PART I—FINANCIAL INFORMATION Financial Statements (Unaudited) The unaudited financial statements as of June 30, 2024, show a reduced net loss and increased assets, with current cash sufficient for at least one year of operations Condensed Consolidated Balance Sheets Condensed Consolidated Balance Sheet Highlights (in thousands USD) | Account | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $5,056 | $5,530 | | Short-term investments | $14,081 | $5,708 | | Total current assets | $20,442 | $11,605 | | Total assets | $21,052 | $12,185 | | Liabilities & Equity | | | | Total current liabilities | $3,914 | $4,028 | | Warrant liability | $3,300 | $0 | | Total liabilities | $7,214 | $4,028 | | Total stockholders' equity | $13,838 | $8,157 | Condensed Consolidated Statements of Operations Condensed Consolidated Statements of Operations (in thousands USD) | Metric | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $4,157 | $3,814 | $7,101 | $10,305 | | General and administrative | $2,372 | $2,769 | $5,195 | $18,618 | | Loss from operations | $(6,529) | $(6,583) | $(12,296) | $(28,923) | | Net loss | $(3,954) | $(6,304) | $(3,824) | $(25,592) | | Net loss per share | $(0.36) | $(1.11) | $(0.37) | $(7.86) | Condensed Consolidated Statements of Cash Flows Condensed Consolidated Statements of Cash Flows Highlights (in thousands USD) | Activity | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(11,507) | $(17,547) | | Net cash (used in) provided by investing activities | $(8,003) | $14,502 | | Net cash provided by financing activities | $19,036 | $20,653 | | Net (decrease) increase in cash and cash equivalents | $(474) | $17,608 | - Financing activities in the first six months of 2024 were primarily driven by $19.0 million in net proceeds from the issuance of common stock. In the same period of 2023, financing activities included $14.9 million in cash acquired from the Graybug merger and $10.3 million from a private placement41 Notes to the Condensed Consolidated Financial Statements - The company is a clinical-stage biopharmaceutical firm focused on therapeutics for inflammatory processes, having completed a reverse merger with Graybug Vision, Inc. on March 20, 2023, with Private CalciMedica as the accounting acquirer444546 - As of June 30, 2024, the company had an accumulated deficit of $149.9 million, with management believing its $19.1 million in cash, cash equivalents, and short-term investments are sufficient to fund operations for at least one year from the financial statement issuance date474951 - In January and February 2024, the company completed a private placement, raising gross proceeds of $20.4 million and net proceeds of approximately $19.0 million121123 - The company has an At-the-Market (ATM) facility to sell up to $17.3 million of common stock, with approximately $17.0 million remaining available as of June 30, 2024125 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's clinical development of Auxora for inflammatory diseases and its financial performance, highlighting reduced net losses and extended cash runway from recent financing Overview - CalciMedica is a clinical-stage biopharmaceutical company focused on developing therapeutics targeting calcium release-activated calcium (CRAC) channels for inflammatory and immunologic diseases156157 - The lead product candidate, Auxora, is an intravenous CRAC channel inhibitor currently being evaluated in multiple Phase 2 trials for acute pancreatitis (AP), asparaginase-induced pancreatotoxicity (AIPT), and acute kidney injury (AKI)158159160161 - The company plans to initiate a pivotal trial for Auxora in AP in 2025 and anticipates data from the AIPT and AKI trials in the same year159160161 - As of June 30, 2024, the company reported an accumulated deficit of $149.9 million and held $19.1 million in cash, cash equivalents, and short-term investments167 Results of Operations Comparison of Operating Results (in thousands USD) | Period | Research & Development | General & Administrative | Total Operating Expenses | Net Loss | | :--- | :--- | :--- | :--- | :--- | | Q2 2024 | $4,157 | $2,372 | $6,529 | $(3,954) | | Q2 2023 | $3,814 | $2,769 | $6,583 | $(6,304) | | H1 2024 | $7,101 | $5,195 | $12,296 | $(3,824) | | H1 2023 | $10,305 | $18,618 | $28,923 | $(25,592) | - The decrease in G&A expenses for the six months ended June 30, 2024, compared to 2023, was primarily due to one-time merger-related charges in 2023, including $8.6 million for accelerated stock option vesting and $4.1 million in severance189 - The increase in Other Income for H1 2024 was mainly due to a $7.9 million gain from the fair value adjustment of the warrant liability resulting from the 2024 Private Placement190 Liquidity and Capital Resources - As of June 30, 2024, the company held $19.1 million in cash, cash equivalents, and short-term investments191 - In January/February 2024, the company raised approximately $19.0 million in net proceeds from a private placement192201 - Management believes current cash resources are sufficient to fund operations into the second half of 2025, covering the advancement of Auxora through key clinical milestones in AP, AIPT, and AKI193 - Net cash used in operating activities was $11.5 million for the first six months of 2024, a decrease from $17.5 million for the same period in 2023203205 Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, CalciMedica is not required to provide quantitative and qualitative disclosures regarding market risk - As a smaller reporting company, CalciMedica is not required to provide quantitative and qualitative disclosures about market risk223 Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2024, with no material changes to internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2024225 - There were no changes in internal control over financial reporting during the quarter that materially affected or are reasonably likely to materially affect the company's internal controls226 PART II—OTHER INFORMATION Legal Proceedings The company reports no current litigation expected to have a material adverse effect on its financial condition or results of operations - The company states it currently has no pending litigation expected to have a material adverse effect on its financial position or operational results230 Risk Factors This section details significant risks including a history of net losses, the need for substantial additional funding, high dependence on Auxora's success, and challenges in clinical development, manufacturing, and intellectual property protection - The company is a clinical-stage entity with a limited operating history, a history of net losses, and an accumulated deficit of $149.9 million as of June 30, 2024, having never generated product revenue234235 - Substantial additional funding is required to complete development and commercialization, as current cash is expected to fund operations only into the second half of 2025 and is insufficient for regulatory approval of any product candidate237240 - The business is highly dependent on the success of its lead product candidate, Auxora, and failure to successfully develop and obtain regulatory approval would significantly harm the company257259 - The company relies on third parties for manufacturing and conducting clinical trials, and any inadequate performance could delay development programs and increase costs324331 - The company's ability to commercialize products may be adversely affected if it cannot obtain and maintain sufficient intellectual property protection for its candidates and technologies406407 Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities during the reporting period495
GRAYBUG VISION(GRAY) - 2024 Q2 - Quarterly Report