Financial Position - As of September 30, 2021, the company had an accumulated deficit of $363.7 million and cash, cash equivalents, and available-for-sale investments of $116.4 million, expected to meet cash requirements for at least one year[76]. - The company has incurred losses and negative cash flows from operations since inception, with expectations to continue this trend for the foreseeable future[76]. - The company expects to finance cash needs through equity offerings, collaborations, and strategic partnerships until substantial product revenues are generated[89]. - The company faces risks related to funding requirements and may need to delay or limit product development if additional funds cannot be raised[90]. Cash Flow - The company reported net cash used in operating activities of $24.99 million for the nine months ended September 30, 2021, compared to $9.9 million for the same period in 2020[84]. - The company reported net cash used in investing activities of $(42.2) million for the nine months ended September 30, 2021, compared to $3.7 million for the same period in 2020[86]. - Net cash provided by financing activities for the nine months ended September 30, 2021 was $80.6 million from common stock issuance, compared to $18.8 million for the same period in 2020[87]. Clinical Development - The Phase 1b/2a clinical trial of ATYR1923 in patients with pulmonary sarcoidosis showed positive results in 37 patients, demonstrating safety and a consistent dose response on key efficacy endpoints[68]. - The company plans to initiate a registrational trial for ATYR1923 for pulmonary sarcoidosis next year based on positive clinical trial results[68]. - The company is advancing its discovery pipeline, including the lead IND candidate ATYR2810 for oncology, with plans to submit an IND application and initiate a Phase 1 clinical trial in 2022[72]. - The company anticipates increased research and development expenses in the current and future years, primarily for ATYR1923 and ATYR2810[97]. Revenue and Expenses - License and collaboration agreement revenues were $0 for the nine months ended September 30, 2021, a decrease of $8.4 million compared to $8.4 million in 2020[108]. - The company has not generated any revenues from product sales to date and expects significant commercialization expenses if marketing approval is obtained for product candidates[88]. - Research and development expenses increased to $17.3 million for the nine months ended September 30, 2021, up from $12.6 million in 2020, reflecting a $4.7 million rise in product development and manufacturing costs[109]. - General and administrative expenses rose to $8.1 million for the nine months ended September 30, 2021, compared to $6.8 million in 2020, an increase of $1.3 million[108]. - General and administrative expenses increased to $8.1 million for the nine months ended September 30, 2021, up from $6.8 million in 2020, representing a $1.3 million increase[110]. - Other income improved to $0.2 million for the nine months ended September 30, 2021, compared to a loss of $(0.3) million in 2020, primarily due to the repayment of term loans[111]. Collaborations and Agreements - In January 2020, the company entered into a collaboration agreement with Kyorin Pharmaceutical for the development of ATYR1923 in Japan, receiving an upfront payment of $8.0 million and a milestone payment of $2.0 million[71]. - The company received an $8.0 million upfront payment and a $2.0 million milestone payment from Kyorin under a collaboration agreement for ATYR1923[93]. Stock and Share Issuance - The company completed a follow-on public offering in September 2021, raising approximately $80.6 million from the sale of 10,781,250 shares at $8.00 per share[79]. - The company sold an aggregate of 3,000,000 shares at an average price of $5.09 per share for net proceeds of $15.2 million under a common stock purchase agreement with Aspire Capital[83]. Subsidiaries and Arrangements - The company has a 98% majority-owned subsidiary in Hong Kong, Pangu BioPharma, included in its consolidated financial statements[92]. - The company currently has no off-balance sheet arrangements during the periods presented[113]. - There are no applicable quantitative and qualitative disclosures about market risk[114].
aTyr Pharma, Inc.(ATYR) - 2021 Q3 - Quarterly Report