Table of Contents As filed with the Securities and Exchange Commission on November 13, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Grayscale Investments, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 6221 39-2149041 (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) 290 Harbor Drive, 4th Floor Stamf ...

Financial Performance - The company reported a net loss of $18.8 million for the nine months ended September 30, 2025, with total operating expenses of $18.7 million and interest expense of $1.1 million[151]. - Net loss for the three months ended September 30, 2025, was $7.8 million, a 39% increase from a net loss of $5.6 million in the same period of 2024[167]. - The company has incurred a net loss of $18.8 million for the nine months ended September 30, 2025, compared to a net loss of $9.4 million for the same period in 2024[190]. - Other income (expense) for the nine months ended September 30, 2025, was an expense of $0.1 million, compared to income of $8.6 million in 2024, reflecting a significant increase in expenses[173]. - Cash used in operating activities was $16.3 million for the nine months ended September 30, 2025, primarily due to operating expenses[192]. - Total operating expenses for the nine months ended September 30, 2025, were $18.7 million, a 4% increase from $18.0 million in 2024[171]. Cash and Funding - As of September 30, 2025, the company had an accumulated deficit of $178.6 million and $14.1 million in cash, cash equivalents, and short-term investments, which are expected to fund operations into the second half of 2026[151]. - The company expects to need substantial additional capital to fund product candidates through regulatory approval and to support ongoing operations[176]. - The company expects to finance future cash requirements through a combination of existing cash, equity offerings, and debt financing[182]. - The company raised gross proceeds of $20.4 million from a private placement transaction in January 2024, with net proceeds of approximately $19.0 million after transaction costs[146]. - An underwritten public offering in November 2024 generated gross proceeds of $10.2 million from the sale of 2,720,000 shares of common stock[147]. - Cash provided by financing activities for the nine months ended September 30, 2025, was $11.5 million, primarily from debt financing[195]. - The company has entered into a Loan Agreement for growth capital loans totaling up to $32.5 million, with the first tranche of $10 million funded on February 28, 2025[150]. - The company has a lease obligation with a monthly rent expense of approximately $10,500, expecting cash requirements of about $32,000 over the next three months[197]. Research and Development - The company has conducted multiple Phase 2 clinical trials for its lead product candidate, Auxora, demonstrating a reduction in organ damage and recovery time in patients[141]. - The company expects to finalize the pivotal trial design for Auxora in acute pancreatitis in the first half of 2026, following positive engagement with the FDA[141]. - The company expects research and development expenses to increase substantially as it continues to invest in clinical trials and regulatory approvals for its product candidates[158]. - Research and development expenses increased by 9% to $3.9 million for the three months ended September 30, 2025, compared to $3.6 million for the same period in 2024[168]. - Research and development expenses for the nine months ended September 30, 2025, were $12.1 million, a 14% increase from $10.6 million in 2024[171]. - The company has paused IND enabling preclinical work on certain compounds to focus resources on clinical programs, pending additional funding[142]. - The company anticipates substantial additional funding will be required to support ongoing clinical trials and commercialization efforts[181]. Going Concern - The company has substantial doubt about its ability to continue as a going concern, as current financial resources may not be sufficient to fund operations into the second half of 2026[176]. - The company has experienced significant operating losses since inception, except for the three-month period ending March 31, 2024[190]. Accounting and Estimates - The company is classified as an emerging growth company and will cease this status on December 31, 2025, allowing it to delay adopting new accounting standards until then[207]. - The company is also a smaller reporting company, with a market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million[208]. - The company has not experienced material differences between accrued costs and actual costs incurred since inception, indicating effective cost estimation practices[202]. - Clinical trial expenses are accrued based on patient enrollment and contracted amounts, with adjustments made for changes in trial protocols[203]. - The fair value of the promissory note is estimated using discounted cash flow analysis, with updates to assumptions potentially impacting results significantly[205]. - Common warrants are valued using the Black-Scholes model, with various scenarios considered that could affect fair value[206]. - The company has not adopted any new accounting pronouncements recently[209]. - The company estimates research and development costs based on the work completed and budget provided, adjusting accrued liabilities as actual costs are known[202]. - The company utilizes estimates for clinical trial costs, which are complicated by the diverse nature of services and lack of timely information[201]. - The company records estimated research and development costs in accrued liabilities and adjusts these as necessary based on actual expenses incurred[202].

Financial Position - Cash position as of September 30, 2025, was $14.1 million, expected to fund operations into the second half of 2026[8] - Total current assets decreased to $14.9 million as of September 30, 2025, from $19.7 million as of December 31, 2024[19] - Total liabilities increased to $15.2 million as of September 30, 2025, compared to $5.4 million as of December 31, 2024[19] Research and Development - Research and development expenses for Q3 2025 were $3.9 million, an increase of 8.3% from $3.6 million in Q3 2024[10] - Research and development expenses increased to $3,851 million in Q3 2025 from $3,546 million in Q3 2024, representing an increase of 8.6%[21] - Enrollment ongoing in Phase 2 KOURAGE trial with a target of 150 patients, data expected in the first half of 2026[4] - Positive discussions with the FDA regarding the pivotal trial design in acute pancreatitis, expected to finalize in the first half of 2026[9] - Collaboration with Telperian announced to leverage AI insights for optimizing the pivotal trial design in acute pancreatitis[9] - Preclinical data published in JCI Insight supports CM5480 as a potential first-in-class therapy for pulmonary arterial hypertension[7] Operating Expenses - General and administrative expenses decreased to $1.8 million in Q3 2025 from $2.2 million in Q3 2024, a reduction of 18.2%[11] - General and administrative expenses decreased to $1,767 million in Q3 2025 from $2,190 million in Q3 2024, a reduction of 19.3%[21] - Total operating expenses slightly decreased to $5,618 million in Q3 2025 compared to $5,736 million in Q3 2024, a decline of 2.1%[21] Net Loss - Net loss for Q3 2025 was $7.8 million, or $0.52 per share, compared to a net loss of $5.6 million, or $0.50 per share, in Q3 2024[13] - The net loss for Q3 2025 was $7,804 million, compared to a net loss of $5,618 million in Q3 2024, indicating an increase in losses of 38.8%[21] - Net loss per share for Q3 2025 was $0.52, compared to $0.50 in Q3 2024, reflecting a 4% increase in loss per share[21] - The total net loss for the nine months ended September 30, 2025, was $18,802 million, compared to $9,442 million for the same period in 2024, reflecting a 98.5% increase in losses[21] Other Income and Expenses - Interest income decreased to $140 million in Q3 2025 from $218 million in Q3 2024, a decline of 35.8%[21] - Total other income (expense) for Q3 2025 was $(2,186) million, compared to $118 million in Q3 2024, indicating a significant negative shift[21] - The change in fair value of financial instruments resulted in a loss of $2,000 million in Q3 2025, compared to a loss of $100 million in Q3 2024[21] Shareholder Information - The weighted-average number of shares outstanding increased to 15,076,456 in Q3 2025 from 11,134,964 in Q3 2024, an increase of 35.5%[21]

Financial Performance - The company reported a net loss of $11.0 million for the six months ended June 30, 2025, with total operating expenses of $13.1 million[153]. - Net loss for Q2 2025 was $5.96 million, representing a 51% increase compared to a net loss of $3.95 million in Q2 2024[169]. - Total operating expenses for the first half of 2025 were $13.12 million, an increase of 7% from $12.30 million in the first half of 2024[173]. - Research and development expenses for the first half of 2025 rose by 17% to $8.28 million, compared to $7.10 million in the first half of 2024[173]. - Other income for Q2 2025 was $0.67 million, a significant decrease of 74% from $2.58 million in Q2 2024[172]. - Other income for the first half of 2025 was $2.12 million, down 75% from $8.47 million in the first half of 2024[175]. - Cash used in operating activities was $11.5 million for the six months ended June 30, 2025, primarily due to the net loss and changes in operating assets and liabilities[194]. - The company has experienced significant operating losses since inception, except for a brief period ending March 31, 2024[192]. Cash and Capital Resources - As of June 30, 2025, the company had an accumulated deficit of $170.8 million and $18.0 million in cash, cash equivalents, and short-term investments[153]. - The company expects to fund its current operating plan into the middle of 2026 with existing cash resources[153]. - The company anticipates needing to raise substantial additional capital to fund product candidates through regulatory approval and further clinical work[178]. - There is substantial doubt about the company's ability to continue as a going concern without additional financing[178]. - The company expects to finance future cash requirements through existing cash, equity offerings, and debt financing, but additional capital raising cannot be assured[183]. - Cash provided by financing activities for the six months ended June 30, 2025, was $10.6 million, primarily from debt financing[197]. - The company raised gross proceeds of $20.4 million from a private placement transaction in January 2024, with net proceeds of approximately $19.0 million after transaction costs[149]. - The company closed an underwritten public offering of 2,720,000 shares at a price of $3.75 per share, generating gross proceeds of $10.2 million[150]. - The company entered into a Loan and Security Agreement for growth capital loans totaling up to $32.5 million, with $10 million funded on the closing date[152]. - The company entered into a Loan Agreement for growth capital loans totaling up to $32.5 million, with specific tranches subject to achieving milestones[189]. - The company filed a Shelf Registration Statement allowing for the offering of up to $100.0 million in various securities, including common stock[184]. Research and Development - The company has conducted multiple Phase 2 clinical trials for its lead product candidate, Auxora, showing a reduction in organ damage and recovery time in treated patients[145]. - The company anticipates data from a Phase 2 trial for acute kidney injury with associated acute hypoxemic respiratory failure in early 2026[145]. - The company expects research and development expenses to increase substantially as it continues to invest in clinical trials and regulatory approvals[159]. - Research and development expenses for Q2 2025 were $4.1 million, a decrease of 3% from $4.2 million in Q2 2024[170]. - The company incurs substantial expenses related to clinical trials, with costs estimated based on the number of services provided but not yet invoiced[203]. - The company has not experienced any material differences between accrued costs and actual costs incurred since its inception[204]. - Clinical trial expenses are accrued based on contracted amounts applied to patient enrollment and activity levels[205]. Company Classification and Accounting - The company is classified as an emerging growth company and will cease this status on December 31, 2025[209]. - The company qualifies as a smaller reporting company, with a market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million[210]. - As a smaller reporting company, the company may present only the two most recent fiscal years of audited financial statements in its Annual Report[210]. - No recently adopted accounting pronouncements were noted[211]. - The company is not required to provide market risk disclosures due to its smaller reporting company status[213]. Lease Obligations - The company has a lease obligation with a monthly rent expense of approximately $10,000, which is expected to total approximately $63,000 over the next six months[198][199].

Financial Position - Cash position as of June 30, 2025, was $18.0 million, expected to fund operations into mid-2026[7] - Total assets as of June 30, 2025, were $19.1 million, a decrease from $19.8 million at the end of 2024[16] Research and Development - Research and development expenses for Q2 2025 were $4.1 million, a slight decrease from $4.2 million in Q2 2024[7] - Enrollment ongoing in the Phase 2 KOURAGE trial of Auxora™ for acute kidney injury (AKI) with respiratory failure, targeting 150 patients with data expected in early 2026[4] - Initial meeting with the FDA regarding Auxora in acute pancreatitis (AP) was productive, with alignment on a pivotal trial anticipated around the end of 2025[3] - The company presented a symposium on Auxora for AKI at the 43rd Vicenza Course in June 2025, highlighting its clinical significance[8] - The manuscript published in the American Journal of Nephrology supports Auxora's potential as a treatment for AKI[4] Financial Performance - Net loss for Q2 2025 was $6.0 million, or $0.40 per share, compared to a net loss of $4.0 million, or $0.36 per share, in Q2 2024[10] - Total operating expenses for Q2 2025 were $6.6 million, compared to $6.5 million in Q2 2024[18] - Other income for Q2 2025 was $0.7 million, down from $2.6 million in Q2 2024, primarily due to a decrease in fair value adjustments[10]

Financial Performance - The company reported a net loss of $5.0 million for the three months ended March 31, 2025, with total operating expenses of $6.5 million and interest expense of $0.4 million[144]. - Net loss for the three months ended March 31, 2025, was $5.0 million, compared to a net income of $0.1 million in the same period of 2024, representing a 3978% decrease[158]. - Other income decreased to $1.5 million for the three months ended March 31, 2025, down 75% from $5.9 million in the same period of 2024[161]. - Cash used in operating activities for the three months ended March 31, 2025 was $4.9 million, primarily due to cash outlays for operations[179]. - The company has had significant operating losses since inception, except for the three-month period ending March 31, 2024, where it reported a net income of $0.1 million[177]. Cash and Investments - As of March 31, 2025, the company had an accumulated deficit of $164.8 million and $24.6 million in cash, cash equivalents, and short-term investments[144]. - Cash, cash equivalents, and short-term investments totaled $24.6 million as of March 31, 2025[162]. - Cash provided by financing activities for the three months ended March 31, 2025 was $10.8 million, comprised of debt financing of $9.8 million and $1.0 million from the ATM[182]. - Cash used in investing activities for the three months ended March 31, 2025 was $1.2 million, consisting of the purchase of short-term investments[181]. - The Company expects cash requirements for its lease obligation to be approximately $95,000 over the next nine months[183]. Funding and Capital - The company raised gross proceeds of $20.4 million from a private placement transaction in January 2024, with net proceeds of approximately $19.0 million after deducting $1.4 million in commissions and other transaction costs[140]. - The company closed an underwritten public offering of 2,720,000 shares at a price of $3.75 per share, generating gross proceeds of $10.2 million on November 1, 2024[141]. - The company entered into a Loan Agreement for growth capital loans totaling up to $32.5 million, with $10 million funded on February 28, 2025[143]. - The company entered into a Loan Agreement for an initial $10.0 million of gross proceeds on February 28, 2025[163]. - The company filed a Shelf Registration Statement in August 2023 for the offering of up to $100.0 million in various securities[170]. Research and Development - The company has paused IND enabling preclinical work on several product candidates to focus resources on clinical programs, pending additional funding[137]. - The company expects to continue incurring net losses for the foreseeable future, with research and development expenses anticipated to increase substantially[145]. - The company has not generated any product revenue and does not expect to do so until successful development and regulatory approval of its product candidates[146]. - Research and development expenses increased to $4.2 million for the three months ended March 31, 2025, up 43% from $2.9 million in the same period of 2024[159]. - The company is currently conducting a Phase 2 trial for Auxora in acute kidney injury, with data expected around the end of 2025[136]. - The company has conducted multiple Phase 2 clinical trials for Auxora, showing a reduction in organ damage and time to recovery in treated patients[136]. Operating Expenses - Total operating expenses for the three months ended March 31, 2025, were $6.5 million, a 13% increase from $5.8 million in the same period of 2024[158]. - General and administrative expenses decreased to $2.3 million for the three months ended March 31, 2025, down 19% from $2.8 million in the same period of 2024[160].

[CalciMedica First Quarter 2025 Financial Results and Corporate Updates](index=1&type=section&id=CalciMedica%20Reports%20First%20Quarter%202025%20Financial%20Results%20and%20Provides%20Clinical%20%26%20Corporate%20Updates) [Recent Clinical & Corporate Highlights](index=1&type=section&id=Recent%20Clinical%20%26%20Corporate%20Highlights) 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](index=1&type=chunk)[4](index=4&type=chunk) - 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](index=1&type=chunk)[5](index=5&type=chunk) - 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](index=1&type=chunk)[3](index=3&type=chunk)[8](index=8&type=chunk) [Acute Kidney Injury (AKI) Program Update](index=1&type=section&id=Acute%20Kidney%20Injury%20%28AKI%29%20Program%20Update) 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](index=4&type=chunk) - 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](index=5&type=chunk) - 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](index=5&type=chunk) [Acute Pancreatitis (AP) Program Update](index=2&type=section&id=Acute%20Pancreatitis%20%28AP%29%20Program%20Update) 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](index=10&type=chunk) - 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](index=10&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) 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](index=7&type=chunk) - On March 5, 2025, the company secured a credit facility providing up to **$32.5 million**, with an initial **$10 million** funded immediately[8](index=8&type=chunk) [Financial Results for the Three Months Ended March 31, 2025](index=2&type=section&id=Financial%20Results%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202025) 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](index=11&type=chunk) 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](index=5&type=section&id=Financial%20Statements) 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](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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** |

Part I [Business](index=10&type=section&id=Item%201.%20Business) 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](index=10&type=section&id=Item%201.%20Business-Overview%20and%20Pipeline) 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](index=27&type=chunk) - 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](index=29&type=chunk) 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](index=12&type=section&id=Item%201.%20Business-Clinical%20Experience%20with%20Auxora) 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](index=34&type=chunk) - 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](index=34&type=chunk)[43](index=43&type=chunk) 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](index=18&type=section&id=Item%201.%20Business-Our%20Science) 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](index=51&type=chunk)[52](index=52&type=chunk) - 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](index=61&type=chunk) - 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](index=63&type=chunk) [Manufacturing, Commercialization, and Competition](index=58&type=section&id=Item%201.%20Business-Manufacturing,%20Commercialization,%20and%20Competition) 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](index=185&type=chunk) - 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](index=181&type=chunk) - 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](index=186&type=chunk)[187](index=187&type=chunk)[188](index=188&type=chunk) [Intellectual Property](index=62&type=section&id=Item%201.%20Business-Intellectual%20Property) 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](index=194&type=chunk) - 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](index=195&type=chunk) [Government Regulation](index=62&type=section&id=Item%201.%20Business-Government%20Regulation) 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](index=200&type=chunk) - 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](index=204&type=chunk)[211](index=211&type=chunk) - 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](index=43&type=chunk)[223](index=223&type=chunk)[221](index=221&type=chunk) [Risk Factors](index=89&type=section&id=Item%201A.%20Risk%20Factors) 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](index=290&type=chunk) - 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](index=292&type=chunk)[293](index=293&type=chunk) - 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](index=311&type=chunk) - 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](index=375&type=chunk)[384](index=384&type=chunk) - 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](index=459&type=chunk) [Cybersecurity](index=142&type=section&id=Item%201C.%20Cybersecurity) 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](index=552&type=chunk)[556](index=556&type=chunk) - The company utilizes a **third-party information technology consultant** to assist management in identifying, assessing, and managing cybersecurity threats[548](index=548&type=chunk)[549](index=549&type=chunk) - A **Cybersecurity Incident Response Policy** is in place to escalate and manage incidents, involving a team of senior management and the IT consultant[555](index=555&type=chunk) [Properties](index=143&type=section&id=Item%202.%20Properties) 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](index=557&type=chunk) - The current lease for its facilities expires on **December 31, 2025**[557](index=557&type=chunk) [Legal Proceedings](index=144&type=section&id=Item%203.%20Legal%20Proceedings) 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](index=559&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=145&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) 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](index=562&type=chunk) - As of **March 21, 2025**, there were approximately **70 holders of record** of the common stock[562](index=562&type=chunk) - The company has never paid cash dividends and does not intend to in the foreseeable future[563](index=563&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=146&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=150&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations-Results%20of%20Operations) 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](index=598&type=chunk) - 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](index=596&type=chunk)[597](index=597&type=chunk) [Liquidity and Capital Resources](index=151&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations-Liquidity%20and%20Capital%20Resources) 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](index=600&type=chunk) - The company believes its existing cash plus a **February 2025 loan** will fund operations through certain clinical milestones into the **middle of 2026**[601](index=601&type=chunk) - 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](index=580&type=chunk)[611](index=611&type=chunk) 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](index=155&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations-Critical%20Accounting%20Estimates) 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](index=625&type=chunk) - 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](index=628&type=chunk) [Financial Statements and Supplementary Data](index=157&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) 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](index=157&type=section&id=Item%209A.%20Controls%20and%20Procedures) 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](index=636&type=chunk) - 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](index=638&type=chunk)[639](index=639&type=chunk) - **No material changes** in internal control over financial reporting occurred during the year ended December 31, 2024[640](index=640&type=chunk) [Other Information](index=158&type=section&id=Item%209B.%20Other%20Information) 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](index=642&type=chunk) - The deadline for stockholder proposals under **Rule 14a-8** for the 2025 Annual Meeting is **March 18, 2025**[645](index=645&type=chunk) 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](index=159&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) 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](index=650&type=chunk) - 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](index=651&type=chunk) [Executive Compensation](index=159&type=section&id=Item%2011.%20Executive%20Compensation) 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](index=652&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=159&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) 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](index=653&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=159&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) 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](index=654&type=chunk) [Principal Accounting Fees and Services](index=159&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) 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](index=655&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=160&type=section&id=Item%2015.%20Exhibits,%20Financial%20Statement%20Schedules) 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](index=661&type=chunk) - An index of all exhibits filed with the Form 10-K is provided, as required by **Item 601 of Regulation S-K**[662](index=662&type=chunk)[659](index=659&type=chunk)

[Executive Summary](index=1&type=section&id=Executive%20Summary) 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](index=1&type=section&id=Company%20Introduction) 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](index=2&type=chunk) [Key Highlights & CEO Statement](index=1&type=section&id=Key%20Highlights%20%26%20CEO%20Statement) 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](index=1&type=chunk)[3](index=3&type=chunk) - 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](index=1&type=chunk)[3](index=3&type=chunk) - The company anticipates its existing cash position will support operations until **mid-2026**[1](index=1&type=chunk)[3](index=3&type=chunk) [Clinical & Corporate Updates](index=1&type=section&id=Clinical%20%26%20Corporate%20Updates) 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](index=1&type=section&id=Clinical%20Program%20Updates) 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](index=1&type=section&id=Acute%20Kidney%20Injury%20(AKI)%20Program%20Update) 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](index=4&type=chunk) - 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](index=8&type=chunk) 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](index=2&type=section&id=Acute%20Pancreatitis%20(AP)%20Program%20Update) 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](index=8&type=chunk) - 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](index=8&type=chunk) [Asparaginase-induced Pancreatic Toxicity (AIPT) Program Update](index=2&type=section&id=Asparaginase-induced%20Pancreatic%20Toxicity%20(AIPT)%20Program%20Update) 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](index=6&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) 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](index=9&type=chunk) - 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](index=9&type=chunk) [Other Business Highlights](index=3&type=section&id=Other%20Business%20Highlights) 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](index=10&type=chunk) - The **3.5-year** credit agreement includes an initial **$10 million** funding, with an additional **$22.5 million** available upon achieving specific milestones[10](index=10&type=chunk) [Financial Results](index=3&type=section&id=Financial%20Results) 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](index=3&type=section&id=2024%20Financial%20Performance%20Summary) 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](index=11&type=chunk) - 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](index=11&type=chunk) - 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](index=11&type=chunk) - 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](index=11&type=chunk) [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) 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](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) 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](index=4&type=section&id=About%20CalciMedica) 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](index=4&type=section&id=Company%20Profile%20and%20Product%20Pipeline) 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](index=12&type=chunk) - The lead candidate Auxora™ has shown positive clinical results in Phase 2b/2 trials for acute pancreatitis (CARPO) and COVID pneumonia (CARDEA)[12](index=12&type=chunk) - 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](index=12&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) 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](index=4&type=section&id=Risks%20and%20Uncertainties) 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](index=13&type=chunk) - Actual results may differ materially from forward-looking statements due to uncertainties, risks, and changing circumstances[13](index=13&type=chunk) - 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](index=13&type=chunk) [Contact Information](index=5&type=section&id=Contact%20Information) This section provides contact information for CalciMedica's investor relations, managed by Argot Partners [Investor Relations Contact](index=5&type=section&id=Investor%20Relations%20Contact) This section provides contact information for CalciMedica's investor relations, managed by Argot Partners - Investor Relations contacts: Sarah Sutton/Kevin Murphy (Argot Partners)[15](index=15&type=chunk) - Contact email: calcimedica@argotpartners.com, Phone: (212) 600-1902[15](index=15&type=chunk)

FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Commission File Number 001-39538 CalciMedica, Inc. (Exact name of Registrant as specified in its Charter) Delaware 45-2120079 (State or other jurisdict ...