Financial Position - The company has an accumulated deficit of $499.8 million as of June 30, 2024, and expects to continue incurring net losses for the foreseeable future[78]. - As of June 30, 2024, the company had cash, cash equivalents, restricted cash, and available-for-sale investments totaling $81.4 million, sufficient to meet material cash requirements for at least one year[78]. - Net cash used in operating activities for the six months ended June 30, 2024, was $42.8 million, compared to $12.6 million for the same period in 2023, primarily due to increased clinical study costs[83]. - Net cash provided by investing activities for the six months ended June 30, 2024, was $5.4 million, a significant improvement from $(42.3) million in 2023[84]. - Net cash provided by financing activities for the six months ended June 30, 2024, was $21.1 million, down from $57.5 million in 2023, mainly due to reduced proceeds from stock offerings[85]. - As of June 30, 2024, the company has $1.7 million in financing lease liabilities and $2.2 million in cash collateral for the financing lease[91]. Fundraising Activities - The company completed a public offering in February 2023, raising approximately $48.1 million from the sale of 23,125,000 shares at $2.25 per share[80]. - Under the Jefferies ATM Offering Program, the company sold 10,530,795 shares at an average price of $1.82 per share, generating net proceeds of approximately $18.4 million in 2023[81]. - Kyorin triggered a $10.0 million milestone payment for dosing the first patient in Japan in the EFZO-FIT study, recorded as revenue in 2022[82]. - Total milestone payments from the Kyorin Agreement to date amount to $20.0 million, with potential additional payments of up to $155.0 million upon achieving specific milestones[82]. Research and Development - The company initiated a global pivotal Phase 3 clinical trial (EFZO-FIT study) for efzofitimod, enrolling 268 patients, with topline data expected in Q3 2025[69]. - The EFZO-CONNECT study for efzofitimod in patients with systemic sclerosis-associated ILD is designed to enroll up to 25 patients, with interim data expected in Q2 2025[71]. - The company is developing additional tRNA synthetase candidates, including ATYR0101 and ATYR0750, targeting fibrosis and inflammation[75][76]. - The company expects research and development expenses to continue increasing, primarily for the clinical development of efzofitimod and other potential therapeutics[96]. - Research and development expenses increased to $14.0 million for the three months ended June 30, 2024, up from $9.8 million in 2023, representing a $4.1 million increase[100]. - Efzofitimod expenses accounted for $11.3 million in the three months ended June 30, 2024, compared to $6.8 million in 2023, reflecting a $4.5 million increase due to advancements in the EFZO-FIT study[100]. - Total research and development expenses for the six months ended June 30, 2024, were $27.3 million, an increase of $8.1 million from $19.2 million in 2023[103]. - Efzofitimod expenses for the six months ended June 30, 2024, were $22.3 million, up from $13.2 million in 2023, marking a $9.1 million increase[103]. Revenue and Expenses - The company has not generated any revenues from product sales to date and anticipates increased expenses related to ongoing clinical development and potential commercialization efforts[86]. - License and collaboration agreement revenues were $0.2 million for the six months ended June 30, 2024, with no revenues reported in the same period of the prior year[102]. - General and administrative expenses decreased to $3.3 million for the three months ended June 30, 2024, down from $3.7 million in 2023, a reduction of $0.4 million[101]. - General and administrative expenses for the six months ended June 30, 2024, were $6.8 million, a decrease of $0.3 million from $7.1 million in 2023[104]. - Other income, net for the six months ended June 30, 2024, was $2.2 million, compared to $2.1 million in 2023, showing a slight increase[105]. - Non-cash expenses related to research and development increased to $0.6 million for the three months ended June 30, 2024, from $0.5 million in 2023[101]. - Non-cash expenses for general and administrative purposes increased to $1.2 million for the six months ended June 30, 2024, from $1.0 million in 2023[104]. Market and Operational Considerations - The company continues to monitor macroeconomic uncertainties that may impact its operations and financial performance[77]. - The company has no sales or marketing capabilities and will need to expand its organization to support commercialization activities[86]. - The company has a lease agreement for approximately 24,866 rentable square feet with a base rent starting at $5.75 per square foot, subject to annual adjustments[90].
aTyr Pharma, Inc.(ATYR) - 2024 Q2 - Quarterly Report