Sionna Therapeutics Inc(SION) - 2025 Q3 - Quarterly Report

Financial Performance - The company reported net losses of $54.8 million and $45.8 million for the nine months ended September 30, 2025, and 2024, respectively, with an accumulated deficit of $235.9 million as of September 30, 2025[85]. - For the three months ended September 30, 2025, total operating expenses decreased by $4.2 million to $23.8 million from $27.9 million in the same period of 2024[106]. - Research and development expenses decreased by $8.5 million to $16.0 million for the three months ended September 30, 2025, primarily due to a decrease in unallocated research and development expenses[107]. - For the nine months ended September 30, 2025, total operating expenses increased by $12.9 million to $65.4 million from $52.4 million in the same period of 2024[111]. - General and administrative expenses increased by $10.9 million to $20.3 million for the nine months ended September 30, 2025, primarily due to increased personnel-related expenses[114]. - Net cash used in operating activities was $49.7 million for the nine months ended September 30, 2025, primarily due to a net loss of $54.8 million[122]. - Interest income increased by $1.1 million to $3.5 million for the three months ended September 30, 2025, driven by increased investment in debt securities[109]. - Interest income increased by $4.0 million to $10.1 million for the nine months ended September 30, 2025, primarily due to increased investment in debt securities[117]. Funding and Capital - The company has raised aggregate net proceeds of $330.4 million from the sale and issuance of preferred stock since its inception in 2019, and $199.6 million from its IPO in February 2025[84]. - Net cash provided by financing activities was $204.1 million during the nine months ended September 30, 2025, primarily due to net proceeds from the IPO[126]. - The company expects existing cash and marketable securities to fund operations into 2028, but will need to raise additional capital in the future[127]. - As of September 30, 2025, the company had $325.0 million in cash, cash equivalents, and marketable securities[120]. Research and Development - The company anticipates that its research and development expenses will increase substantially as it advances its product candidates into later-stage development efforts[96]. - The company has initiated a Phase 2a trial for SION-719 in CF patients, with topline data expected in mid-2026[81]. - The company in-licensed three clinical-stage compounds from AbbVie to expand its portfolio, including galicaftor (SION-2222) which has completed Phase 2 trials[82]. - The company is currently engaged in discovery, preclinical studies, and clinical trials for its product candidates, with ongoing assessments of costs and timelines[129]. Regulatory and Compliance - The company has not generated any revenue to date and does not expect to do so for several years, if ever, pending regulatory approvals for its product candidates[88]. - The company expects general and administrative expenses to increase to support research and development activities and compliance with public company reporting[101]. - The company is classified as an "emerging growth company" and may utilize certain exemptions from reporting requirements until it no longer meets the criteria[136]. - The company will remain an emerging growth company until it achieves total annual gross revenue of at least $1.235 billion or meets other specified conditions[136]. - The company is also classified as a "smaller reporting company," allowing it to take advantage of scaled disclosures until certain revenue and market capitalization thresholds are met[138]. Risks and Uncertainties - The company may face negative impacts on its financial condition if it fails to raise additional funds or enter into strategic agreements[130]. - The company has the potential to delay or limit product development if it is unable to secure additional funding[131]. - The company is required to make estimates and assumptions that affect the reported amounts in its financial statements, which may differ from actual results[133]. - The company has elected to use an extended transition period for complying with new accounting standards, which may affect comparability with other public companies[136]. - There were no material changes to the company's critical accounting estimates during the nine months ended September 30, 2025[134]. - There were no material changes to the company's contractual obligations and commitments during the nine months ended September 30, 2025[132].