a Therapeutics(US:COYA)2024-08-12 12:13Financial Performance - The company reported net losses of $2.9 million and $3.1 million for the three months ended June 30, 2024 and 2023, respectively, and $7.9 million and $5.8 million for the six months ended June 30, 2024 and 2023, respectively, with an accumulated deficit of $33.8 million as of June 30, 2024[73]. - The net loss for Q2 2024 was $2,891,680, a decrease of $203,695 from a net loss of $3,095,375 in Q2 2023[96]. - Net loss for the six months ended June 30, 2024, was $7.9 million compared to a net loss of $5.8 million for the same period in 2023, representing an increase of $2.1 million[100]. - Cash used in operating activities was $2.4 million for the six months ended June 30, 2024, compared to $6.7 million for the same period in 2023[110]. - As of June 30, 2024, the company had $36.6 million in cash and cash equivalents and an accumulated deficit of $33.8 million[104]. - The company expects existing cash and cash equivalents to fund operating expenses and capital expenditures into 2026[104]. Research and Development - COYA 302, the company's lead asset, is a combination of proprietary low dose interleukin-2 (COYA 301) and the immunomodulatory drug CTLA4-Ig, targeting neurodegenerative disorders[73]. - A proof of concept study for COYA 302 in 4 ALS patients showed no decline or minimal decline in the ALSFRS-R scale at 24 and 48 weeks, indicating safety and tolerability[78]. - The company plans to conduct a well-powered Phase 2 study for COYA 302 based on positive proof of concept data[78]. - The company is focused on developing therapies to target Treg dysfunction, which is linked to neurodegenerative, autoimmune, and metabolic diseases[71]. - The POC study for COYA 301 in 8 AD patients showed improved or stable cognitive function, enhanced Treg function, and reduced pro-inflammatory cytokines[80]. - A Phase II clinical trial for LD IL-2 in Alzheimer's Disease has fully enrolled 38 patients, with data presentation scheduled for CTAD24 in Madrid from October 29 to November 1, 2024[81]. - The company expanded its pipeline to include FTD and PD for COYA 302, in addition to ALS and AD, targeting complex immune pathways in neurodegenerative diseases[82]. - The company expects research and development expenses to continue to grow significantly as it advances clinical trials and prepares regulatory filings[90]. - Research and development expenses rose by $3.5 million from $1.1 million in Q2 2023 to $4.6 million in Q2 2024, primarily due to preclinical advancements for COYA 302[97]. - Research and development expenses rose by $5.4 million from $2.3 million for the six months ended June 30, 2023, to $7.7 million for the six months ended June 30, 2024[101]. Funding and Capital - The company has funded operations primarily through private convertible preferred stock offerings, convertible debt financing, and a public offering that closed in January 2023[73]. - The company will need to raise substantial additional capital to support ongoing operations and growth strategy[76]. - The company entered into a Securities Purchase Agreement for a private placement of 603,136 shares at $8.29 per share, resulting in net proceeds of $4.9 million for a Phase 2 study of COYA 302 in FTD[84]. Collaboration and Revenue - Collaboration revenue for Q2 2024 was $3,425,271, compared to $0 in Q2 2023, marking a significant increase[96]. - Other income, net increased by $0.5 million from the six months ended June 30, 2023, to the same period in 2024, primarily due to interest and dividend income[103]. Agreements and Milestones - The DRL Development Agreement includes potential milestone payments of up to $40.0 million and sales milestones of up to $677.3 million related to COYA 302[116]. - The company received a one-time payment of $3.9 million from Dr. Reddy's under the First Amendment to the DRL Development Agreement[115]. - Company agreed to make contingent milestone payments to Methodist totaling up to $0.3 million for ALS treatment and between $0.2 million and $0.4 million for other indications[119]. - Royalty payments to Methodist range from 1% to 10% of annual worldwide net sales of licensed products, with a minimum of $0.1 million annually starting January 1, 2025[119]. - Sponsored Research Agreement with Houston Methodist Research Institute increased funding from $0.5 million to $1.0 million, extending the term through September 2025[121]. - 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[124]. - Under the DRL Agreement, company will pay up to approximately $2.9 million in pre-approval regulatory milestone payments and an additional $20.0 million for other milestones[125]. - Company paid a one-time, non-refundable upfront fee of $0.4 million for the DRL Agreement[125]. - The ARS License Agreement includes tiered payments based on developmental milestones, totaling $11.8 million for the first Mono Product in a new indication[124]. - Company is required to pay royalties on sublicense income ranging from 10% to 20% under the ARS License Agreement[124]. - The Methodist License Agreement allows termination if the company is not "Actively Attempting to Develop or Commercialize" after five years[120].