GRAYBUG VISION(GRAY) - 2024 Q1 - Quarterly Report

PART I—FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) Presents CalciMedica's unaudited condensed consolidated financial statements and detailed notes for Q1 2024 and 2023 Condensed Consolidated Balance Sheets Summarizes CalciMedica's assets, liabilities, and equity at March 31, 2024, and December 31, 2023 Condensed Consolidated Balance Sheets (in thousands) | Metric | March 31, 2024 | December 31, 2023 | | :-------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $6,755 | $5,530 | | Short-term investments | $18,955 | $5,708 | | Total current assets | $26,604 | $11,605 | | Total assets | $27,134 | $12,185 | | Total current liabilities | $4,287 | $4,028 | | Warrant liability | $5,600 | — | | Total liabilities | $9,887 | $4,028 | | Total stockholders' equity | $17,247 | $8,157 | - Total assets increased significantly from $12.185 million at December 31, 2023, to $27.134 million at March 31, 2024, primarily driven by an increase in short-term investments and cash and cash equivalents[26] - A new warrant liability of $5.6 million was recognized as of March 31, 2024, contributing to the increase in total liabilities[26] Condensed Consolidated Statements of Operations Reports CalciMedica's revenues, expenses, and net income (loss) for the three months ended March 31, 2024, and 2023 Condensed Consolidated Statements of Operations (in thousands, except per share amounts) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $2,944 | $6,491 | | General and administrative | $2,823 | $15,849 | | Total operating expenses | $5,767 | $22,340 | | Loss from operations | $(5,767) | $(22,340) | | Change in fair value of financial instruments | $5,590 | $3,168 | | Net income (loss) | $130 | $(19,288) | | Basic EPS | $0.01 | $(23.43) | | Diluted EPS | $0.01 | $(23.43) | - The company reported a net income of $0.130 million for the three months ended March 31, 2024, a significant improvement from a net loss of $19.288 million in the same period of 2023[29] - Total operating expenses decreased by 74% from $22.340 million in Q1 2023 to $5.767 million in Q1 2024, primarily due to lower general and administrative expenses[29][183] - A substantial gain from the change in fair value of financial instruments ($5.590 million in Q1 2024 vs. $3.168 million in Q1 2023) significantly contributed to the net income[29] Condensed Consolidated Statement of Comprehensive Income (Loss) Details CalciMedica's net income (loss) and other comprehensive income (loss) for Q1 2024 and 2023 Condensed Consolidated Statements of Comprehensive Income (Loss) (in thousands) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net income (loss) | $130 | $(19,288) | | Unrealized loss on available-for-sale securities, net of tax | $(19) | — | | Comprehensive income (loss) | $111 | $(19,288) | - Comprehensive income for Q1 2024 was $0.111 million, compared to a comprehensive loss of $19.288 million in Q1 2023, reflecting the improved net income and a minor unrealized loss on available-for-sale securities[32] Condensed Consolidated Statements of Stockholders' Equity (Deficit) Details changes in CalciMedica's stockholders' equity (deficit) for Q1 2024 and 2023 Changes in Stockholders' Equity (Deficit) (in thousands) | Metric | Balance Dec 31, 2023 | Stock-based Comp | Private Placement Shares | Warrants Issuance | Unrealized Loss | Net Income | Balance Mar 31, 2024 | | :-------------------------------- | :------------------- | :--------------- | :----------------------- | :---------------- | :-------------- | :--------- | :------------------- | | Common Stock Amount | $1 | — | $2 | — | — | — | $3 | | Additional Paid-In Capital | $154,218 | $414 | $7,903 | $660 | — | — | $163,195 | | Accumulated Deficit | $(146,064) | — | — | — | — | $130 | $(145,934) | | Accumulated Other Comprehensive Loss | $2 | — | — | — | $(19) | — | $(17) | | Total Stockholders' Equity | $8,157 | $414 | $7,905 | $660 | $(19) | $130 | $17,247 | - Total stockholders' equity increased from $8.157 million at December 31, 2023, to $17.247 million at March 31, 2024, primarily due to the issuance of common shares from a private placement ($7.905 million) and warrants ($0.660 million), along with net income[34] - The accumulated deficit decreased slightly from $146.064 million to $145.934 million, reflecting the net income for the quarter[34] Condensed Consolidated Statements of Cash Flows Summarizes CalciMedica's cash flows from operating, investing, and financing activities for Q1 2024 and 2023 Condensed Consolidated Statements of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(4,715) | $(5,355) | | Net cash provided by (used in) investing activities | $(13,103) | $4,750 | | Net cash provided by financing activities | $19,043 | $23,515 | | Net increase in cash and cash equivalents | $1,225 | $22,910 | | Cash and cash equivalents at end of period | $6,755 | $24,386 | - Net cash used in operating activities decreased from $5.355 million in Q1 2023 to $4.715 million in Q1 2024[41][202][203] - Investing activities shifted from providing $4.750 million in Q1 2023 to using $13.103 million in Q1 2024, primarily due to increased purchases of investments[41][204] - Financing activities provided $19.043 million in Q1 2024, mainly from the 2024 Private Placement, compared to $23.515 million in Q1 2023, which included cash acquired from the Merger[41][205][206] Notes to the Condensed Consolidated Financial Statements Provides detailed explanations and disclosures supporting the condensed consolidated financial statements 1. Nature of Business Describes CalciMedica's operations as a clinical-stage biopharmaceutical company and its financial position - CalciMedica, Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutics for serious illnesses driven by inflammatory processes and cellular damage, specifically targeting CRAC channels[43] - The company completed a reverse merger with Graybug Vision, Inc. on March 20, 2023, with Private CalciMedica treated as the accounting acquirer, resulting in former Private CalciMedica equity holders owning 72% of the combined company[44][45] - As of March 31, 2024, the company had an accumulated deficit of $145.9 million but reported a net income of $0.1 million for the three months ended March 31, 2024, primarily due to a fair value adjustment to warrant liability and interest income[46] - Management believes current cash, cash equivalents, and short-term investments of $25.7 million (as of March 31, 2024) are sufficient to fund operations for at least one year, but additional funding will be required for product development and commercialization[48][49][50] 2. Summary of Significant Accounting Policies Outlines the key accounting principles and methods used in preparing the financial statements - The condensed consolidated financial statements are prepared in conformity with U.S. GAAP and include the accounts of Graybug Vision, Inc. and CalciMedica Subsidiary, Inc. for the three months ended March 31, 2024 and 2023[51][52][53] - The company manages its operations as a single segment, focusing on developing CRAC channel inhibitors, with no revenue generated since inception and all tangible assets held in the United States[61] - Research and development costs, including salaries, consultant fees, and laboratory supplies, are expensed as incurred[67] - Warrant liabilities are recognized at fair value on the balance sheet, with changes in fair value recorded in other income (expense) in the statements of operations[72][73] - The company adopted ASU 2020-06 as of January 1, 2024, which simplified accounting for certain financial instruments with liability and equity characteristics, without material impact on its financial statements[90] 3. Merger and Related Transactions Details the reverse merger with Graybug Vision, Inc. and its financial implications - The Merger on March 20, 2023, was accounted for as a reverse recapitalization, with Private CalciMedica as the accounting acquirer, resulting in its stockholders owning approximately 72% of the combined company[91][93] - As part of the reverse recapitalization, Private CalciMedica received $29.4 million in cash, cash equivalents, and short-term investments, net of transaction costs[94] - The company incurred one-time charges of $10.5 million for accelerated Graybug stock awards and $5.7 million in severance charges for the three months ended March 31, 2023, due to the Merger[95] - A 14:1 reverse stock split of Graybug's common stock was effected on March 17, 2023, in connection with the Merger[96] 4. Fair Value Measurements Details valuation methods and categorization of financial assets and liabilities measured at fair value - The company's financial assets and liabilities measured at fair value include short-term investments and warrants for common stock, revalued at each measurement period[97] - Fair value measurements are categorized into Level 1 (quoted prices in active markets), Level 2 (observable inputs other than Level 1), and Level 3 (unobservable inputs)[102][104] Financial Assets Measured at Fair Value (March 31, 2024, in thousands) | Asset Type | Level 1 | Level 2 | Level 3 | Total | | :----------------------- | :------ | :------ | :------ | :------ | | Money market funds | $6,133 | — | — | $6,133 | | Commercial paper (Cash Eq.) | — | $500 | — | $500 | | Corporate debt securities | — | $1,210 | — | $1,210 | | Commercial paper (ST Inv.) | — | $17,745 | — | $17,745 | | Total assets | $6,133 | $19,455 | — | $25,588 | Financial Liabilities Measured at Fair Value (March 31, 2024, in thousands) | Liability Type | Level 1 | Level 2 | Level 3 | Total | | :--------------- | :------ | :------ | :------ | :------ | | Warrant Liability | — | — | $5,600 | $5,600 | - The warrant liability of $5.6 million as of March 31, 2024, is classified as Level 3, reflecting the use of unobservable inputs in its valuation[107][108] 5. Convertible Promissory Notes and Convertible Promissory Note Warrants Details the terms and conversion of convertible promissory notes and warrants before the Merger - In April 2022, Private CalciMedica approved a convertible promissory note financing of up to $5.0 million, later amended to $8.5 million, with notes convertible into common stock and Convertible Promissory Note Warrants[109][110] - Immediately prior to the Merger, all outstanding convertible promissory notes and accrued interest automatically converted into 590,031 shares of Graybug common stock[111] - Convertible Promissory Note Warrants, initially classified as a liability, were automatically net exercised into 152,875 shares of Graybug common stock prior to the Merger[112][113] 6. Accrued Expenses Provides a breakdown of accrued liabilities, including payroll, professional fees, and other expenses Accrued Expenses (in thousands) | Category | March 31, 2024 | March 31, 2023 | | :----------------------------- | :------------- | :------------- | | Accrued payroll and other employee benefits | $1,126 | $935 | | Accrued severance | $22 | $89 | | Accrued professional fees | $507 | $345 | | Accrued franchise tax | $49 | $77 | | Accrued other | $48 | $22 | | Total accrued expenses | $1,752 | $1,468 | - Total accrued expenses increased from $1.468 million in Q1 2023 to $1.752 million in Q1 2024, primarily driven by increases in accrued payroll and professional fees[114] 7. Convertible Preferred Stock, Common Stock and Stockholders' Deficit Details the company's capital structure, stock issuances, and warrant classifications - The company's authorized capital stock includes 500,000,000 shares of common stock and 10,000,000 shares of preferred stock, both with a par value of $0.0001 per share[115] - Prior to the Merger, 84,820,880 shares of Private CalciMedica preferred stock were converted into common stock, which were then exchanged for 2,442,852 shares of Graybug's common stock[116] - In January/February 2024, the company completed a private placement, issuing 4,985,610 shares of common stock, 306,506 Pre-Funded Warrants, and Tranche A and B Common Warrants, generating net proceeds of approximately $19.0 million[119][121] - The company has a shelf registration statement allowing for the offering of up to $100.0 million in securities, with $99.7 million remaining available as of March 31, 2024, and an at-the-market (ATM) facility for up to $17.3 million of common stock, with $17.1 million remaining[122][123] - Tranche A and B Common Warrants issued in the 2024 Private Placement are classified as liabilities, with fair values of $1.4 million and $4.2 million, respectively, as of March 31, 2024, reflecting changes in fair value recorded in operations[129][130] 8. Stock-based Compensation Explains the company's equity incentive plans and the accounting for stock-based compensation expenses - The company operates under the 2006 Equity Incentive Plan (assumed from Private CalciMedica) and the 2023 Equity Incentive Plan, which became effective at the Merger closing, with 91,516 shares available for grant under the 2023 Plan as of March 31, 2024[133][134] Stock Option Transactions (2023 Plan) | Metric | Total Options | Weighted Average Exercise Price | | :-------------------------- | :------------ | :------------------------------ | | Outstanding at Dec 31, 2023 | 1,739,270 | $15.71 | | Granted | 595,250 | $4.16 | | Cancelled | (223,308) | $76.63 | | Outstanding at Mar 31, 2024 | 2,111,212 | $6.01 | | Vested and exercisable at Mar 31, 2024 | 883,869 | $7.18 | Stock-based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :----------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $171 | $2,080 | | General and administrative | $243 | $9,046 | | Total stock-based compensation expense | $414 | $11,126 | - Total stock-based compensation expense decreased significantly from $11.126 million in Q1 2023 to $0.414 million in Q1 2024, primarily due to one-time charges related to the acceleration of Graybug stock options vesting in 2023[139] 9. Commitments and Contingencies Outlines contractual obligations, lease agreements, and potential legal contingencies - The company has ongoing contracts with contract development and manufacturing organizations (CDMOs) and vendors for preclinical research and manufacturing, with approximately $1.1 million and $1.2 million of associated costs still in effect for future services as of March 31, 2024[143] - The company leases office space in La Jolla, California, under a short-term operating lease, with monthly rent of approximately $10,000[145] - Rent expense for the three months ended March 31, 2024, was $30,000, a decrease from $65,000 in the same period of 2023[146] 10. Employee Benefits Describes the company's defined contribution 401(k) plan for employees - The company adopted a defined contribution 401(k) plan in January 2007 for substantially all employees[147] - No contributions were made by the company to the 401(k) plan for the three months ended March 31, 2024, and 2023[147] 11. Income Taxes Discusses the company's income tax position, including deferred tax assets and valuation allowances - The company did not record a provision or benefit for income taxes during the three months ended March 31, 2024, and 2023, due to continuing losses[148] - A full valuation allowance is maintained against all deferred tax assets due to the history of cumulative net losses[148] 12. Net Income (Loss) Per Share Presents the calculation of basic and diluted net income (loss) per share for common stockholders Net Income (Loss) Per Share (in thousands, except per share amounts) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net Income (loss) | $130 | $(19,288) | | Weighted-average common shares outstanding, basic | 9,754,517 | 823,069 | | Weighted-average common shares outstanding, diluted | 10,047,415 | 823,069 | | Basic EPS | $0.01 | $(23.43) | | Diluted EPS | $0.01 | $(23.43) | - Basic and diluted EPS for Q1 2024 were $0.01, a significant improvement from $(23.43) in Q1 2023[149] - Potentially dilutive shares, including stock options and warrants, were excluded from diluted EPS calculation in Q1 2023 due to their anti-dilutive effect during a net loss period[151] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management's analysis of CalciMedica's financial condition, operations, and liquidity for Q1 2024 and 2023 Overview Provides a high-level summary of CalciMedica's business, product candidates, and key financial highlights for Q1 2024 - CalciMedica is a clinical-stage biopharmaceutical company developing CRAC channel inhibitors for serious inflammatory and immunologic illnesses[153][154] - Auxora, the lead product candidate, is an intravenous CRAC channel inhibitor in Phase 2 clinical development for acute pancreatitis (AP), asparaginase pancreatic toxicity (AIPT), and acute kidney injury (AKI)[155][156][157][158][160] - Topline results for the CARPO Phase 2b trial in AP are anticipated in Q2 2024, with a Phase 3 trial planned for 2025; patient enrollment for the KOURAGE Phase 2 trial in AKI is expected to begin in Q2 2024[156][160] - The company reported a net income of $0.1 million for Q1 2024, primarily due to a $5.6 million gain from fair value adjustment to warrant liability and $0.3 million in interest income, offsetting $5.8 million in operating expenses[166] - As of March 31, 2024, the company had an accumulated deficit of $145.9 million and $25.7 million in cash, cash equivalents, and short-term investments[166] Components of Operating Results Explains the nature and drivers of CalciMedica's R&D, G&A, and other income (expense) categories - Research and development (R&D) expenses include personnel costs, fees to consultants and contract organizations, manufacturing costs for preclinical and clinical materials, and laboratory expenses[171][175] - R&D expenses are expected to increase substantially as product candidates advance through clinical trials and regulatory approvals[173][179] - General and administrative (G&A) expenses primarily cover personnel costs, professional services (legal, audit, accounting), and facility-related fees, and are also expected to increase due to public company operations and growth[180] - Other income (expense) includes interest income and changes in the fair value of warrant liabilities and convertible promissory notes[181] Results of Operations Compares CalciMedica's operating expenses and net income (loss) for Q1 2024 and 2023 Results of Operations (in thousands) | Metric | Q1 2024 | Q1 2023 | Change Amount | Change % | | :-------------------------- | :------ | :------ | :------------ | :------- | | Research and development | $2,944 | $6,491 | $(3,547) | (55%) | | General and administrative | $2,823 | $15,849 | $(13,026) | (82%) | | Total operating expenses | $5,767 | $22,340 | $(16,573) | (74%) | | Loss from operations | $(5,767) | $(22,340) | $16,573 | (74%) | | Other income (expense), net | $5,897 | $3,052 | $2,845 | 93% | | Net income (loss) | $130 | $(19,288) | $19,418 | (101%) | - Research and development expenses decreased by $3.6 million (55%) in Q1 2024 compared to Q1 2023, primarily due to one-time charges in 2023 related to stock option acceleration and severance from the Merger[184] - General and administrative expenses decreased by $13.0 million (82%) in Q1 2024, mainly due to a $13.9 million reduction in personnel costs from one-time Merger-related charges in 2023, partially offset by increased professional services[185] - Net other income increased by $2.8 million (93%) in Q1 2024, driven by a $5.6 million gain from fair value adjustments to warrant liability, partially offset by a $3.2 million gain from warrant liability and convertible notes in Q1 2023[186] Liquidity and Capital Resources Discusses CalciMedica's cash position, funding requirements, and capital sources for future operations - As of March 31, 2024, CalciMedica had $25.7 million in cash, cash equivalents, and short-term investments[188] - The company believes its current resources, including $19.0 million net proceeds from the 2024 Private Placement, are sufficient to fund operations into the second half of 2025, covering clinical milestones for Auxora in AP, AIPT, and AKI[189] - Substantial additional funding will be required to complete development and commercialization of product candidates, as current funds are insufficient for regulatory approval or expanding into new indications[189][190] - Future funding requirements are dependent on clinical trial progress, regulatory review, manufacturing arrangements, and potential collaborations[191][192] - Cash used in operating activities was $4.7 million in Q1 2024, while financing activities provided $19.0 million, primarily from the 2024 Private Placement[201][202][205] Critical Accounting Policies and Significant Judgments and Estimates Details critical accounting policies and significant management judgments and estimates in financial reporting - The preparation of financial statements requires management to make estimates and assumptions, particularly for research and development costs and the valuation of warrants[211] - Research and development costs, especially those from CROs and external vendors, are estimated based on services performed, progress to completion, and budget, with adjustments made as actual costs become known[212][213][214] - Common Warrants are valued using the Black-Scholes model, incorporating inputs like risk-free interest rate, volatility, exercise price, and stock price, with fair value changes impacting results of operations[215] - CalciMedica is an 'emerging growth company' and 'smaller reporting company,' allowing it to delay adopting new accounting standards and benefit from reduced disclosure requirements[216][217] Recently Adopted Accounting Pronouncements Refers to Note 2 for details on new accounting standards adopted by the company - Refer to Note 2 of the condensed consolidated financial statements for information on recently adopted accounting pronouncements[218] Item 3. Quantitative and Qualitative Disclosures About Market Risk CalciMedica, as a smaller reporting company, is exempt from providing market risk disclosures - CalciMedica is a smaller reporting company and is exempt from providing quantitative and qualitative disclosures about market risk[219] Item 4. Controls and Procedures Details the evaluation of CalciMedica's disclosure controls and internal control over financial reporting Evaluation of Disclosure Controls and Procedures Reports on management's assessment of disclosure controls and procedures effectiveness as of March 31, 2024 - Management, with the CEO and Interim CFO's participation, evaluated disclosure controls and procedures as of March 31, 2024[220] - Based on the evaluation, disclosure controls and procedures were concluded to be effective at a reasonable assurance level[221] Changes in Internal Control over Financial Reporting Confirms no material changes in internal control over financial reporting during Q1 2024 - There were no changes in internal control over financial reporting during Q1 2024 that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[222] PART II—OTHER INFORMATION Item 1. Legal Proceedings No pending litigation is believed to have a material adverse effect on the company's financial condition - The company may be involved in legal proceedings in the ordinary course of business, with uncertain outcomes that could negatively impact financial results[225] - Currently, there is no litigation pending that is believed to have a material adverse effect on the company's results of operations or financial condition[226] Item 1A. Risk Factors Outlines significant risks related to CalciMedica's business, financial condition, and common stock investment Risks Related to Our Limited Operating History, Financial Position and Capital Requirements Discusses risks from limited operating history, substantial funding needs, and potential dilution - CalciMedica is a clinical-stage biopharmaceutical company with a limited operating history, no product revenue, and a history of net losses, anticipating significant future losses[230][231] - The company will require substantial additional funding beyond its current $25.7 million in cash, cash equivalents, and short-term investments to complete product development and commercialization, with current funds only sufficient into the second half of 2025[233][236] - Raising additional capital may dilute stockholders, restrict operations through debt covenants, or require relinquishing rights to proprietary platforms or product candidates[241][242] - Any acquisitions or strategic collaborations could increase capital requirements, dilute stockholders, incur debt, or assume contingent liabilities[244][245] - Failure to maintain Nasdaq listing could reduce stock liquidity and subject it to 'penny stock' rules[246][249] Risks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates Addresses risks in drug development, clinical trials, and regulatory approval processes - The company's CRAC channel inhibition science is novel and unproven, leading to unforeseen risks, difficulty in predicting development time/cost, and potential failure to result in approvable or marketable products[250][251][252] - Business success is highly dependent on Auxora, the lead product candidate, which may fail to achieve successful development or regulatory approval[253][254][255][257] - Clinical development is lengthy, expensive, and uncertain; preclinical and early clinical trial results are not always predictive of future outcomes, and later-stage trials may fail[258][259] - Delays in site initiation, patient enrollment, manufacturing, or other difficulties can significantly extend or terminate clinical trials[262][264] - Preliminary, interim, and topline data from clinical trials are subject to change and audit, and may differ from final results, potentially harming business prospects[272][273] - Serious adverse events (SAEs), undesirable side effects, or unexpected properties of product candidates could lead to discontinuation of development, refusal of regulatory approval, or market withdrawal[274][276][278][279][280] - Special designations (e.g., Fast Track, Breakthrough Therapy, Orphan Drug) may be sought to expedite approvals but are not guaranteed and may not ultimately benefit the development process[281][285][286][287][288][291][292] - Product candidates must meet extensive regulatory requirements, and any approval may come with limitations, conditions, or require substantial additional development expenses[296][298][299][300][301] - Failure to obtain FDA approval for proposed product names, including Auxora, could adversely affect branding and commercialization[302][304] - Ongoing regulatory obligations post-approval, including compliance with cGMP and post-marketing studies, may result in significant additional expense and potential penalties for non-compliance[305][306][307][308][309] - Improper promotion of off-label uses of approved products could lead to significant liability, fines, and restrictions[310][312] - Disruptions at the FDA and other government agencies due to funding shortages or global health concerns could delay product development and approval[313][314] - Failure to identify or discover other product candidates or capitalize on the proprietary platform could limit commercial opportunities[315][316][317] Risks Related to Manufacturing, Commercialization and Reliance on Third Parties Covers risks from third-party reliance, manufacturing, market acceptance, and reimbursement - The company relies heavily on third parties (CROs, clinical investigators) for research, preclinical studies, and clinical trials, and their failure to perform satisfactorily could delay development programs or increase costs[321][322][325][326][327] - Reliance on third-party manufacturers for product candidates carries risks of limited or interrupted supply, unsatisfactory quality, and non-compliance with cGMP regulations, potentially delaying development or commercialization[328][329][330][331][332] - Approved product candidates may fail to achieve sufficient market acceptance by physicians, patients, hospitals, and healthcare payors, limiting commercial success[333][335] - Unfavorable pricing regulations or third-party coverage and reimbursement policies could make it difficult to sell product candidates profitably, as patients rely on payors to cover costs[336][337][338][339][340][341][342][343] - Inability to establish internal sales and marketing capabilities or secure agreements with third parties for these functions would hinder successful commercialization of approved product candidates[344][345][346] - Failure to obtain regulatory approval or commercialize product candidates outside the United States would limit their full market potential[347] Risks Related to Our Industry and Business Operations Examines risks concerning personnel, competition, data protection, and healthcare regulations - The company is highly dependent on key personnel, and failure to attract and retain qualified individuals could impede development and commercialization efforts[348][349][350][351] - The CEO and CBO also serve as managing directors for Valence, a significant stockholder, potentially leading to conflicts of interest or diversion of attention[352] - Expected expansion of development, regulatory, and operational capabilities may lead to difficulties in managing growth, potentially disrupting operations[353][354][355][356] - The company faces substantial competition from larger, more resourced companies, as well as smaller entities, which could result in competitors developing or commercializing products more quickly or successfully[357][358][359][360][361][363] - Future collaboration arrangements may not be successful, potentially altering or delaying development and commercialization plans[364][365][366] - Failure to comply with applicable data protection laws (e.g., CCPA, GDPR, DPDP) could lead to government enforcement actions, private litigation, and adverse publicity, negatively affecting operating results[367][368][369][370][371][372][373][374] - Information technology systems, or those of third parties, may suffer security breaches or disruptions, compromising confidential information, delaying development, and exposing the company to liability[375][376][377][378][379][380] - Adverse effects from natural disasters, terrorism, or unforeseen events could disrupt business continuity, especially given reliance on single-site operations and lack of comprehensive disaster recovery plans[381] - The ability to utilize net operating loss (NOL) carryforwards and other tax attributes may be limited due to ownership changes or changes in tax laws, potentially increasing future tax liability[382][383][384] - Changes in healthcare laws and regulations (e.g., Affordable Care Act, IRA) and healthcare policy could significantly impact the business, affecting marketing approval, post-approval activities, and profitability[385][386][387][388][389][390][391][392][393] - Non-compliance with fraud and abuse, transparency, government price reporting, and other healthcare laws could lead to substantial penalties, exclusion from government programs, and reputational harm[394][396][397][398][399][400] - Misconduct by employees, principal investigators, consultants, or commercial partners, including non-compliance with regulatory standards or insider trading, could result in significant penalties and harm to reputation[401] Risks Related to Our Intellectual Property Details risks concerning patent protection, intellectual property infringement, and trade secret confidentiality - Inability to obtain and maintain sufficient intellectual property protection for Auxora and other proprietary technologies could allow competitors to commercialize similar products, adversely affecting the business[402][403][404][405][406][407][408][409][410][411] - Patent terms may be inadequate to protect competitive position for product candidates for a sufficient duration, leading to competition from generic products upon expiration[414][416] - Failure to obtain patent term extension for Auxora could materially harm the business by reducing the period of exclusive market rights[415][418] - Non-compliance with procedural, document submission, and fee payment requirements by governmental patent agencies could lead to reduced or eliminated patent protection[419] - Changes in U.S. patent law, including recent Supreme Court decisions and the America Invents Act, could diminish the value of patents and impair the ability to protect Auxora[420][421][422] - Inability to protect intellectual property rights globally, due to varying national laws and enforcement, could allow third parties to practice inventions in countries without patent protection[423][424][425][426][427] - Claims challenging inventorship or ownership of patents and other intellectual property could lead to loss of valuable rights, monetary damages, and substantial litigation costs[428] - Failure to obtain or maintain necessary rights to product components and processes through acquisitions and in-licenses could hinder business growth and commercialization[429][430][431][432][433] - Third-party claims alleging intellectual property infringement may prevent or delay drug discovery and development efforts, leading to costly litigation, damages, or the need for licenses[434][435][436][437][438][439][440][441][442][443][444][445][446][447] - Claims of wrongful hiring or use/disclosure of confidential information/trade secrets from former employers could lead to litigation, loss of intellectual property rights, or personnel[448] - Lawsuits to protect or enforce patents can be expensive, time-consuming, and unsuccessful, potentially leading to invalidation of patents or substantial costs[450][451][452][453][454][455] - Inability to protect the confidentiality of trade secrets, especially when shared with third parties, could harm the business and competitive position[456][457][458] - Inadequate protection of trademarks and trade names could prevent building name recognition and adversely affect the business[459][460][461] - Future collaboration arrangements may not be successful, depending heavily on collaborators' efforts and potentially leading to relinquishing control or costly disputes[462][463] General Risk Factors Covers broad risks including litigation, compliance, stock volatility, and corporate governance - Business operations may lead to disputes, claims, and lawsuits, which can be costly, time-consuming, and adversely impact financial position and results of operations[462][464][465] - Failure to comply with environmental, health, and safety laws and regulations could result in fines, penalties, or substantial costs[466][467][468][469][470][471] - Future changes in financial accounting standards or practices may cause adverse and unexpected revenue fluctuations and affect reported results of operations[472] - The company is subject to U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws, with violations leading to serious consequences[473][475] - The market price of the company's stock has been and may continue to be volatile due to various factors, potentially leading to loss of investment[476][477][478] - Financial reporting obligations as a public company are expensive and time-consuming, requiring substantial management time for compliance[479] - The management team's relative lack of public company experience may put the company at a competitive disadvantage in complying with legal and regulatory requirements[480] - Substantial future sales of common stock by existing stockholders could adversely affect the market price[481][482] - Principal stockholders and management own a significant percentage of stock, allowing them to exert significant control over matters subject to stockholder approval, potentially conflicting with other stockholders' interests[483] - As a smaller reporting company, reduced disclosure requirements may make common stock less attractive to investors or limit the ability to raise additional funds[484] - The company does not anticipate paying cash dividends, making capital appreciation the sole source of gain for investors[485] - If equity research analysts do not publish research or publish unfavorable reports, the stock price and trading volume could decline[486] - Anti-takeover provisions in charter documents and Delaware law could make an acquisition more difficult and prevent stockholders from replacing management[487] - Bylaws designating Delaware courts as the exclusive forum for disputes could limit stockholders' ability to choose a favorable judicial forum[488][490] - Unfavorable global economic conditions could adversely affect business, financial condition, or results of operations[491] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds Reports no unregistered sales of equity securities or use of proceeds for the period - No unregistered sales of equity securities or use of proceeds were reported[492] Item 3. Defaults Upon Senior Securities No defaults upon senior securities were reported - No defaults upon senior securities were reported[493] Item 4. Mine Safety Disclosures Confirms that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable to CalciMedica, Inc[494] Item 5. Other Information Indicates that no other information was reported - No other information was reported[495] Item 6. Exhibits Lists all exhibits filed as part of the Quarterly Report on Form 10-Q - The exhibits include the Amended and Restated Certificate of Incorporation, Restated Bylaws, various forms of Registration Rights Agreements, and Warrants to Purchase Common Stock[497][498] - Certifications from the Principal Executive Officer and Principal Financial Officer, pursuant to Rules 13a-14(a) and 15d-14(a) and 18 U.S.C. Section 1350, are included[498] - Inline XBRL Instance Document, Taxonomy Extension Schema, and Cover Page Interactive Data File are also part of the exhibits[498] SIGNATURES Contains the required signatures of the registrant's authorized officers - The report is signed by A. Rachel Leheny, Ph.D., Chief Executive Officer, and Daniel Geffken, Interim Chief Financial Officer, on May 13, 2024[503]