GRAYBUG VISION(GRAY) - 2024 Q4 - Annual Results

Executive Summary CalciMedica, a clinical-stage biopharmaceutical company, advances its Auxora™ Phase 2 KOURAGE trial and reports a 62.7% relative mortality reduction in the CARDEA trial for AKI Company Introduction CalciMedica is a clinical-stage biopharmaceutical company developing CRAC channel inhibitor therapies for inflammatory and immunological diseases - CalciMedica is a clinical-stage biopharmaceutical company focused on developing CRAC channel inhibitor therapies for acute and chronic inflammatory and immunological diseases[2] Key Highlights & CEO Statement Auxora™ Phase 2 KOURAGE trial for AKI and respiratory failure is on track for late 2025 data, with CARDEA trial analysis showing a 62.7% relative mortality reduction in AKI - Enrollment for the Phase 2 KOURAGE trial (Auxora™ for AKI and respiratory failure) is ongoing, with data expected in late 2025[1][3] - Late-stage analysis of AKI patients in the Phase 2 CARDEA trial showed a 62.7% relative reduction in mortality at 30 days, sustained through 60 days, for the Auxora treatment group[1][3] - The company anticipates its existing cash position will support operations until mid-2026[1][3] Clinical & Corporate Updates CalciMedica provided updates on Auxora™ clinical programs for AKI, AP, and AIPT, detailing trial enrollment, data timelines, and key late-stage analysis Clinical Program Updates CalciMedica provided updates on Auxora™ clinical programs for AKI, AP, and AIPT, detailing trial enrollment, data timelines, and key late-stage analysis Acute Kidney Injury (AKI) Program Update The Phase 2 KOURAGE trial for severe AKI with acute hypoxic respiratory failure is enrolling 150 patients, with data expected in late 2025, and CARDEA trial analysis showed significant mortality reduction - The Phase 2 KOURAGE trial for severe AKI with acute hypoxic respiratory failure is enrolling, targeting 150 patients, with data expected in late 2025[4] - Late-stage analysis of AKI patients in the Phase 2 CARDEA trial showed a 62.7% relative reduction and 29.3% absolute reduction in mortality at 30 and 60 days for the Auxora treatment group[8] CARDEA Trial AKI Patient 30- and 60-Day Mortality | Group | Number of Deaths at 30 and 60 Days | Total Patients | Mortality Rate | | :---- | :--------------------------------- | :------------- | :------------- | | Placebo | 7 | 15 | 46.7% | | Auxora | 4 | 23 | 17.4% | Acute Pancreatitis (AP) Program Update The company plans a Phase 2 end-of-study meeting with the FDA in mid-2025 and anticipates initiating a Phase 3 program for AP with SIRS by late 2025, subject to additional funding - The company plans a Phase 2 end-of-study meeting with the FDA in mid-2025 and expects to initiate a Phase 3 program for AP with Systemic Inflammatory Response Syndrome (SIRS) by late 2025, contingent on additional funding[8] - Collaborator Prof. Robert Sutton presented a plenary session at the 2024 American Pancreatic Association (APA) annual meeting on Auxora's reduction of severe organ failure development in AP with SIRS patients[8] Asparaginase-induced Pancreatic Toxicity (AIPT) Program Update Enrollment for the Phase 2 portion of the CRSPA study for AIPT is over 50% complete, with updates expected in H2 2025 - Enrollment for the Phase 2 portion of the CRSPA study for AIPT is over 50% complete, with updates expected in the second half of 2025[6] Corporate Updates CalciMedica strengthened its leadership team with Stephen Bardin appointed CFO in November 2024 and Dr. Alan Glicklich joining the Board in January 2025 - In November 2024, Stephen Bardin was appointed Chief Financial Officer, bringing extensive experience in financing, corporate development, and strategic finance[9] - In January 2025, Dr. Alan Glicklich was appointed to the company's Board of Directors, with over 20 years of experience in the biotechnology industry[9] Other Business Highlights CalciMedica secured a credit agreement for up to $32.5 million with Avenue Venture Opportunities Fund II, L.P. on March 5, 2025, including an initial $10 million funding - On March 5, 2025, CalciMedica entered into a credit agreement for up to $32.5 million with a fund managed by Avenue Capital Group[10] - The 3.5-year credit agreement includes an initial $10 million funding, with an additional $22.5 million available upon achieving specific milestones[10] Financial Results CalciMedica significantly reduced its net loss in FY2024 to $13.7 million from $34.4 million in 2023, driven by decreased R&D and G&A expenses and increased other income 2024 Financial Performance Summary CalciMedica significantly reduced its net loss in FY2024 to $13.7 million from $34.4 million in 2023, driven by decreased R&D and G&A expenses and increased other income 2024 Key Financial Data (in thousands of US dollars) | Metric | 2024 | 2023 | Year-over-Year Change | | :--------------- | :----- | :----- | :-------------------- | | R&D Expenses | 14,478 | 15,859 | (1,381) | | G&A Expenses | 9,726 | 22,216 | (12,490) | | Other Income | 10,504 | 3,718 | 6,786 | | Net Loss | (13,700) | (34,357) | 20,657 | - As of December 31, 2024, cash, cash equivalents, and short-term investments totaled $18.7 million, which, combined with $9.7 million net proceeds from recent debt financing announced in March 2025, is expected to fund operations until mid-2026[11] - R&D expenses decreased by $1.4 million, primarily due to a $3.3 million reduction in one-time personnel costs from the Graybug Vision merger in 2023, partially offset by a $1.3 million increase in chemistry, manufacturing, and control activities for Auxora Phase 2 clinical trials[11] - G&A expenses decreased by $12.5 million, primarily due to a $13.0 million reduction in one-time merger-related personnel costs in 2023[11] - Other income increased by $6.8 million, primarily due to a $9.5 million increase in fair value adjustment of warrant liabilities from a private placement in 2024[11] Consolidated Balance Sheets As of December 31, 2024, total assets increased to $19.794 million, driven by growth in cash and investments, while liabilities rose due to warrant liabilities, and stockholders' equity improved Consolidated Balance Sheet Key Data (in thousands of US dollars) | Metric | December 31, 2024 | December 31, 2023 | | :----------------------- | :---------------- | :---------------- | | Cash and cash equivalents | 7,935 | 5,530 | | Short-term investments | 10,734 | 5,708 | | Total current assets | 19,665 | 11,605 | | Total assets | 19,794 | 12,185 | | Total current liabilities | 3,684 | 4,028 | | Warrant liabilities | 1,700 | — | | Total liabilities | 5,384 | 4,028 | | Total stockholders' equity | 14,410 | 8,157 | Consolidated Statements of Operations The company's net loss significantly narrowed to $13.7 million in FY2024 from $34.357 million in 2023, primarily due to reduced operating expenses and increased other income Consolidated Statements of Operations Key Data (in thousands of US dollars, except per share amounts) | Metric | Year Ended December 31, 2024 | Year Ended December 31, 2023 | | :--------------------------------- | :--------------------------- | :--------------------------- | | Research and development expenses | 14,478 | 15,859 | | General and administrative expenses | 9,726 | 22,216 | | Total operating expenses | 24,204 | 38,075 | | Operating loss | (24,204) | (38,075) | | Change in fair value of financial instruments | 9,490 | 3,168 | | Other income | 1,014 | 550 | | Total other income | 10,504 | 3,718 | | Net loss | (13,700) | (34,357) | | Net loss per share - basic and diluted | (1.22) | (7.66) | | Weighted-average shares used in computing net loss per share | 11,245,915 | 4,486,258 | About CalciMedica CalciMedica is a clinical-stage biopharmaceutical company developing CRAC channel inhibitor therapies to modulate immune responses and protect tissue cells, with Auxora™ showing positive results in trials Company Profile and Product Pipeline CalciMedica is a clinical-stage biopharmaceutical company developing CRAC channel inhibitor therapies to modulate immune responses and protect tissue cells, with Auxora™ showing positive results in trials - CalciMedica focuses on developing CRAC channel inhibitor therapies to modulate immune responses and protect tissue cells from damage, treating life-threatening inflammatory and immunological diseases[12] - The lead candidate Auxora™ has shown positive clinical results in Phase 2b/2 trials for acute pancreatitis (CARPO) and COVID pneumonia (CARDEA)[12] - Currently, Phase 2 KOURAGE trial (for AKI with AHRF, data expected late 2025) and Phase 1/2 CRSPA trial (for pediatric AIPT, updates expected 2025) are ongoing[12] Forward-Looking Statements This report contains forward-looking statements regarding CalciMedica's cash flow, clinical trial timelines, Auxora's potential benefits, and future plans, subject to uncertainties and risks Risks and Uncertainties This report contains forward-looking statements regarding CalciMedica's cash flow, clinical trial timelines, Auxora's potential benefits, and future plans, subject to uncertainties and risks - Forward-looking statements cover the company's cash flow expectations, clinical trial plans and timelines, potential benefits of Auxora, and future financing plans[13] - Actual results may differ materially from forward-looking statements due to uncertainties, risks, and changing circumstances[13] - Risks and uncertainties include global financial market volatility, the company's ability to execute plans, regulatory approvals for Auxora, clinical trial outcomes, potential safety complications, intellectual property protection, and the need for additional capital[13] Contact Information This section provides contact information for CalciMedica's investor relations, managed by Argot Partners Investor Relations Contact This section provides contact information for CalciMedica's investor relations, managed by Argot Partners - Investor Relations contacts: Sarah Sutton/Kevin Murphy (Argot Partners)[15] - Contact email: calcimedica@argotpartners.com, Phone: (212) 600-1902[15]