aTyr Pharma(LIFE)2022-11-14 13:18Financial Position - The company reported an accumulated deficit of $410.1 million as of September 30, 2022, compared to $372.3 million as of December 31, 2021[87]. - Cash, cash equivalents, restricted cash, and available-for-sale investments totaled $79.6 million as of September 30, 2022, down from $107.9 million as of December 31, 2021[87]. - As of September 30, 2022, the company has material cash requirements primarily related to its operating lease and financing lease agreements, totaling significant ongoing obligations[102]. - The company anticipates financing its cash needs through equity offerings, grant funding, collaborations, and strategic partnerships, with potential dilution of existing stockholder interests[101]. Research and Development - The company initiated a global pivotal Phase 3 clinical trial (EFZO-FIT™ study) for efzofitimod, aiming to enroll 264 subjects with pulmonary sarcoidosis[76]. - Efzofitimod received orphan drug designation from the FDA for the treatment of sarcoidosis and systemic sclerosis, and fast track designation for pulmonary sarcoidosis[73]. - The Phase 1b/2a clinical trial for efzofitimod showed positive results in 37 patients, demonstrating consistent dose response on key efficacy endpoints[74]. - The company has focused resources on the efzofitimod program, delaying the initiation of a Phase 1 study for ATYR2810 due to current market conditions[81]. - The company has been advancing its discovery pipeline of tRNA synthetases and NRP2 antibodies, with new programs announced in February 2021[79]. - Research and development expenses increased to $9.9 million for the three months ended September 30, 2022, up from $5.1 million in the same period in 2021, representing a $4.7 million increase[118]. - For the nine months ended September 30, 2022, research and development expenses were $27.9 million, compared to $17.3 million in 2021, reflecting a $10.6 million increase[121]. - The increase in research and development expenses was primarily due to $3.0 million in start-up costs for the EFZO-FIT™ study and increased manufacturing costs[118]. - The company anticipates that research and development expenses will continue to rise in future years, focusing on clinical development and manufacturing of efzofitimod[111]. - The ongoing COVID-19 pandemic has caused delays in clinical trials, impacting the timelines and costs of product candidates[112]. - The company is unable to estimate with certainty the costs and timelines for future clinical trials due to the unpredictable nature of development[114]. Collaboration and Funding - The company entered into a collaboration with Kyorin Pharmaceutical for the development and commercialization of efzofitimod in Japan, with potential milestone payments of up to $165 million[77]. - The company received an upfront payment of $8.0 million and a milestone payment of $2.0 million under the Kyorin Agreement, with potential additional payments of up to $165.0 million based on future milestones[94]. - The company completed a public offering in September 2021, raising approximately $80.6 million from the sale of 10,781,250 shares at $8.00 per share[89]. - The company entered into an "at-the-market" offering program allowing the sale of up to $65.0 million in common stock, generating approximately $3.1 million in net proceeds from 951,175 shares sold at a weighted-average price of $3.55 per share during the nine months ended September 30, 2022[91]. - Under a previous offering program, the company sold 986,267 shares at a weighted-average price of $4.75 per share, resulting in net proceeds of $4.4 million in 2021[92]. - The company has a common stock purchase agreement with Aspire Capital, allowing for the sale of up to $20.0 million in shares, with $4.8 million remaining available for issuance as of September 30, 2022[93]. Operating Performance - For the nine months ended September 30, 2022, net cash used in operating activities was $(31.5) million, an increase from $(25.0) million in the same period of 2021, primarily due to increased R&D expenditures[96]. - Net cash provided by investing activities was $45.2 million for the nine months ended September 30, 2022, compared to $(42.2) million in 2021, reflecting timing differences in investment transactions[97]. - Financing activities generated $4.6 million in net proceeds from stock issuance during the nine months ended September 30, 2022, significantly lower than $80.6 million in the same period of 2021[98]. - The company has not generated any revenues from product sales to date and expects expenses to increase as it advances clinical development and seeks marketing approval for product candidates[99]. General and Administrative Expenses - General and administrative expenses for the three months ended September 30, 2022, were $3.6 million, an increase of $1.0 million from $2.6 million in 2021[119]. - General and administrative expenses for the nine months ended September 30, 2022, totaled $10.6 million, up from $8.1 million in 2021, marking a $2.5 million increase[122]. - Other income for the three months ended September 30, 2022, was $0.2 million, compared to $59,000 in 2021, indicating an increase of $188,000[120]. - Other income for the nine months ended September 30, 2022, was $0.6 million, up from $0.2 million in 2021, representing a $0.5 million increase[123]. Market Conditions - The ongoing COVID-19 pandemic and geopolitical tensions have introduced significant uncertainties affecting the company's operations and financial performance[86].