Financial Position - The company has an accumulated deficit of $566.5 million as of June 30, 2025, and expects to continue incurring net losses for the foreseeable future [82]. - As of June 30, 2025, the company had cash, cash equivalents, restricted cash, and available-for-sale investments totaling $83.2 million, sufficient to meet material cash requirements for at least one year [82]. - As of June 30, 2025, financing lease liabilities totaled $1.2 million, with $1.7 million in cash collateral included in restricted cash [96]. Revenue and Agreements - The company has generated $20.0 million in upfront and milestone payments under the Kyorin Agreement and is eligible for an additional $155.0 million upon achieving certain milestones [86]. - The Kyorin Agreement has generated $20.0 million in upfront and milestone payments, with potential for an additional $155.0 million upon achieving certain milestones [99]. - License and collaboration agreement revenues were $0 for the six months ended June 30, 2025, a decrease of $235,000 compared to $235,000 in 2024 [111]. Clinical Trials and Development - The EFZO-FIT study for efzofitimod has enrolled 268 subjects, exceeding the target enrollment, with topline data expected in mid-September 2025 [74]. - In the Phase 1b/2a clinical trial, efzofitimod demonstrated consistent dose response on key efficacy endpoints, including improvements in lung function and inflammatory biomarkers compared to placebo [73]. - The company initiated an Individual Patient Expanded Access Program for efzofitimod based on feedback from the EFZO-FIT study participants [75]. - The EFZO-CONNECT study for efzofitimod in patients with systemic sclerosis-associated ILD is designed to evaluate efficacy, safety, and tolerability, with interim data showing significant improvement in three out of four patients [76]. Cash Flow and Expenses - Net cash used in operating activities decreased from $42.8 million in 2024 to $29.3 million in 2025, primarily due to timing of efzofitimod manufacturing payments [87]. - Net cash provided by financing activities increased from $21.1 million in 2024 to $36.5 million in 2025, mainly from $36.7 million in net proceeds from common stock issuance [89]. - Research and development expenses rose to $15.4 million in Q2 2025 from $14.0 million in Q2 2024, driven by increased manufacturing costs for potential BLA filing [107]. - General and administrative expenses increased to $4.9 million in Q2 2025 from $3.3 million in Q2 2024, primarily due to higher personnel and pre-commercialization costs [108]. - Total research and development expenses were $27.2 million for the six months ended June 30, 2025, slightly down from $27.3 million in 2024, reflecting a decrease in EFZO-FIT expenses [112]. - General and administrative expenses increased to $8.9 million for the six months ended June 30, 2025, up from $6.8 million in 2024, primarily due to higher personnel and pre-commercialization costs [113]. - Other income (expense), net decreased to $0.8 million for the three months ended June 30, 2025, from $1.0 million in the same period in 2024, primarily due to lower interest income [109]. - Other income, net was $1.7 million for the six months ended June 30, 2025, down from $2.2 million in 2024, attributed to lower interest income [114]. Future Expectations - The company has not generated any revenues from product sales to date and expects expenses to rise as it advances efzofitimod in clinical development [90]. - The company anticipates increased research and development expenses as it progresses towards the commercialization of efzofitimod [102]. - Research and development expenses are expected to increase as the company advances toward the potential commercialization of efzofitimod [112]. - General and administrative expenses are also expected to rise due to ongoing pre-commercialization costs for efzofitimod [113].
aTyr Pharma, Inc.(ATYR) - 2025 Q2 - Quarterly Report