GRAYBUG VISION(GRAY) - 2025 Q1 - Quarterly Results

CalciMedica First Quarter 2025 Financial Results and Corporate Updates Recent Clinical & Corporate Highlights CalciMedica advances its AKI program with ongoing KOURAGE trial enrollment and positive Auxora data, while securing new financing and strengthening its board - Enrollment is ongoing in the Phase 2 KOURAGE trial for Auxora™ in acute kidney injury (AKI), with data expected around the end of 2025[1][4] - A post-hoc analysis of the Phase 2 CARDEA trial in a subset of patients with AKI showed a 62.7% relative reduction in mortality for those treated with Auxora compared to placebo[1][5] - The company's cash position is expected to fund operations into mid-2026, supported by a new credit facility of up to $32.5 million[1][3][8] Acute Kidney Injury (AKI) Program Update The AKI program advances with the Phase 2 KOURAGE trial, expecting data by year-end 2025, supported by positive post-hoc CARDEA analysis demonstrating Auxora's mortality reduction - Enrollment is ongoing in the KOURAGE Phase 2 trial, which will enroll 150 patients with Stage 2 or 3 AKI and acute hypoxemic respiratory failure (AHRF) Data is anticipated around the end of 2025[4] - A post-hoc analysis of the CARDEA trial showed that in a subset of 38 patients with AKI, Auxora treatment led to a 62.7% relative reduction in mortality versus placebo at day 30[5] - Mortality rates in the CARDEA post-hoc analysis were 17.4% (4 out of 23) for the Auxora group, compared to 46.7% (7 out of 15) for the placebo group at both day 30 and day 60[5] Acute Pancreatitis (AP) Program Update CalciMedica plans an end-of-Phase 2 FDA meeting around mid-2025 for its AP program, aiming to initiate a Phase 3 trial by year-end, contingent on additional funding - An end-of-Phase 2 meeting with the U.S FDA is planned for around the middle of 2025[10] - The company anticipates being ready to start a Phase 3 program in AP with SIRS around the end of 2025, subject to additional funding[10] Corporate Updates CalciMedica strengthened its governance by appointing a new board member and enhanced financial flexibility by securing a credit facility of up to $32.5 million - In January 2025, Alan Glicklich, M.D., was appointed to the Company's Board of Directors[7] - On March 5, 2025, the company secured a credit facility providing up to $32.5 million, with an initial $10 million funded immediately[8] Financial Results for the Three Months Ended March 31, 2025 CalciMedica reported a net loss of $5.9 million for Q1 2025, driven by increased R&D expenses and decreased other income, ending the quarter with $24.6 million in cash - Cash, cash equivalents, and short-term investments totaled $24.6 million as of March 31, 2025, which is expected to fund operations into mid-2026[11] Q1 2025 vs Q1 2024 Financial Highlights | Financial Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change (in millions) | | :--- | :--- | :--- | :--- | | R&D Expenses | $4.2 | $2.9 | +$1.3 | | G&A Expenses | $2.3 | $2.8 | -$0.5 | | Other Income | $1.5 | $5.9 | -$4.4 | | Net (Loss) Income | ($5.9) | $0.1 | -$6.0 | Financial Statements Unaudited condensed consolidated financial statements show CalciMedica's total assets increased to $25.3 million due to a new promissory note, while total liabilities rose to $14.5 million, resulting in a net loss of $5.0 million for the quarter Condensed Consolidated Balance Sheets As of March 31, 2025, CalciMedica's total assets increased to $25.3 million, driven by cash from a new promissory note, while total liabilities rose to $14.5 million, leading to a decrease in total stockholders' equity to $10.9 million Balance Sheet Summary (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total current assets | $25,218 | $19,665 | | Cash and cash equivalents | $12,556 | $7,935 | | Total assets | $25,347 | $19,794 | | Total current liabilities | $4,459 | $3,684 | | Promissory note | $8,600 | $— | | Total liabilities | $14,459 | $5,384 | | Total stockholders' equity | $10,888 | $14,410 | Condensed Consolidated Statements of Operations For Q1 2025, the company reported total operating expenses of $6.5 million, resulting in a net loss of $5.0 million, or ($0.36) per share, a significant downturn from the prior year's net income Statement of Operations Summary (in thousands, except per share data) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $4,224 | $2,944 | | General and administrative | $2,273 | $2,823 | | Total operating expenses | $6,497 | $5,767 | | Loss from operations | ($6,497) | ($5,767) | | Net (loss) income | ($5,042) | $130 | | Basic EPS | ($0.36) | $0.01 | | Diluted EPS | ($0.36) | $0.01 |