GRAYBUG VISION(GRAY) - 2024 Q4 - Annual Report

Part I Business CalciMedica, Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutics for inflammatory and immunologic diseases by inhibiting calcium release-activated calcium (CRAC) channels Overview and Pipeline CalciMedica is a clinical-stage biopharmaceutical company developing a new class of drugs that inhibit CRAC channels to treat serious inflammatory and immunologic illnesses - The company focuses on developing therapeutics for serious illnesses driven by inflammatory and immunologic processes, targeting calcium release-activated calcium (CRAC) channels[27] - The company's lead product candidate is Auxora, an intravenous (IV) small molecule CRAC channel inhibitor. It is currently in Phase 2 trials for Acute Kidney Injury (AKI) with AHRF (KOURAGE) and a Phase 1/2 trial for Asparaginase-Induced Pancreatic Toxicity (AIPT) (CRSPA)[29] Product Candidate Pipeline | Product Candidate | Indication | Stage of Development | | :--- | :--- | :--- | | Auxora (IV) | Acute Kidney Injury (AKI) with AHRF | Phase 2 (KOURAGE) | | Auxora (IV) | Acute Pancreatitis (AP) with SIRS | Phase 3 Planned | | Auxora (IV) | Asparaginase-Induced Pancreatic Toxicity (AIPT) | Phase 1/2 (CRSPA) | | Oral CRACi | Chronic Inflammatory & Immunologic Diseases | Preclinical | Clinical Experience with Auxora Auxora has been studied in multiple Phase 2 trials across different acute critical care conditions, consistently showing a reduction in organ damage and time to recovery - In the CARDEA trial (COVID-19 Pneumonia), Auxora showed a statistically significant 56% relative reduction in mortality at 30 days (p=0.016)[34] - In the CARPO trial (Acute Pancreatitis), the medium and high doses of Auxora demonstrated a 100% relative risk reduction in new-onset severe respiratory failure compared to placebo (p=0.0027 for combined high/medium doses vs. combined placebo/low doses)[34][43] Summary of Clinical Experience with Auxora | Trial | Indication | Phase | Year | Key Auxora Result | | :--- | :--- | :--- | :--- | :--- | | CARDEA | COVID-19 Pneumonia | 2 | 2021 | 56% reduction in mortality at 30 days | | CARPO | Acute Pancreatitis | 2b | 2024 | 100% reduction in new-onset severe respiratory failure (high/med dose) | | KOURAGE | Acute Kidney Injury | 2 | Ongoing (exp. 2025) | Primary Endpoint: Days ALIVE, not on VENTILATOR, not on DIALYSIS | Our Science The company's scientific approach targets CRAC channels, which are crucial for calcium signaling in cells - CRAC channels, comprised of STIM1 and Orai1 proteins, are responsible for replenishing cellular calcium stores. In pathological conditions, their overactivation can lead to excessive calcium influx, causing cellular injury or death[51][52] - The company's CRAC channel inhibitors provide a dual mechanism of action: they block direct tissue damage and down-regulate inflammation by acting upstream of multiple pro-inflammatory pathways[61] - Auxora is formulated as an IV lipid nanoemulsion, designed to facilitate rapid delivery to lipophilic organs such as the pancreas, lung, and kidney, which is critical for treating acute illnesses[63] Manufacturing, Commercialization, and Competition CalciMedica does not own manufacturing facilities and relies entirely on contract manufacturing organizations (CMOs) for the production of its product candidates - The company does not own or operate manufacturing facilities and relies on CMOs for all raw materials, drug substance, and drug product needs. It does not have long-term agreements with these third parties[185] - The company has not yet established a commercial organization or distribution capabilities and intends to build an internal infrastructure or collaborate with partners to support sales[181] - Competition comes from large pharmaceutical companies and other biotechs, including some developing CRAC channel inhibitors for various indications. For its lead indication, acute pancreatitis, most competitors focus on symptoms rather than being disease-modifying[186][187][188] Intellectual Property As of December 31, 2024, CalciMedica's intellectual property portfolio includes issued and pending patents in the U.S. and other countries covering compositions of matter, methods of use, formulations, and synthetic processes for Auxora and other product candidates - The company owns four issued U.S. patents and over 60 issued patents worldwide for compositions covering Auxora, with expirations ranging from 2031 to 2036[194] - For methods of using Auxora to treat acute pancreatitis (AP), the company owns two issued U.S. patents and over 30 issued patents worldwide, with expected expirations between 2031-2046[195] Government Regulation CalciMedica is subject to extensive regulation by the FDA in the U.S. and similar authorities abroad - The company's products are subject to extensive regulation by the FDA and other government authorities, covering research, development, manufacturing, and marketing[200] - The FDA drug approval process generally involves preclinical studies, an Investigational New Drug (IND) application, and three phases of human clinical trials to establish safety and efficacy[204][211] - The company has received Fast Track designation from the FDA and orphan drug designation in the EU from the EMA for Auxora for the treatment of acute pancreatitis[43][223][221] Risk Factors The company faces substantial risks, including a history of significant net losses and the need for additional capital to fund operations and clinical trials - The company has a history of net losses, with an accumulated deficit of $159.8 million as of December 31, 2024, and anticipates incurring significant future losses[290] - Substantial additional funding is required to complete development and commercialization. Current resources are expected to fund operations into mid-2026, but are insufficient to get any product candidate through regulatory approval[292][293] - The company's business is highly dependent on the success of its lead product candidate, Auxora, which may fail in development or not receive regulatory approval[311] - The company relies on third parties for manufacturing, preclinical studies, and clinical trials. Failure by these parties to perform adequately could delay development programs[375][384] - The company faces risks of intellectual property challenges, including being unable to obtain and maintain sufficient patent protection, which could allow competitors to develop similar products[459] Cybersecurity CalciMedica has established a cybersecurity risk management program overseen by the Audit Committee of the Board of Directors - The Audit Committee of the Board of Directors is responsible for overseeing the company's cybersecurity risk management processes[552][556] - The company utilizes a third-party information technology consultant to assist management in identifying, assessing, and managing cybersecurity threats[548][549] - A Cybersecurity Incident Response Policy is in place to escalate and manage incidents, involving a team of senior management and the IT consultant[555] Properties The company's corporate headquarters are located in La Jolla, California, where it leases approximately 2,850 square feet of office and laboratory space - CalciMedica leases approximately 2,850 square feet of office and laboratory space for its headquarters in La Jolla, California[557] - The current lease for its facilities expires on December 31, 2025[557] Legal Proceedings As of the report date, CalciMedica believes there is no pending litigation that could, individually or in the aggregate, have a material adverse effect on its financial condition or results of operations - The company currently believes there is no pending litigation that could have a material adverse effect on its financial condition or results of operations[559] Part II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities CalciMedica's common stock is traded on The Nasdaq Capital Market under the ticker symbol "CALC", with approximately 70 holders of record as of March 21, 2025 - The company's common stock trades on The Nasdaq Capital Market under the symbol 'CALC'[562] - As of March 21, 2025, there were approximately 70 holders of record of the common stock[562] - The company has never paid cash dividends and does not intend to in the foreseeable future[563] Management's Discussion and Analysis of Financial Condition and Results of Operations For the year ended December 31, 2024, CalciMedica reported a net loss of $13.7 million, a significant reduction from the $34.4 million net loss in 2023 Results of Operations For the year ended December 31, 2024, CalciMedica's net loss decreased to $13.7 million from $34.4 million in 2023, primarily due to reduced general and administrative expenses Comparison of Results of Operations (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | Change | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $14,478 | $15,859 | $(1,381) | (9%) | | General and administrative | $9,726 | $22,216 | $(12,490) | (56%) | | Total operating expenses | $24,204 | $38,075 | $(13,871) | (36%) | | Loss from operations | $(24,204) | $(38,075) | $13,871 | (36%) | | Other income | $10,504 | $3,718 | $6,786 | 183% | | Net loss | $(13,700) | $(34,357) | $20,657 | (60%) | - The $12.5 million decrease in G&A expenses was primarily due to a $13.0 million reduction in personnel costs. The 2023 figure included one-time charges for acceleration of stock option vesting ($8.6 million) and severance ($4.1 million) related to the merger[598] - The $1.4 million decrease in R&D expenses was mainly due to a $3.3 million decrease in personnel expense, which in 2023 included one-time merger-related charges for stock option vesting ($1.9 million) and severance ($1.6 million). This was partially offset by a $1.3 million increase in manufacturing activities in 2024[596][597] Liquidity and Capital Resources As of December 31, 2024, the company had $18.7 million in cash, cash equivalents, and short-term investments, expected to fund operations into mid-2026 with a new loan - As of December 31, 2024, the company had cash, cash equivalents, and short-term investments of $18.7 million[600] - The company believes its existing cash plus a February 2025 loan will fund operations through certain clinical milestones into the middle of 2026[601] - In February 2025, the company entered into a loan agreement for up to $32.5 million, with an initial tranche of $10.0 million funded at closing[580][611] Cash Flow Summary (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(21,146) | $(25,730) | | Net cash (used in) provided by investing activities | $(4,423) | $8,884 | | Net cash provided by financing activities | $27,974 | $20,900 | | Net increase in cash and cash equivalents | $2,405 | $4,054 | Critical Accounting Estimates The company's critical accounting estimates involve significant management judgment, particularly for the accrual of research and development costs and the valuation of warrants - A key estimate is the accrual for research and development costs, especially for clinical trials, which is based on an evaluation of progress and services provided by vendors like CROs[625] - The valuation of common stock warrants is a critical estimate, calculated using the Black-Scholes model. Changes in assumptions like volatility or the probability of settlement scenarios can significantly impact the fair value and, consequently, the results of operations[628] Financial Statements and Supplementary Data This section presents the audited consolidated financial statements of CalciMedica, Inc. for the fiscal years ended December 31, 2024, and 2023, including auditor reports and notes Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Assets | | | | 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 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $3,684 | $4,028 | | Warrant liability | $1,700 | $— | | Total liabilities | $5,384 | $4,028 | | Total stockholders' equity | $14,410 | $8,157 | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Research and development | $14,478 | $15,859 | | General and administrative | $9,726 | $22,216 | | Loss from operations | $(24,204) | $(38,075) | | Net loss | $(13,700) | $(34,357) | | Net loss per share | $(1.22) | $(7.66) | Controls and Procedures As of December 31, 2024, management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of December 31, 2024[636] - Based on an assessment using the COSO 2013 framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2024[638][639] - No material changes in internal control over financial reporting occurred during the year ended December 31, 2024[640] Other Information The company announced its 2025 Annual Meeting of Stockholders is intended for June 24, 2025, with new deadlines for stockholder proposals due to a date change - The 2025 Annual Meeting of Stockholders is intended to be held on or about June 24, 2025[642] - The deadline for stockholder proposals under Rule 14a-8 for the 2025 Annual Meeting is March 18, 2025[645] Part III Part III of this Annual Report on Form 10-K incorporates information by reference from the company's definitive Proxy Statement for its 2025 Annual Meeting of Stockholders, to be filed by April 30, 2025 Directors, Executive Officers and Corporate Governance Information on directors, executive officers, and corporate governance will be incorporated by reference from the company's 2025 proxy statement - Required information for this item is incorporated by reference from the company's 2025 Proxy Statement[650] - The company has adopted a Code of Conduct and Ethics, available on its website, with disclosures for amendments or waivers for executive officers or directors[651] Executive Compensation Information regarding executive and director compensation will be incorporated by reference from the company's 2025 proxy statement - Required information regarding executive compensation is incorporated by reference from the company's 2025 Proxy Statement[652] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Information detailing security ownership by certain beneficial owners and management, and equity compensation plans, will be incorporated by reference from the company's 2025 proxy statement - Required information regarding security ownership and equity compensation plans is incorporated by reference from the company's 2025 Proxy Statement[653] Certain Relationships and Related Transactions, and Director Independence Information concerning related-party transactions and director independence will be incorporated by reference from the company's 2025 proxy statement - Required information regarding related transactions and director independence is incorporated by reference from the company's 2025 Proxy Statement[654] Principal Accounting Fees and Services Information detailing fees paid to and services provided by the principal independent registered public accounting firm will be incorporated by reference from the company's 2025 proxy statement - Required information regarding principal accountant fees and services is incorporated by reference from the company's 2025 Proxy Statement[655] Part IV Exhibits, Financial Statement Schedules This section lists the financial statements and exhibits filed with the Annual Report, including consolidated financial statements, auditor reports, and a detailed index of exhibits - This item includes the company's consolidated financial statements and the reports of its independent registered public accounting firms[661] - An index of all exhibits filed with the Form 10-K is provided, as required by Item 601 of Regulation S-K[662][659]