Will O'Connor Stern Investor Relations 212-362-1200 Will@sternir.com CHIMERIX, INC. CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data) | --- | --- | --- | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-----------------|-------|------------| | | | December \n2023 | | 31, ...

PART I [Item 1. Business](index=5&type=section&id=Item%201.%20Business) Chimerix develops imipridones for cancer, with lead candidate ONC201 in Phase 3 for H3 K27M-mutant diffuse glioma - Chimerix's primary mission is to develop medicines for deadly diseases, with a current focus on imipridones as selective cancer therapies[232](index=232&type=chunk) - The lead product candidate, dordaviprone (ONC201), is in a global Phase 3 clinical trial (the ACTION Study) for H3 K27M-mutant diffuse glioma, a patient population with few treatment options[105](index=105&type=chunk)[232](index=232&type=chunk) - The company's strategy centers on the successful execution of the ONC201 Phase 3 trial, preparing for its commercialization, leveraging external capital for its early-stage pipeline (ONC206, ONC212, CMX521), and exploring in-licensing opportunities to expand its pipeline[449](index=449&type=chunk) - Chimerix relies on third-party contract manufacturers for its product supply and does not own or operate its own manufacturing facilities[439](index=439&type=chunk)[462](index=462&type=chunk) - The company's operations are highly regulated by the FDA in the U.S. and other international authorities, covering all stages from research and development to manufacturing and marketing[441](index=441&type=chunk)[464](index=464&type=chunk) [Product Pipeline](index=6&type=section&id=Product%20Pipeline) The company's pipeline features lead candidate ONC201 in Phase 3 for glioma, alongside ONC206 and other preclinical programs - ONC201 (dordaviprone) is the lead candidate, currently in the Phase 3 ACTION Study for H3 K27M-mutant diffuse glioma. The study is enrolling approximately **450 patients** across **13 countries** to evaluate Overall Survival (OS) and Progression-Free Survival (PFS)[72](index=72&type=chunk)[105](index=105&type=chunk) - Recent peer-reviewed publications in *Cancer Discovery* and the *Journal of Clinical Oncology* reported promising survival data for ONC201 in patients with H3 K27M-mutant diffuse midline gliomas, showing a median OS of **13.7 months** in the recurrent setting compared to **5.1 months** in a natural history study[75](index=75&type=chunk)[76](index=76&type=chunk)[217](index=217&type=chunk) - ONC206, a second-generation imipridone, is in Phase 1 dose escalation trials for patients with advanced central nervous system tumors. It has shown greater potency than ONC201 in preclinical models[96](index=96&type=chunk)[97](index=97&type=chunk)[109](index=109&type=chunk) - Early-stage pipeline includes ONC212 (targeting GPR132 and ClpP) and CMX521 (an antiviral for SARS-CoV-2), which are in preclinical development and collaborations with academic institutions[86](index=86&type=chunk)[87](index=87&type=chunk)[220](index=220&type=chunk) [Significant Agreements and Commercial Operations](index=11&type=section&id=Significant%20Agreements%20and%20Commercial%20Operations) The company divested TEMBEXA rights, acquired Oncoceutics for its pipeline, and plans U.S. commercialization of ONC201 - In September 2022, Chimerix sold the worldwide rights to TEMBEXA® to Emergent BioSolutions for a **$238 million upfront payment**, with potential for up to **$136.5 million in future milestones and royalties**[410](index=410&type=chunk)[428](index=428&type=chunk) - The acquisition of Oncoceutics in January 2021 brought the imipridone pipeline to Chimerix. The deal included upfront cash and stock, with up to **$360.0 million in contingent milestone payments** and tiered royalties on future sales of ONC201 and ONC206[452](index=452&type=chunk)[453](index=453&type=chunk) - Chimerix has licensing agreements with Ohara Pharmaceutical for ONC201 in Japan and with CR Sanjiu for ONC201 in Greater China, which include potential milestone payments and royalties[454](index=454&type=chunk)[455](index=455&type=chunk) - The company plans to commercialize ONC201 in the United States with a small, specialized commercial infrastructure and may seek partners for commercialization outside the U.S.[431](index=431&type=chunk)[456](index=456&type=chunk) [Intellectual Property](index=14&type=section&id=Intellectual%20Property) The company's success relies on robust patent protection for its imipridone and antiviral portfolios, with ONC201 protection into 2037 - The company's success is significantly dependent on its ability to obtain, maintain, and defend patent protection for its products and technology[460](index=460&type=chunk) - As of February 12, 2024, the imipridone patent portfolio includes **441 patents or applications**, with protection for ONC201's lead indication expected to extend into **2037** in the U.S.[437](index=437&type=chunk)[461](index=461&type=chunk) - The antiviral patent portfolio includes **26 patents or applications** owned or in-licensed by the company[438](index=438&type=chunk)[493](index=493&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) The company faces risks from financial losses, clinical development uncertainty, third-party reliance, IP challenges, and regulatory and cybersecurity threats - The company has a history of significant net losses, with a net loss of **$82.1 million** for the year ended December 31, 2023, and an accumulated deficit of approximately **$795.5 million**. Future profitability is not guaranteed[531](index=531&type=chunk)[565](index=565&type=chunk) - All product candidates are still in clinical development and face a high risk of failure. Success depends on positive trial results, regulatory approvals, and successful commercialization, none of which are certain[148](index=148&type=chunk)[544](index=544&type=chunk) - Chimerix relies on third-party manufacturers for all preclinical, clinical, and potential commercial supplies, exposing it to risks of supply interruption, quality issues, and manufacturing delays[149](index=149&type=chunk)[633](index=633&type=chunk)[666](index=666&type=chunk) - The company's ability to compete depends on protecting its intellectual property. There are risks that patents may not be granted, may be challenged, or may not provide sufficient protection against competitors[8](index=8&type=chunk)[689](index=689&type=chunk) - The business is subject to extensive and evolving healthcare laws, including anti-kickback statutes and data privacy regulations like GDPR and HIPAA, which could lead to significant penalties if violated[18](index=18&type=chunk)[30](index=30&type=chunk)[698](index=698&type=chunk) - Cybersecurity threats, including ransomware and phishing attacks, pose a significant risk to the company's information systems and sensitive data, which could lead to operational disruptions, regulatory actions, and financial loss[33](index=33&type=chunk)[34](index=34&type=chunk) [Item 1B. Unresolved Staff Comments](index=55&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - There are no unresolved staff comments[39](index=39&type=chunk)[50](index=50&type=chunk)[754](index=754&type=chunk) [Item 1C. Cybersecurity](index=55&type=section&id=Item%201C.%20Cybersecurity) The company integrates cybersecurity risk management into its overall processes, overseen by the Audit Committee, with no material threats to date - Chimerix has established processes to identify, assess, and manage material risks from cybersecurity threats, which are integrated into the company's overall risk management framework[755](index=755&type=chunk)[756](index=756&type=chunk) - The Board of Directors' Audit Committee oversees the cybersecurity risk management processes, receiving quarterly reports from the Senior Director of IT[43](index=43&type=chunk)[760](index=760&type=chunk) - The company utilizes third-party service providers for various functions and has a vendor qualification program to manage associated cybersecurity risks, which includes assessments and contractual obligations[41](index=41&type=chunk)[71](index=71&type=chunk) - To date, the company has not experienced a cybersecurity threat that has had a material effect on its business[757](index=757&type=chunk) [Item 2. Properties](index=56&type=section&id=Item%202.%20Properties) The company leases office and lab space in Durham, NC, totaling **29,250 sq ft**, with leases expiring July 2026 - The company leases its corporate headquarters (approx. **21,325 sq. ft.**) and laboratory space (approx. **7,925 sq. ft.**) in Durham, NC, with leases expiring in **July 2026**[761](index=761&type=chunk) [Item 3. Legal Proceedings](index=56&type=section&id=Item%203.%20Legal%20Proceedings) The company reports no material legal proceedings - There are no legal proceedings to report[762](index=762&type=chunk) [Item 4. Mine Safety Disclosures](index=56&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[47](index=47&type=chunk)[763](index=763&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=57&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) CMRX common stock trades on Nasdaq, with no history or plans for cash dividends, and no share repurchases during the period - The company's common stock trades on the Nasdaq Global Market under the ticker symbol **"CMRX"**[765](index=765&type=chunk) - Chimerix has never paid cash dividends and does not anticipate paying them in the foreseeable future, intending to retain earnings for operations and growth[49](index=49&type=chunk)[765](index=765&type=chunk) - The company did not purchase any of its own securities during the period covered by the Annual Report[79](index=79&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=57&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Revenue significantly decreased in 2023 to **$0.3 million**, resulting in an **$82.1 million** net loss, with **$204.5 million** capital expected to fund operations for 12 months [Results of Operations](index=70&type=section&id=Results%20of%20Operations) In 2023, total revenues declined by **99.0%** to **$0.3 million**, leading to a **$82.1 million** net loss, primarily due to the TEMBEXA sale in 2022 Comparison of Years Ended December 31, 2023 and 2022 (in thousands) | | Years Ended 2023 | December 31, 2022 | Dollar Change | % Change | |---|---|---|---|---| | **Total revenues** | $324 | $33,824 | $(33,500) | (99.0)% | | **Research and development** | $68,788 | $71,631 | $(2,843) | (4.0)% | | **General and administrative** | $24,601 | $22,132 | $2,469 | 11.2% | | **Loss from operations** | $(93,065) | $(60,386) | $(32,679) | 54.1% | | **Gain on sale of business, net** | $— | $229,670 | $(229,670) | (100.0)% | | **Net (loss) income** | $(82,095) | $172,167 | $(254,262) | (147.7)% | - Total revenues decreased by **99.0%** in 2023 compared to 2022, primarily due to the completion of international TEMBEXA procurement agreement deliveries in 2022[180](index=180&type=chunk) - Research and development expenses decreased by **4.0%** in 2023, driven by the discontinuation of the DSTAT program and reduced pipeline development costs, partially offset by increased expenses for the ONC201 Phase 3 study[182](index=182&type=chunk)[205](index=205&type=chunk) - General and administrative expenses increased by **11.2%** in 2023, mainly due to a **$3.4 million** increase in non-cash stock compensation expenses related to a management transition[184](index=184&type=chunk)[206](index=206&type=chunk) - The company reported a net loss of **$82.1 million** in 2023, a stark contrast to the net income of **$172.2 million** in 2022, which was primarily driven by a one-time net gain of **$229.7 million** from the sale of TEMBEXA[180](index=180&type=chunk)[186](index=186&type=chunk) [Liquidity and Capital Resources](index=73&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2023, the company had **$204.5 million** in capital, sufficient to fund operations for at least 12 months - As of December 31, 2023, the company had approximately **$204.5 million** in capital available to fund operations and an accumulated deficit of **$795.5 million**[236](index=236&type=chunk) - The company believes its existing cash, cash equivalents, and investments are sufficient to fund operating expenses and capital requirements for at least the next **12 months**[242](index=242&type=chunk)[249](index=249&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | |---|---|---|---| | Net cash used in operating activities | $(69,088) | $(46,867) | $(99,930) | | Net cash provided by (used in) investing activities | $70,599 | $70,037 | $(44,091) | | Net cash provided by (used in) financing activities | $308 | $(12,725) | $112,429 | - The company has a **$50.0 million** secured revolving loan facility with Silicon Valley Bank, of which no amount has been drawn down as of December 31, 2023[239](index=239&type=chunk) - Future funding may be required and could be raised through equity offerings, debt financing, or strategic partnerships, which may result in dilution to stockholders or restrictive covenants[241](index=241&type=chunk)[275](index=275&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=76&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its investment portfolio, with a **10%** rate change not expected to materially affect results - The primary market risk exposure is interest rate sensitivity on the company's cash, cash equivalents, and available-for-sale investments[278](index=278&type=chunk) - Due to the short-term and low-risk nature of the investment portfolio, a **10%** change in interest rates is not expected to have a material effect on the fair market value of the portfolio or on operating results[278](index=278&type=chunk) - The company does not believe that inflation has had a material effect on its results of operations for the years ended December 31, 2023 or 2022[279](index=279&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=77&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited consolidated financial statements for 2021-2023, with an unqualified opinion from Ernst & Young LLP Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2023 | Dec 31, 2022 | |---|---|---| | **Cash and cash equivalents** | $27,661 | $25,842 | | **Total current assets** | $189,110 | $228,138 | | **Total assets** | $212,774 | $279,341 | | **Total current liabilities** | $18,443 | $20,415 | | **Total liabilities** | $19,745 | $22,484 | | **Total stockholders' equity** | $193,029 | $256,857 | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | |---|---|---|---| | **Total revenues** | $324 | $33,824 | $1,979 | | **Total operating expenses** | $93,389 | $93,763 | $175,379 | | **Net (loss) income** | $(82,095) | $172,167 | $(173,236) | | **Net (loss) income per share, basic** | $(0.93) | $1.97 | $(2.04) | - The independent auditor, Ernst & Young LLP, issued an unqualified opinion on the consolidated financial statements, stating they present fairly, in all material respects, the financial position and results of operations of the company[283](index=283&type=chunk) - A critical audit matter identified was the estimation of accrued research and development expenses, which requires significant judgment due to the timing difference between service provision and vendor invoicing[286](index=286&type=chunk)[287](index=287&type=chunk)[288](index=288&type=chunk) [Item 9A. Controls and Procedures](index=107&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2023, with no material changes in the last quarter - The principal executive and financial officers concluded that the company's disclosure controls and procedures were effective as of December 31, 2023[821](index=821&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2023, based on the COSO 2013 framework[833](index=833&type=chunk) - There were no changes in internal control over financial reporting during the fourth quarter that materially affected, or are reasonably likely to materially affect, these controls[834](index=834&type=chunk)[865](index=865&type=chunk) PART III [Items 10-14](index=109&type=section&id=Items%2010-14) Information for Items 10-14, covering governance, compensation, and related matters, is incorporated by reference from the upcoming 2024 Proxy Statement - Information for Item 10 (Directors, Executive Officers and Corporate Governance) is incorporated by reference from the upcoming 2024 Proxy Statement[837](index=837&type=chunk) - Information for Item 11 (Executive Compensation) is incorporated by reference from the upcoming 2024 Proxy Statement[838](index=838&type=chunk) - Information for Item 12 (Security Ownership), Item 13 (Certain Relationships and Related Transactions), and Item 14 (Principal Accounting Fees and Services) is incorporated by reference from the upcoming 2024 Proxy Statement[846](index=846&type=chunk)[847](index=847&type=chunk)[850](index=850&type=chunk) PART IV [Item 15. Exhibits and Financial Statement Schedules](index=110&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all financial statements, schedules, and exhibits filed with the Form 10-K, including key corporate documents and SOX certifications - This item lists all financial statements and exhibits filed with the annual report[839](index=839&type=chunk)[848](index=848&type=chunk) - No financial statement schedules are included as the information is either provided elsewhere, not required, or immaterial[852](index=852&type=chunk) - Key exhibits include the merger agreement with Oncoceutics, the Asset Purchase Agreement with Emergent BioSolutions, and the Loan and Security Agreement with Silicon Valley Bank[849](index=849&type=chunk)[854](index=854&type=chunk)[877](index=877&type=chunk)

Financial Data and Key Metrics Changes - The company ended the third quarter with $217 million in cash and equivalents, aligning with previous guidance of approximately $200 million by year-end [22] - The company continues to expect its cash balance to support operations into the end of 2026 and through expected clinical endpoints [10] Business Line Data and Key Metrics Changes - The ACTION study of ONC201 has 113 sites open across 12 countries, exceeding the prior guidance of 100 sites by September 30 [19] - Enrollment in the ACTION study is progressing, with first and second interim overall survival data expected in 2025 [19] Market Data and Key Metrics Changes - The company has seen strong engagement in Europe, evidenced by rapid site activations, while Canada has been slower due to regulatory factors [53] - The company participated in the European Association for Neuro-Oncology Conference, which saw record attendance and increased site activity post-conference [5][4] Company Strategy and Development Direction - The company is preparing for the potential commercialization of ONC201 and is finalizing the recruitment of a Chief Commercial Officer [8] - The company is focused on advancing ONC201 and exploring business development opportunities to broaden its pipeline [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing ACTION study and the potential of ONC201 as a first-in-class therapy for H3 K27M-mutant glioma [13] - The management highlighted the importance of in-person medical conferences for driving engagement and awareness in the neuro-oncology community [5] Other Important Information - The company has approved protocol amendments for ONC206 dose escalation studies, allowing for a more intense dosing schedule [9] - A recent publication in Cancer Discovery supports the efficacy of ONC201 in frontline settings, showing a survival rate of 21.7 months for treated patients compared to 12 months for those who did not receive the treatment [12][11] Q&A Session Summary Question: When is full enrollment expected for the ACTION study? - Management has not provided specific guidance but expects first interim efficacy data in the first half of 2025, suggesting a similar timeline for full enrollment [29] Question: What is the status of ONC206 enrollment? - There are three separate arms ongoing in the Phase I studies, and management expects enrollment to be completed in the first half of 2024, with safety data likely released first [31][32] Question: How long has the GBM patient been on ONC206 therapy? - The patient has been on study for about 1.5 years and has graduated to dose level 4, showing a durable response [36] Question: What data will be presented at the upcoming SNO conference? - Management expects at least three oral presentations on ONC201, focusing on its role as a combinatorial backbone in DMG and associated safety and outcomes [39] Question: What is the expected expense trajectory for the next few quarters? - The company anticipates a similar cash burn rate of approximately $15 million to $17 million per quarter, with a potential uptick in expenses as preparations for commercialization begin [76][78]

Part I - Financial Information [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited consolidated financial statements for Chimerix, Inc. as of September 30, 2023, and for the three and nine-month periods then ended, including balance sheets, statements of operations, changes in stockholders' equity, and cash flows, along with accompanying notes [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Consolidated Balance Sheet Summary (in thousands) | Account | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $14,118 | $25,842 | | Short-term investments | $180,357 | $191,492 | | Total current assets | $200,622 | $228,138 | | Total assets | $225,282 | $279,341 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $15,510 | $20,415 | | Total liabilities | $16,979 | $22,484 | | Total stockholders' equity | $208,303 | $256,857 | | Total liabilities and stockholders' equity | $225,282 | $279,341 | [Consolidated Statements of Operations and Comprehensive (Loss) Income](index=5&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20(Loss)%20Income) Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $11 | $32,555 | $320 | $33,010 | | Total operating expenses | $26,700 | $20,576 | $72,575 | $69,135 | | (Loss) income from operations | ($26,689) | $11,646 | ($72,255) | ($36,572) | | Gain on sale of business, net | $— | $229,670 | $— | $229,670 | | Net (loss) income | ($23,986) | $241,362 | ($63,934) | $193,127 | | Net (loss) income per share, basic | ($0.27) | $2.75 | ($0.72) | $2.21 | | Net (loss) income per share, diluted | ($0.27) | $2.75 | ($0.72) | $2.17 | [Consolidated Statements of Stockholders' Equity (Deficit)](index=6&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) - Total stockholders' equity decreased from **$256.9 million** at December 31, 2022, to **$208.3 million** at September 30, 2023, primarily driven by a net loss of **$63.9 million** for the nine-month period, partially offset by share-based compensation of **$15.2 million**[24](index=24&type=chunk)[26](index=26&type=chunk) [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Consolidated Statements of Cash Flows Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($54,500) | ($26,879) | | Net cash provided by investing activities | $42,530 | $298,436 | | Net cash provided by (used in) financing activities | $246 | ($12,693) | | Net (decrease) increase in cash and cash equivalents | ($11,724) | $258,864 | - The significant decrease in cash from investing activities in 2023 compared to 2022 is primarily due to the absence of proceeds from the sale of TEMBEXA, which generated **$234.0 million** in 2022[26](index=26&type=chunk) [Notes to the Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) - The company is focused on developing imipridones as selective cancer therapies, with dordaviprone (ONC201) for H3 K27M-mutant glioma as its lead program[54](index=54&type=chunk) - On September 26, 2022, the company sold its worldwide rights to TEMBEXA® to an affiliate of Emergent BioSolutions Inc. for an upfront payment of approximately **$238 million** and potential future milestones and royalties, resulting in a net gain on sale of **$229.7 million** in Q3 2022[15](index=15&type=chunk)[75](index=75&type=chunk)[132](index=132&type=chunk) Share-based Compensation Expense (in thousands) | Period | Research & Development | General & Administrative | Total | | :--- | :--- | :--- | :--- | | **Three Months Ended Sep 30, 2023** | $1,739 | $6,141 | $7,880 | | **Three Months Ended Sep 30, 2022** | $2,097 | $1,722 | $3,819 | | **Nine Months Ended Sep 30, 2023** | $5,619 | $9,585 | $15,204 | | **Nine Months Ended Sep 30, 2022** | $5,827 | $5,293 | $11,120 | - In December 2022, the company restructured its operations, including a workforce reduction of 20 full-time employees, resulting in termination benefit expenses of **$1.9 million**[138](index=138&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and results of operations, focusing on its transition to a cancer-focused biopharmaceutical company developing imipridones like dordaviprone (ONC201), highlighting decreased revenue post-TEMBEXA sale, increased operating expenses, and sufficient liquidity [Overview](index=23&type=section&id=Overview) - The company's primary focus is on developing imipridones as a new class of selective cancer therapies, with the lead candidate, dordaviprone (ONC201), in a Phase 3 ACTION trial for H3 K27M-mutant glioma, with interim data expected in 2025[143](index=143&type=chunk)[170](index=170&type=chunk) - The early-stage pipeline includes ONC206, currently in Phase 1 dose escalation trials for CNS tumors, with dose escalation expected to be completed in the first half of 2024[146](index=146&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Comparison of Nine Months Ended September 30, 2023 and 2022 (in thousands) | Account | 2023 | 2022 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $320 | $33,010 | ($32,690) | (99.0)% | | Research and development | $53,144 | $52,350 | $794 | 1.5% | | General and administrative | $19,431 | $16,785 | $2,646 | 15.8% | | Loss from operations | ($72,255) | ($36,572) | ($35,683) | 97.6% | | Net (loss) income | ($63,934) | $193,127 | ($257,061) | (133.1)% | - The **99% decrease in revenue** for the nine months ended Sep 30, 2023, is primarily due to the absence of revenue from international TEMBEXA procurement agreements secured in 2022[215](index=215&type=chunk) - The **15.8% increase in G&A expenses** for the nine-month period was mainly due to a **$4.3 million increase** in non-cash stock compensation related to the CEO transition, offset by a **$1.7 million decrease** in legal and operational expenses from the 2022 Asset Sale[191](index=191&type=chunk)[192](index=192&type=chunk) Comparison of Three Months Ended September 30, 2023 and 2022 (in thousands) | Account | 2023 | 2022 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $11 | $32,555 | ($32,544) | (100.0)% | | Research and development | $17,396 | $15,263 | $2,133 | 14.0% | | General and administrative | $9,304 | $5,313 | $3,991 | 75.1% | | (Loss) income from operations | ($26,689) | $11,646 | ($38,335) | (329.2)% | | Net (loss) income | ($23,986) | $241,362 | ($265,348) | (109.9)% | - The **14.0% increase in R&D expenses** for Q3 2023 was driven by a **$2.5 million increase** in costs for the ONC201 ACTION Phase 3 study[195](index=195&type=chunk)[219](index=219&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2023, the company had approximately **$217.0 million** in capital available to fund operations, which is believed to be sufficient for at least the next 12 months[250](index=250&type=chunk)[224](index=224&type=chunk) - The company has a **$50.0 million** secured revolving loan facility with Silicon Valley Bank, but availability of future advances was suspended in September 2022 following the TEMBEXA asset sale, with no amount drawn down as of September 30, 2023[251](index=251&type=chunk) - Net cash used in operating activities for the nine months ended Sep 30, 2023, was **$54.5 million**, primarily due to the **$63.9 million net loss**[253](index=253&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposure is interest income sensitivity from its investment portfolio, but due to the short-term duration and low-risk profile of its investments, a 10% change in interest rates is not expected to have a material effect on its financial condition or cash flows, and inflation is also not considered material - The company's main market risk is interest income sensitivity, but due to the short-term nature and low-risk profile of its investment portfolio, an immediate **10% change in interest rates** is not expected to have a material effect on the portfolio's fair market value[230](index=230&type=chunk) - Inflation is not believed to have had a material effect on the results of operations for the three and nine months ended September 30, 2023 and 2022[231](index=231&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the principal executive and financial officers, evaluated the company's disclosure controls and procedures and concluded they were effective as of September 30, 2023, with no material changes to internal control over financial reporting identified during the third quarter of 2023 - The principal executive officer and principal financial officer concluded that as of September 30, 2023, the company's disclosure controls and procedures were effective[259](index=259&type=chunk) - There were no changes to the company's internal control over financial reporting during the third quarter of 2023 that materially affected, or are reasonably likely to materially affect, internal controls[260](index=260&type=chunk) Part II - Other Information [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material legal proceedings during the period - The company reported no material legal proceedings[262](index=262&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks to the company's business, financial condition, and stock price, including a history of significant losses, dependence on successful clinical development and regulatory approval of ONC201, reliance on third parties, potential future funding needs, competition, intellectual property, government contracts, data security, and stock price volatility - **Financial Risks:** The company has a history of significant losses (except for Q3 2022 due to the Asset Sale) and anticipates incurring significant losses for the foreseeable future, potentially needing to raise additional capital which could be dilutive or on unfavorable terms[237](index=237&type=chunk)[264](index=264&type=chunk) - **Clinical & Regulatory Risks:** The company's success is highly dependent on the successful clinical development, regulatory approval, and commercialization of its product candidates, particularly ONC201, with no guarantee of successful clinical trials or regulatory approval[263](index=263&type=chunk)[311](index=311&type=chunk) - **Third-Party Reliance Risks:** The company relies on third-party manufacturers for drug supply and CROs for clinical trials, and any disruption, delay, or failure by these third parties could significantly harm development and commercialization efforts[339](index=339&type=chunk)[378](index=378&type=chunk) - **Commercialization Risks:** The company currently lacks a sales and marketing organization and may be unable to generate significant revenue even if products are approved, as success depends on market acceptance, pricing, and reimbursement from third-party payers[352](index=352&type=chunk)[380](index=380&type=chunk) - **Intellectual Property Risks:** The company's ability to compete depends on obtaining and protecting intellectual property rights, but patents may not be issued, or if issued, may be challenged or invalidated[396](index=396&type=chunk)[424](index=424&type=chunk) - **Data Privacy & IT Risks:** The company processes sensitive personal and business data, subjecting it to numerous evolving data privacy and security laws (e.g., GDPR, HIPAA), where a compromise of its IT systems could lead to regulatory action, litigation, and business disruption[497](index=497&type=chunk)[503](index=503&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=66&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - The company reported no unregistered sales of equity securities[513](index=513&type=chunk) [Item 3. Defaults Upon Senior Securities](index=67&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports that this item is not applicable - Not applicable[545](index=545&type=chunk) [Item 4. Mine Safety Disclosures](index=67&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reports that this item is not applicable - Not applicable[561](index=561&type=chunk) [Item 5. Other Information](index=67&type=section&id=Item%205.%20Other%20Information) The company reports no other information required to be disclosed during the period - The company reported no other information[514](index=514&type=chunk) [Item 6. Exhibits](index=68&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the quarterly report, including certifications by the principal executive and financial officers and XBRL data files - This section lists the exhibits filed with the report, including officer certifications and Inline XBRL documents[516](index=516&type=chunk)[562](index=562&type=chunk)

Financial Data and Key Metrics Changes - The company reported a cash balance of $233 million at the end of Q2 2023, aligning with the guidance of approximately $200 million by year-end [73][77] - The burn rate for the first half of 2023 was $33 million, reflecting disciplined expense control and capital allocation [73][78] Business Line Data and Key Metrics Changes - The ACTION study has 77 active sites across 11 countries, with expectations to exceed 100 sites by the end of Q3 2023 [63][67] - Patient enrollment in the ACTION study is on schedule, with the first interim overall survival assessment expected in early 2025 [64] Market Data and Key Metrics Changes - The company has seen strong engagement from the neuro-oncology community, participating in various forums to address critical issues in brain tumor treatment [7][59] - The ACTION trial represents the first time ONC201 will be available through official channels for patients with H3 K27-mutant glioma [74] Company Strategy and Development Direction - The company is focused on executing the ACTION study and preparing for the launch of ONC201 while developing ONC206 [53][56] - There is an ongoing search for a Chief Commercial Officer to lead commercial development strategy as the company prepares for potential product launches [47][56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ACTION study's progress and the potential for ONC201 and ONC206 to address significant unmet medical needs [9][56] - The company is actively looking for external assets to complement its pipeline, particularly as ONC206 shows promise [78] Other Important Information - The company has begun a process to backfill the CFO and CBO roles, with updates expected later in the year [6] - The BARDA contract could yield milestone payments of $31 million for each full option exercise, along with royalties on gross profits [6] Q&A Session Questions and Answers Question: What is the goal for the number of sites in the ACTION trial? - The company aims for around 120 sites and may exceed that based on engagement levels [11][67] Question: Will data from ONC206 be shared before the full escalation data next year? - The company plans to provide quarterly updates on the study's activity and will share any significant efficacy signals as they arise [13][14] Question: What changes to strategy can be expected under new leadership? - The company does not anticipate major strategic changes during the leadership transition, focusing on executing existing plans [48][53] Question: How consistent is the standard of care across different sites? - The company has ensured consistency in radiation doses across activated sites, addressing concerns about standard care variability [86][118]

• Baseline Performance Status ≥60 • Corticosteroids stable or decreasing for at least 3 days prior to baseline scan • Excluded: DIPG, primary spinal tumors, atypical and non-astrocytic hist., leptomeningeal spread, CSF dissemination -100 • Responses require both imaging and clinical criteria -75 | --- | --- | --- | --- | --- | --- | --- | --- | |-----------------------------------------------|-------|-------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ...

Financial Performance - Total revenues for the three months ended June 30, 2023, were $26,000, a decrease from $440,000 in the same period of 2022[28]. - Total revenues for the six months ended June 30, 2023, were $309,000, down from $455,000 in the same period of 2022, reflecting a decrease of 32.2%[28]. - The company reported a gross profit of $26,000 for the three months ended June 30, 2023, compared to $341,000 for the same period in 2022[28]. - The net loss for the three months ended June 30, 2023, was $18,576,000, compared to a net loss of $23,468,000 for the same period in 2022, indicating an improvement of 20.3%[28]. - Net loss for the six months ended June 30, 2023, was $39,948,000, compared to a net loss of $48,235,000 for the same period in 2022, representing a 17.5% improvement[32]. - The company reported a comprehensive loss of $19,158,000 for the three months ended June 30, 2023, compared to a comprehensive loss of $23,463,000 for the same period in 2022, an improvement of 18.5%[28]. Expenses - Research and development expenses for the six months ended June 30, 2023, were $35,748,000, a decrease of 3.6% compared to $37,087,000 for the same period in 2022[28]. - Research and development expenses for the three months ended June 30, 2023, were $16,926,000, compared to $18,047,000 for the same period in 2022, a reduction of 6.2%[28]. - Total operating expenses for the six months ended June 30, 2023, were $45,875,000, down from $48,559,000 in the same period of 2022, reflecting a 5.5% reduction[28]. - General and administrative expenses for the three months ended June 30, 2023, were $4,448,000, down from $5,840,000 in the same period of 2022, a decrease of 23.8%[28]. Cash and Assets - Cash and cash equivalents as of June 30, 2023, were $20,099,000, down from $25,842,000 at the end of 2022, indicating a decrease of 22.5%[26]. - Total assets as of June 30, 2023, were $241,085,000, a decrease from $279,341,000 at the end of 2022, representing a decline of 13.7%[26]. - The company had total stockholders' equity (deficit) of $224,112,000 as of June 30, 2023, compared to $256,857,000 at the end of 2022, indicating a decrease of 12.8%[30]. - The accumulated deficit as of June 30, 2023, was $753,377,000, an increase from $713,429,000 as of December 31, 2022[30]. - Cash flows used in operating activities for the six months ended June 30, 2023, were $36,567,000, compared to $34,007,000 for the same period in 2022, showing an increase of 7.5%[32]. Company Information - Chimerix, Inc. is a Delaware corporation and has obtained a registered trademark for Chimerix® in the United States[38]. - The company is classified as a smaller reporting company and has not elected to use the extended transition period for complying with new financial accounting standards[36]. - The common stock of Chimerix, Inc. is traded on The Nasdaq Global Market under the symbol CMRX[36].

Financial Data and Key Metrics Changes - For Q1 2023, the company reported a net loss of $21.4 million, an improvement from a net loss of $24.8 million in Q1 2022 [17] - Research and development expenses decreased to $18.8 million in Q1 2023 from $19 million in the same period in 2022 [17] - General and administrative expenses slightly increased to $5.7 million in Q1 2023 compared to $5.6 million in Q1 2022 [17] - The company ended Q1 2023 with approximately $246 million in cash and equivalents, with a projected year-end cash of around $200 million sufficient to fund operations into 2027 [18][19] Business Line Data and Key Metrics Changes - The ACTION study is progressing with regulatory approval in nine countries, including recent approval from the European Union [10] - The company is on track for the first efficacy analysis of the ACTION study in early 2025, which will include an overall survival assessment [10] - The dose escalation for ONC206 is expected to complete by the first half of 2024, with ongoing studies indicating potential for broader patient populations [15][19] Market Data and Key Metrics Changes - The company anticipates that approximately two-thirds of patients in the ACTION study will come from the U.S. or North America, with the potential for more than 120 global sites for patient enrollment [24][38] - The company has seen positive feedback and higher-than-expected interest in participation from sites in Europe, which may accelerate patient enrollment [38] Company Strategy and Development Direction - The company is focusing on expanding the potential market for ONC206 beyond H3K27M glioblastoma, with preclinical data suggesting broader activity [33] - The company aims to leverage findings from recent studies to inform future development strategies for both ONC201 and ONC206, particularly in indications exhibiting loss of H3K27 trimethyl [46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing trials and the potential for ONC201 and ONC206, highlighting the significance of recent findings related to H3K27 trimethyl loss [11][14] - The company is preparing for a quick submission following the ACTION study, with a focus on maintaining capital efficiency and exploring additional investment opportunities [17][19] Other Important Information - The company is actively collecting tissue and blood samples from patients to support additional molecular assays and studies [45][46] - The financial impact of a previously announced reduction in force is expected to take effect in the current quarter [17] Q&A Session Summary Question: What is the expected split between U.S. and outside U.S. sites for the ACTION study? - Management estimates that most patients will come from the U.S. or North America, approximately two-thirds, with the potential for more than 120 global sites [24] Question: What is the timing for the PFS readout in relation to the OS assessment? - The PFS readout is expected to occur after the initial OS assessment, likely still during 2025 [26] Question: What are the ultimate market opportunities for ONC206 compared to ONC201? - ONC206 has demonstrated activity in non-H3K27M glioblastoma, suggesting a potential market that is significantly larger than that for ONC201 [28][33] Question: Can you provide more details on the future data updates for ONC206? - The focus will be on safety and the ability to escalate dosing safely, with potential efficacy signals expected to emerge as the study progresses [35]

Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share CMRX The Nasdaq Global Market Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨ Indi ...

Chimerix, Inc. (NASDAQ:CMRX) Q4 2022 Earnings Conference Call March 2, 2023 8:30 AM ET Company Participants Michelle LaSpaluto - Vice President-Strategic Planning and Investor Relations Mike Sherman - President and Chief Executive Officer Josh Allen - Chief Technology Officer of Imipridones Mike Andriole - Chief Financial and Business Officer Allen Melemed - Chief Medical Officer Conference Call Participants Kevin Strang - Jefferies Joseph Thome - TD Cowen Naureen Quibria - Capital One Securities Soumit Roy ...