Cardiff Oncology(CRDF) - 2023 Q3 - Quarterly Report

Filing Information This section provides details on the Form 10-Q filing, registrant, and filer status for Cardiff Oncology, Inc Form Type and Registrant Details This document is a Quarterly Report on Form 10-Q for Cardiff Oncology, Inc., a Delaware-incorporated clinical-stage biotechnology company - The filing is a Quarterly Report on Form 10-Q for the period ended September 30, 2023[4] - Cardiff Oncology, Inc. is a Delaware corporation, headquartered in San Diego, California[3] - The company's common stock is listed on the Nasdaq Capital Market under the ticker symbol 'CRDF'[183] Filer Status as of September 30, 2023 | Filer Status | Indication | | :---------------------- | :--------- | | Large accelerated filer | ☐ | | Accelerated filer | ☐ | | Non-accelerated filer | ☒ | | Smaller reporting company | ☒ | | Emerging growth company | ☐ | PART I. FINANCIAL INFORMATION This part presents the unaudited condensed financial statements and management's discussion and analysis for the company Item 1. Financial Statements (unaudited) This section presents the unaudited condensed financial statements for Cardiff Oncology, Inc., highlighting continued net losses and negative operating cash flows Condensed Balance Sheets This section provides a snapshot of the company's financial position, showing a decrease in total assets and stockholders' equity Condensed Balance Sheet Highlights (in thousands) | Metric | September 30, 2023 | December 31, 2022 | | :-------------------------- | :----------------- | :---------------- | | Total Assets | $88,452 | $116,191 | | Total Current Assets | $83,905 | $111,284 | | Cash and cash equivalents | $15,233 | $16,347 | | Short-term investments | $66,130 | $88,920 | | Total Liabilities | $10,625 | $9,848 | | Total Stockholders' Equity | $77,827 | $106,343 | - Total assets decreased from $116.2 million at December 31, 2022, to $88.5 million at September 30, 2023, primarily due to a reduction in short-term investments[10] - Total stockholders' equity decreased from $106.3 million to $77.8 million over the same period, largely due to accumulated deficit from net losses[10] Condensed Statements of Operations This section details the company's financial performance, showing increased net losses and higher research and development expenses Condensed Statements of Operations Highlights (in thousands, except per share) | 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 | | :--------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Royalty revenues | $141 | $93 | $332 | $258 | | Research and development | $8,022 | $6,009 | $25,094 | $20,665 | | Selling, general and administrative | $2,939 | $3,077 | $10,318 | $10,103 | | Total operating expenses | $10,961 | $9,086 | $35,412 | $30,768 | | Loss from operations | $(10,820) | $(8,993) | $(35,080) | $(30,510) | | Interest income, net | $1,068 | $458 | $3,061 | $841 | | Net loss | $(9,731) | $(8,571) | $(32,104) | $(30,007) | | Net loss per common share — basic and diluted | $(0.22) | $(0.20) | $(0.72) | $(0.69) | - Net loss increased to $(9.731) million for the three months ended September 30, 2023, from $(8.571) million in the prior year, and to $(32.104) million for the nine months ended September 30, 2023, from $(30.007) million in the prior year[11] - Research and development expenses increased significantly, by $2.0 million for the three-month period and $4.4 million for the nine-month period, primarily due to clinical program costs and increased headcount[11][115][141] Condensed Statements of Comprehensive Loss This section presents the total comprehensive loss, reflecting net loss and unrealized gains or losses on available-for-sale securities Condensed Statements of Comprehensive Loss Highlights (in thousands) | 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 | | :--------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Net loss | $(9,731) | $(8,571) | $(32,104) | $(30,007) | | Unrealized gain (loss) on securities available-for-sale | $24 | $203 | $(12) | $(637) | | Total comprehensive loss | $(9,707) | $(8,368) | $(32,116) | $(30,644) | | Comprehensive loss attributable to common stockholders | $(9,713) | $(8,374) | $(32,134) | $(30,662) | - Total comprehensive loss for the nine months ended September 30, 2023, was $(32.116) million, compared to $(30.644) million for the same period in 2022[24] Condensed Statements of Stockholders' Equity This section outlines changes in stockholders' equity, primarily driven by net losses and stock-based compensation Condensed Statements of Stockholders' Equity Highlights (in thousands) | Metric | Balance, January 1, 2023 | Stock-based compensation | Other comprehensive gain (loss) | Net loss | Balance, September 30, 2023 | | :----------------------------------- | :----------------------- | :----------------------- | :------------------------------ | :---------- | :-------------------------- | | Preferred Stock Shares | 61 | — | — | — | 61 | | Common Stock Shares | 44,677 | — | — | — | 44,677 | | Additional Paid-In Capital | $404,834 | $1,064 | — | — | $408,434 | | Accumulated Other Comprehensive Loss | $(395) | — | $319 | — | $(407) | | Accumulated Deficit | $(298,100) | — | — | $(11,223) | $(330,204) | | Total Stockholders' Equity | $106,343 | $1,064 | $319 | $(11,223) | $77,827 | - Total stockholders' equity decreased from $106.343 million at January 1, 2023, to $77.827 million at September 30, 2023, primarily due to net losses[1] - Additional paid-in capital increased by $3.6 million during the nine months ended September 30, 2023, mainly due to stock-based compensation[1][68] Condensed Statements of Cash Flows This section details cash flow activities, showing continued cash usage in operations and changes in investing activities Condensed Statements of Cash Flows Highlights (in thousands) | Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :---------------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(23,748) | $(24,430) | | Net cash provided by investing activities | $22,634 | $31,129 | | Net cash provided by financing activities | $0 | $75 | | Net change in cash and cash equivalents | $(1,114) | $6,774 | | Cash and cash equivalents—End of period | $15,233 | $18,717 | - Net cash used in operating activities was $(23.7) million for the nine months ended September 30, 2023, a slight decrease from $(24.4) million in the prior year, primarily driven by net loss[12][165] - Net cash provided by investing activities decreased to $22.6 million in 2023 from $31.1 million in 2022, mainly due to changes in sales and maturities of short-term investments[12][144] Notes to Condensed Financial Statements This section provides detailed explanations and disclosures supporting the condensed financial statements, covering accounting policies, fair value, and equity 1. Organization and Basis of Presentation Cardiff Oncology, Inc. is a clinical-stage biotechnology company focused on developing novel cancer therapies, with sufficient cash for the next 12 months - Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition to develop cancer therapies, with onvansertib as its lead asset[37] - The company has incurred net losses and negative operating cash flows since inception[38] - As of September 30, 2023, the company had $81.4 million in cash, cash equivalents, and short-term investments, sufficient for at least the next 12 months[38] 2. Summary of Significant Accounting Policies This note confirms GAAP and SEC compliance for interim financial statements, with no significant accounting policy changes, and ongoing evaluation of ASU 2020-06 - Unaudited interim condensed financial statements are prepared in accordance with GAAP and SEC rules for Form 10-Q[55] - No changes to significant accounting policies were made during the nine months ended September 30, 2023[56] - The company is evaluating ASU 2020-06 regarding convertible instruments and diluted EPS, with adoption planned for January 1, 2024[80] Potentially Dilutive Securities Excluded from Diluted Net Loss Per Share (as of September 30, 2023 and December 31, 2022) | Security Type | September 30, 2023 | December 31, 2022 | | :----------------------------------- | :----------------- | :---------------- | | Options to purchase Common Stock | 6,652,427 | 5,101,572 | | Warrants to purchase Common Stock | 2,807,948 | 4,490,159 | | Series A Convertible Preferred Stock | 877 | 877 | | Series E Convertible Preferred Stock | — | 1,342,250 | | Total Potentially Dilutive Securities| 9,461,252 | 10,934,858 | 3. Fair Value Measurements This note details fair value measurements of assets, primarily cash equivalents and available-for-sale investments, mostly classified as Level 2 Fair Value Measurements at September 30, 2023 (in thousands) | Asset Category | Level 1 (Quoted Prices) | Level 2 (Observable Inputs) | Level 3 (Unobservable Inputs) | Total | | :---------------------------------- | :---------------------- | :-------------------------- | :---------------------------- | :------- | | Money market fund | $14,928 | — | — | $14,928 | | Total included in cash and cash equivalents | $14,928 | — | — | $14,928 | | Available for sale investments: | | | | | | Certificate of deposit | — | $9,181 | — | $9,181 | | Corporate debt securities | — | $22,368 | — | $22,368 | | Commercial paper | — | $7,613 | — | $7,613 | | U.S. government agencies | — | $6,821 | — | $6,821 | | U.S. treasury securities | $20,147 | — | — | $20,147 | | Total available for sale investments| $20,147 | $45,983 | — | $66,130 | | Total assets measured at fair value on a recurring basis | $35,075 | $45,983 | — | $81,058 | - No transfers into or out of Level 3 of the fair value hierarchy occurred during the nine months ended September 30, 2023[83] 4. Supplementary Balance Sheet Information This note provides detailed breakdowns of investments, property, and accrued liabilities, noting unrealized losses due to interest rates Investments Available for Sale at September 30, 2023 (in thousands) | Investment Type | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Market Value | | :-------------------------- | :------------- | :--------------------- | :---------------------- | :---------------- | | Maturity less than 1 year: | | | | | | Certificate of deposit | $9,181 | $3 | $(3) | $9,181 | | Corporate debt securities | $12,194 | $3 | $(28) | $12,169 | | Commercial paper | $7,616 | — | $(3) | $7,613 | | U.S. government agencies | $6,852 | — | $(31) | $6,821 | | U.S. treasury securities | $1,935 | — | $(13) | $1,922 | | Total maturity less than 1 year | $37,778 | $6 | $(78) | $37,706 | | Maturity 1 to 2 years: | | | | | | Corporate debt securities | $10,281 | $3 | $(85) | $10,199 | | U.S. treasury securities | $18,478 | — | $(253) | $18,225 | | Total maturity 1 to 2 years | $28,759 | $3 | $(338) | $28,424 | | Total short-term investments| $66,537 | $9 | $(416) | $66,130 | - Unrealized losses on available-for-sale debt securities at September 30, 2023, were primarily due to increases in interest rates, not credit risks[85] Accrued Liabilities (in thousands) | Accrued Liability | September 30, 2023 | December 31, 2022 | | :-------------------------- | :----------------- | :---------------- | | Accrued compensation | $2,455 | $1,849 | | Clinical trials | $2,878 | $2,333 | | Research agreements and services | $591 | $509 | | Director fees | $125 | $125 | | Patent, license and other fees | $33 | $24 | | Other accrued liabilities | $69 | $337 | | Total accrued liabilities | $6,151 | $5,177 | 5. Stockholders' Equity This note details stock-based compensation, option and warrant activity, and preferred stock changes, including a modification for a departing employee Stock-based Compensation Expense (in thousands) | Expense Category | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :---------------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Included in research and development expense | $294 | $286 | $985 | $746 | | Included in selling, general and administrative expense | $661 | $751 | $2,615 | $2,498 | | Total stock-based compensation expense | $955 | $1,037 | $3,600 | $3,244 | - Unrecognized compensation cost for non-vested stock options was $7.5 million as of September 30, 2023, to be recognized over a weighted-average remaining vesting period of 2.3 years[88] Stock Option Activity (as of September 30, 2023) | Metric | Total Options | Weighted-Average Exercise Price Per Share | | :-------------------------------------- | :------------ | :---------------------------------------- | | Balance outstanding, December 31, 2022 | 5,069,458 | $5.92 | | Granted | 2,138,624 | $1.70 | | Forfeited and expired | (555,655) | $8.40 | | Balance outstanding, September 30, 2023 | 6,652,427 | $4.36 | - The company modified stock options for a departing employee in June 2023, resulting in an incremental stock-based compensation expense of $0.6 million[93] - On August 8, 2023, the company filed a Certificate of Elimination for Series B, C, D, and E Convertible Preferred Stock, returning previously designated but unissued shares to authorized but undesignated status[73] 6. Commitments and Contingencies This note outlines commitments under research and development agreements, including onvansertib licensing, and confirms no material legal liabilities - The company has a license agreement for onvansertib with Nerviano, involving potential development and commercial milestones, and sales-based royalties[96] - No milestone or royalty payments were made under the onvansertib license agreement during the nine months ended September 30, 2023 and 2022[96] - Management believes there are no legal liabilities that are probable or reasonably possible requiring accrual or disclosure, nor any claims that would result in a material adverse effect[97] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition, operations, business strategy, clinical trials, and liquidity Forward-Looking Statements This section highlights that the report contains forward-looking statements subject to risks and uncertainties, and actual results may differ - The report contains forward-looking statements regarding future financial position, business strategy, and operational plans, identified by words like 'believe,' 'may,' 'will,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'should,' 'plan,' and 'expect'[77] - These statements are based on current expectations and projections but are subject to risks, uncertainties, and assumptions, and actual results may differ materially[77][99] Overview Cardiff Oncology is a clinical-stage biotechnology company developing novel cancer therapies by inhibiting PLK1, with onvansertib as its lead asset - Cardiff Oncology is a clinical-stage biotechnology company focused on developing novel therapies for various cancers by inhibiting PLK1, a validated oncology drug target[122] - The company's strategy involves combining onvansertib, an oral and highly selective PLK1 inhibitor, with standard-of-care therapeutics to target tumor vulnerabilities[122] - Clinical programs are focused on RAS-mutated metastatic colorectal cancer (mCRC), metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), and triple negative breast cancer (TNBC)[122] Our Lead Drug Candidate, Onvansertib Onvansertib is an oral, highly specific PLK1 inhibitor with high potency and selectivity, showing synergistic effects in studies - Onvansertib is an oral, small molecule drug candidate that is highly specific for PLK1 inhibition with a 24-hour half-life[123] - It demonstrates high potency and selectivity against the PLK1 enzyme (IC50 = 2nM), with low or no activity on other PLK members or a panel of 63 other kinases[124] - In vitro and in vivo studies show synergistic effects when onvansertib is combined with various cytotoxic agents and standard-of-care cancer agents[103][125] RAS-mutated mCRC Program The CRDF-004 Phase 2 trial evaluates onvansertib in first-line RAS-mutated mCRC, with enrollment starting in Q4 2023 and interim data in mid-2024 - CRDF-004 is a Phase 2 open-label, randomized multi-center clinical trial evaluating onvansertib in combination with FOLFIRI and bevacizumab or FOLFOX and bevacizumab for first-line treatment of RAS-mutated mCRC[126] - Primary objectives include evaluating safety, efficacy, and two doses (20mg and 30mg) of onvansertib against standard-of-care alone, with objective response rate (ORR) as the primary endpoint[126] - Enrollment is expected to begin in Q4 2023, with interim data anticipated in mid-2024, and Pfizer Ignite is responsible for clinical execution[126] Phase 1b/2 Clinical Trial in KRAS-mutated mCRC The TROV-054 trial for KRAS-mutated mCRC showed a 29% ORR and 9.3 months mPFS, with bevacizumab-naïve patients achieving 73% ORR and 15 months mPFS - TROV-054 is a Phase 1b/2 open-label multi-center clinical trial of onvansertib with FOLFIRI and bevacizumab for second-line treatment of KRAS-mutated mCRC, which completed enrollment in October 2022[46] - Data presented on August 7, 2023, showed an Objective Response Rate (ORR) of 29% and median Progression-Free Survival (mPFS) of 9.3 months across all evaluable patients[107][128][129] - A subgroup analysis revealed that bevacizumab-naïve patients (n=15) had a 73% ORR and 15 months mPFS, significantly higher than historical controls and patients previously treated with bevacizumab[108] mDPAC Program The CRDF-001 Phase 2 trial for mPDAC showed a 19% ORR and 5.0 months mPFS, with an ongoing biomarker discovery trial - CRDF-001 is a Phase 2 open-label multi-center clinical trial of onvansertib in combination with nanoliposomal irinotecan, leucovorin, and fluorouracil for second-line treatment of mPDAC, with enrollment closing in October 2023[47][131] - Preliminary data from September 26, 2023, showed a 19% Objective Response Rate (ORR) compared to a historical control of 7.7% in the second-line setting, and a median Progression-Free Survival (mPFS) of 5.0 months compared to 3.1 months for standard of care[109][132] - A biomarker discovery trial for onvansertib monotherapy in mPDAC patients is ongoing, with preliminary data showing an 86% decrease in Ki67 and a 28% decrease in CA 19-9 in one patient[109][156] Other Clinical Programs Ongoing Phase 2 trials include onvansertib monotherapy for SCLC, showing a 57% disease control rate, and combination therapy for TNBC - A single-arm, two-stage, Phase 2 investigator-initiated trial of onvansertib monotherapy in patients with relapsed Small Cell Lung Cancer (SCLC) is open for enrollment, with a primary endpoint of Objective Response Rate (ORR)[48][134] - Preliminary efficacy data for seven SCLC patients showed 1 confirmed partial response, 3 stable disease, and 3 progressive disease, resulting in a 57% disease control rate[111] - A Phase 1b/2 investigator-initiated trial of onvansertib in combination with paclitaxel for unresectable locally advanced or metastatic Triple Negative Breast Cancer (TNBC) is open for enrollment[135][158] Critical Accounting Policies This section confirms no changes to the company's critical accounting policies since December 31, 2022 - There have been no changes to the company's critical accounting policies since December 31, 2022, as described in its Annual Report on Form 10-K[136] Results of Operations - Three Months Ended September 30, 2023 and 2022 This section analyzes the company's financial performance for the three-month period, detailing changes in revenues and expenses Revenues Royalty revenues for the three months ended September 30, 2023, increased to $141,000 from $93,000 in the prior year Royalty Revenues (in thousands) | Period | 2023 | 2022 | Change | | :------------------------------------ | :--- | :--- | :----- | | Three Months Ended September 30, 2023 | $141 | $93 | +$48 | - Revenue recognition depends on the timing and overall sales activities of the licensees[113] Research and Development Expenses Research and development expenses increased by $2.0 million for the three months ended September 30, 2023, due to clinical program costs and headcount growth Research and Development Expenses (in thousands) | Expense Category | 2023 | 2022 | Increase (Decrease) | | :------------------------------------ | :----- | :----- | :------------------ | | Salaries and staff costs | $1,615 | $1,000 | $615 | | Stock-based compensation | $294 | $286 | $8 | | Clinical trials, outside services, and lab supplies | $5,603 | $4,279 | $1,324 | | Facilities and other | $510 | $444 | $66 | | Total research and development | $8,022 | $6,009 | $2,013 | - Average headcount in research and development grew by 50% over the comparative period[115] Selling, General and Administrative Expenses Selling, general and administrative expenses decreased by $0.1 million for the three months, mainly due to lower headcount and reduced stock-based compensation Selling, General and Administrative Expenses (in thousands) | Expense Category | 2023 | 2022 | Increase (Decrease) | | :------------------------------------ | :----- | :----- | :------------------ | | Salaries and staff costs | $731 | $808 | $(77) | | Stock-based compensation | $661 | $751 | $(90) | | Outside services and professional fees | $1,011 | $840 | $171 | | Facilities and other | $536 | $678 | $(142) | | Total selling, general and administrative | $2,939 | $3,077 | $(138) | - The decrease was primarily due to lower headcount, reduced stock-based compensation, and lower insurance costs[138] - Outside services and professional fees increased due to additional legal fees for contract reviews[138] Interest Income, Net Net interest income increased to $1.1 million for the three months ended September 30, 2023, driven by higher interest rates Interest Income, Net (in thousands) | Period | 2023 | 2022 | Change | | :------------------------------------ | :----- | :----- | :----- | | Three Months Ended September 30, 2023 | $1,068 | $458 | +$610 | - The increase was primarily due to higher interest rates on the short-term investments portfolio[139] Results of Operations - Nine Months Ended September 30, 2023 and 2022 This section analyzes the company's financial performance for the nine-month period, detailing changes in revenues and expenses Revenues Total royalty revenues for the nine months ended September 30, 2023, increased to $332,000 from $258,000 in the prior year Royalty Revenues (in thousands) | Period | 2023 | 2022 | Change | | :----------------------------------- | :--- | :--- | :----- | | Nine Months Ended September 30, 2023 | $332 | $258 | +$74 | - Revenues are from sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib[161] Research and Development Expenses Research and development expenses increased by $4.4 million for the nine months ended September 30, 2023, due to clinical program costs and headcount growth Research and Development Expenses (in thousands) | Expense Category | 2023 | 2022 | Increase (Decrease) | | :------------------------------------ | :------ | :------ | :------------------ | | Salaries and staff costs | $4,475 | $3,131 | $1,344 | | Stock-based compensation | $985 | $746 | $239 | | Clinical trials, outside services, and lab supplies | $18,118 | $15,699 | $2,419 | | Facilities and other | $1,516 | $1,089 | $427 | | Total research and development | $25,094 | $20,665 | $4,429 | - Average headcount in research and development grew by 37% over the comparative period[141] Selling, General and Administrative Expenses Selling, general and administrative expenses increased by $0.2 million for the nine months, mainly due to higher salaries and staff costs Selling, General and Administrative Expenses (in thousands) | Expense Category | 2023 | 2022 | Increase (Decrease) | | :------------------------------------ | :------ | :------ | :------------------ | | Salaries and staff costs | $2,888 | $2,460 | $428 | | Stock-based compensation | $2,615 | $2,498 | $117 | | Outside services and professional fees | $3,102 | $3,119 | $(17) | | Facilities and other | $1,713 | $2,026 | $(313) | | Total selling, general and administrative | $10,318 | $10,103 | $215 | - Salaries and staff costs increased due to an employee severance agreement[142] Interest Income, Net Net interest income significantly increased to $3.1 million for the nine months ended September 30, 2023, due to higher interest rates Interest Income, Net (in thousands) | Period | 2023 | 2022 | Change | | :----------------------------------- | :----- | :--- | :----- | | Nine Months Ended September 30, 2023 | $3,061 | $841 | +$2,220 | - The increase was primarily due to higher interest rates on the short-term investments portfolio[143] Liquidity and Capital Resources The company has $81.4 million in cash and investments, sufficient for at least 12 months, but expects continued losses and need for additional capital - As of September 30, 2023, the company had working capital of $74.9 million and $81.4 million in cash, cash equivalents, and short-term investments[145] - The company believes it has sufficient cash to meet its funding requirements for at least the next 12 months and expects capital resources to fund operations into 2025[145] - The company expects to continue incurring losses and negative operating cash flows, requiring additional capital to advance clinical trial programs[147][165] - There is uncertainty regarding the availability of additional funding on acceptable terms, and future equity issuances could dilute stockholders[147] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section states that the information regarding quantitative and qualitative disclosures about market risk is not applicable to the company - This item is not applicable to Cardiff Oncology, Inc[148] Item 4. Controls and Procedures This section details the evaluation of the company's disclosure controls and procedures, confirming their effectiveness and no material changes to internal control Evaluation of Disclosure Controls and Procedures Management concluded that disclosure controls and procedures were effective as of September 30, 2023, providing reasonable assurance for information reporting - Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of September 30, 2023[149] - Disclosure controls are designed to provide reasonable assurance that information required to be disclosed is recorded, processed, summarized, and reported within specified time periods[149][169] Changes in Internal Control over Financial Reporting There were no material changes in internal control over financial reporting during the three months ended September 30, 2023 - There was no change in internal control over financial reporting during the three months ended September 30, 2023, that materially affected, or is reasonably likely to materially affect, internal control over financial reporting[170] PART II. OTHER INFORMATION This part covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits Item 1. Legal Proceedings This section states no material changes from the legal proceedings disclosed in the company's prior Form 10-K - No material changes from the legal proceedings disclosed in the Form 10-K for the year ended December 31, 2022[177] Item 1A. Risk Factors This section indicates no material changes from the risk factors disclosed in the company's prior Form 10-K - No material changes from the risk factors disclosed in the Form 10-K for the year ended December 31, 2022[177] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section states that there is no information to report regarding unregistered sales of equity securities and use of proceeds - None to report for unregistered sales of equity securities and use of proceeds[36] Item 3. Defaults Upon Senior Securities This section states that there is no information to report regarding defaults upon senior securities - Not applicable for defaults upon senior securities[152] Item 4. Mine Safety Disclosures This section states that there is no information to report regarding mine safety disclosures - None to report for mine safety disclosures[178] Item 5. Other Information This section states that there is no other information to report - None to report for other information[172] Item 6. Exhibits This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including certifications and XBRL documents List of Exhibits | Exhibit Number | Description of Exhibit | | :------------- | :---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | 31.1 | Certification of Principal Executive Officer required by Rule 13a-14(a)/15d-14(a) under the Exchange Act. | | 31.2 | Certification of Principal Financial Officer required by Rule 13a-14(a)/15d-14(a) under the Exchange Act. | | 32.1 | Certification of Principal Executive Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | | 32.2 | Certification of Principal Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | | 101.INS | Inline XBRL Instance Document | | 101.SCH | Inline XBRL Taxonomy Extension Schema | | 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase | | 101.LAB | Inline XBRL Taxonomy Extension Labels Linkbase | | 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase | | 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase | | 104 | Cover Page Interactive Data File - the cover page from the Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, is formatted in Inline XBRL | SIGNATURES This section confirms the official signing of the Quarterly Report on Form 10-Q by the company's executive officers Signatories The Quarterly Report on Form 10-Q was duly signed on November 2, 2023, by the Chief Financial Officer and Chief Executive Officer - The report was signed on November 2, 2023[176][181] - Signed by James Levine, Chief Financial Officer[176] - Signed by Mark Erlander, Chief Executive Officer[181]