GRAYBUG VISION(GRAY) - 2024 Q3 - Quarterly Results

Overview and Highlights CalciMedica reported Q3 2024 results, highlighting positive CARPO Phase 2b trial data for Auxora and extended cash runway - Announced additional positive data, including a win ratio analysis, from the CARPO Phase 2b trial of Auxora™ in acute pancreatitis (AP), with plans to initiate a Phase 3 program in 2025[1][2] - Enrollment is ongoing in the Phase 2 KOURAGE trial for acute kidney injury (AKI) and the Phase 2 CRSPA trial for asparaginase-induced pancreatic toxicity (AIPT), with data from both expected in 2025[1] - Completed a public offering in October, strengthening the cash position to fund operations into the first half of 2026[1][7] Clinical Updates and Pipeline Progress CalciMedica reported positive CARPO Phase 2b data for Auxora, with ongoing enrollment for KOURAGE and CRSPA trials CARPO Phase 2b Trial (Acute Pancreatitis - AP) The CARPO trial for Auxora in AP showed statistically significant results, including a 100% relative risk reduction in severe respiratory failure - Auxora demonstrated a statistically significant 100% relative risk reduction (p = 0.0027) in new-onset severe respiratory failure and a 64.2% reduction (p = 0.0476) in new-onset persistent respiratory failure[7] - Analysis found a statistically significant stratified win ratio of 1.640 (p = 0.0372) for high-dose Auxora patients compared to placebo patients[7] - The company is planning an end-of-Phase 2 meeting with the FDA and expects to be in a position to initiate a Phase 3 program in 2025[4] KOURAGE Phase 2 Trial (Acute Kidney Injury - AKI) Enrollment continues for the KOURAGE Phase 2 trial of Auxora in severe AKI patients, with topline data expected in 2025 - The KOURAGE trial is evaluating Auxora in patients with severe AKI (stage 2 and stage 3) with associated acute hypoxemic respiratory failure (AHRF)[7] - The company expects to enroll 150 patients, with topline data expected in 2025[7] CRSPA Phase 2 Trial (AIPT) Enrollment is ongoing for the CRSPA Phase 2 trial in AIPT, targeting 24 patients with data expected in 2025 - Enrollment is ongoing in the Phase 2 portion of the CRSPA study in asparaginase-induced pancreatic toxicity (AIPT)[7] - The trial is expected to enroll approximately 24 patients, and data are expected in 2025[7] Financial Results and Corporate Updates CalciMedica reported a Q3 2024 net loss of $5.6 million, with a public offering extending cash runway into H1 2026 Financial Performance (Q3 2024) CalciMedica reported a Q3 2024 net loss of $5.6 million and a nine-month net loss of $9.4 million Financial Performance (Q3 2024) | Metric | Three Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2024 | | :--- | :--- | :--- | | Loss from Operations | $(5.7) million | $(18.0) million | | Net Loss | $(5.6) million | $(9.4) million | | Net Loss Per Share | $(0.50) | $(0.88) | Financial Position and Liquidity As of Sep 30, 2024, CalciMedica held $14.6 million in cash, with a public offering boosting pro-forma cash to $23.7 million - As of September 30, 2024, the company had approximately $14.6 million in cash, cash equivalents, and short-term investments[7] - A public offering completed on November 1, 2024, raised gross proceeds of $10.2 million[7] - The pro-forma cash balance of approximately $23.7 million is expected to fund current operations into the first half of 2026[7] Financial Statements This section presents CalciMedica's unaudited condensed consolidated financial statements as of and for Q3 and nine months ended Sep 30, 2024 Condensed Consolidated Balance Sheets As of Sep 30, 2024, CalciMedica reported total assets of $16.2 million, liabilities of $7.2 million, and equity of $9.0 million Condensed Consolidated Balance Sheets (in thousands) | Account (in thousands) | Sep 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $9,151 | $5,530 | | Total current assets | $15,686 | $11,605 | | Total assets | $16,212 | $12,185 | | Total liabilities | $7,182 | $4,028 | | Total stockholders' equity | $9,030 | $8,157 | Condensed Consolidated Statements of Operations For Q3 2024, net loss was $5.6 million; for nine months, net loss was $9.4 million, a significant decrease from 2023 Condensed Consolidated Statements of Operations (Three Months Ended) | Account (in thousands) | Three Months Ended Sep 30, 2024 | Three Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Research and development | $3,546 | $2,772 | | General and administrative | $2,190 | $2,061 | | Loss from operations | $(5,736) | $(4,833) | | Net loss | $(5,618) | $(4,619) | Condensed Consolidated Statements of Operations (Nine Months Ended) | Account (in thousands) | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Loss from operations | $(18,032) | $(33,756) | | Change in fair value of financial instruments | $7,790 | $3,168 | | Net loss | $(9,442) | $(30,211) | About CalciMedica and Forward-Looking Statements This section provides CalciMedica's corporate overview as a clinical-stage biopharmaceutical company and outlines forward-looking statements Company Profile CalciMedica is a clinical-stage biopharmaceutical company developing CRAC channel inhibition therapies, with Auxora™ showing positive clinical results - CalciMedica is a clinical-stage biopharmaceutical company focused on developing novel CRAC channel inhibition therapies for inflammatory and immunologic diseases[8] - The company's lead product candidate, Auxora™, has demonstrated positive and consistent clinical results in multiple completed efficacy clinical trials, including for acute pancreatitis (CARPO) and COVID pneumonia (CARDEA)[8] Forward-Looking Statements This section details forward-looking statements regarding cash runway, clinical trials, and regulatory plans, subject to inherent risks and uncertainties - Forward-looking statements cover expected cash runway, clinical trial timing and design, plans for FDA meetings, and the potential benefits of Auxora[9] - Actual outcomes may differ due to risks such as global financial market fluctuations, ability to obtain regulatory approval, and potential safety complications from Auxora[9]