Capricor Therapeutics(CAPR) - 2022 Q2 - Quarterly Report

Special Note Regarding Forward-Looking Statements This section outlines the nature and inherent risks of forward-looking statements in the Form 10-Q, covering liquidity, drug development, and financial performance Forward-Looking Statements Overview This section outlines the nature of forward-looking statements, highlighting their inherent risks and uncertainties across various operational and financial aspects - Forward-looking statements relate to future events or financial/operating performance, identifiable by words like 'may,' 'will,' 'expects,' 'plans,' 'anticipates,' 'believes,' 'estimates,' 'predicts,' or 'potential'[7] - Key areas of forward-looking statements include maintaining liquidity, funding operations, timing and completion of clinical trials, regulatory approvals, manufacturing capabilities, intellectual property protection, impact of COVID-19, ability to raise additional financing, and market acceptance of products[7] - The company cautions that actual results, events, or circumstances could differ materially from those described in forward-looking statements due to risks, uncertainties, and a competitive environment, and undertakes no obligation to update them unless required by law[9][11][12] PART I. Financial Information This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations Item 1. Financial Statements This section presents Capricor Therapeutics' unaudited condensed consolidated financial statements, including balance sheets, statements of operations, equity, and cash flows, for the specified periods Condensed Consolidated Balance Sheets Balance sheets reveal increased total assets and liabilities, primarily due to deferred revenue from a new distribution agreement, enhancing liquidity | ASSETS (USD) | June 30, 2022 | December 31, 2021 | | :---------------------------------- | :------------ | :---------------- | | Cash and cash equivalents (USD) | $16,394,067 | $34,885,274 | | Marketable securities (USD) | $35,022,883 | — | | TOTAL CURRENT ASSETS (USD) | $52,623,799 | $36,436,961 | | TOTAL ASSETS (USD) | $58,065,574 | $41,330,323 | | LIABILITIES (USD) | | | | Deferred revenue, current (USD) | $15,745,576 | — | | Deferred revenue, net of current (USD)| $14,254,424 | — | | TOTAL CURRENT LIABILITIES (USD) | $19,547,219 | $4,133,391 | | TOTAL LONG-TERM LIABILITIES (USD) | $19,789,360 | $5,828,966 | | TOTAL LIABILITIES (USD) | $39,336,579 | $9,962,357 | | STOCKHOLDERS' EQUITY (USD) | | | | TOTAL STOCKHOLDERS' EQUITY (USD) | $18,728,995 | $31,367,966 | - Total assets increased by approximately $16.7 million from December 31, 2021, to June 30, 2022, primarily due to the addition of marketable securities and an increase in current assets[17] - Total liabilities significantly increased by approximately $29.4 million, largely driven by the recognition of $30.0 million in deferred revenue from a new distribution agreement[17] Condensed Consolidated Statements of Operations and Comprehensive Loss The company reported increased net and comprehensive losses for Q2 and H1 2022, driven by higher operating expenses and zero revenue | Metric (USD) | 3 Months Ended June 30, 2022 | 3 Months Ended June 30, 2021 | 6 Months Ended June 30, 2022 | 6 Months Ended June 30, 2021 | | :----------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Revenue (USD) | $0 | $204,082 | $0 | $244,898 | | Research and development (USD) | $4,965,088 | $3,497,275 | $10,080,787 | $6,793,597 | | General and administrative (USD) | $2,356,666 | $1,789,974 | $5,072,501 | $3,695,556 | | TOTAL OPERATING EXPENSES (USD) | $7,321,754 | $5,287,249 | $15,153,288 | $10,489,153 | | LOSS FROM OPERATIONS (USD) | $(7,321,754) | $(5,083,167) | $(15,153,288) | $(10,244,255) | | NET LOSS (USD) | $(7,109,411) | $(4,748,266) | $(14,927,505) | $(9,900,189) | | COMPREHENSIVE INCOME (LOSS) (USD) | $(7,086,581) | $(4,748,266) | $(14,904,675) | $(9,900,189) | | Net loss per share, basic and diluted (USD)| $(0.29) | $(0.21) | $(0.61) | $(0.44) | - Revenue for both the three and six months ended June 30, 2022, was $0, a decrease from $204,082 and $244,898 in the respective periods of 2021[20] - Research and development expenses increased by approximately $1.5 million (41.9%) for the three months and $3.3 million (48.4%) for the six months ended June 30, 2022, compared to 2021[20] - Net loss increased by approximately $2.36 million (49.9%) for the three months and $5.03 million (50.8%) for the six months ended June 30, 2022, compared to 2021[20] Condensed Consolidated Statements of Stockholders' Equity Stockholders' equity decreased to $18.7 million by June 30, 2022, primarily due to net losses, despite stock-based compensation | Metric (USD) | Balance at Dec 31, 2021 | Balance at June 30, 2022 | | :----------------------------------- | :---------------------- | :----------------------- | | Common Shares | 24,185,001 | 24,334,952 | | Stock Amount (USD) | $24,185 | $24,335 | | Additional Paid-In Capital (USD) | $139,404,060 | $141,669,614 | | Accumulated Other Comprehensive Income (USD)| — | $22,830 | | Accumulated Deficit (USD) | $(108,060,279) | $(122,987,784) | | TOTAL STOCKHOLDERS' EQUITY (USD) | $31,367,966 | $18,728,995 | - Stock-based compensation contributed $2,223,233 to additional paid-in capital for the six months ended June 30, 2022[24] - Net loss for the six months ended June 30, 2022, was $(14,927,505), increasing the accumulated deficit[20][24] Condensed Consolidated Statements of Cash Flows Operating cash flow improved to a $17.5 million inflow due to a distribution agreement, but investing activities consumed $36.0 million, leading to a net cash decrease | Cash Flow Data (USD) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Net loss (USD) | $(14,927,505) | $(9,900,189) | | Net cash provided by (used in) operating activities (USD)| $17,504,295 | $(7,843,813) | | Net cash used in investing activities (USD)| $(36,037,973) | $(359,371) | | Net cash provided by financing activities (USD)| $42,471 | $13,615,274 | | Net increase (decrease) in cash and cash equivalents (USD)| $(18,491,207) | $5,412,090 | | Cash and cash equivalents balance at end of period (USD)| $16,394,067 | $38,077,964 | - Operating activities generated $17.5 million in cash for the six months ended June 30, 2022, a significant improvement from a $7.8 million usage in the same period of 2021, primarily due to a $30.0 million upfront payment from Nippon Shinyaku[32][204] - Investing activities used $36.0 million, largely for purchases of marketable securities ($49.0 million) and property/equipment, partially offset by proceeds from sales of marketable securities ($14.0 million)[32][208] - Financing activities provided $42,471, a substantial decrease from $13.6 million in the prior year, mainly due to lower proceeds from stock issuance via ATM programs[32][209] Notes to Condensed Consolidated Financial Statements These notes detail significant accounting policies, financial position, and operational activities, including a $30.0 million upfront payment and increased R&D expenses 1. Organization and Summary of Significant Accounting Policies This note describes Capricor Therapeutics' business and outlines significant accounting policies, covering liquidity, COVID-19 impact, revenue recognition, and R&D expenses - Capricor Therapeutics is a clinical-stage biotechnology company developing cell and exosome-based therapeutics for Duchenne muscular dystrophy (DMD) and other unmet medical needs[35] - Cash, cash equivalents, and marketable securities increased to approximately $51.4 million as of June 30, 2022, from $34.9 million at December 31, 2021, primarily due to a $30.0 million upfront payment from Nippon Shinyaku[40] - The company expects substantial future capital requirements for R&D, clinical trials, manufacturing, and commercialization, and will need additional financing, which may lead to dilution for existing stockholders[43][45] - The COVID-19 pandemic continues to impact business operations, and the full extent of its future impact remains uncertain, affecting clinical trials, product development, and financing[46][47][48] - The company adopted ASU 2021-10, Government Assistance (Topic 832), in Q1 2022, which did not materially impact financial statements[78] 2. Note Payable This note details the $318,160 PPP Loan received in 2020, which was forgiven in Q2 2021, resulting in a recognized gain - Capricor received a $318,160 loan under the SBA Paycheck Protection Program in 2020[80] - The PPP Loan was forgiven in the second quarter of 2021, leading to a recognized gain of $318,160[80] 3. Stockholder's Equity This note details the company's ATM equity programs for common stock sales and the number of shares outstanding as of June 30, 2022 - The May 2020 ATM Program, with an aggregate offering price of up to $40.0 million, sold 6,027,852 shares for gross proceeds of approximately $37.1 million before expiring on June 21, 2021[83] - The June 2021 ATM Program, with an aggregate offering price of up to $75.0 million, sold 1,267,475 shares for gross proceeds of approximately $7.5 million through September 30, 2021. No shares were sold in Q4 2021 or Q1/Q2 2022 under this program[84] - As of June 30, 2022, the company had 24,334,952 shares of common stock issued and outstanding[86] 4. Stock Awards, Warrants and Options This note details the company's warrant and stock option activity, including various equity incentive plans and recognized stock-based compensation expense | Warrants | Outstanding at Dec 31, 2021 | Outstanding at June 30, 2022 | | :----------------------- | :-------------------------- | :--------------------------- | | Number of Warrants | 105,782 | 105,782 | | Weighted Average Exercise Price (USD)| $1.37 | $1.37 | | Stock Options | Outstanding at Dec 31, 2021 | Outstanding at June 30, 2022 | | :----------------------------------- | :-------------------------- | :--------------------------- | | Number of Options | 3,793,824 | 6,036,421 | | Weighted Average Exercise Price (USD)| $2.68 | $2.98 | | Aggregate Intrinsic Value (USD) | $3,104,631 | $4,381,251 | | Stock-Based Compensation Expense (USD) | 3 Months Ended June 30, 2022 | 3 Months Ended June 30, 2021 | 6 Months Ended June 30, 2022 | 6 Months Ended June 30, 2021 | | :---------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | General and administrative (USD) | $910,638 | $625,141 | $1,768,221 | $1,258,261 | | Research and development (USD) | $247,266 | $87,158 | $455,012 | $207,000 | | Total (USD) | $1,157,904 | $712,299 | $2,223,233 | $1,465,261 | - As of June 30, 2022, 2,601,223 options remain available for issuance under the respective stock option plans[96] - The total unrecognized fair value compensation cost related to non-vested stock options was approximately $12.7 million as of June 30, 2022, expected to be recognized over approximately 1.5 years[102] 5. Concentrations This note highlights that $51.1 million of the company's deposits were uninsured as of June 30, 2022, though credit risk is deemed low - As of June 30, 2022, the company maintained approximately $51.1 million of uninsured deposits across its checking accounts at two financial institutions[104] - The company believes it is not exposed to any significant credit risk on its cash, cash equivalents, and marketable securities[104] 6. Government Grant Awards This note details the $3.4 million CIRM Award for the HOPE-Duchenne trial, accounted for as a liability due to potential repayment - Capricor received a CIRM Award of approximately $3.4 million to fund its Phase I/II HOPE-Duchenne clinical trial for DMD[105] - The CIRM Award is classified as a liability because Capricor has the right to convert the grant into a loan, which would require repayment of some or all awarded amounts[106] - As of June 30, 2022, Capricor's liability balance for the CIRM Award was approximately $3.4 million[107] 7. Commitments and Contingencies This note outlines the company's commitments and contingencies, including operating leases, legal matters, funding agreements, and employee severance packages - Short-term operating lease expenses to unrelated parties were $17,394 (Q2 2022) and $39,219 (Q2 2021), and to related parties were $32,120 (Q2 2022) and $47,415 (Q2 2021)[112] - The company entered into a long-term operating lease for 9,396 sq ft of office/laboratory space in San Diego, with an estimated ROU asset and liability of approximately $2.7 million as of October 1, 2021[113] Lease Liabilities Maturities (USD) | Lease Liabilities Maturities (USD) | Amount (USD) | | :------------------------------------ | :----- | | 2022 (remainder of the year) | $321,677 | | 2023 | $656,678 | | 2024 | $674,931 | | 2025 | $693,732 | | 2026 | $562,627 | | Total minimum lease payments | $2,909,645 | | Less: imputed interest | $(171,296) | | Total operating lease liabilities | $2,738,349 | - Long-term operating lease costs recognized under ASC 842 were $158,084 for the three months and $316,168 for the six months ended June 30, 2022[118] - The company is not a party to any material legal proceedings and has approved severance packages for specific employees, though no liability has been recorded as of June 30, 2022[119][123] 8. License and Distribution Agreements This note details Capricor's license and distribution agreements, including a significant $30.0 million upfront payment from Nippon Shinyaku for CAP-1002 commercialization - Capricor holds exclusive license agreements for intellectual property rights related to cardiac-derived cells (CDCs) with the University of Rome, JHU, and CSMC, and for exosomes with CSMC and JHU[125] - Under the JHU License Agreement for CDCs, Capricor paid a $250,000 development milestone in March 2022 related to a Phase 2 study, with a next milestone of $500,000 due upon successful completion of a full Phase 3 study[131] - In January 2022, Capricor entered into an Exclusive Commercialization and Distribution Agreement with Nippon Shinyaku for CAP-1002 for DMD in the US, receiving a $30.0 million upfront payment[155][156] - The Nippon Shinyaku agreement includes potential additional sales and development milestone payments of up to $705.0 million[156] - The $30.0 million upfront payment is allocated to the HOPE-3, Phase 3 clinical study, with revenue to be recognized using a proportional performance method based on patient visit status, resulting in $15.7 million current and $14.3 million long-term deferred revenue as of June 30, 2022[158] 9. Related Party Transactions This note details transactions with related parties, including CSMC and Dr. Eduardo Marbán, covering leases, consulting, R&D, and clinical trial costs - Capricor has lease agreements with CSMC, which also serves as an investigative site for clinical trials. Dr. Eduardo Marbán, a co-founder and stockholder, is the Director of the Cedars-Sinai Smidt Heart Institute[159] - Accounts payable and accrued expenses to related parties decreased from $599,388 at December 31, 2021, to $94,135 at June 30, 2022, with CSMC accounting for the majority[163] - Payments to CSMC for R&D, clinical trial costs, license/patent fees, and facilities rent totaled approximately $714,500 for the six months ended June 30, 2022, compared to $238,800 in 2021[163] - The company provided CAP-1002 for two CSMC-sponsored clinical trials (REGRESS and ALPHA), receiving approximately $1.7 million in monetary compensation, with $245,000 recognized as revenue in 2021 and none in 2022[164] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on Capricor's financial condition, discussing operating losses, R&D expenses, and the impact of a new distribution agreement on liquidity Company Overview Capricor Therapeutics, a clinical-stage biotech, focuses on DMD and exosome therapies, reporting net losses of $7.1 million and $14.9 million for Q2 and H1 2022 - Capricor Therapeutics is a clinical-stage biotechnology company focused on developing transformative cell and exosome-based therapeutics for Duchenne muscular dystrophy (DMD) and other diseases[168] - The company reported net losses of $7.1 million for the three months and $14.9 million for the six months ended June 30, 2022, with an accumulated deficit of approximately $123.0 million[175] - CAP-1002 for DMD is in a Phase 3 clinical study (HOPE-3), with enrollment expected to complete by Q3 2023 and topline data by Q3 2024. Positive one-year results from the HOPE-2 OLE study were announced in June 2022[170][179] - An Exclusive Commercialization and Distribution Agreement with Nippon Shinyaku for CAP-1002 in the US was signed in January 2022, including a $30.0 million upfront payment and potential additional milestones up to $705.0 million[177] - Cash, cash equivalents, and marketable securities of approximately $51.4 million as of June 30, 2022, are estimated to fund operations into Q2 2024[176] Financial Operations Overview The company relies on equity financings, grants, and collaboration payments, incurring significant R&D and G&A expenses, including non-cash stock-based compensation - The company has no commercial product sales to date and does not expect to generate product revenue until regulatory approval, which is several years away, if ever[184] - Major sources of working capital include proceeds from public equity sales and the upfront payment from the NS Distribution Agreement with Nippon Shinyaku[184] - Research and development (R&D) expenses primarily consist of salaries, clinical trial costs, manufacturing costs, and intellectual property prosecution, expensed as incurred[185] - General and administrative (G&A) expenses include salaries for executive and administrative personnel, professional fees, and corporate expenses[186] - Non-cash stock-based compensation expense is recognized for stock options and warrants, impacting both G&A and R&D expenses[187] Results of Operations The company reported zero miscellaneous income for Q2 and H1 2022, while other income was $0.2 million from ERC, and operating expenses significantly increased | Revenue (USD) | 3 Months Ended June 30, 2022 | 3 Months Ended June 30, 2021 | 6 Months Ended June 30, 2022 | 6 Months Ended June 30, 2021 | | :----------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Miscellaneous Income (USD)| $0 | $0.2 million | $0 | $0.2 million | | Other Income (USD) | $0.2 million | $0 | $0.2 million | $0 | | Operating Expenses (USD) | 3 Months Ended June 30, 2022 | 3 Months Ended June 30, 2021 | 6 Months Ended June 30, 2022 | 6 Months Ended June 30, 2021 | | :------------------------------------ | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | General and Administrative (USD) | $2.4 million | $1.8 million | $5.1 million | $3.7 million | | Research and Development (USD) | $5.0 million | $3.5 million | $10.1 million | $6.8 million | - The increase in G&A expenses for Q2 2022 was primarily due to a $0.3 million increase in stock-based compensation and $0.3 million in salaries, legal, and other general expenses[191] - The increase in R&D expenses for Q2 2022 was driven by a $1.0 million increase in product candidate R&D, $0.5 million in CAP-1002 clinical development, and $0.2 million in stock-based compensation[193] - For the first half of 2022, R&D expenses increased by $3.3 million, mainly due to a $2.0 million increase in the exosomes program and $0.9 million in CAP-1002 clinical development[194] Products Under Active Development Capricor is developing CAP-1002 for DMD (Phase 3) with $9.0-$11.0 million expected spend in 2022, and an exosome platform with $5.0-$6.0 million anticipated spend - Expected expenditures for the CAP-1002 DMD program in 2022 are approximately $9.0 million to $11.0 million, covering clinical, regulatory, and manufacturing expenses, including scale-up for potential commercial manufacturing[195][196] - The exosome platform is in early-stage development, with an expected spend of approximately $5.0 million to $6.0 million in 2022 for personnel, preclinical studies, and manufacturing, focusing on expanding the engineered exosomes platform[200] - The duration and cost of clinical development programs are highly uncertain and depend on factors such as trial results, patient recruitment, manufacturing costs, regulatory approvals, and potential delays from the COVID-19 pandemic[201] Liquidity and Capital Resources Capricor's liquidity improved to $51.4 million by June 30, 2022, driven by a $30.0 million upfront payment, despite $36.0 million consumed by investing activities | Liquidity and Capital Resources (thousands USD) | June 30, 2022 | December 31, 2021 | | :------------------------------------------------- | :------------ | :---------------- | | Cash, cash equivalents and marketable securities (thousands USD)| $51,417 | $34,885 | | Working capital (thousands USD) | $33,077 | $32,304 | | Stockholders' equity (thousands USD) | $18,729 | $31,368 | | Cash Flow Data (thousands USD) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :------------------------------------ | :----------------------------- | :----------------------------- | | Operating activities (thousands USD) | $17,504 | $(7,844) | | Investing activities (thousands USD) | $(36,038) | $(359) | | Financing activities (thousands USD) | $43 | $13,615 | | Net increase (decrease) in cash and cash equivalents (thousands USD)| $(18,491) | $5,412 | | Cash and cash equivalents balance at end of period (thousands USD)| $16,394 | $38,078 | - The increase in cash, cash equivalents, and marketable securities to $51.4 million was primarily driven by the $30.0 million upfront payment from Nippon Shinyaku[203] - Cash used in investing activities increased significantly to $36.0 million, mainly due to net purchases of marketable securities and investments in property and equipment for the San Diego laboratory space[208] - The company believes its cash resources are sufficient to fund operations for at least the next twelve months but will require substantial additional capital for long-term R&D and clinical programs[210][211] Financing Activities by the Company Capricor's financing includes a $30.0 million upfront payment from Nippon Shinyaku, capital raised through ATM equity programs, and the CIRM Grant Award - In January 2022, Capricor received a $30.0 million upfront payment from Nippon Shinyaku as part of an exclusive commercialization and distribution agreement for CAP-1002 for DMD in the US, with potential additional milestones up to $705.0 million[214][215] - Under the June 2021 ATM Program (up to $75.0 million), the company sold 1,267,475 shares for approximately $7.5 million through September 30, 2021. No shares were sold in Q4 2021 or Q1/Q2 2022, but 11,281 shares were sold for $54,300 after June 30, 2022[216][217] - The May 2020 ATM Program (up to $40.0 million) sold 6,027,852 shares for approximately $37.1 million before expiring on June 21, 2021[218][220] - The CIRM Award of approximately $3.4 million, which funded the HOPE-Duchenne clinical trial, is accounted for as a liability due to Capricor's right to convert it into a loan requiring repayment[221][222][223] Off-Balance Sheet Arrangements The company reported no off-balance sheet arrangements during the periods presented, nor does it currently have any, as defined by SEC rules - Capricor Therapeutics did not have any off-balance sheet arrangements during the periods presented and currently has none[224] Critical Accounting Policies and Estimates This section outlines critical accounting policies and estimates requiring significant judgment, including leases, revenue recognition, CIRM Grant, R&D accruals, and stock-based compensation - The company's critical accounting policies involve significant estimates and assumptions, particularly for research and development and clinical trial accruals, and stock-based compensation[225][227] - Leases are recognized on the balance sheet with a right-to-use (ROU) asset and lease liabilities, classified as operating leases, with the incremental borrowing rate used for present value calculations[228][231] - Revenue from contracts with customers (ASU 606) is recognized over time as performance obligations are satisfied, with upfront payments and potential milestones contributing to the transaction price[233][234] - The CIRM Grant Award is accounted for as a long-term liability because the company has the right to convert it into a loan, requiring potential repayment[238] - R&D expenses and clinical trial accruals are based on estimates of services received and efforts expended, with adjustments made if actual results differ from estimates[239][240][241] - Stock-based compensation expense is recognized over the vesting period, with fair value estimated using the Black-Scholes option-pricing model, requiring assumptions about volatility, expected term, and risk-free interest rates[246][247] Recently Issued or Newly Adopted Accounting Pronouncements The company adopted ASU 2021-10 in Q1 2022, requiring government assistance disclosures, which had no material impact on financial statements - The company adopted ASU 2021-10, Government Assistance (Topic 832), in Q1 2022, which mandates disclosures for transactions with government entities[250] - The adoption of ASU 2021-10 did not have a material impact on the company's financial statements and footnote disclosures[250] - Other recent accounting pronouncements are not believed to have a material impact on the company's financial statement presentation or disclosures[251][252] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section discusses the company's market risk exposure, primarily from interest rate fluctuations on its $51.4 million marketable securities and cash - The company's market risk exposure primarily stems from changes in interest rates affecting its marketable securities and cash and cash equivalents, which totaled approximately $51.4 million as of June 30, 2022[254] - The investment policy prioritizes placing investments with highly rated credit issuers and limiting credit exposure, primarily investing in short-term U.S. treasury securities, money market funds, and bank accounts[255] - Due to the short-term maturities of its investments, a hypothetical 100 basis point increase or decrease in interest rates is not expected to significantly impact the fair value of the investment portfolio[255] Item 4. Controls and Procedures The company's disclosure controls and procedures were effective as of June 30, 2022, with no material changes in internal control over financial reporting - The company's disclosure controls and procedures were evaluated and concluded to be effective at the reasonable assurance level as of June 30, 2022[257] - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2022[258] PART II. Other Information This section presents other information, including legal proceedings, risk factors, equity sales, defaults, mine safety disclosures, and exhibits Item 1. Legal Proceedings The company is not currently involved in any material pending legal proceedings - The company is not involved in any material pending legal proceedings[260] Item 1A. Risk Factors No material changes have occurred in the company's risk factors since those disclosed in the Annual Report on Form 10-K for 2021 - No material changes have occurred in the company's risk factors since those disclosed in the Annual Report on Form 10-K for the year ended December 31, 2021[261][263] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This item is not applicable for the reporting period - This item is not applicable[265] Item 3. Defaults Upon Senior Securities This item is not applicable for the reporting period - This item is not applicable[267] Item 4. Mine Safety Disclosures This item is not applicable for the reporting period - This item is not applicable[269] Item 5. Other Information No other information is reported under this item - No other information is reported under this item[271] Item 6. Exhibits This section lists the exhibits filed as part of the Form 10-Q, including corporate documents, officer certifications, and iXBRL financial information - Exhibits include various corporate documents such as merger agreements (2.1, 2.2, 2.3), certificates of incorporation (3.1, 3.2, 3.3), and amended bylaws (3.4)[273] - Certifications of the Principal Executive Officer (31.1, 32.1) and Principal Financial Officer (31.2, 32.2) are filed herewith[273] - Financial information from the Quarterly Report, including condensed consolidated financial statements, is provided in Inline eXtensible Business Reporting Language (iXBRL) as Exhibit 101[273] Signatures The report is duly signed on behalf of Capricor Therapeutics, Inc. by its CEO, Linda Marbán, Ph.D., and CFO, Anthony J. Bergmann, on August 11, 2022 - The report was signed by Linda Marbán, Ph.D., Chief Executive Officer, and Anthony J. Bergmann, Chief Financial Officer, on August 11, 2022[279]