a Therapeutics(US:COYA)2025-11-12 13:13Financial Performance - The company reported net losses of $2.1 million and $4.0 million for the three months ended September 30, 2025 and 2024, respectively, and $15.5 million and $12.0 million for the nine months ended September 30, 2025 and 2024, respectively[97]. - As of September 30, 2025, the company had an accumulated deficit of $56.3 million[97]. - The net loss for the three months ended September 30, 2025, was $2.1 million, a decrease of $1.9 million compared to a net loss of $4.0 million in Q3 2024[120]. - Cash used in operating activities was $9.7 million for the nine months ended September 30, 2025, compared to $7.9 million in 2024, reflecting a net loss of $15.5 million[140]. - The total operating expenses for the nine months ended September 30, 2025, were $20.5 million, an increase of $3.8 million compared to $16.7 million in the same period of 2024[127]. Research and Development - The company is currently conducting the ALSTARS Trial, a Phase 2 study for COYA 302, which is an investigational product not yet approved by the FDA[95]. - COYA 303 demonstrated a statistically significant increase in Treg suppressive function of 42% compared to single agents, indicating its potential effectiveness in inflammatory conditions[101]. - The company expects research and development expenses to increase significantly in 2025, driven by the advancement of COYA 302 in a Phase 2 study for ALS[113]. - Research and development expenses increased by $0.7 million from $2.2 million in Q3 2024 to $2.9 million in Q3 2025, driven by a $0.4 million increase in preclinical and clinical expenses related to COYA 302[122]. - Research and development expenses for the nine months ended September 30, 2025, totaled $11.8 million, up $1.9 million from $9.9 million in the same period of 2024[129]. Revenue and Financing - The company raised approximately $23.0 million from an underwritten public offering of 4,181,818 shares at an offering price of $5.50 per share[106]. - Collaboration revenue is derived from the DRL Development Agreement, granting Dr. Reddy's exclusive rights to commercialize COYA 302 for ALS in specified territories[107]. - Collaboration revenue for the three months ended September 30, 2025, was $3.6 million, primarily due to the immediate recognition of $3.3 million of License revenue upon receiving FDA acceptance of the IND for the Phase 2 Study[121]. - For the nine months ended September 30, 2025, collaboration revenue was $4.0 million, an increase of $0.4 million compared to $3.6 million in the same period of 2024[128]. - The company plans to finance operations through equity sales, debt financings, or collaborations, with no assurance of obtaining adequate financing[100]. Expenses - Total operating expenses for the three months ended September 30, 2025, were $6.0 million, an increase of $1.5 million compared to $4.5 million in Q3 2024[120]. - General and administrative expenses rose by $0.3 million from $2.2 million in Q3 2024 to $2.6 million in Q3 2025, primarily due to increased employee compensation and public filing costs[125]. - General and administrative expenses rose to $8.2 million for the nine months ended September 30, 2025, up from $6.7 million in 2024, primarily due to a $1.0 million increase in employee compensation[132]. Cash and Investments - As of September 30, 2025, the company had $28.1 million in cash and cash equivalents and an accumulated deficit of $56.3 million[134]. - The company expects existing cash and cash equivalents, along with $23.0 million in gross proceeds from an offering, to fund operations for at least one year[134]. - Cash used in investing activities was $516,000 for the nine months ended September 30, 2025, compared to $25,000 in 2024[142]. - The company has no credit facility or committed sources of capital and will need significant additional funds for operational needs and clinical trials[136]. Agreements and Milestones - The DRL Development Agreement includes potential milestone payments of up to $40.0 million for development and $677.3 million for sales, contingent on achieving specific targets[147]. - The company received a nonrefundable upfront payment of $7.5 million in January 2024 under the DRL Development Agreement[146]. - The company will pay an aggregate of $13.3 million in developmental milestone payments for the first Combination Product in a new indication under the ARS License Agreement[155]. - For each subsequent new indication of the Combination Product, the company will pay $11.6 million in developmental milestone payments[155]. - The company will pay $11.8 million for the first Mono Product and $5.9 million for each subsequent new indication[155]. - The company has paid a $0.3 million milestone to ARS in connection with the IND Milestone during the three and nine months ended September 30, 2025[155]. - Under the DRL Agreement, the company paid a one-time, non-refundable upfront fee of $0.4 million for the license[156]. - The company will pay up to approximately $2.9 million in pre-approval regulatory milestone payments for the first indication under the DRL Agreement[156]. - An additional approximately $20.0 million will be paid if all development, regulatory approval, and sales milestones are achieved under the DRL Agreement[156]. - The company paid a $0.3 million milestone to DRL in connection with the IND Milestone during the three and nine months ended September 30, 2025[156]. - Royalties on net sales for licensed products will range from low to mid-single digit percentages[155]. - Royalties on sublicense income will range from 10% to 20% if the company sublicenses its rights under the ARS License Agreement[155].