Chimerix, Inc.

Good morning, ladies and gentlemen, and welcome to the Chimerics fourth quarter and year-end 2022 earnings conference call. I would now like to introduce your host for today's call, Michelle Laspelluto, Vice President of Strategic Planning and Investor Relations at Chimerics. Please proceed.

Thank you, Jeff. Good morning, everyone, and welcome to the Chimerics fourth quarter and year-end 2022 financial and operating results conference call. This morning, we issued a press release in our fourth quarter operating update. You can access this press release in the investor section of the website. With me on today's call are President and Chief Executive Officer Mike Sherman, Chief Medical Officer Ellen Melamed, Chief Financial and Business Officer Mike Andreol, and Chief Technology Officer Josh Allen. Before we begin, I would 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 if 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 would like to turn the call over to our President and Chief Executive Officer, Mike Sherman.

Thanks, Michelle. Good morning, everyone. Thanks for joining us. We completed an important transition for the company in 2022, monetizing Timbexa and fully capitalizing the company without shareholder dilution, establishing runway into 2027 in the process. This was a very attractive transaction for Chimerix with potential for additional meaningful economics in the future. We've now also largely completed our transition responsibilities for Timbexa, which allows for full focus on our oncology pipeline. Our confidence in these programs continues to grow as we announce new independent survival analysis related to Onc201 or Dirt Avoprone treatment late last year, and now today, a clinical milestone for our next generation, Imipridone Onc206. We began opening sites for the phase three on to a one action trial in the US late last year and just opened our first international site in Israel. We also received recent approval to proceed from health authorities in both the UK and Canada. We expect to activate sites in those countries shortly, followed by the rest of Europe this spring. We remain on track for most sites to open for enrollment by mid year and we've been encouraged in the meantime by the referral process through which sites that have not yet opened are sending patients to already active sites to initiate treatment. Those patients will later transfer back to their home site. We continue to expect first data readouts in early 2025 and look forward to sharing our continued progress as we open more sites. As a bit of an aside, it was nice to hear from one of our leaders at our CRO partner, PPD, meeting yesterday recognized the particularly strong collaboration they have with our team, distinguishing it from other trials they're working on. That speaks both to the quality of the team in both organizations and the uniqueness of this trial, particularly the pull we get from patients and investigators. It's worth noting that our endpoint strategy is designed to optimize the speed to data as well as provide multiple opportunities for success. The interim overall survival analyses at 164 and 246 events provide the opportunity to stop the trial early if a survival advantage is observed. If results are consistent with the independent analysis previously reported at the recent snow conference, this is what we would expect to happen. That's particularly true with the inclusion of the higher dosing arm, which is independently powered. Trial design also provides another opportunity for success with the incorporation of the PFS analysis at 286 events, which is expected to occur just after the first interim overall survival analysis. With a successful PFS analysis, we plan to speak to the FDA about seeking an accelerated approval and then would incorporate the overall survival analysis as a post-marketing requirement. The independent data announced in December supporting an ONC201 survival benefit in the H3K27M mutant population, more than doubling median survival compared with those not treated with ONC201, 26 months compared to 12 months in the frontline setting. The flexibility afforded by our trial design on top of the durable response data we've previously disclosed from Phase 2, we remain confident the probability of success for the action trials at least is higher than other Phase 3 trials. In parallel to executing in the clinic, we're completing the ClinPharm and CMC work that will otherwise be required for regulatory filing. That work has proceeded with supportive findings along the way. We also continue to generate data that enhances the scientific understanding of our pipeline, adding to our confidence in the ability of imipridones broadly to uniquely address high unmet needs in oncology. Recent data released at Snow demonstrated the ability of ALK201 and ALK206 to selectively tap novel targets for oncology to control multiple critical aspects of tumor biology. Josh will elaborate on this in a bit. As it relates to our earlier stage pipeline, including OG206, we have new reason to anticipate additional catalysts on the horizon for that program while we're executing the action trial. We're certainly encouraged to learn of a confirmed response in one of the early dose cohorts. We wouldn't ordinarily highlight a single case of tumor response, but because this happened so early in the escalation, And in a patient with non-H3K27M glioblastoma, this is a setting where we've never seen a tumor response with ONC201. It stands out as an important signal for ONC206, an important signal about potential broader market opportunities. I'll now turn the call over to Josh Allen to provide some updates on the science and more color on this ONC206 development.