CalciMedica(CALC) - 2022 Q2 - Quarterly Report

PART I—FINANCIAL INFORMATION This section presents Graybug Vision, Inc.'s unaudited condensed consolidated financial statements as of June 30, 2022 Item 1. Financial Statements This section presents Graybug Vision, Inc.'s unaudited condensed consolidated financial statements as of June 30, 2022, detailing a net loss of $18.4 million and an accumulated deficit of $187.6 million Condensed Consolidated Balance Sheets The balance sheet as of June 30, 2022, shows total assets of $54.0 million and stockholders' equity of $49.7 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2022 (unaudited) | December 31, 2021 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $13,872 | $13,364 | | Short-term investments | $36,817 | $50,306 | | Total current assets | $51,727 | $67,078 | | Total assets | $54,022 | $69,088 | | Liabilities & Equity | | | | Total current liabilities | $4,330 | $4,057 | | Total liabilities | $4,330 | $4,065 | | Accumulated deficit | $(187,578) | $(169,188) | | Total stockholders' equity | $49,692 | $65,023 | Condensed Consolidated Statements of Operations The company reported a net loss of $8.2 million for the three months and $18.4 million for the six months ended June 30, 2022 Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $4,058 | $4,166 | $10,115 | $10,614 | | General and administrative | $4,243 | $3,575 | $8,370 | $8,615 | | Loss from operations | $(8,301) | $(7,741) | $(18,485) | $(19,229) | | Net loss | $(8,241) | $(7,708) | $(18,390) | $(19,157) | | Net loss per share | $(0.38) | $(0.36) | $(0.86) | $(0.91) | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities was $10.7 million for the six months ended June 30, 2022 Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(10,663) | $(17,045) | | Net cash provided by (used in) investing activities | $11,240 | $(9,096) | | Net cash (used in) provided by financing activities | $(69) | $587 | | Net increase (decrease) in cash | $508 | $(25,554) | Notes to the Condensed Consolidated Financial Statements Key notes detail the company's strategic review, RainBio acquisition, and new lease accounting standards adoption - On June 28, 2022, the company announced a comprehensive review of strategic alternatives, including potential acquisition, sale, merger, or asset divestiture. Subsequently, on August 11, 2022, all clinical development was put on hold to conserve capital[34] - Management believes the company's current cash, cash equivalents, and short-term investments are adequate to meet its cash needs for at least 12 months from the report's issuance date[37] - In March 2022, the company acquired RainBio, Inc. for approximately $2.2 million, which was expensed as in-process research and development (IPR&D). The deal includes potential future contingent payments of up to $17.5 million upon achieving certain milestones[65][66] - The company adopted new lease accounting standard ASC 842 on January 1, 2022, resulting in the recognition of an operating lease right-of-use asset of $0.6 million and an operating lease liability of $0.6 million[50] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's financial condition, strategic decision to halt clinical development, and H1 2022 results - On June 28, 2022, the company initiated a review of strategic alternatives, and on August 11, 2022, it halted all clinical development of GB-102, GB-401, and GB-501 to conserve capital pending the review's outcome[91] - As of June 30, 2022, the company had $50.7 million in cash, cash equivalents, and short-term investments and an accumulated deficit of $187.6 million[89] - The company believes its existing cash will fund operations into the fourth quarter of 2023, based on an operating plan that is subject to change pending the strategic review[121] - In July 2022, the company regained compliance with Nasdaq's minimum bid price requirement after its stock price closed at or above $1.00 for ten consecutive business days[92] Results of Operations Total operating expenses decreased by 4% to $18.5 million for the six months ended June 30, 2022 Comparison of Operating Results (in thousands) | Metric | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | Change Amount | Change % | | :--- | :--- | :--- | :--- | :--- | | Research and development | $10,115 | $10,614 | $(499) | (5%) | | General and administrative | $8,370 | $8,615 | $(245) | (3%) | | Total operating expenses | $18,485 | $19,229 | $(744) | (4%) | | Net loss | $(18,390) | $(19,157) | $767 | (4%) | - The decrease in R&D expenses for the six-month period was primarily due to the completion of the GB-102 Phase 2b clinical trial extension in May 2021, offset by a $2.2 million expense for the acquisition of in-process R&D from RainBio, Inc. in March 2022[117] - The decrease in G&A expenses for the six-month period was mainly due to a $1.4 million write-off of deposits on fixed-asset purchase commitments in March 2021, partially offset by increased stock compensation and professional services in 2022[118] Liquidity and Capital Resources As of June 30, 2022, the company held $50.7 million in cash and investments, expected to fund operations into Q4 2023 - The company's cash, cash equivalents, and short-term investments totaled $50.7 million as of June 30, 2022[119] - The company believes its existing cash will fund operating expenses and capital requirements into the fourth quarter of 2023, based on a revised operating plan that no longer includes the cost of Phase 3 trials for GB-102 without a partner[121][128] - Future funding needs will depend on the outcome of the strategic review and many factors, including the scope of R&D, costs of clinical trials, and potential collaborations or licenses[131] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Graybug Vision is not required to provide market risk disclosures - As a smaller reporting company, Graybug Vision is not required to provide quantitative and qualitative disclosures about market risk[145] Item 4. Controls and Procedures Management concluded disclosure controls and procedures were effective as of June 30, 2022, with no material internal control changes - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[146] - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[147] PART II—OTHER INFORMATION This section provides other information relevant to the company's financial reporting Item 1. Legal Proceedings The company is not currently a party to any material legal proceedings - As of the filing date, the company is not involved in any material legal proceedings[150] Item 1A. Risk Factors This section outlines significant risks including strategic review uncertainty, funding needs, clinical trial failures, and stock volatility - The company may not be successful in its strategic review to find a merger, sale, or other transaction, and failure could lead to liquidation where shareholders might receive significantly less than the market value of their shares[153][154] - The company has a history of significant losses, expects to incur more, and will need substantial additional funding to support operations. Without a strategic transaction, further development of its lead product candidate, GB-102, is unlikely[155][156] - The company faces risks from its unproven therapeutic approach, potential failure of clinical trials to demonstrate safety and efficacy, and serious adverse side effects identified during development[158] - The company is heavily reliant on third parties for manufacturing and may encounter difficulties in production, scale-up, and quality control, particularly for its novel and complex gene therapies[160] - The stock price has been and may continue to be volatile, and the company faces the risk of delisting from Nasdaq if it fails to meet the minimum bid requirement[162] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities occurred, and there was no material change in the planned use of IPO proceeds - There were no unregistered sales of equity securities in the reported period[474] - The company raised approximately $92.0 million in net proceeds from its IPO in September/October 2020. There has been no material change in the planned use of these proceeds[475][476] Item 3. Defaults Upon Senior Securities There have been no defaults upon senior securities - None[477] Item 4. Mine Safety Disclosures This item is not applicable to the company - Not applicable[478] Item 5. Other Information No other information is reported for this item - None[479] Item 6. Exhibits This section lists exhibits filed with the Form 10-Q, including SOX certifications and Inline XBRL documents - The exhibits filed include certifications from the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[481][482][483] - Inline XBRL data files are included as exhibits, providing interactive data for the financial statements[483]