. Hopefully next quarter we will have a little bit more information on that.

That exercise I think goes out to 2027, Michelle. It is a multiyear exercise of a clinic or an option that is just over half of the value of that next option.

That is correct. That is our understanding.

Great.

Thank you so much for taking my questions.

You're welcome.

Again, if you would like to ask a question, press start and then the number one your telephone keypad. All right. That concludes our question and answer

session. I will now turn the conference back over to Mike Andrea for closing remarks.

Thanks, Leonardo. Thank you everyone for your time this morning and 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.