Chimerix(CMRX) - 2023 Q1 - Quarterly Report

FORM 10-Q Filing Information This section details the company's filing status, registrant information, and the report's overall structure Filing Status and Registrant Information Chimerix, Inc. filed its Quarterly Report on Form 10-Q for the period ended March 31, 2023, classified as a non-accelerated filer and a smaller reporting company - Non-accelerated filer and smaller reporting company status confirmed[2] Common Stock Outstanding | Metric | Value | | :----- | :---- | | Common Stock Outstanding (as of April 28, 2023) | 88,583,567 shares | - The company is not a shell company[3] Table of Contents The report's index outlines two main parts: Part I – Financial Information, and Part II – Other Information - The report is structured into two main parts: Part I (Financial Information) and Part II (Other Information)[5] - Part I encompasses Consolidated Financial Statements, Management's Discussion and Analysis, Market Risk Disclosures, and Controls and Procedures[5] - Part II covers Legal Proceedings, Risk Factors, Unregistered Sales of Equity Securities, Defaults Upon Senior Securities, Mine Safety Disclosures, Other Information, and Exhibits[5] PART I - Financial Information This section provides the unaudited consolidated financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures ITEM 1. Consolidated Financial Statements This section presents the unaudited consolidated financial statements, including Balance Sheets, Statements of Operations, Stockholders' Equity, and Cash Flows, along with detailed notes Consolidated Balance Sheets The balance sheet shows a decrease in total assets and stockholders' equity from December 2022 to March 2023 Consolidated Balance Sheet Highlights (in thousands) | Metric | March 31, 2023 | December 31, 2022 | | :------------------------------------ | :------------- | :---------------- | | Cash and cash equivalents | $15,951 | $25,842 | | Short-term investments | $198,801 | $191,492 | | Total current assets | $224,750 | $228,138 | | Total assets | $258,533 | $279,341 | | Total current liabilities | $16,431 | $20,415 | | Total liabilities | $18,222 | $22,484 | | Total stockholders' equity | $240,311 | $256,857 | - Total assets decreased from $279.3 million at December 31, 2022, to $258.5 million at March 31, 2023[9] - Total stockholders' equity decreased from $256.9 million to $240.3 million over the same period[9] Consolidated Statements of Operations and Comprehensive Loss The statements reflect a significant increase in revenue and a reduction in net loss for Q1 2023 compared to Q1 2022 Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Total revenues | $283 | $15 | | Gross profit | $283 | ($99) | | Research and development expenses | $18,822 | $19,040 | | General and administrative expenses | $5,679 | $5,632 | | Total operating expenses | $24,501 | $24,672 | | Loss from operations | ($24,218) | ($24,771) | | Interest income and other, net | $2,846 | $4 | | Net loss | ($21,372) | ($24,767) | | Net loss, basic and diluted (per share) | ($0.24) | ($0.28) | - Total revenues significantly increased to $0.3 million in Q1 2023 from $15 thousand in Q1 2022, primarily due to contract and grant revenue[11] - Net loss decreased to $21.4 million in Q1 2023 from $24.8 million in Q1 2022, driven by higher interest income and slightly lower operating expenses[11] Consolidated Statements of Stockholders' Equity (Deficit) Stockholders' equity declined due to net loss, partially mitigated by share-based compensation and stock plan activities Changes in Stockholders' Equity (in thousands) | Metric | Balance, Dec 31, 2022 | Balance, Mar 31, 2023 | | :------------------------------------ | :-------------------- | :-------------------- | | Common Stock (Shares) | 88,054,127 | 88,583,567 | | Common Stock (Amount) | $88 | $89 | | Additional Paid-in Capital | $970,535 | $975,254 | | Accumulated Other Comprehensive Loss | ($337) | ($231) | | Accumulated Deficit | ($713,429) | ($734,801) | | Total Stockholders' Equity (Deficit) | $256,857 | $240,311 | - Stockholders' equity decreased by $16.5 million, primarily due to a net loss of $21.4 million, partially offset by share-based compensation and employee stock purchase plan activities[16] - Share-based compensation contributed $4.4 million to additional paid-in capital during Q1 2023[16] Consolidated Statements of Cash Flows Cash flows show reduced operating cash usage but a significant decrease in cash from investing activities for Q1 2023 Consolidated Statements of Cash Flows Highlights (in thousands) | Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | ($22,225) | ($23,447) | | Net cash provided by investing activities | $12,135 | $53,467 | | Net cash provided by (used in) financing activities | $199 | ($13,460) | | Net (decrease) increase in cash and cash equivalents | ($9,891) | $16,560 | - Net cash used in operating activities decreased slightly from $23.4 million in Q1 2022 to $22.2 million in Q1 2023[20] - Net cash provided by investing activities significantly decreased from $53.5 million in Q1 2022 to $12.1 million in Q1 2023, primarily due to lower proceeds from maturities of short-term investments[20] Notes to the Consolidated Financial Statements These notes provide detailed explanations of accounting policies, financial instruments, commitments, equity, taxes, agreements, and other financial events Note 1. The Business and Summary of Significant Accounting Policies Chimerix is a biopharmaceutical company focused on developing imipridones for cancer therapies, with financial statements prepared in accordance with GAAP - Chimerix is a biopharmaceutical company developing imipridones for cancer therapies, with ONC201 as the lead candidate for H3 K27M-mutant glioma[32][165] Fair Value Measurements of Assets (March 31, 2023, in thousands) | Asset Type | Total | Level 1 | Level 2 | Level 3 | | :----------------------- | :------ | :------ | :------ | :------ | | Cash equivalents | $13,272 | $13,272 | $0 | $0 | | Short-term investments | $198,801 | $26,463 | $172,338 | $0 | | Long-term investments | $31,322 | $10,278 | $21,044 | $0 | | Total assets | $243,395 | $50,013 | $193,382 | $0 | - The company recognized $0.2 million in contract revenue for support provided to Emergent in Q1 2023, following the BARDA Agreement novation[55] - A $50.0 million secured revolving loan facility with Silicon Valley Bank has future advances suspended pending Loan Agreement amendment[30][41] Note 2. Investments All investments are classified as available-for-sale, primarily in high credit quality debt securities, with unrealized losses considered temporary Debt Investments (March 31, 2023, in thousands) | Investment Type | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | | :----------------------- | :------------- | :--------------------- | :---------------------- | :------------------- | | Corporate bonds | $23,072 | $0 | ($34) | $23,038 | | U.S. treasury securities | $92,152 | $55 | ($138) | $92,069 | | Commercial paper | $115,130 | $9 | ($123) | $115,016 | | Total investments | $230,354 | $64 | ($295) | $230,123 | - The investment policy prioritizes safety, preservation of funds, and liquidity, focusing on high credit quality marketable debt securities[84] - Unrealized losses on debt investments are considered temporary, primarily due to interest rate changes, with the company believing investment costs are recoverable[67][85] Note 3. Commitments and Contingencies The company has long-term operating leases for its facilities and has recorded a provision for potential refundable amounts related to federal research contract funds Operating Lease Liabilities (March 31, 2023, in thousands) | Metric | Amount | | :------------------------------------ | :----- | | Operating lease right-of-use assets | $1,848 | | Operating lease short-term liabilities | ($590) | | Operating lease long-term liabilities | ($1,666) | | Total operating lease liabilities | ($2,256) | - The weighted-average remaining lease term for operating leases was 3.34 years as of March 31, 2023, with a 7.89% discount rate[68][87] - A provision of $52 thousand was recorded for potential refundable amounts related to BARDA federal research contract funds[70] Note 4. Equity Transactions and Share-based Compensation Share-based compensation expense increased in Q1 2023, influenced by accelerated vesting due to workforce reduction and extended exercise periods for directors' stock options Share-based Compensation Expense (in thousands) | Expense Type | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Research and development expense | $2,312 | $1,903 | | General and administrative expense | $2,051 | $1,805 | | Total share-based compensation expense | $4,363 | $3,708 | - An additional $0.6 million was recognized in Q1 2023 due to accelerated vesting of stock options and RSUs from a December 2022 workforce reduction[120] - An expense of approximately $0.3 million was recorded in Q1 2023 for extending non-employee directors' stock option exercise periods[94] Note 5. Income Taxes Chimerix estimates a 0.0% effective tax rate for 2023 due to expected net losses, with a full valuation allowance applied to deferred tax assets - The company estimates a 0.0% effective tax rate for 2023 due to expected net losses[95] - A full valuation allowance is applied to deferred tax assets due to cumulative losses, indicating uncertain realization[121] - No unrecognized tax benefits that would reduce the effective tax rate were present as of March 31, 2023[96] Note 6. Significant Agreements This note details the TEMBEXA Asset Sale to Emergent BioSolutions, including upfront and potential future milestone/royalty payments, and ONC201 licensing agreements - The TEMBEXA Asset Sale to Emergent BioSolutions in September 2022 included an upfront cash payment of approximately $238 million[125] - Chimerix is eligible for up to $124 million in BARDA-related milestone payments, 15% royalty on ex-U.S. TEMBEXA gross profits, 20% royalty on U.S. gross profits above 1.7 million treatment courses, and up to $12.5 million for other developmental milestones[125] - The BARDA Agreement for TEMBEXA was novated to Emergent in December 2022, with Chimerix guaranteeing Emergent's performance[124] - Licensing agreements for ONC201 in Japan (Ohara) and China (CR Sanjiu) include potential milestone payments and double-digit tiered royalties[130][155] Note 7. DSTAT Contract Close-out Following the discontinuation of DSTAT development, the company is closing out related vendor contracts, with $1.1 million in costs recorded as of March 31, 2023 - The company discontinued DSTAT development for AML in May 2022, initiating contract close-out activities[103] DSTAT Contract Close-out Costs Activity (in thousands) | Metric | Balance at Dec 31, 2022 | Revised Estimates (Q1 2023) | Payments (Q1 2023) | Balance at Mar 31, 2023 | | :----------------------- | :---------------------- | :-------------------------- | :----------------- | :---------------------- | | Contract Close-out Costs | $1,311 | $10 | ($250) | $1,071 | - As of March 31, 2023, $1.1 million in DSTAT contract close-out costs were recorded in accrued liabilities, with payments expected in H1 2023[103] Note 8. Restructuring Costs In December 2022, the company restructured operations, including a workforce reduction, resulting in employee termination benefits and additional stock compensation expense - The company initiated a restructuring in December 2022, reducing its workforce by 20 full-time employees[159] Employee Termination Benefits Activity (in thousands) | Metric | Balance at Dec 31, 2022 | Revised Estimates (Q1 2023) | Payments (Q1 2023) | Balance at Mar 31, 2023 | | :----------------------- | :---------------------- | :-------------------------- | :----------------- | :---------------------- | | Employee Termination Benefits | $1,442 | ($73) | ($641) | $728 | - An additional $0.6 million in stock compensation expense related to the workforce reduction was recognized in Q1 2023[120] Note 9. Subsequent Events Subsequent events have been evaluated through the financial statements' issuance date, with all material events appropriately disclosed or recognized - Subsequent events have been evaluated through the financial statements' issuance date[162] ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides an overview of Chimerix's business, pipeline developments, and a detailed analysis of its financial condition and results of operations for Q1 2023 Overview Chimerix is a biopharmaceutical company focused on developing imipridones for cancer, with ONC201 in Phase 3, and completed the TEMBEXA asset sale in September 2022 - Chimerix focuses on developing imipridones for cancer therapies, with ONC201 in Phase 3 for H3 K27M-mutant glioma[165] - The Phase 3 ACTION Study for ONC201 is ongoing, with interim OS/PFS data expected in 2025 and final OS data in 2026[167][168] - The TEMBEXA Asset Sale to Emergent BioSolutions in September 2022 yielded $238 million upfront, plus potential future milestones and royalties[144][147] - Preclinical work is ongoing for ONC206 and ONC212, while CMX521 is being developed for SARS-CoV-2 in collaboration with UNC[140][141][143] Financial Overview The company's revenue has historically been modest and non-recurring, with significant R&D expenses, increased interest income, and share-based compensation recognized over the vesting period - Historically, revenue has been modest and non-recurring, primarily from government grants, contracts, and upfront collaboration/license proceeds[146] Research and Development Expenses (in thousands) | Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Direct R&D expenses | $11,260 | $11,344 | | R&D personnel costs (excl. stock-based comp) | $4,518 | $5,328 | | R&D personnel costs (stock-based comp) | $2,312 | $1,903 | | Indirect R&D expenses | $732 | $465 | | Total R&D expenses | $18,822 | $19,040 | - Net interest income significantly increased to $2.8 million in Q1 2023 from $4 thousand in Q1 2022, driven by higher cash balances[183][218] - Total share-based compensation expense was $4.4 million in Q1 2023, up from $3.7 million in Q1 2022[184] Critical Accounting Policies and Significant Judgments and Estimates Financial statements rely on management estimates and assumptions, particularly for stock option valuation and deferred tax asset valuation allowances, with no material changes reported for Q1 2023 - Financial statement preparation requires management estimates and assumptions, especially for stock option valuation and deferred tax asset valuation allowances[186] - No material changes to critical accounting policies or significant judgments and estimates were reported for Q1 2023[213] Results of Operations For Q1 2023, total revenue increased significantly, R&D expenses slightly decreased, G&A expenses remained stable, and net interest income saw a substantial increase Summary of Results of Operations (in thousands, except percentages) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Dollar Change | % Change | | :------------------------------------ | :-------------------------------- | :-------------------------------- | :------------ | :--------- | | Total revenues | $283 | $15 | $268 | 1,786.7% | | Gross profit | $283 | ($99) | $382 | (385.9)% | | Research and development expenses | $18,822 | $19,040 | ($218) | (1.1)% | | General and administrative expenses | $5,679 | $5,632 | $47 | 0.8% | | Loss from operations | ($24,218) | ($24,771) | $553 | (2.2)% | | Interest income and other, net | $2,846 | $4 | $2,842 | 71,050.0% | | Net loss | ($21,372) | ($24,767) | $3,395 | (13.7)% | - Total revenue increased by $0.3 million, primarily from reimbursable operational support provided to Emergent[216] - Research and development expenses decreased by $0.2 million, driven by a $1.7 million decrease in DSTAT costs and a $0.4 million decrease in compensation, offset by a $2.1 million increase in ONC201 Phase 3 study expenses[190][217] - Net interest income significantly increased to $2.8 million, mainly due to interest earned on higher cash balances[218] Liquidity and Capital Resources As of March 31, 2023, Chimerix had $246.1 million in capital available, sufficient for at least the next 12 months, despite an accumulated deficit of $734.8 million - As of March 31, 2023, the company had approximately $246.1 million in capital available for operations[219] - Existing cash, cash equivalents, and investments are expected to fund operations for at least the next 12 months[222] Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | ($22,225) | ($23,447) | | Net cash provided by investing activities | $12,135 | $53,467 | | Net cash provided by (used in) financing activities | $199 | ($13,460) | | Net (decrease) increase in cash and cash equivalents | ($9,891) | $16,560 | - The company had an accumulated deficit of $734.8 million as of March 31, 2023, and anticipates continued losses[191] ITEM 3. Quantitative and Qualitative Disclosures About Market Risk Chimerix's primary market risk is interest income sensitivity to U.S. interest rate changes, with no material impact expected due to its short-term, low-risk investment portfolio - Primary market risk exposure is interest income sensitivity to changes in U.S. interest rates[259] - A 10% change in interest rates is not expected to materially affect the investment portfolio's fair value or operating results/cash flows due to short-term, low-risk investments[259] - Inflation has not materially affected the company's results of operations for Q1 2023 and Q1 2022[201] ITEM 4. Controls and Procedures As of March 31, 2023, the company's disclosure controls and procedures were effective, with no material changes to internal control over financial reporting during Q1 2023 - Disclosure controls and procedures were effective as of March 31, 2023[202] - No material changes to internal control over financial reporting occurred during Q1 2023[231] PART II - Other Information This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits ITEM 1. Legal Proceedings There are no material legal proceedings to report - No material legal proceedings are currently reported[263] ITEM 1A. Risk Factors This section outlines significant risks, including financial condition, clinical development, reliance on third parties, commercialization, intellectual property, government contracts, business operations, common stock, data privacy, and information technology Summary of Risk Factors Key risks include ongoing losses, uncertain product approval, reliance on third parties, and the contingent nature of TEMBEXA asset sale benefits - The company anticipates continued significant losses and may never achieve profitability[264] - All product candidates are under clinical development and may not obtain regulatory approval or be successfully commercialized[264] - Reliance on third-party manufacturers and limited supply sources poses risks to development and commercialization[264] - Anticipated benefits from the TEMBEXA asset sale may not be fully realized, as future contingent consideration depends on Emergent's success[264] Risks Related to Our Financial Condition and Need For Additional Capital Chimerix has a history of significant losses and an accumulated deficit, requiring substantial additional financing, with its credit facility currently suspended - The company has incurred significant net losses since inception, with an accumulated deficit of approximately $734.8 million as of March 31, 2023[266] - Future profitability is uncertain and depends on successfully developing, obtaining regulatory approval for, and commercializing product candidates[268][270] - Substantial expenses for imipridone development and regulatory approvals are expected, requiring additional capital[267] - The $50.0 million credit facility with Silicon Valley Bank is suspended, and non-compliance or lack of financing could severely impact liquidity and operations[248][278] Risks Related to Clinical Development and Regulatory Approval All product candidates are in clinical development, facing uncertainties, potential delays, and extensive post-approval regulatory requirements - All product candidates are under clinical development and may not obtain regulatory approval or be successfully commercialized[281] - Clinical trials are expensive, difficult, and uncertain, with potential for delays due to patient enrollment, negative results, or regulatory requirements[287][317][318] - ONC201's rare pediatric disease designation does not guarantee a priority review voucher, and its approval may depend on a companion diagnostic test[294][295][324] - Even if approved, products will face extensive ongoing regulatory requirements, potential restrictions, and costly post-approval studies[297][327][328] Risks Related to Our Reliance on Third Parties Chimerix heavily relies on third-party manufacturers and CROs, and its contingent payments from the TEMBEXA sale depend on Emergent's performance, which Chimerix guarantees - The company relies on third-party manufacturers for all drug supplies, facing risks such as inability to meet specifications, manufacturing delays, and compliance issues[309][371][372] - Contingent consideration from the TEMBEXA asset sale depends on Emergent's successful development and commercialization of TEMBEXA[341][375] - Chimerix guarantees Emergent's performance under the BARDA Agreement, potentially requiring the company to fulfill obligations if Emergent fails[344][377] - Reliance on CROs for clinical studies means limited control over their performance, potentially leading to delays, unreliable data, or trial termination[346][348][379] Risks Related to Commercialization of Our Product Candidates Commercial success depends on market acceptance and reimbursement, while the company faces challenges in establishing sales capabilities and competing in a highly competitive industry - Market acceptance and sales of approved product candidates depend on clinical safety/efficacy, convenience, and reimbursement from third-party payers[382] - The company lacks internal sales and marketing capabilities, facing challenges in establishing them or securing effective third-party collaborations, potentially delaying commercialization[352][355][385][386] - International commercialization involves additional risks such as differing regulatory requirements, economic/political instability, and foreign currency fluctuations[357][389] - The biotechnology and pharmaceutical industries are intensely competitive, with many competitors possessing substantially greater resources[359][390] Risks Related to Our Intellectual Property Chimerix relies on patents and trade secrets, but patent strength is uncertain, vulnerable to challenges, and third-party infringement claims could impede development - The company relies on patents, trade secret protection, and confidentiality agreements, but patent strength is uncertain and vulnerable to challenges[364][395][397] - Third-party IP infringement claims could prevent or delay development and commercialization, leading to substantial litigation or unfavorable licenses[399][401][427] - Failure to comply with patent agency procedural and fee requirements can result in abandonment or lapse of patent rights[404][405][433] - U.S. federal government funding of research may grant the government certain rights, including nonexclusive licenses and 'march-in' rights, to resulting patents[398] Risks Related to United States Government Contracts and Grants U.S. government contracts contain unfavorable provisions, requiring extensive compliance and exposing the company to audits and investigations that could lead to penalties - U.S. government contracts contain unfavorable provisions, allowing unilateral termination, scope reduction, and audit rights[406][407][435] - The company must comply with extensive government contracting regulations, including FAR and business ethics obligations, requiring significant compliance[408][436] - Government audits and investigations can lead to contract termination, profit forfeiture, fines, and suspension from U.S. government business[410][439][440] Risks Related to Our Business Operations and Industry Increasing demand for unapproved therapies could impact clinical trials, competition from IITs may divert patients, and retaining key personnel is challenging in a competitive industry, while product liability lawsuits pose significant risks - Increasing demand for compassionate use or third-party supply of unapproved therapies could impair clinical trials and negatively impact product safety profiles[411][442][536] - Competition from Investigator Initiated Clinical Trials (IITs) could divert eligible patients from the Phase 3 ACTION Study, delaying its completion[444][475] - Future success depends heavily on retaining key executives and attracting/motivating qualified personnel, challenging in a competitive industry[445][446][478] - Product liability lawsuits pose a significant risk, potentially leading to substantial liabilities, reputational harm, and commercialization limitations[447][479][537] Risks Related to Our Common Stock The common stock price is highly volatile, influenced by various factors, and future equity issuances could dilute existing stockholders, with no anticipated cash dividends - The common stock market price is highly volatile, influenced by clinical trial results, regulatory developments, funding, and competitive landscape[449][481] - Principal stockholders and management own a significant 35.8% of voting stock, allowing substantial control over company matters[450][482] - Future sales and issuances of common stock or rights to purchase common stock, including under equity incentive plans, could dilute existing stockholders[454][487][488] - The company does not anticipate paying cash dividends, making capital appreciation the sole source of stockholder gain[462][495] - Corporate charter documents and Delaware law provisions could make third-party acquisitions more difficult or costly[463][464][465][496] Risks Related to Data Privacy The company is subject to stringent and evolving U.S. and foreign data privacy laws, requiring significant resources for compliance, with potential for regulatory actions and business disruptions from non-compliance - The company is subject to stringent and evolving data privacy and security laws in the U.S. (HIPAA, CCPA, CPRA) and internationally (EU GDPR, UK GDPR)[466][467][497][520][521] - Compliance with these obligations requires significant resources and may necessitate changes to business practices and systems[522] - Failure to comply with data privacy obligations, especially regarding cross-border data transfers, could lead to regulatory actions, fines, litigation, and business disruptions[468][469][500][501] Risks Related to Information Technology The company's IT systems and sensitive data are vulnerable to increasingly sophisticated cyber-attacks and security incidents, with reliance on third-party providers introducing additional risks - The company's IT systems and sensitive data are vulnerable to increasingly sophisticated cyber-attacks, malicious activity, and security incidents[471][502][503][524][525] - Reliance on third-party service providers for critical business systems introduces additional cybersecurity risks due to potentially inadequate security practices[504] - A security incident could result in unauthorized data access, business disruptions, regulatory actions, litigation, fines, and reputational harm[527][530] - Increasing employee social media use also poses risks of liability, data security breaches, or reputational damage[509][531] ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities or use of proceeds are reported in this section - No unregistered sales of equity securities or use of proceeds are reported[532] ITEM 3. Defaults Upon Senior Securities No defaults upon senior securities are reported - No defaults upon senior securities are reported[532] ITEM 4. Mine Safety Disclosures Mine safety disclosures are not applicable to the company's operations - Mine safety disclosures are not applicable to the company[532] ITEM 5. Other Information No other information is reported in this section - No other information is reported[532] ITEM 6. Exhibits This section lists all exhibits filed as part of the Form 10-Q, including corporate organizational documents, executive certifications, and Inline XBRL documents - Exhibits include the Amended and Restated Certificate of Incorporation and Bylaws of the Registrant[533] - Certifications of the Principal Executive Officer and Principal Financial Officer are included per Rules 13a-14(a) and 13a-14(b) of the Securities Exchange Act of 1934[533] - Inline XBRL documents (Instance, Schema, Calculation, Definition, Label, Presentation Linkbase Documents, and Cover Page Interactive Data File) are filed[533] Signatures The report was duly signed on behalf of Chimerix, Inc. by its President and CEO, and its Chief Business and Financial Officer, on May 4, 2023 - The report was signed by Michael A. Sherman, President and CEO, and Michael T. Andriole, Chief Business and Financial Officer, on May 4, 2023[518][535]