History and Milestones
Chimerix was founded in 2000 with the goal of developing antiviral therapies. The company's initial focus was on antiviral drug candidates, including brincidofovir (TEMBEXA), which was approved by the FDA in 2021 for the treatment of smallpox. Over the years, the company has evolved its strategic focus, leveraging its expertise in nucleoside and nucleotide analogs to expand into oncology. In 2021, Chimerix acquired Oncoceutics, a clinical-stage biotechnology company pioneering the development of imipridone compounds, including the lead candidate dordaviprone.
Dordaviprone, Chimerix's most advanced asset, is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent H3 K27M-mutant diffuse glioma, a rare and aggressive form of brain cancer. The company submitted the New Drug Application (NDA) for dordaviprone in December 2024, seeking accelerated approval, and the FDA has granted the application Priority Review with a target action date of August 18, 2025.
In addition to dordaviprone, Chimerix's pipeline includes ONC206, a second-generation imipridone compound that has demonstrated promising activity in both adult and pediatric central nervous system (CNS) tumors. The company is currently evaluating ONC206 in Phase 1 dose-escalation studies, with the goal of identifying lead indications to advance into further clinical development.
Chimerix has faced challenges throughout its history. In 2019, the company experienced a setback when a late-stage trial of brincidofovir for the prevention of cytomegalovirus infection in stem cell transplant recipients failed to meet its primary endpoint. This resulted in the company undergoing a restructuring and refocusing its efforts on its pipeline of novel drug candidates.
Financial Overview
Chimerix reported a net loss of $65.4 million for the nine months ended September 30, 2024, compared to a net loss of $63.9 million for the same period in 2023. The increase in net loss was primarily driven by higher research and development expenses related to the ongoing Phase 3 ACTION study of dordaviprone and the continued development of ONC206.
For the most recent fiscal year, Chimerix reported annual revenue of $324,000 and an annual net loss of $82.1 million. The company's annual operating cash flow was negative $69.1 million, with annual free cash flow at negative $69.2 million.
In the most recent quarter (Q3 2024), Chimerix reported revenue of $26,000, representing a 136.4% increase from $11,000 in Q3 2023. The net loss for Q3 2024 was $22.9 million, a 4.6% decrease from the $24 million loss reported in Q3 2023. The company's total revenues for the first nine months of 2024 were $155 million, primarily consisting of contract and grant revenue.
As of September 30, 2024, the company had $152.4 million in cash, cash equivalents, and investments, providing a runway into the fourth quarter of 2026. Chimerix's research and development expenses for the nine-month period totaled $56.9 million, while general and administrative expenses were $15.3 million.
It's worth noting that in September 2022, Chimerix completed the sale of its TEMBEXA program and related assets to Emergent BioSolutions for an upfront payment of approximately $238 million, as well as potential milestone payments and royalties. This transaction has provided additional financial resources to support the company's ongoing drug development efforts.
Liquidity
Chimerix's strong cash position of $152.4 million as of September 30, 2024, provides the company with a solid financial foundation to support its ongoing research and development activities. The runway extending into the fourth quarter of 2026 offers Chimerix ample time to advance its pipeline candidates, particularly dordaviprone and ONC206, through critical clinical and regulatory milestones.
The company's liquidity ratios are favorable, with both the current ratio and quick ratio at 6.33. Chimerix has a low debt-to-equity ratio of 0.0047, indicating minimal leverage. As of September 30, 2024, the company had $23.64 million in cash and cash equivalents. Additionally, Chimerix has access to a $50 million secured revolving loan facility with Silicon Valley Bank, which remains undrawn, providing further financial flexibility if needed.
The additional financial resources gained from the TEMBEXA asset sale further bolster the company's liquidity position, potentially enabling strategic investments in its drug development programs and operational capabilities.
Regulatory and Clinical Developments
The FDA's acceptance of Chimerix's NDA for dordaviprone and granting of Priority Review status represent a significant milestone for the company and the patients it aims to serve. If approved, dordaviprone would become the first therapy specifically indicated for the treatment of recurrent H3 K27M-mutant diffuse glioma, addressing a critical unmet medical need.
Chimerix's global Phase 3 ACTION study, which is evaluating dordaviprone in patients with H3 K27M-mutant diffuse glioma, continues to enroll participants across 15 countries. The company recently reported that the study's independent Data Monitoring Committee (DMC) has completed a prespecified interim safety review and recommended that the trial continue as planned, with no changes to the study conduct. This positive outcome reinforces the favorable safety profile of dordaviprone observed in previous clinical trials. The first interim data readout from the ACTION study is expected to be potentially less than a year away.
In addition to the progress with dordaviprone, Chimerix is also advancing its second-generation imipridone compound, ONC206, through Phase 1 dose-escalation studies in adult and pediatric patients with primary CNS tumors. Over 80 patients have been enrolled in these studies so far, with a similar safety profile observed in both pediatric and adult populations. The majority of treatment-related adverse events have been mild to moderate. The company expects to announce next steps for the ONC206 program in the coming months, as it reviews the accumulating clinical and preclinical data.
Chimerix is also preparing to file an NDA for provisional approval of dordaviprone in Australia around the end of 2024, further expanding its global regulatory strategy.
Competitive Landscape and Risks
The treatment of rare and aggressive brain cancers, such as H3 K27M-mutant diffuse glioma, remains a significant challenge in the oncology field. Chimerix's dordaviprone faces competition from other investigational therapies, including those in development by larger pharmaceutical companies. However, the lack of approved treatments for this patient population presents an opportunity for Chimerix to potentially establish dordaviprone as a new standard of care, provided it can demonstrate robust efficacy and safety in clinical trials.
Chimerix forecasts a potential global market opportunity for dordaviprone of over $750 million, highlighting the significant commercial potential if the drug receives regulatory approval.
Risks for Chimerix include the inherent uncertainties associated with drug development, potential delays or setbacks in the regulatory approval process, and the ability to successfully commercialize its products, if approved. The company also faces competition for patient enrollment in its clinical trials, which could impact the timelines for completing key studies.
Additionally, as a smaller biopharmaceutical company, Chimerix may have limited resources and manufacturing capabilities compared to its larger peers, which could pose challenges in ensuring reliable supply and distribution of its products.
Outlook and Conclusion
Chimerix's focus on rare and deadly cancers, particularly brain tumors, positions the company as a potential leader in an area of high unmet medical need. The company's lead candidate, dordaviprone, has the potential to become the first approved therapy for patients with recurrent H3 K27M-mutant diffuse glioma, a devastating disease with limited treatment options.
With the NDA for dordaviprone under Priority Review and the continued advancement of the ONC206 program, Chimerix is poised to deliver meaningful progress in the coming year. The company's strong cash position and the financial resources gained from the TEMBEXA asset sale provide a solid foundation to support its ongoing drug development efforts.
As Chimerix navigates the regulatory and clinical landscape, the company's ability to successfully execute on its strategic priorities and demonstrate the efficacy and safety of its drug candidates will be crucial to its long-term success. Investors will closely follow the FDA's decision on the dordaviprone NDA, as well as the further development of the company's pipeline, to assess Chimerix's potential to transform the treatment of rare and deadly cancers.
The company's focus on developing imipridones as a potential new class of selective cancer therapies sets it apart in the biopharmaceutical industry. With dordaviprone in late-stage clinical development and ONC206 progressing through early-stage trials, Chimerix is building a robust pipeline of novel oncology treatments.
While Chimerix currently only sells its products in the United States, the company's plans to file for provisional approval in Australia and its ongoing global clinical trials suggest a strategy for international expansion in the future. As Chimerix approaches potential commercialization of dordaviprone, the company's ability to navigate the complexities of drug pricing, market access, and global distribution will be critical factors in realizing the projected market opportunity.