Part I [Business](index=5&type=section&id=Item%201.%20Business) Chimerix is a biopharmaceutical company focused on developing imipridones as cancer therapies, with its lead candidate ONC201 in a Phase 3 trial for H3 K27M-mutant glioma, following the strategic sale of TEMBEXA in 2022 - The company's primary mission is to develop medicines for deadly diseases, with a current focus on imipridones like ONC201 for treating H3 K27M-mutant glioma[22](index=22&type=chunk) - In September 2022, Chimerix sold its worldwide rights for TEMBEXA to Emergent for an upfront payment of **$238 million**. The deal includes potential future milestone payments up to **$136.5 million** and royalties on sales[362](index=362&type=chunk) - The company launched the Phase 3 ACTION study for ONC201 in November 2022, a pivotal trial for patients with newly diagnosed H3 K27M-mutant glioma, with interim data expected in early 2025[24](index=24&type=chunk)[25](index=25&type=chunk) - The company's strategy involves executing the ONC201 Phase 3 study, preparing for its potential commercialization, maintaining financial flexibility, and seeking to in-license other development programs[363](index=363&type=chunk)[364](index=364&type=chunk) [Imipridone Platform (ONC201, ONC206, ONC212)](index=6&type=section&id=Imipridone%20Platform%20(ONC201%2C%20ONC206%2C%20ONC212)) The imipridone platform represents a potential new class of selective cancer therapies, with lead candidate ONC201 in a Phase 3 trial for H3 K27M-mutant glioma, and earlier-stage candidates ONC206 and ONC212 in development - The Phase 3 ACTION study for ONC201 is a randomized, placebo-controlled trial enrolling 450 patients to evaluate two dosing frequencies against a placebo, with primary endpoints of Overall Survival (OS) and Progression-Free Survival (PFS)[25](index=25&type=chunk) - A Blinded Independent Central Review (BICR) of Phase 2 data for ONC201 in recurrent H3 K27M-mutant glioma showed a **20.0% Overall Response Rate (ORR)** by RANO-HGG criteria and a **30% response rate** when including RANO-LGG criteria[348](index=348&type=chunk)[349](index=349&type=chunk)[351](index=351&type=chunk) - ONC206 is in first-in-human clinical trials for adults with recurrent primary CNS tumors and a separate dose-escalating trial for pediatric patients[330](index=330&type=chunk) [Antiviral Programs (CMX521 and Chemical Library)](index=11&type=section&id=Antiviral%20Programs%20(CMX521%20and%20Chemical%20Library)) The company maintains an antiviral program focused on CMX521 for SARS-CoV-2 and a proprietary chemical library for future pandemic threats - CMX521 is an antiviral candidate for SARS-CoV-2 being developed with READDI at UNC, supported by a **~$1.7 million grant** from North Carolina to fund prodrug synthesis and animal studies[359](index=359&type=chunk) - The Chimerix Chemical Library contains over **10,000 compounds**, including approximately **3,500 nucleoside analogs**, which are being screened for activity against SARS-CoV-2 and other potential pandemic viruses[360](index=360&type=chunk) [TEMBEXA (brincidofovir, BCV) Asset Sale](index=12&type=section&id=TEMBEXA%20(brincidofovir%2C%20BCV)%20Asset%20Sale) Chimerix completed the sale of its FDA-approved smallpox therapy, TEMBEXA, to Emergent BioSolutions for **$238 million** upfront cash plus potential milestones and royalties - Chimerix sold its exclusive worldwide rights to TEMBEXA to Emergent for **$238 million** upfront[362](index=362&type=chunk)[391](index=391&type=chunk) - The company is eligible for significant contingent payments, including up to **$124 million** in milestones from BARDA procurement options and royalties on future gross profits[90](index=90&type=chunk)[391](index=391&type=chunk) - Prior to the sale, Chimerix secured international procurement agreements for TEMBEXA, including a **$9.3 million** supply agreement and a contract with Canada's Public Health Agency (PHAC) for up to **$25.3 million**, which generated **$32.0 million** in procurement revenue in 2022[149](index=149&type=chunk)[370](index=370&type=chunk)[396](index=396&type=chunk) [Intellectual Property](index=16&type=section&id=Intellectual%20Property) Chimerix protects its technology through patents and trade secrets, with its imipridone patent portfolio including 416 patents or applications as of February 2023 Imipridone Patent Portfolio (as of Feb 15, 2023) | Description | Count | | :--- | :--- | | Total patents or applications | 416 | | Issued US and foreign patents (ONC201) | 213 | | Pending US and foreign applications (ONC201) | 65 | - Patent protection for ONC201's lead indication is expected to last until **2037** in the U.S., with a potential extension to **2042** with full patent term restoration[434](index=434&type=chunk) [Government Regulation](index=17&type=section&id=Government%20Regulation) The company's operations are subject to extensive regulation by the FDA and similar authorities abroad, covering all stages from R&D to manufacturing and marketing - The drug development and approval process in the U.S. is lengthy and complex, requiring preclinical testing, an effective IND, and adequate and well-controlled clinical trials (Phase 1, 2, and 3) to establish safety and efficacy before an NDA can be submitted to the FDA[411](index=411&type=chunk)[414](index=414&type=chunk)[442](index=442&type=chunk) - ONC201 has been granted Orphan Drug Designation for treating malignant glioma, which may provide seven years of market exclusivity for that indication if it is the first to receive FDA approval[353](index=353&type=chunk)[420](index=420&type=chunk)[483](index=483&type=chunk) - The company utilizes expedited FDA programs, including Fast Track designation for ONC201, which is intended to facilitate the development and expedite the review of drugs for serious conditions with unmet medical needs[353](index=353&type=chunk)[453](index=453&type=chunk) [Risk Factors](index=29&type=page&id=Item%201A.%20Risk%20Factors) An investment in Chimerix involves a high degree of risk, including a history of significant financial losses, heavy dependence on ONC201's success, and the need for future financing - The company has a history of significant losses and anticipates future losses, with 2022 profitability due to the one-time sale of TEMBEXA and not indicative of ongoing operational profitability[542](index=542&type=chunk)[509](index=509&type=chunk)[198](index=198&type=chunk) - The company's future success is highly dependent on the successful clinical development, regulatory approval, and commercialization of ONC201, which is still in development and may not succeed[35](index=35&type=chunk)[173](index=173&type=chunk)[176](index=176&type=chunk) - Chimerix relies on third-party manufacturers for its drug supply and CROs for clinical trials, exposing it to risks of supply disruption, quality issues, and trial delays if these third parties fail to perform[36](index=36&type=chunk)[533](index=533&type=chunk)[572](index=572&type=chunk) - The company may need additional financing to fund operations, and failure to secure funding could force delays or elimination of development programs[204](index=204&type=chunk) [Unresolved Staff Comments](index=56&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[717](index=717&type=chunk) [Properties](index=56&type=section&id=Item%202.%20Properties) Chimerix leases approximately 21,325 square feet of office space for its corporate headquarters and 7,925 square feet of laboratory space in Durham, North Carolina, with both leases expiring in July 2026 - The company leases its corporate headquarters (**21,325 sq. ft.**) and laboratory space (**7,925 sq. ft.**) in Durham, NC, with leases expiring in July 2026[475](index=475&type=chunk)[545](index=545&type=chunk) [Legal Proceedings](index=56&type=section&id=Item%203.%20Legal%20Proceedings) The company reports no material legal proceedings - There are no material legal proceedings to report[719](index=719&type=chunk) [Mine Safety Disclosures](index=56&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[720](index=720&type=chunk) Part II [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) The company's common stock trades on The Nasdaq Global Market under 'CMRX', with no cash dividends ever paid or planned, and no equity repurchases during the period - The company's common stock trades on The Nasdaq Global Market under the symbol **CMRX**[10](index=10&type=chunk) - Chimerix has never declared or paid cash dividends and does not plan to in the foreseeable future[696](index=696&type=chunk) - The company made no purchases of its equity securities during the reporting period[724](index=724&type=chunk)[754](index=754&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=58&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion highlights the company's shift to an oncology-focused pipeline after the 2022 TEMBEXA sale, which generated **$33.8 million** in revenue and a **$229.7 million** net gain, resulting in a **$172.2 million** net income - The sale of TEMBEXA to Emergent for **$238 million** upfront was a key event in 2022, providing significant capital and allowing the company to focus on its oncology pipeline[735](index=735&type=chunk) Financial Results Comparison (2022 vs. 2021) | Metric | 2022 | 2021 | | :--- | :--- | :--- | | Total Revenues | $33.8M | $2.0M | | R&D Expenses | $71.6M | $73.8M | | G&A Expenses | $22.1M | $18.7M | | Net Income (Loss) | $172.2M | ($173.2M) | - The company believes its existing cash, cash equivalents, and investments of approximately **$266.0 million** will fund operations and capital requirements for at least the next 12 months[834](index=834&type=chunk)[836](index=836&type=chunk) [Results of Operations](index=68&type=section&id=Results%20of%20Operations) For 2022, total revenues significantly increased to **$33.8 million** due to TEMBEXA procurement, while R&D expenses slightly decreased, and a **$229.7 million** net gain from the TEMBEXA sale led to a **$172.2 million** net income, reversing a **$173.2 million** net loss in 2021 - Total revenues increased by **$31.8 million** in 2022, driven by **$32.0 million** in procurement revenue from international TEMBEXA agreements[825](index=825&type=chunk)[149](index=149&type=chunk) - R&D expenses decreased by **$2.2 million (3.0%)** in 2022, mainly due to a **$20.0 million** milestone payment made in 2021 not recurring, and a **$4.8 million** decrease in DSTAT costs, which offset a **$20.3 million** increase in ONC201 program expenses[826](index=826&type=chunk)[44](index=44&type=chunk)[859](index=859&type=chunk) - General and administrative expenses increased by **$3.5 million (18.5%)** in 2022, primarily due to higher compensation and a **$1.8 million** increase in legal and consulting expenses related to the TEMBEXA transactions[45](index=45&type=chunk)[798](index=798&type=chunk) - The company recorded a net gain of **$229.7 million** in 2022 from the sale of TEMBEXA[829](index=829&type=chunk)[159](index=159&type=chunk) - There was no acquired in-process research and development (IPR&D) expense in 2022, compared to **$82.9 million** in 2021 related to the Oncoceutics acquisition[860](index=860&type=chunk)[828](index=828&type=chunk) [Liquidity and Capital Resources](index=71&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2022, Chimerix had approximately **$266.0 million** in capital, significantly bolstered by **$234.0 million** in proceeds from the TEMBEXA sale, and management believes current capital is sufficient for at least the next 12 months Cash Flow Summary (in thousands) | Activity | 2022 | 2021 | 2020 | | :--- | :--- | :--- | :--- | | Net Cash Used in Operating Activities | $(46,867) | $(99,930) | $(36,038) | | Net Cash Provided by (Used in) Investing Activities | $70,037 | $(44,091) | $64,713 | | Net Cash (Used in) Provided by Financing Activities | $(12,725) | $112,429 | $1,413 | - Net cash used in operating activities was **$46.9 million** in 2022, primarily reflecting net income of **$172.2 million** offset by a non-cash gain of **$229.7 million** on the sale of TEMBEXA[53](index=53&type=chunk) - Net cash provided by investing activities was **$70.0 million** in 2022, driven by **$234.0 million** in proceeds from the TEMBEXA sale, offset by net purchases of investments[872](index=872&type=chunk) - Net cash used in financing activities was **$12.7 million** in 2022, mainly due to a **$14.0 million** note payment related to the Oncoceutics acquisition[55](index=55&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=75&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, but due to the short-term, low-risk nature of its investments, a 10% rate change is considered immaterial - The company's main market risk exposure is to interest rate changes affecting its investment portfolio, but due to the short-term, low-risk nature of the investments, the impact of a **10%** rate change is considered immaterial[844](index=844&type=chunk) - Inflation is not considered to have had a material effect on the company's results of operations for the years ended December 31, 2022 or 2021[845](index=845&type=chunk) [Financial Statements and Supplementary Data](index=76&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section contains the company's audited consolidated financial statements for 2022, 2021, and 2020, with an unqualified auditor's opinion and accrued R&D expenses identified as a critical audit matter - The independent auditor, Ernst & Young LLP, issued an unqualified opinion on the consolidated financial statements and the effectiveness of internal control over financial reporting as of December 31, 2022[911](index=911&type=chunk)[62](index=62&type=chunk)[851](index=851&type=chunk) - The primary critical audit matter identified was the accounting for accrued research and development expenses, which involves significant management judgment in estimating costs for services that have been rendered but not yet invoiced[63](index=63&type=chunk)[97](index=97&type=chunk)[849](index=849&type=chunk) [Consolidated Financial Statements](index=80&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements show a significant improvement in financial position in 2022, with total assets increasing to **$279.3 million** and net income of **$172.2 million**, reversing prior year losses Consolidated Balance Sheet Data (in thousands) | Account | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $25,842 | $15,397 | | Total current assets | $228,138 | $95,805 | | Total assets | $279,341 | $100,540 | | Total current liabilities | $20,415 | $29,896 | | Total liabilities | $22,484 | $32,288 | | Total stockholders' equity | $256,857 | $68,252 | Consolidated Statement of Operations Data (in thousands) | Account | 2022 | 2021 | 2020 | | :--- | :--- | :--- | :--- | | Total revenues | $33,824 | $1,979 | $5,372 | | Total operating expenses | $93,763 | $175,379 | $49,888 | | Gain on sale of business, net | $229,670 | $— | $— | | Net income (loss) | $172,167 | $(173,236) | $(43,522) | [Notes to Consolidated Financial Statements](index=84&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes provide detailed disclosures on the TEMBEXA sale, the Oncoceutics acquisition, a 2022 restructuring, and the company's tax situation, including a full valuation allowance against deferred tax assets - The sale of TEMBEXA to Emergent included an upfront cash payment of **~$238 million** and eligibility for up to **~$124 million** in milestones tied to BARDA procurement options, plus royalties, with the company recording a net gain of **$229.7 million** on the sale[90](index=90&type=chunk)[267](index=267&type=chunk)[268](index=268&type=chunk) - The 2021 acquisition of Oncoceutics was accounted for as an asset acquisition, resulting in an immediate expense of **$82.9 million** for acquired in-process research and development (IPR&D)[276](index=276&type=chunk)[304](index=304&type=chunk)[332](index=332&type=chunk) - In December 2022, the company initiated a restructuring that included a reduction of **20 full-time employees**, recording one-time termination benefit expenses of **$1.9 million**[278](index=278&type=chunk)[307](index=307&type=chunk)[334](index=334&type=chunk) - As of Dec 31, 2022, the company had federal and state net operating loss carryforwards of approximately **$394.8 million** and **$394.4 million**, respectively, with a full valuation allowance recorded against deferred tax assets due to uncertainty of realization[237](index=237&type=chunk)[234](index=234&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=105&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on any matter of accounting principles or practices, or financial statement disclosure - None reported[309](index=309&type=chunk) [Controls and Procedures](index=105&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2022, with no material changes during the last fiscal quarter - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2022[310](index=310&type=chunk) - Based on the COSO 2013 framework, management concluded that internal control over financial reporting was effective as of December 31, 2022[338](index=338&type=chunk) - No changes in internal control over financial reporting occurred during the last fiscal quarter that materially affected, or are reasonably likely to materially affect, these controls[313](index=313&type=chunk) [Other Information](index=106&type=section&id=Item%209B.%20Other%20Information) This item is not applicable - Not applicable[314](index=314&type=chunk) Part III Part III of the 10-K, covering Items 10 through 14, incorporates information by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders [Directors, Executive Officers and Corporate Governance](index=107&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information required by this item, including details on directors, executive officers, and the company's Code of Business Conduct and Ethics, will be incorporated by reference from the company's 2023 Proxy Statement - The required information is incorporated by reference from the registrant's 2023 Proxy Statement[316](index=316&type=chunk) [Executive Compensation](index=107&type=section&id=Item%2011.%20Executive%20Compensation) Information required by this item regarding executive compensation will be incorporated by reference from the company's 2023 Proxy Statement - The required information is incorporated by reference from the registrant's 2023 Proxy Statement[341](index=341&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=107&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information required by this item, concerning security ownership by certain beneficial owners and management, as well as matters related to equity compensation plans, will be incorporated by reference from the company's 2023 Proxy Statement - The required information is incorporated by reference from the registrant's 2023 Proxy Statement[342](index=342&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=107&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information required by this item regarding related party transactions and director independence will be incorporated by reference from the company's 2023 Proxy Statement - The required information is incorporated by reference from the registrant's 2023 Proxy Statement[318](index=318&type=chunk) [Principal Accounting Fees and Services](index=107&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information required by this item concerning fees paid to the principal accountant and the audit committee's pre-approval policies will be incorporated by reference from the company's 2023 Proxy Statement - The required information is incorporated by reference from the registrant's 2023 Proxy Statement[941](index=941&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=108&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the financial statements, financial statement schedules, and exhibits filed as part of the Form 10-K, including certifications by the CEO and CFO - This section includes the financial statements (filed under Item 8) and a list of all exhibits filed with the annual report[952](index=952&type=chunk)[960](index=960&type=chunk) - Key exhibits filed include the Oncoceutics Merger Agreement, the Asset Purchase Agreement with Emergent, loan agreements, and executive employment letters[951](index=951&type=chunk)[932](index=932&type=chunk)[954](index=954&type=chunk) - Certifications of the Principal Executive Officer and Principal Financial Officer pursuant to Sarbanes-Oxley Sections 302 and 906 are included as exhibits[962](index=962&type=chunk)[933](index=933&type=chunk)[955](index=955&type=chunk)

Chimerix, Inc. (NASDAQ:CMRX) Q3 2022 Earnings Conference Call November 3, 2022 8:30 AM ET Company Participants Michelle LaSpaluto - Vice President-Strategic Planning & Investor Relations Mike Sherman - Chief Executive Officer Mike Andriole - Chief Business Officer & Chief Financial Officer Allen Melemed - Chief Medical Officer Conference Call Participants Kevin Strang - Jefferies Naureen Quibria - Capital One Ed White - H.C. Wainwright Joseph Thome - Cowen Operator Good morning, ladies and gentlemen, and we ...

Financial Performance - Total revenue for the nine months ended September 30, 2022, increased to $33.0 million, up from $1.9 million for the same period in 2021, primarily due to international TEMBEXA procurement agreements[168]. - The company recognized $31.9 million in procurement revenue for the nine months ended September 30, 2022, with contract and grant revenue decreasing by 73.9% to $503,000[167]. - The gross profit for the nine months ended September 30, 2022, was $32.6 million, compared to $1.9 million in the same period in 2021, reflecting a significant increase of 1,584.6%[167]. - Operating expenses decreased by 49.1% to $69.1 million for the nine months ended September 30, 2022, compared to $135.8 million for the same period in 2021[167]. - The company reported a net income of $193.1 million for the nine months ended September 30, 2022, compared to a net loss of $133.7 million for the same period in 2021, marking a change of 244.4%[167]. - Total revenues for the three months ended September 30, 2022, reached $32.6 million, a significant increase from $0.1 million for the same period in 2021, primarily due to international TEMBEXA procurement agreements[179]. - The company reported a net income of $241.4 million for the three months ended September 30, 2022, compared to a net loss of $18.6 million for the same period in 2021[179]. Research and Development - Research and development expenses for the nine months ended September 30, 2022, were $52.4 million, an increase of $12.9 million compared to $39.5 million for the same period in 2021[170]. - Research and development expenses included a $15.6 million increase related to ONC201 research and development expenses for the nine months ended September 30, 2022[170]. - Research and development expenses increased to $15.3 million for the three months ended September 30, 2022, compared to $13.8 million for the same period in 2021, reflecting a $1.4 million increase[180]. - The company expects to incur significant research and development expenses as it continues to develop Oncoceutics' lead compound, ONC201, for U.S. regulatory approval[156]. - The ACTION Study for ONC201 aims to enroll 450 patients and is expected to begin site activation in November 2023[130]. - A 50-patient analysis of ONC201 showed an overall response rate of 20% and a median duration of response of 11.2 months[135]. - ONC206 is currently in Phase I dose escalation trials, targeting solid tumors and demonstrating anti-cancer activity in pre-clinical models[136]. Revenue Streams - Chimerix received an upfront cash payment of approximately $238 million from Emergent BioSolutions upon closing the Asset Sale[142]. - The company is eligible for up to approximately $124 million in milestone payments under the BARDA Agreement[142]. - Chimerix can earn a 20% royalty on gross profits from TEMBEXA sales in the U.S. exceeding 1.7 million treatment courses[124]. - The company also expects to receive a 15% royalty on gross profits from TEMBEXA sales outside the U.S.[124]. - A Supply Agreement was established with a third party for TEMBEXA treatment courses, generating approximately $9.3 million in revenue[127]. - The Public Health Agency of Canada awarded a contract valued at approximately CAD $33.0 million ($25.3 million) for TEMBEXA, resulting in $22.6 million of revenue[128]. - The company recorded a net gain of $229.7 million on the sale of exclusive worldwide rights to brincidofovir, including TEMBEXA, for the nine months ended September 30, 2022[176]. Expenses and Liabilities - The company incurred $2.3 million in accounts payable and contract close-out accruals related to the discontinued DSTAT program as of September 30, 2022[157]. - Share-based compensation expense recognized was $3.8 million for the three months ended September 30, 2022, compared to $3.4 million for the same period in 2021[161]. - General and administrative expenses increased to $16.8 million for the nine months ended September 30, 2022, up from $13.4 million in the same period of 2021, representing a $3.4 million increase[173]. - Total operating expenses for the three months ended September 30, 2022, were $20.6 million, an increase from $18.7 million in the same period of 2021, marking a 10.0% increase[178]. Cash Flow and Financial Position - Net cash used in operating activities was $26.9 million for the nine months ended September 30, 2022, a decrease from $65.9 million in the same period of 2021[193]. - The company had approximately $284.6 million available to fund operations as of September 30, 2022, despite an accumulated deficit of $692.5 million[185]. - Net cash provided by investing activities was $298.4 million for the nine months ended September 30, 2022, primarily due to proceeds from the sale of TEMBEXA[195]. - Net cash used by financing activities was $12.7 million for the nine months ended September 30, 2022, primarily due to a $14.0 million payment related to the Oncoceutics acquisition[196]. - The company had net cash provided by financing activities of $112.4 million for the nine months ended September 30, 2021, mainly from $107.8 million in proceeds from the issuance of common stock[196]. Market and Economic Factors - The company does not expect significant effects on operating results or cash flows from a sudden change in market interest rates due to the short-term duration of its investment portfolio[202]. - Inflation has not had a material effect on the company's results of operations for the three and nine months ended September 30, 2022, or September 30, 2021[204]. - The company could be required to pay up to an aggregate of $340.0 million in remaining milestone payments to former Oncoceutics securityholders, contingent upon achieving specified milestones[200]. - The company is required to purchase an additional $2.4 million of DSTAT active pharmaceutical ingredient by December 31, 2023, unless the contract is terminated earlier[199].

Financial Data and Key Metrics Changes - The company reported a net loss of $23.5 million or $0.27 per basic and diluted share for Q2 2022, compared to a net loss of $17.8 million or $0.21 per basic and diluted share in Q2 2021 [32] - Research and development expenses increased to $18 million for Q2 2022, up from $13.8 million in the same period in 2021, primarily driven by ongoing development related to ONC201 [32] - General and administrative expenses rose to $5.8 million for Q2 2022, compared to $4.4 million for the same period in 2021 [32] Business Line Data and Key Metrics Changes - The company achieved its first TEMBEXA product revenue of $35 million in July 2022, covered by two international agreements [6] - The company expects to realize at least $32 million of revenue in Q3 2022 from the TEMBEXA sales [28] Market Data and Key Metrics Changes - The company noted that the monkeypox outbreak has introduced new considerations for both BARDA and Chimerix, impacting their operational strategies [7] - The market research indicates high awareness of ONC201 among top prescribing neuro-oncologists, with expectations for rapid adoption if the ACTION study is successful [25][27] Company Strategy and Development Direction - The company is focused on advancing the ACTION study for ONC201, which targets a specific patient population with the H3 K27M mutation [9][14] - The company plans to revisit the potential for accelerated approval based on Phase 2 data with the FDA later in the year [24][40] - The company is actively working to finalize the BARDA contract, which is crucial for advancing its pipeline programs [31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential success of the ACTION study, citing a high probability of success due to the focused patient population and robust study design [9][10] - The management acknowledged the ongoing discussions with international parties regarding TEMBEXA, particularly in light of the monkeypox outbreak [46][55] Other Important Information - The company welcomed Christopher Jordan as the new Vice President of Regulatory Affairs, bringing over 30 years of pharma experience [33] - The company has completed a robust safety assessment of ONC201 involving over 200 patients, revealing an attractive safety profile [13][21] Q&A Session Summary Question: Can either of the initial interim assessments at 164 or 246 events be enough to file for approval? - Management confirmed that these assessments are designed to provide statistical significance and could serve as the basis for regulatory submission and approval [35] Question: Can you talk more about the twice a week dosing and its rationale? - Management explained that the twice weekly dosing has shown safety in prior studies and aims to maximize efficacy by prolonging exposure [36][37] Question: Is there a timeframe mandated for administering ONC201 post-radiation? - Management clarified that patients will be enrolled within two to six weeks post-radiation, which is closer than the previous Phase 2 analysis [42][45] Question: What is the timeline for the BARDA contract and additional ex-U.S. revenues? - Management indicated that the BARDA contract needs to be finalized by September 30, 2022, and discussions for international opportunities are ongoing [46][47] Question: Have you set a meeting date with the FDA regarding accelerated approval? - Management stated they are preparing materials for the meeting and believe the ongoing Phase 3 study will support their case for accelerated approval [50][52] Question: What are the preclinical data for monkeypox and your thoughts on pursuing studies? - Management highlighted that TEMBEXA shows strong in vitro sensitivity to monkeypox and has demonstrated efficacy in animal models [54][56]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35867 CHIMERIX, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 33-0903395 (State or Other Jurisdiction of ...

Chimerix, Inc. (NASDAQ:CMRX) Q1 2022 Earnings Conference Call May 16, 2022 8:30 AM ET Company Participants Mike Sherman – President & Chief Executive Officer Michael Andriole – Chief Financial & Business Officer Allen Melemed – Chief Medical Officer Joshua Allen – Chief Technology Officer, Imipridones Michelle Laspaluto – Vice President, Strategic Planning & Investor Relations Conference Call Participants Maury Raycroft – Jefferies Edward White – H.C. Wainwright & Co. Naureen Quibria – Maxim Group Soumit Ro ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35867 CHIMERIX, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 33-0903395 (State or Other Jurisdiction of ...

Chimerix 1Q2022 Corporate Presentation Forward-Looking Statements 2 These slides contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things, results from the BICR of the 50- patient cohort of ONC201 for the treatment of recurrent H3 K27M-mutant glioma, the status of Ch ...

Financial Data and Key Metrics Changes - The company reported a net loss of $39.5 million or $0.45 per basic and diluted share for Q4 2021, compared to a net loss of $11.7 million or $0.19 per share in Q4 2020 [37] - Revenues for Q4 2021 decreased to $46,000 from $1.1 million in the same period in 2020, primarily due to the completion of a BARDA research and development contract [38] - Research and development expenses increased to $34.3 million in Q4 2021 from $8.7 million in Q4 2020, largely due to a $20 million success milestone payment related to ONC201 [38] Business Line Data and Key Metrics Changes - The TEMBEXA program is expected to provide significant non-dilutive capital to fund oncology drug development, with a BARDA request for up to 1.7 million courses of treatment [10][11] - The ONC201 drug showed compelling response data in glioma, with a median tumor reduction of over 50% achieved at just over eight months after treatment initiation [13] - The DSTAT program's Phase III trial in frontline AML has faced slower enrollment due to COVID-19 staffing shortages, prompting a review of options to accelerate development [19] Market Data and Key Metrics Changes - The company is exploring international opportunities for TEMBEXA, particularly in Canada and Europe, as pandemic preparedness becomes increasingly critical [55] - The geopolitical uncertainty in Eastern Europe is noted as a consideration for potential stockpiling opportunities, although significant international demand is not expected in 2022 [56] Company Strategy and Development Direction - The company aims to initiate its first commercial product sale of TEMBEXA to the U.S. Strategic National Stockpile in Q2 2022, which is expected to enable full investment in its oncology pipeline [35][36] - The focus remains on advancing the oncology pipeline while also evaluating the antiviral library, particularly CMX521, which has shown promising preclinical efficacy against COVID-19 [21][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the BARDA negotiations, indicating that the process typically takes 60 to 90 days and that they feel good about their pricing proposal [41][42] - The company anticipates that 2022 will be pivotal, with expected revenue from TEMBEXA sales allowing for further investment in oncology programs [35][36] Other Important Information - The company has approximately $90 million in capital to fund operations as of December 2021, and has entered into a $50 million revolving credit line for additional financial flexibility [32][33] - The collaboration with the University of North Carolina has been highlighted as a key factor in evaluating the antiviral library's potential value [21] Q&A Session Summary Question: Confidence in BARDA negotiations timeline - Management indicated that negotiations typically take 60 to 90 days and expressed confidence in their proposal for pricing and delivery schedule [41][42] Question: Business development focus post-BARDA contract - The company will continuously evaluate external opportunities but will focus on internal projects, particularly ONC206 and ONC212, which may require additional investment [43] Question: Triggers for first TEMBEXA procurement - The initial shipment quantity is part of the negotiation, and future shipments will be subject to BARDA's orders based on the proposed manufacturing schedule [46] Question: Components needed for ONC201 regulatory filing - Key components include clinpharm activities, CMC activities, and a broader safety database beyond the initial efficacy analysis [47][48] Question: Safety data requirements for ONC201 submission - Management does not expect safety data from the upcoming Phase 3 trial to be required for the NDA submission, as prior safety evaluations have been sufficient [52][53] Question: Demand for TEMBEXA outside the U.S. - The company is exploring stockpiling opportunities in Canada and Europe, with ongoing discussions about potential procurement mechanisms [55][56] Question: Timing for initial studies and human data for CMX521 - Management indicated that they would provide more details on the timeline for human studies in subsequent calls, emphasizing the promising safety profile of CMX521 [59] Question: Details on the natural history study - The study will consist of two cohorts, one mirroring the ONC201 registration cohort and another broader population study to understand overall survival and progression [62][63]

Part I [Item 1. Business](index=5&type=section&id=Item%201.%20Business) Chimerix is a biopharmaceutical company developing medicines for deadly diseases, with an FDA-approved smallpox drug and advanced clinical programs for glioma and AML [Company Overview and Pipeline](index=5&type=section&id=Company%20Overview%20and%20Pipeline) Chimerix, a biopharmaceutical company, has an FDA-approved smallpox product and late-stage clinical programs for glioma and AML - Chimerix develops medicines for deadly diseases, featuring **FDA-approved TEMBEXA** for smallpox and advanced clinical programs for glioma and AML[18](index=18&type=chunk) - In January 2021, Chimerix acquired Oncoceutics, gaining **ONC201** for recurrent H3 K27M-mutant glioma and the imipridone platform[25](index=25&type=chunk) - The company is developing **DSTAT** as a first-line therapy for AML in combination with standard chemotherapy, currently in a Phase 3 trial[53](index=53&type=chunk) [TEMBEXA (brincidofovir, BCV)](index=5&type=section&id=TEMBEXA%20(brincidofovir%2C%20BCV)) TEMBEXA, approved by the FDA in June 2021 for smallpox, holds orphan drug exclusivity and is subject to a potential BARDA procurement contract - On June 4, 2021, the FDA approved **TEMBEXA** for smallpox treatment in adult and pediatric patients[19](index=19&type=chunk) - BARDA issued an RFP, intending to negotiate a sole source contract for up to **1.7 million treatment courses of TEMBEXA**[22](index=22&type=chunk)[23](index=23&type=chunk) - **TEMBEXA** has seven years of U.S. orphan drug exclusivity and patent coverage expected until **2034**[19](index=19&type=chunk) [ONC201 and Imipridones](index=6&type=section&id=ONC201%20and%20Imipridones) ONC201 shows positive efficacy in H3 K27M-mutant glioma, with plans for a Phase 3 trial, and the imipridone pipeline includes ONC206 and ONC212 ONC201 Efficacy Data in Recurrent H3 K27M-mutant Glioma (50-Patient Cohort) | Metric | Result (RANO-HGG) | 95% Confidence Interval | | :--- | :--- | :--- | | Overall Response Rate (ORR) | 20.0% | 10.0-34% | | Disease Control Rate | 40% | 26-55% | | Median Duration of Response (mDOR) | 11.2 months | 3.8 - not reached | | Median Time to Response | 8.3 months | N/A | ONC201 Survival Data | Timepoint | Overall Survival | 95% Confidence Interval | | :--- | :--- | :--- | | 12 months | 57% | 41-70% | | 24 months | 35% | 21-49% | - Achieving the **20% ORR milestone** triggered a **$20 million payment** to former Oncoceutics shareholders in Q4 2021[44](index=44&type=chunk) - Chimerix plans to meet with the FDA in H1 2022 to discuss the design for a first-line Phase 3 trial of **ONC201** in H2 2022[43](index=43&type=chunk) [Dociparstat sodium (DSTAT)](index=11&type=section&id=Dociparstat%20sodium%20(DSTAT)) DSTAT is in a Phase 3 trial for first-line AML, targeting overall survival, with enrollment impacted by COVID-19 and an early assessment planned for 80 patients - **DSTAT** is in a Phase 3 trial (DASH AML) for newly diagnosed AML patients, evaluating its efficacy with standard chemotherapy[60](index=60&type=chunk)[61](index=61&type=chunk) - The primary endpoint of the DASH AML trial is **overall survival (OS)**, with event-free survival (EFS) as a potential secondary endpoint[62](index=62&type=chunk) - Enrollment for the first **80 evaluable patients** for early assessment has been slower than anticipated due to COVID-19 and competition[65](index=65&type=chunk) [Our Strategy](index=13&type=section&id=Our%20Strategy) Chimerix's strategy centers on commercializing TEMBEXA, advancing ONC201 and DSTAT through clinical trials, and developing its early-stage pipeline - Deliver **TEMBEXA** to the U.S. Strategic National Stockpile under a potential sole source contract with BARDA[69](index=69&type=chunk) - Develop **ONC201** for recurrent H3 K27M-mutant glioma, potentially seeking accelerated approval[69](index=69&type=chunk) - Advance the Phase 3 DASH AML trial for **DSTAT**, with an early assessment planned after the first **80 evaluable patients**[69](index=69&type=chunk) - Continue development of pipeline assets **ONC206** and **ONC212**, and explore the antiviral library, including **CMX521**[71](index=71&type=chunk) [Significant Agreements](index=14&type=section&id=Significant%20Agreements) Chimerix holds key agreements with BARDA for TEMBEXA, Cantex for DSTAT, Oncoceutics for its imipridone pipeline, and SymBio for BCV rights - BARDA development contract for **TEMBEXA** completed in September 2021, providing **$72.5 million** in reimbursement and **$4.6 million** in fees, with a new procurement contract for up to **1.7 million courses** under negotiation[72](index=72&type=chunk)[73](index=73&type=chunk)[75](index=75&type=chunk) - Acquired exclusive worldwide rights for **DSTAT** from Cantex in July 2019 for **$30 million cash**, **10 million shares**, and potential milestones up to **$587.5 million**[77](index=77&type=chunk)[79](index=79&type=chunk) - Acquired Oncoceutics in January 2021 for approximately **$25 million cash**, **8.7 million shares**, a **$14 million promissory note**, and up to **$360 million** in contingent payments, with a **$20 million milestone** paid in Q4 2021[82](index=82&type=chunk)[83](index=83&type=chunk) - Licensed exclusive worldwide rights for **BCV** (excluding orthopoxviruses) to SymBio in September 2019 for a **$5 million upfront payment** and up to **$180 million** in milestones[80](index=80&type=chunk)[81](index=81&type=chunk) [Commercial Operations, Competition, and IP](index=17&type=section&id=Commercial%20Operations%2C%20Competition%2C%20and%20IP) Chimerix focuses TEMBEXA commercialization on government procurement, faces competition for ONC201 and DSTAT, and maintains robust IP protection for its portfolio - Commercialization of **TEMBEXA** targets the U.S. Strategic National Stockpile, while **ONC201** and **DSTAT** may involve a small U.S. commercial team or partnerships[88](index=88&type=chunk)[90](index=90&type=chunk) - **ONC201** faces competition from existing brain cancer therapies, and **DSTAT** competes with standard AML treatments and targeted agents[95](index=95&type=chunk)[96](index=96&type=chunk) Intellectual Property Portfolio Summary | Product/Platform | Patent Count (Patents/Applications) | Expected U.S. Expiration | | :--- | :--- | :--- | | Antiviral (incl. TEMBEXA) | 80 | 2034 | | DSTAT | 64 | 2033 (potential to 2038) | | Oncoceutics (incl. ONC201) | 404 | 2037 (potential to 2042) | [Manufacturing and Government Regulation](index=20&type=section&id=Manufacturing%20and%20Government%20Regulation) Chimerix relies on third-party manufacturers for all products and is subject to extensive FDA and global regulations, utilizing expedited programs for key candidates - The company operates a virtual manufacturing model, relying entirely on **third-party contract manufacturers** for all candidates[109](index=109&type=chunk) - Manufacturing processes for **TEMBEXA** drug substance and tablets have been scaled up, with suspension scale-up planned for 2022[113](index=113&type=chunk)[114](index=114&type=chunk) - U.S. drug development requires extensive preclinical and clinical trials under INDs, adherence to **GCP** and **cGMP** standards, and NDA submission for FDA approval[117](index=117&type=chunk)[119](index=119&type=chunk)[123](index=123&type=chunk) - **ONC201** and **DSTAT** have Fast Track Designation; **ONC201**, **DSTAT**, and **BCV** (for smallpox) also hold Orphan Drug Designation[138](index=138&type=chunk)[140](index=140&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including financial losses, dependence on TEMBEXA contract, clinical development success, third-party reliance, and COVID-19 impacts - The company has a history of significant losses, with a **net loss of $173.2 million** in 2021 and an accumulated deficit of **$885.6 million** as of December 31, 2021[196](index=196&type=chunk)[197](index=197&type=chunk) - There is no guarantee that a contract with BARDA for **TEMBEXA** procurement will be finalized on favorable terms or at all[364](index=364&type=chunk) - The company's product candidates, **ONC201** and **DSTAT**, are in clinical development and face significant hurdles for regulatory approval and commercial success[231](index=231&type=chunk)[234](index=234&type=chunk) - Reliance on **third-party manufacturers** and limited supply sources presents risks of delays and disruptions[291](index=291&type=chunk)[297](index=297&type=chunk) - The **COVID-19 pandemic** poses a risk of significant disruption to preclinical studies, clinical trial enrollment, and supply chains[228](index=228&type=chunk)[229](index=229&type=chunk) [Item 1B. Unresolved Staff Comments](index=65&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - None[443](index=443&type=chunk) [Item 2. Properties](index=65&type=section&id=Item%202.%20Properties) Chimerix leases its corporate headquarters and laboratory space in Durham, North Carolina, and a small office in Philadelphia, Pennsylvania - The company's corporate headquarters and laboratory are in Durham, North Carolina, with leases expiring in **July 2026**[444](index=444&type=chunk) - The subsidiary, Oncoceutics, Inc., leases a small office in Philadelphia, Pennsylvania on a month-to-month basis[444](index=444&type=chunk) [Item 3. Legal Proceedings](index=65&type=section&id=Item%203.%20Legal%20Proceedings) The company reports that it is not involved in any legal proceedings - None[446](index=446&type=chunk) [Item 4. Mine Safety Disclosures](index=65&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[447](index=447&type=chunk) Part II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=66&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) This section details the company's stock performance, stockholder count, and dividend policy, noting no cash dividends have ever been paid - As of February 25, 2022, there were **82 stockholders of record** for the company's common stock[454](index=454&type=chunk) - The company has never paid cash dividends and does not intend to in the foreseeable future, retaining funds for growth[455](index=455&type=chunk) [Item 6. Reserved](index=67&type=section&id=Item%206.%20Reserved) This item is reserved and contains no information [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=67&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Chimerix reported a significant net loss in 2021, driven by R&D expenses and an acquisition charge, but maintains sufficient capital and a new credit facility for future operations [Results of Operations](index=76&type=section&id=Results%20of%20Operations) Chimerix's net loss significantly increased in 2021 due to higher R&D expenses, an acquired IPR&D charge from the Oncoceutics acquisition, and decreased revenues Results of Operations Comparison (2021 vs. 2020) | Metric | 2021 (in thousands) | 2020 (in thousands) | Change (%) | | :--- | :--- | :--- | :--- | | Total Revenues | $1,979 | $5,372 | (63.2)% | | Research and Development | $73,817 | $36,232 | 103.7% | | General and Administrative | $18,672 | $13,656 | 36.7% | | Acquired in-process R&D | $82,890 | $0 | N/A | | Loss from Operations | ($173,400) | ($44,516) | 289.5% | | Net Loss | ($173,236) | ($43,522) | 298.0% | - The increase in R&D expenses in 2021 was primarily due to a **$20 million** success milestone payment and a **$14.2 million** increase in manufacturing and clinical support for **ONC201**[529](index=529&type=chunk)[531](index=531&type=chunk) - The company recorded **$82.9 million** in acquired in-process R&D expenses in 2021 related to the Oncoceutics acquisition[533](index=533&type=chunk) [Liquidity and Capital Resources](index=78&type=section&id=Liquidity%20and%20Capital%20Resources) Chimerix ended 2021 with $90.4 million in capital, sufficient for 12 months, supplemented by a $50 million revolving credit facility secured in January 2022 - The company had **$90.4 million** in capital available as of December 31, 2021[542](index=542&type=chunk) Cash Flow Summary (in thousands) | Activity | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | ($99,930) | ($36,038) | ($75,181) | | Net cash (used in) provided by investing activities | ($44,091) | $64,713 | $10,631 | | Net cash provided by financing activities | $112,429 | $1,413 | $345 | - In January 2021, the company raised net proceeds of approximately **$107.8 million** from a public offering of common stock[545](index=545&type=chunk) - In January 2022, the company secured a four-year, **$50.0 million** revolving loan facility with Silicon Valley Bank[547](index=547&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=84&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on investments, deemed immaterial due to short-term, low-risk holdings - The primary market risk is interest income sensitivity from U.S. interest rate changes, expected to be immaterial due to the **short-term, low-risk investment portfolio**[565](index=565&type=chunk) - The company maintains cash and cash equivalents at financial institutions exceeding federally insured limits[566](index=566&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=85&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's consolidated financial statements, along with an unqualified audit opinion from Ernst & Young LLP [Report of Independent Registered Public Accounting Firm](index=86&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Ernst & Young LLP issued an unqualified opinion on Chimerix's financial statements and internal controls, identifying accrued R&D expenses as a critical audit matter - Ernst & Young LLP provided an **unqualified audit opinion** on consolidated financial statements and internal control effectiveness[572](index=572&type=chunk)[582](index=582&type=chunk) - The audit identified "Accrued Research and Development Expenses" as a **Critical Audit Matter**, due to subjective judgment in estimating expenses when vendor invoicing does not align with service periods[576](index=576&type=chunk)[578](index=578&type=chunk)[579](index=579&type=chunk) [Consolidated Financial Statements](index=89&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements show total assets of $100.5 million, a net loss of $173.2 million, and an accumulated deficit of $885.6 million as of December 31, 2021 Consolidated Balance Sheet Data (in thousands) | Account | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $15,397 | $46,989 | | Total current assets | $95,805 | $81,658 | | Total assets | $100,540 | $84,723 | | Total current liabilities | $29,896 | $8,533 | | Total liabilities | $32,288 | $11,347 | | Total stockholders' equity | $68,252 | $73,376 | Consolidated Statement of Operations Data (in thousands) | Account | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | Total revenues | $1,979 | $5,372 | $12,519 | | Total operating expenses | $175,379 | $49,888 | $128,502 | | Loss from operations | ($173,400) | ($44,516) | ($115,983) | | Net loss | ($173,236) | ($43,522) | ($112,576) | | Net loss per share | ($2.04) | ($0.70) | ($2.03) | [Notes to Consolidated Financial Statements](index=93&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail accounting policies, including revenue recognition and IPR&D expensing, and provide information on the Oncoceutics acquisition, inventory, and deferred tax assets - The Oncoceutics acquisition was an asset acquisition, resulting in immediate expensing of **$82.9 million** in acquired in-process R&D[714](index=714&type=chunk)[716](index=716&type=chunk) - **TEMBEXA** inventory costs began capitalization on June 4, 2021, with a **$2.8 million** work-in-process balance as of December 31, 2021[620](index=620&type=chunk)[623](index=623&type=chunk) - The company maintains a **full valuation allowance** against net deferred tax assets due to a history of losses[690](index=690&type=chunk) - Total stock-based compensation expense was **$12.3 million** in 2021, up from **$5.6 million** in 2020[683](index=683&type=chunk) [Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=114&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[731](index=731&type=chunk) [Item 9A. Controls and Procedures](index=114&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2021 - The company's principal executive and financial officers concluded that disclosure controls and procedures were effective as of **December 31, 2021**[732](index=732&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of **December 31, 2021**[736](index=736&type=chunk) [Item 9B. Other Information](index=116&type=section&id=Item%209B.%20Other%20Information) This item is not applicable - Not applicable[739](index=739&type=chunk) Part III [Item 10. Directors, Executive Officers and Corporate Governance](index=117&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance will be incorporated by reference from the 2022 Proxy Statement - Information for this item is incorporated by reference from the company's definitive Proxy Statement, to be filed within **120 days** of the fiscal year end[742](index=742&type=chunk) [Item 11. Executive Compensation](index=117&type=section&id=Item%2011.%20Executive%20Compensation) Information on executive compensation will be incorporated by reference from the company's 2022 Proxy Statement - Information for this item is incorporated by reference from the company's definitive Proxy Statement[744](index=744&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=117&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information on security ownership and related stockholder matters will be incorporated by reference from the company's 2022 Proxy Statement - Information for this item is incorporated by reference from the company's definitive Proxy Statement[745](index=745&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=117&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information on related party transactions and director independence will be incorporated by reference from the company's 2022 Proxy Statement - Information for this item is incorporated by reference from the company's definitive Proxy Statement[746](index=746&type=chunk) [Item 14. Principal Accounting Fees and Services](index=117&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information on principal accounting fees and services will be incorporated by reference from the company's 2022 Proxy Statement - Information for this item is incorporated by reference from the company's definitive Proxy Statement[747](index=747&type=chunk) Part IV [Item 15. Exhibits, Financial Statement Schedules](index=118&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists financial statements and an index of all exhibits filed with the Form 10-K, including material agreements and certifications - This section contains the index of exhibits filed with the Annual Report, including material agreements like the **Oncoceutics merger agreement**, **BARDA contract**, and **Cantex license agreement**[751](index=751&type=chunk)[752](index=752&type=chunk)