
PART I - FINANCIAL INFORMATION Item 1. Financial Statements This section presents the unaudited consolidated financial statements of Lisata Therapeutics, Inc. and its subsidiaries for the periods ended September 30, 2023, and December 31, 2022, including balance sheets, statements of operations, comprehensive loss, equity, and cash flows, along with detailed notes explaining the company's business, accounting policies, merger impact, and other financial details Consolidated Balance Sheets Consolidated Balance Sheet Highlights (in thousands) | Metric | Sep 30, 2023 (Unaudited) | Dec 31, 2022 | | :-------------------------------- | :----------------------- | :----------- | | Cash and cash equivalents | $32,428 | $32,154 | | Marketable securities | $21,966 | $37,072 | | Total current assets | $57,233 | $71,876 | | Total assets | $58,089 | $73,034 | | Total current liabilities | $5,132 | $6,383 | | Total liabilities | $5,385 | $6,710 | | Total stockholders' equity | $52,704 | $66,324 | Consolidated Statements of Operations Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :------------------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Research and development | $3,380 | $3,335 | $9,721 | $9,853 | | In-process research and development | $— | $30,393 | $— | $30,393 | | General and administrative | $2,584 | $3,992 | $9,962 | $10,815 | | Total operating expenses | $5,964 | $37,720 | $19,683 | $51,061 | | Operating loss | $(5,964) | $(37,720) | $(19,683) | $(51,061) | | Net loss attributable to Lisata Therapeutics, Inc. | $(5,261) | $(37,383) | $(15,475) | $(48,235) | | Basic and diluted loss per share | $(0.65) | $(7.88) | $(1.92) | $(11.28) | Consolidated Statements of Comprehensive Loss Consolidated 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 | $(5,261) | $(37,383) | $(15,475) | $(48,235) | | Total other comprehensive loss | $(50) | $(20) | $(71) | $(20) | | Comprehensive loss attributable to common stockholders | $(5,311) | $(37,403) | $(15,546) | $(48,255) | Consolidated Statements of Equity - Total stockholders' equity decreased from $66,324 thousand at December 31, 2022, to $52,704 thousand at September 30, 2023, primarily due to the net loss incurred during the period1526 - The company issued 3,773 thousand shares of common stock in connection with the Merger in September 2022, increasing additional paid-in capital by $26,094 thousand24 - Accumulated deficit increased from $(507,241) thousand at December 31, 2022, to $(522,716) thousand at September 30, 2023, reflecting the net loss1526 Consolidated Statements of Cash Flows Consolidated 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 | $(15,963) | $(14,702) | | Net cash provided by investing activities | $15,816 | $21,805 | | Net cash provided by (used in) financing activities | $361 | $(238) | | Net increase in cash and cash equivalents | $274 | $6,831 | | Cash and cash equivalents at end of period | $32,428 | $31,478 | Notes to Unaudited Consolidated Financial Statements Note 1 – The Business Lisata Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on innovative therapies for solid tumors, with its lead product candidate LSTA1 designed to enhance drug penetration. The company completed a merger with Cend Therapeutics, Inc. in September 2022, which included a name change and a 1:15 reverse stock split, and was accounted for as an asset acquisition - Lisata Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on discovering, developing, and commercializing innovative therapies for solid tumors and other major diseases32 - The lead investigational product candidate, LSTA1, is designed to activate a novel uptake pathway for co-administered anti-cancer drugs to penetrate solid tumors more effectively and potentially modify the tumor microenvironment32 - On September 15, 2022, the company (then Caladrius Biosciences, Inc.) completed the acquisition of Cend Therapeutics, Inc., changed its name to Lisata Therapeutics, Inc., and effected a 1:15 reverse stock split3435 - The merger was accounted for as an asset acquisition, with substantially all fair value concentrated in in-process research and development (IPR&D), which was expensed38 Note 2 – Summary of Significant Accounting Policies This note outlines the company's key accounting policies, including the classification and valuation of cash, marketable securities, property and equipment, and the expensing of research and development costs, including in-process R&D. It also details the revenue recognition policy, noting no revenue was recognized from license or collaboration arrangements in the reported periods - All marketable securities are classified as available-for-sale, carried at estimated fair values, with unrealized gains and losses reported in accumulated other comprehensive income (loss)47 - Research and development (R&D) expenses, including salaries, clinical trial costs, and contract fees, are expensed as incurred53 - Upfront payments for new drug compounds and pre-commercial milestone payments are immediately expensed as in-process research and development (IPR&D) if the drug has no alternative future use without regulatory approval55 - No revenue was recognized from license and collaboration arrangements for the three and nine months ended September 30, 2023 and 202258 Note 3 – Merger The merger with Cend Therapeutics was accounted for as an asset acquisition with a total purchase price of $36.1 million, primarily allocated to in-process research and development (IPR&D) which was expensed - The Merger was accounted for as an asset acquisition, with substantially all of the fair value concentrated in IPR&D62 Merger Purchase Price Calculation and Allocation (in thousands) | Item | Amount | | :---------------------------------------------------- | :------- | | Total purchase price | $36,098 | | Acquired in-process research and development | $30,393 | | License | $355 | | Cash and cash equivalents | $7,062 | | Net working capital (excluding cash) | $(1,690) | | Other liabilities | $(22) | | Net assets acquired | $36,098 | Note 4 – Available-for-Sale-Securities The company's available-for-sale securities portfolio, totaling $51.1 million at September 30, 2023, primarily consists of corporate debt, commercial paper, money market funds, agency bonds, treasury bills, and municipal debt securities, all with maturities less than one year Available-for-Sale Securities (in thousands) | Security Type | Sep 30, 2023 Estimated Fair Value | Dec 31, 2022 Estimated Fair Value | | :-------------------- | :-------------------------------- | :-------------------------------- | | Corporate debt securities | $28,812 | $44,291 | | Commercial paper | $1,978 | $7,953 | | Money market funds | $13,572 | $4,871 | | Agency bonds | $1,986 | $— | | Treasury bills | $3,996 | $— | | Municipal debt securities | $725 | $7,625 | | Total | $51,069 | $64,740 | - All available-for-sale securities at September 30, 2023, have contractual maturities of less than one year65 Note 5 – Property and Equipment Net property and equipment decreased to $204 thousand at September 30, 2023, from $296 thousand at December 31, 2022, with depreciation expense of $89 thousand for the nine months ended September 30, 2023 Property and Equipment, Net (in thousands) | Item | Sep 30, 2023 | Dec 31, 2022 | | :---------------------- | :----------- | :----------- | | Property and equipment, gross | $661 | $713 | | Accumulated depreciation | $(457) | $(417) | | Property and equipment, net | $204 | $296 | - Depreciation expense for the nine months ended September 30, 2023, was approximately $89 thousand, compared to $22 thousand for the same period in 202266 Note 6 – Income (Loss) Per Share Due to net losses incurred, potentially dilutive securities such as stock options, warrants, and restricted stock units were excluded from the diluted loss per share calculation as they were anti-dilutive - Basic and diluted loss per share for Lisata Therapeutics, Inc. common stockholders was $(1.92) for the nine months ended September 30, 2023, and $(11.28) for the nine months ended September 30, 202218 Potentially Dilutive Securities Excluded from Diluted Loss Per Share (in thousands) | Security Type | Sep 30, 2023 | Sep 30, 2022 | | :-------------------- | :----------- | :----------- | | Stock options | 1,321 | 1,399 | | Warrants | 1,422 | 1,424 | | Restricted stock units | 202 | 48 | Note 7 – Fair Value Measurements The company classifies its financial assets and liabilities based on a fair value hierarchy, with cash equivalents primarily in Level 1 and marketable securities in Level 2, reflecting observable inputs Fair Value Measurements (in thousands) as of September 30, 2023 | Asset Type | Level 1 | Level 2 | Level 3 | Total | | :------------------------------------ | :------ | :------ | :------ | :------ | | Cash equivalents | $29,103 | $— | $— | $29,103 | | Marketable securities - available for sale | $— | $21,966 | $— | $21,966 | | Total Assets | $29,103 | $21,966 | $— | $51,069 | - The carrying values of accounts payable and accrued expenses approximate fair value due to their short maturity70 Note 8 – Accrued Liabilities Accrued liabilities totaled $3,820 thousand at September 30, 2023, with salaries, employee benefits, and clinical/R&D related liabilities being the largest components Accrued Liabilities (in thousands) | Item | Sep 30, 2023 | Dec 31, 2022 | | :------------------------------------ | :----------- | :----------- | | Salaries, employee benefits and related taxes | $2,366 | $2,586 | | Clinical and R&D related liabilities | $915 | $785 | | Accounting & tax consulting liabilities | $230 | $— | | Operating lease liabilities — current | $164 | $180 | | Other | $145 | $177 | | Total | $3,820 | $3,728 | Note 9 – Operating Leases The company has an operating lease for office space expiring in 2025, with a right-of-use asset of $348 thousand and total operating lease liabilities of $345 thousand as of September 30, 2023 Operating Lease Balances (in thousands) | Item | Sep 30, 2023 | Dec 31, 2022 | | :-------------------------- | :----------- | :----------- | | Right-of-Use Assets (Other assets) | $348 | $487 | | Operating Lease Liabilities (Current) | $164 | $180 | | Operating Lease Liabilities (Long-term) | $181 | $305 | | Total Operating Lease Liabilities | $345 | $485 | - As of September 30, 2023, the weighted average remaining lease term was 2.0 years, and the weighted average discount rate was 9.625%73 Future Minimum Lease Payments (in thousands) | Year | Operating Leases | | :--- | :--------------- | | 2023 | $48 | | 2024 | $190 | | 2025 | $143 | | Total lease payments | $381 | | Less: Amounts representing interest | $(36) | | Present value of lease liabilities | $345 | Note 10 – Stockholders' Equity This note details changes in stockholders' equity, including the 1:15 reverse stock split in September 2022, the issuance of common stock through an At The Market (ATM) offering, and activity related to stock options, warrants, and restricted stock/units - The company implemented a 1:15 reverse stock split on September 14, 2022, to increase its common stock's per share trading price for Nasdaq listing compliance3975 - During the nine months ended September 30, 2023, the company issued 64,394 shares of common stock under its ATM Agreement for net proceeds of $270,774 thousand76 Stock Options and Warrants Activity (Nine Months Ended Sep 30, 2023) | Item | Stock Options (Shares) | Warrants (Shares) | | :------------------------------------ | :--------------------- | :---------------- | | Outstanding at December 31, 2022 | 1,391,352 | 1,423,774 | | Granted | 180,896 | — | | Exercised | (82,500) | — | | Forfeited | (144,594) | — | | Expired | (24,603) | (2,000) | | Outstanding at September 30, 2023 | 1,320,551 | 1,421,744 | | Weighted Average Exercise Price (Stock Options) | $10.82 | N/A | | Weighted Average Exercise Price (Warrants) | N/A | $42.51 | - The company issued 159,950 restricted stock and 188,850 restricted stock units for services during the nine months ended September 30, 20238081 Note 11 – Share-Based Compensation Total share-based compensation expense for the nine months ended September 30, 2023, was $1,565 thousand, with $221 thousand in unrecognized compensation cost for stock options, $161 thousand for restricted stock units, and $483 thousand for restricted stock Share-Based Compensation Expense (in thousands) | 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 | | :-------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Research and development | $103 | $271 | $517 | $63 | | General and administrative | $203 | $769 | $1,048 | $1,53 | | Total share-based compensation expense | $306 | $1,040 | $1,565 | $2,16 | Unrecognized Compensation Cost (in thousands) as of September 30, 2023 | Award Type | Unrecognized Compensation Cost | | :-------------------- | :----------------------------- | | Stock Options | $221 | | Restricted Stock Units | $161 | | Restricted Stock | $483 | Note 12 – Income Taxes The company maintains a full valuation allowance against its net deferred tax assets due to uncertainty regarding future utilization of net operating losses (NOLs). Ownership changes in 2021 and 2022 significantly limited the usability of Federal NOLs, and the company received $2.2 million from the sale of New Jersey NOLs in April 2023 - A full valuation allowance is provided against net deferred tax assets due to uncertainty of future utilization of existing deferred tax assets, including NOLs84 - Ownership changes on January 25, 2021, and September 15, 2022, resulted in $168.8 million and $88.2 million, respectively, of Federal NOLs expiring unutilized8587 - In April 2023, the company received final approval to sell a percentage of its New Jersey NOLs for net proceeds of $2.2 million, recorded as a benefit from income taxes93 Note 13 – Australia Research and Development Tax Incentive The company's Australian subsidiary is eligible for a refundable R&D tax incentive, with $0.5 million recorded as a receivable for the nine months ended September 30, 2023, and a $0.6 million refund received for the 2022 tax year - The Australian subsidiary is eligible for a refundable tax incentive of 43.5% to 48.5% for qualified research and development activities95 - As of September 30, 2023, $0.5 million was recorded as an income tax incentive receivable95 - A $0.6 million tax refund related to the 2022 tax year was received from the Australian Taxation Office on September 4, 202396 Note 14 – Contingencies The company is involved in a legal proceeding with Lingmed Limited, which filed a complaint in May 2022 claiming entitlement to a success fee related to Cend's collaboration with Qilu Pharmaceuticals. The trial date is set for August 2, 2024, and the company intends to vigorously defend itself - Lingmed Limited filed a complaint in May 2022, alleging breach of contract, fraud, and declaratory relief, claiming a success fee based on Cend's agreement with Qilu Pharmaceuticals98 - A trial date for the Lingmed litigation has been set for August 2, 202498 - The company denies Lingmed's allegations and intends to vigorously defend itself98 Note 15 – Technology Transfer Agreement In July 2023, the company transferred its rights to the tumor penetrating nanocomplex (TPN) platform to Impilo Therapeutics, receiving 574,500 shares of Impilo's pre-seed preferred stock as consideration - In July 2023, the company entered into a technology transfer agreement with Impilo Therapeutics, transferring its rights to the tumor penetrating nanocomplex (TPN) platform99 - As consideration, Impilo issued 574,500 shares of its pre-seed preferred stock to the company99 Note 16 – License Agreements The company holds license agreements with Sanford Burnham Prebys (SBP) for LSTA1, with potential milestone payments up to $10.6 million and 4% royalties. Licenses with the University of California at San Diego (UCSD) and a second SBP agreement were assigned to Impilo, and a license with MIT was terminated effective December 30, 2023 - The company has an exclusive, worldwide, royalty-bearing license with Sanford Burnham Prebys (SBP) for LSTA1, with potential aggregate milestone payments of approximately $10.6 million and 4% royalties on net sales100 - A license agreement with UCSD for nano-particles to modulate immune response was assigned in full to Impilo on August 2, 2023104106 - A second license agreement with SBP was assigned in full to Impilo on September 14, 2023102 - The license agreement with MIT for tissue-specific delivery of interfering RNA was terminated, effective December 30, 2023107109 Note 17 – Research Collaboration and License Agreement Cend (now Lisata) granted an exclusive license to Qilu Pharmaceutical for the development and commercialization of LSTA1 in Greater China, receiving an upfront payment of $10 million and a $5 million development milestone prior to the merger. The company is eligible for additional milestone payments up to $220 million and tiered royalties - Cend granted an exclusive license to Qilu Pharmaceutical for the development and commercialization of LSTA1 in the Greater Area of China110 - Prior to the Merger, Cend received and recognized an upfront payment of $10 million and a $5 million development milestone from Qilu110 - The company is eligible to receive additional developmental and commercial milestone payments up to $95 million and $125 million, respectively, and tiered royalties on net sales ranging from 10% to 15%110 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 and results of operations, highlighting its focus on LSTA1 for solid tumors, the impact of the Cend merger, and a detailed comparison of financial performance for the three and nine months ended September 30, 2023, versus 2022, along with an outlook on liquidity and capital resources Overview Lisata Therapeutics is a clinical-stage pharmaceutical company developing LSTA1 to enhance anti-cancer drug penetration in solid tumors by activating the CendR active transport system. LSTA1 has shown favorable safety and activity in clinical trials for pancreatic cancer. The company also has CD34+ cell therapy programs for ischemic repair, which it is seeking to partner, and completed a merger with Cend Therapeutics in September 2022 - Lisata Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative therapies for solid tumors, with LSTA1 as its lead investigational product candidate114 - LSTA1 is designed to activate the C-end rule (CendR) active transport system, enabling more selective and efficient uptake of co-administered anti-cancer drugs into solid tumors and potentially modifying the tumor microenvironment117119 - LSTA1 has demonstrated favorable safety, tolerability, and activity in clinical trials for metastatic pancreatic ductal adenocarcinoma (mPDAC), with an Objective Response Rate (ORR) of 59% and median overall survival of over 13 months120 - The company also has development programs based on its autologous CD34+ cell therapy technology platform for ischemic repair, which it is seeking to partner124125 - The merger with Cend Therapeutics, Inc. was completed on September 15, 2022, leading to a name change and a 1:15 reverse stock split, and was accounted for as an asset acquisition127128130 Results of Operations The company reported a significant reduction in net loss for both the three and nine months ended September 30, 2023, compared to the prior year, primarily driven by the absence of a large in-process research and development expense related to the Cend merger in 2022 - Net loss decreased significantly to $5.3 million for the three months ended September 30, 2023, from $37.4 million in the prior year133 - Net loss decreased to $15.5 million for the nine months ended September 30, 2023, from $48.2 million in the prior year138 - The primary driver for the decrease in net loss and operating expenses was the absence of the $30.4 million in-process research and development expense related to the Cend merger, which was recognized in the prior year134139 Three Months Ended September 30, 2023 Compared to Three Months Ended September 30, 2022 For the three months ended September 30, 2023, net loss decreased by $32.1 million to $5.3 million, primarily due to the $30.4 million in-process R&D expense in the prior year. Operating expenses decreased by 84.2%, or 18.6% excluding the IPR&D expense, driven by lower general and administrative costs Operating Expenses (in thousands) - Three Months Ended September 30 | Expense Category | 2023 | 2022 | Change | | :-------------------------- | :----- | :----- | :------- | | Research and development | $3,380 | $3,335 | $45 | | In-process research and development | $— | $30,393 | $(30,393) | | General and administrative | $2,584 | $3,992 | $(1,408) | | Total operating expenses | $5,964 | $37,720 | $(31,756) | | Net loss | $(5,261) | $(37,383) | $32,122 | - General and administrative expenses decreased by $1.4 million (35.3%) due to non-recurring merger-related costs, lower equity expense, and timing of the annual stockholder meeting in the prior year136 - Research and development expenses slightly increased by $45 thousand (1.3%) due to LSTA1 clinical trial activities, offset by reduced expenses for Ischemic Repair programs136 Nine Months Ended September 30, 2023 Compared to Nine Months Ended September 30, 2022 For the nine months ended September 30, 2023, net loss decreased by $32.8 million to $15.5 million. Total operating expenses decreased by 61.5%, or 4.8% excluding the IPR&D expense, driven by lower general and administrative costs and a slight decrease in R&D expenses Operating Expenses (in thousands) - Nine Months Ended September 30 | Expense Category | 2023 | 2022 | Change | | :-------------------------- | :----- | :----- | :------- | | Research and development | $9,721 | $9,853 | $(132) | | In-process research and development | $— | $30,393 | $(30,393) | | General and administrative | $9,962 | $10,815 | $(853) | | Total operating expenses | $19,683 | $51,061 | $(31,378) | | Net loss | $(15,475) | $(48,235) | $32,760 | - General and administrative expenses decreased by $0.9 million (7.9%) due to non-recurring merger-related costs, lower equity expense, reduced annual stockholder meeting expenses, and decreased D&O insurance premiums, partially offset by severance costs140 - Research and development expenses slightly decreased by $0.1 million (1.3%) due to LSTA1 clinical trial activities being offset by reduced expenses for Ischemic Repair programs140 - The company recognized a $2.3 million benefit from income taxes in 2023 from the sale of New Jersey NOLs, compared to $2.5 million in 2022142143 Analysis of Liquidity and Capital Resources As of September 30, 2023, the company had $54.4 million in cash, cash equivalents, and marketable securities, and $52.1 million in working capital. Net cash used in operating activities was $16.0 million, while investing activities provided $15.8 million, and financing activities provided $0.4 million. The company believes existing cash and marketable securities will fund operations for at least the next 12 months but acknowledges the need for additional capital for long-term needs Liquidity and Capital Resources (in thousands) | Metric | Sep 30, 2023 | | :------------------------------------ | :----------- | | Cash, cash equivalents and marketable securities | $54,400 | | Working capital | $52,100 | | Stockholders' equity | $53,000 | Net Cash Flows (in thousands) - Nine Months Ended September 30 | Activity | 2023 | 2022 | | :------------------------------------ | :--------- | :--------- | | Net cash used in operating activities | $(15,963) | $(14,702) | | Net cash provided by investing activities | $15,816 | $21,805 | | Net cash provided by (used in) financing activities | $361 | $(238) | - Cash provided by financing activities in 2023 included $0.3 million from the ATM Agreement and $0.2 million from option exercises, partially offset by tax withholding payments151 - The company believes its cash on hand and marketable securities will fund operating expenses for at least the next 12 months153 - Future capital requirements are difficult to forecast and may necessitate additional debt or equity financings, partnerships, or asset sales, with no assurance of availability on acceptable terms153156 Off-Balance Sheet Arrangements The company does not have any off-balance sheet arrangements - The company does not have any off-balance sheet arrangements157 Critical Accounting Policies and Estimates There have been no material changes in the company's critical accounting policies and estimates during the three and nine months ended September 30, 2023, compared to those reported in its 2022 Form 10-K - No material changes occurred in critical accounting policies and estimates during the three and nine months ended September 30, 2023, compared to the 2022 Form 10-K158 Item 3. Quantitative and Qualitative Disclosures About Market Risk This section states that there are no quantitative and qualitative disclosures about market risk applicable to the company for the reported period - The company states that this item is not applicable159 Item 4. Controls and Procedures Management, including the Chief Executive Officer, evaluated the effectiveness of the company's disclosure controls and procedures as of September 30, 2023, concluding they were effective at a reasonable assurance level. There were no material changes in internal control over financial reporting during the quarter - As of September 30, 2023, the Chief Executive Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level161 - There were no changes in internal control over financial reporting during the last quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting162 PART II - OTHER INFORMATION Item 1. Legal Proceedings There are no material changes to the legal proceedings disclosures previously reported in the company's 2022 Form 10-K, other than those detailed in Note 14 – Contingencies - No material changes to legal proceedings disclosures from the 2022 Form 10-K, except as disclosed in Note 14 – Contingencies164 Item 1A. Risk Factors There have been no material changes to the risk factors previously reported in the company's 2022 Form 10-K - No material changes to the risk factors previously reported in the 2022 Form 10-K165 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds There were no unregistered sales of equity securities or use of proceeds to report for the period - None to report for this item165 Item 3. Defaults Upon Senior Securities There were no defaults upon senior securities to report for the period - None to report for this item166 Item 4. Mine Safety Disclosures This item is not applicable to the company - The company states that this item is not applicable167 Item 5. Other Information There is no other information to report for the period - None to report for this item168 Item 6. Exhibits This section incorporates the Exhibit Index by reference, listing certifications and Inline XBRL documents - The Exhibit Index, appearing immediately after the signature page, is incorporated by reference169 - Exhibits include certifications of principal executive and financial officers (31.1, 32) and Inline XBRL documents (101.INS, 101.SCH, 101.CAL, 101.DEF, 101.LAB, 101.PRE, 104)175