Financial Performance - The company reported a net loss of $9.4 million for the nine months ended September 30, 2024, with total operating expenses of $18.0 million [78]. - As of September 30, 2024, the company had an accumulated deficit of $155.5 million and $14.6 million in cash, cash equivalents, and short-term investments [78]. - Net loss for Q3 2024 was $5.6 million, a 22% increase from $4.6 million in Q3 2023 [84]. - The net loss for the nine months ended September 30, 2024 was $9.4 million, a significant improvement from a net loss of $30.2 million for the same period in 2023 [94]. - Cash used in operating activities for the nine months ended September 30, 2024 was $16.2 million, compared to $22.1 million for the same period in 2023 [96]. - Other income for the nine months ended September 30, 2024 was $8.5 million, an increase of $5.0 million compared to $3.5 million for the same period in 2023 [91]. - Total operating expenses for the nine months ended September 30, 2024, were $18.0 million, a decrease of 47% from $33.8 million in the same period of 2023 [88]. Research and Development - The lead product candidate, Auxora, demonstrated a 100% reduction in new onset severe respiratory failure in a Phase 2b trial compared to placebo [76]. - In the CARPO trial, Auxora showed a statistically significant dose response in median time to solid food tolerance and a 64.2% reduction in new onset persistent respiratory failure [76]. - The company plans to initiate a Phase 3 program for Auxora in acute pancreatitis in 2025 following discussions with the FDA [76]. - The KOURAGE trial will evaluate 150 patients with severe acute kidney injury and acute hypoxemic respiratory failure, with results expected in 2025 [77]. - Research and development expenses for Q3 2024 were $3.5 million, an increase of 28% from $2.8 million in Q3 2023 [84]. - Research and development expenses for the nine months ended September 30, 2024, were $10.6 million, a decrease of 19% from $13.1 million in the same period of 2023 [88]. - The company expects research and development expenses to increase as it continues to develop product candidates and seek regulatory approvals [78]. - The company expects research and development expenses to continue increasing as product candidates advance into later stages of clinical development [84]. General and Administrative Expenses - General and administrative expenses for Q3 2024 were $2.2 million, a 6% increase from $2.1 million in Q3 2023 [82]. - General and administrative expenses for the nine months ended September 30, 2024, were $7.4 million, a significant decrease of 64% from $20.7 million in the same period of 2023 [90]. - The company anticipates general and administrative expenses to rise over the next several years to support ongoing research and development and operational activities [82]. Capital and Funding - The company closed the 2024 Follow-On offering of 2,720,000 shares at $3.75 per share, generating gross proceeds of $10.2 million [93]. - Cash provided by financing activities for the nine months ended September 30, 2024 was $19.1 million, primarily from the 2024 Private Placement [98]. - The company expects its current cash and investments, including proceeds from the 2024 Follow-On, to fund operations through certain clinical milestones into the first half of 2026 [93]. - The company will need to raise substantial additional capital to complete the development and commercialization of its product candidates [94]. Legal and Compliance - The company is involved in various legal proceedings, but currently believes there is no pending litigation that could materially adversely affect its financial condition [112]. - There were no changes in the internal control over financial reporting during the quarter ended September 30, 2024, that materially affected the company's financial reporting [109]. - The company is classified as an emerging growth company under the JOBS Act, allowing it to delay adopting new accounting standards until they apply to private companies [103]. - The market value of the company's stock held by non-affiliates is less than $700 million, and its annual revenue is below $100 million, qualifying it as a smaller reporting company [103]. Operational Costs - The company incurs substantial expenses related to clinical trials, with costs estimated based on patient enrollment and contracted amounts, ensuring that accrued expenses are adjusted as actual costs become known [101]. - The company has a lease obligation for office and laboratory space in La Jolla, California, with a monthly rent expense of approximately $10,000, totaling an expected cash requirement of about $30,000 over the next three months [99]. - The company has not experienced any material differences between accrued costs and actual costs incurred since its inception, indicating effective cost estimation practices [101]. Accounting and Valuation - The company utilizes the Black-Scholes model for valuing common warrants, with various scenarios considered to arrive at the final valuation [102]. - The company has adopted recent accounting pronouncements, with potential impacts on its financial condition and results of operations assessed [105]. - The company has entered into contracts with third-party service providers for clinical trials and other services, which are generally terminable upon notice, minimizing non-cancelable obligations [99].
CalciMedica(CALC) - 2024 Q3 - Quarterly Report