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 2024[167]. - 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]. - 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 an increase in expenses of $8.7 million[173]. - Cash used in operating activities was $16.3 million for the nine months ended September 30, 2025, primarily due to the net loss and non-cash items totaling $2.2 million[192]. - The company has experienced significant operating losses since inception, except for the three-month period ending March 31, 2024[190]. 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 its cash resources may not be sufficient to fund operations beyond the second half of 2026, indicating substantial doubt about its ability to continue as a going concern[176]. - The company will need to raise substantial additional capital to complete the development and commercialization of its product candidates[177]. - The company expects to finance future cash requirements through a combination of existing cash, equity offerings, and debt financing, but there is no assurance that additional capital can be raised[182]. - The company entered into a Loan Agreement for initial gross proceeds of $10.0 million on February 28, 2025[175]. - Cash provided by financing activities for the nine months ended September 30, 2025, was $11.5 million, primarily from debt financing of $9.7 million[195]. - The company entered into a Loan Agreement for growth capital loans totaling up to $32.5 million, with the first tranche of $10 million funded on the closing date[189]. 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 time to recovery in patients[141]. - The company anticipates significant increases in research and development expenses as it continues to advance its product candidates and seek regulatory approvals[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 not generated any product revenue and does not expect to do so until successful development and regulatory approval of its product candidates[153]. - The company has paused IND enabling preclinical work on certain compounds to focus resources on clinical programs, pending additional funding[142]. Regulatory and Compliance - 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 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 in the most recently completed fiscal year[208]. Accounting and Estimates - 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 or scope[203]. - The fair value of the promissory note is estimated using a 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 based on updated assumptions[206]. - The company records estimated research and development costs based on services provided but not yet invoiced, impacting accrued liabilities and expenses[201]. - The company capitalizes payments made prior to receiving goods or services for research and development until they are received[201]. - The company utilizes estimates for accrued liabilities and prepaid expenses, adjusting them as actual costs become known[202]. - No recently adopted accounting pronouncements were reported, indicating stability in accounting practices[209].
CalciMedica(CALC) - 2025 Q3 - Quarterly Report