Financial 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].

Financial Position - As of September 30, 2025, Coya Therapeutics had cash and cash equivalents of $28.1 million[6] - Cash and cash equivalents decreased from $31,057,395 at the end of September 2024 to $28,129,866 at the end of September 2025, a decline of approximately 9%[24] - The company experienced a net decrease in cash and cash equivalents of $10,209,896 in 2025, compared to a decrease of $1,569,373 in 2024, highlighting a worsening cash position[24] Revenue and Collaboration - Collaboration revenues for the three months ended September 30, 2025, were $3.6 million, primarily due to the recognition of $3.3 million in license revenue following FDA acceptance of the IND for the Phase 2 study[6] - The company expects to receive a $4.2 million milestone payment from Dr. Reddy's Laboratories upon the first patient dosing in the COYA 302 ALS trial[7] - Collaboration receivable was reported as zero in 2025, compared to $7,500,000 in 2024, indicating a significant reduction in expected collaboration revenue[24] Expenses - Research and development (R&D) expenses increased to $2.9 million for the three months ended September 30, 2025, compared to $2.2 million for the same period in 2024, reflecting a $0.4 million increase in clinical advancement costs[7] - General and administrative expenses rose to $2.6 million for the three months ended September 30, 2025, from $2.2 million in the prior year, primarily due to increased employee compensation[8] - Coya's total operating expenses for the three months ended September 30, 2025, were $6.0 million, compared to $4.5 million for the same period in 2024[22] - Stock-based compensation increased significantly to $3,186,687 in 2025 from $1,872,990 in 2024, reflecting a rise of about 70%[24] - The company reported a cash outflow of $515,996 for the purchase of in-process research and development assets in 2025, compared to $25,000 in 2024, indicating a substantial increase in investment in R&D[24] Net Loss - The net loss for the three months ended September 30, 2025, was $2.1 million, an improvement from a net loss of $4.0 million for the same period in 2024[9] - Net loss for the nine months ended September 30, 2025, was $15,517,565, compared to a net loss of $11,965,011 for the same period in 2024, representing an increase of approximately 29%[24] Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2025, was $9,732,174, compared to $7,879,055 in 2024, indicating a 23% increase in cash outflow[24] - The net cash provided by financing activities was $38,274 in 2025, a decrease from $6,334,682 in 2024, reflecting a decline of approximately 99%[24] - Proceeds from the exercise of stock options amounted to $38,274 in 2025, up from $1,975 in 2024, showing a significant increase in stock option exercises[24] Clinical Development - Coya Therapeutics completed a $23.0 million upsized public offering, extending its cash runway into the second half of 2027[4] - The company launched the ALSTARS Trial, a Phase 2 clinical study for COYA 302 in ALS, with the first patient dosed[4] - Coya anticipates submitting an IND for COYA 302 in Frontotemporal Dementia (FTD) by the end of 2025[11]

Core Insights - Coya Therapeutics, Inc. is focused on developing therapies that modulate regulatory T cells to treat neurodegenerative, autoimmune, and metabolic diseases [1] - The consensus price target for Coya has remained stable at $17, with a more optimistic target of $18 from analyst Raghuram Selvaraju [2][6] - A recent 10.7% increase in Coya's share price indicates investor optimism, although earnings estimate revisions have not shown sustained improvement [3][6] - Future clinical trial results and regulatory approvals are critical for the company's stock performance and future price targets [4][6] - Advancements in Coya's product pipeline or strategic partnerships could influence analysts' perspectives on the company [5]

Core Insights - Greenlight Capital's funds returned -3.6% in Q3 2025, underperforming the S&P 500's 8.1% return, and YTD returns were 0.4% compared to the index's 14.8% [1] Company Overview - Coya Therapeutics, Inc. (NASDAQ:COYA) is a clinical-stage biotechnology company focused on developing treatments for ALS, with its lead drug recently entering clinical trials [3] - As of October 27, 2025, Coya Therapeutics' stock closed at $6.47 per share, with a market capitalization of $108.325 million [2] Investment Position - Greenlight Capital holds a small position in Coya Therapeutics, being the largest shareholder, due to its market capitalization of approximately $100 million [3] - Coya Therapeutics has shown a one-month return of 14.31%, but its shares have decreased by 36.51% over the past 52 weeks [2] Market Sentiment - Coya Therapeutics is not among the top 30 most popular stocks among hedge funds, with only 5 hedge fund portfolios holding the stock at the end of Q2 2025 [4] - While acknowledging Coya's potential, the company believes that certain AI stocks present greater upside potential and lower downside risk [4]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Qualigen Therapeutics, Inc. (QLGN) increased by 69% to $6.00 - Inhibrx Biosciences, Inc. (INBX) rose by 62% to $46.04 - MidWestOne Financial Group, Inc. (MOFG) gained 33% to $37.87 - Neuphoria Therapeutics Inc. (NEUP) up by 31% to $5.32 - Nextracker Inc. (NXT) increased by 13% to $102.44 - Avalon Holdings Corporation (AWX) rose by 11% to $2.98 - Beyond Meat, Inc. (BYND) up by 9% to $3.12 - SLM Corporation (SLM) increased by 8% to $29.00 - Reborn Coffee, Inc. (REBN) rose by 7% to $2.40 - Oriental Culture Holding LTD (OCG) increased by 5% to $3.55 [3] Premarket Losers - Picard Medical, Inc. (PMI) decreased by 70% to $3.89 - Fusemachines Inc. Common stock (FUSE) down by 17% to $3.29 - American Rebel Holdings, Inc. (AREB) fell by 16% to $3.14 - Armata Pharmaceuticals, Inc. (ARMP) down by 13% to $6.16 - Coya Therapeutics, Inc. (COYA) decreased by 13% to $6.01 - Deckers Outdoor Corporation (DECK) down by 12% to $90.00 - Safe & Green Holdings Corp. (SGBX) fell by 12% to $2.58 - Beasley Broadcast Group, Inc. (BBGI) decreased by 8% to $5.55 - Booz Allen Hamilton Holding Corporation (BAH) down by 7% to $92.73 - Brera Holdings PLC (SLMT) decreased by 6% to $10.67 [4]

Core Viewpoint - Coya Therapeutics, Inc. has announced a public offering of common stock priced at $5.50 per share, aiming to raise capital for its clinical-stage biotechnology initiatives focused on neurodegenerative disorders [1] Company Summary - Coya Therapeutics is a clinical-stage biotechnology company that specializes in developing biologics to enhance regulatory T cell (Treg) function [1] - The company has priced an underwritten public offering of 3,636,364 shares of its common stock [1] - An option has been granted to the underwriter to purchase an additional 545,454 shares within a 30-day period [1]

Core Viewpoint - Coya Therapeutics, Inc. has announced its intention to conduct an underwritten public offering of common stock to raise funds for working capital and clinical development [1][2]. Company Overview - Coya Therapeutics is a clinical-stage biotechnology company based in Houston, TX, focused on developing biologics that enhance regulatory T cell (Treg) function to address neurodegenerative disorders [5]. - The company is developing proprietary treatments targeting systemic inflammation and neuroinflammation, with a focus on restoring the anti-inflammatory functions of Tregs [5][6]. Proposed Public Offering - The company plans to offer shares of its common stock and may grant underwriters a 30-day option to purchase an additional 15% of the shares at the public offering price [1]. - The net proceeds from the offering will be used for working capital and general corporate purposes, including funding its clinical development plan [2]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1][2]. Clinical Development - Coya's investigational product candidate pipeline includes various therapeutic modalities aimed at enhancing Treg functions, such as Treg-enhancing biologics and autologous Treg cell therapy [6]. - The company is currently conducting the ALSTARS Trial, a Phase 2 study evaluating the efficacy and safety of its investigational product COYA 302 for the treatment of ALS [8].

Core Insights - Coya Therapeutics has completed patient enrollment for a proof-of-concept study on low-dose IL-2 and CTLA4-Ig combination treatment in patients with Frontotemporal Dementia (FTD) [1][2] - The study is progressing without safety issues, with completion anticipated in Q4 2025 [1][2] - The company aims to develop effective treatments for FTD, a neurodegenerative disease with high unmet medical need [3] Study Details - A total of 9 patients have been enrolled in the study, following positive interim results from 5 patients reported earlier [2] - The treatment regimen includes subcutaneous administration of CTLA4-Ig followed by a 5-day course of low-dose IL-2 every four weeks for a total of 22 weeks [1] - No serious adverse events or discontinuations due to safety issues have been reported, indicating a favorable safety profile [2] About Frontotemporal Dementia - FTD is characterized by altered behavior and language, with an estimated 30,000 Americans affected [4] - The average age of onset is 58, with an average survival time of 7.5 years [4] - FTD includes various subtypes, primarily behavioral-variant frontotemporal dementia and two language variants [4] Company Overview - Coya Therapeutics is a clinical-stage biotechnology company focused on developing treatments that enhance regulatory T cell (Treg) function to address systemic inflammation and neuroinflammation [5] - The company’s pipeline includes Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy [6]

Core Insights - Coya Therapeutics, Inc. is developing COYA 303, a proprietary combination of LD-IL-2 and GLP-1RA, aimed at treating diseases like Alzheimer's Disease driven by chronic inflammation [1][2][3] - The initial results from an in vivo study indicate that COYA 303 significantly reduces neuroinflammation and enhances regulatory T cell (Treg) function, suggesting its potential in neurodegenerative conditions [2][3][6] - The company is currently conducting further experimental cohorts to evaluate modified treatment protocols and the timing of treatment initiation [4] Company Overview - Coya Therapeutics is a clinical-stage biotechnology company focused on enhancing Treg function to target systemic and neuroinflammation [5][7] - The company believes that Treg dysfunction is a key factor in various diseases, including neurodegenerative and autoimmune conditions [5][7] - Coya's therapeutic pipeline includes Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy [7] Study Findings - COYA 303 demonstrated significant systemic and central immunomodulatory effects, including enhanced Treg numbers and function, reduced activated myeloid cells, and attenuation of neuroinflammation in the cortex and hippocampus [6] - The findings from the first cohort of the study align with previous in vitro results, reinforcing the potential of COYA 303 in modulating inflammatory pathways associated with Alzheimer's Disease [1][3][6] - The CEO of Coya highlighted the growing interest in GLP-1 receptor agonists as potential therapies beyond metabolic diseases, positioning COYA 303 as a unique approach to address neuroinflammation [5]

Summary of Coya Therapeutics FY Conference Call Company Overview - **Company**: Coya Therapeutics (NasdaqCM: COYA) - **Focus**: Development of transformative therapies for patients suffering from neurodegenerative diseases such as ALS, frontotemporal dementia, Alzheimer's, and Parkinson's [2][3] Core Points and Arguments - **Vision and Mission**: Coya aims to make neurodegenerative diseases manageable, shifting the narrative from the disease to the patients' lives [3] - **Scientific Approach**: The company believes that neurodegenerative diseases are primarily neuroinflammatory and that addressing neuroinflammation can halt disease progression [5][6] - **Lead Program**: COIA-302, a combination of low-dose interleukin-2 and CTLA-4, is set to enter a pivotal Phase 2b study involving 120 ALS patients, with the first patient expected to be dosed in Q4 2025 [8][24] - **Clinical Trial Support**: Coya has partnered with the NILS Foundation, the largest ALS consortium, to facilitate faster recruitment for the trial [9] Clinical Data and Outcomes - **Current ALS Treatment Landscape**: Existing therapies show minimal efficacy, with patients declining by approximately 6 points in 6 months on the ALSFRS scale [14] - **Initial Study Results**: In a small investigator-initiated study, Coya observed stabilization or improvement in ALSFRS scores, contrasting with expected declines [16][17] - **Mechanistic Insights**: The combination therapy has shown to maintain Treg function and numbers, which are crucial for managing neuroinflammation [12][18] Future Plans and Partnerships - **Regulatory Pathway**: The primary endpoint for the Phase 2b trial is set for 6 months, with plans to approach the FDA for a BLA filing based on the data [23] - **Commercialization Partnership**: Coya has partnered with Dr. Reddy's Laboratories for the commercialization of COIA-302, which will alleviate some financial burdens associated with bringing the product to market [24][26] - **Funding and Cash Flow**: A $700 million partnership with Dr. Reddy's provides non-dilutive cash flow, enhancing Coya's financial position [26] Additional Indications - **Frontotemporal Dementia (FTD)**: Coya plans to file an IND for FTD this year, with a small randomized study expected to start in 2026, supported by a $5 million investment from the Alzheimer's Drug Discovery Foundation [29] - **COIA-303 Development**: A new product combining COIA-301 with GLP-1 weight loss drugs shows promise in reducing neuroinflammatory markers, with potential applications in Alzheimer's disease [30][31] Key Metrics and Milestones - **Upcoming Milestones**: - Dosing of the first ALS patient in 2025, triggering a $4.2 million payment from Dr. Reddy's [33] - Filing for FTD IND and additional data from ongoing trials expected by the end of 2025 [33] Conclusion - Coya Therapeutics is positioned to make significant advancements in the treatment of neurodegenerative diseases, with a strong scientific foundation, promising early clinical data, and strategic partnerships that enhance its operational and financial capabilities [34]