Summary of Coya Therapeutics Update - February 17, 2026 Company Overview - **Company**: Coya Therapeutics (NasdaqCM: COYA) - **Focus**: Development of targeted therapies for ALS (Amyotrophic Lateral Sclerosis) Key Industry Insights - **ALS Treatment Landscape**: The approval of tofersen for SOD1 ALS has marked a significant development, indicating that targeted therapies can have a substantial impact on the disease's biology, potentially slowing, halting, or even reversing progression for a small subset of patients [3][4] - **Current Therapies**: Existing therapies show only modest benefits due to a lack of focus and understanding of the disease's biology. The industry is shifting towards more biologically informed clinical trials [5][6] Core Scientific Insights - **Neuroinflammation**: Neuroinflammation is identified as a critical factor in ALS pathology. The understanding of its role has evolved, with a focus on specific biological processes rather than broad observations [6][12] - **Regulatory T Cells (Tregs)**: Tregs are crucial for neuroprotection but are dysfunctional in ALS patients. Enhancing Treg function is a potential therapeutic target [13][14] Combination Therapy Rationale - **Combination of Low-Dose IL-2 and CTLA-4**: The rationale for this combination therapy is based on the need to enhance Treg function while suppressing inflammatory responses from activated macrophages. This dual approach aims to prevent Treg dysfunction and improve therapeutic outcomes [16][18][19] Clinical Trial Insights - **Initial Study Results**: A small study involving four ALS patients showed promising results, with some patients experiencing slowed progression and improved biomarkers related to inflammation and oxidative stress [24][25][26] - **ALSTARS Phase 2 Trial**: The upcoming trial aims to enroll 120 patients, with a design that includes a placebo group and two different dosing regimens for the combination therapy. The trial will measure clinical outcomes and biomarkers over six months [40][41][42] Safety and Tolerability - **Safety Profile**: Previous studies indicate that both IL-2 and CTLA-4 have favorable safety profiles, with no significant increase in infection rates observed. The low-dose IL-2 specifically activates Tregs without causing pro-inflammatory responses [56][59] Future Considerations - **Potential for FDA Approval**: If the trial meets its primary efficacy endpoint, Coya plans to submit an application for FDA approval. The strength of the data will be crucial for this process [65][66] - **Long-Term Outcomes**: There is optimism that slowing disease progression could correlate with improved survival rates, although ongoing monitoring of inflammation levels will be essential [62][64] Conclusion Coya Therapeutics is at the forefront of developing targeted therapies for ALS, with a strong focus on understanding the underlying biology of the disease. The upcoming ALSTARS trial represents a significant step towards validating the efficacy of combination therapies aimed at neuroinflammation and Treg dysfunction.

Summary of Coya Therapeutics FY Conference Call (December 02, 2025) Company Overview - **Company**: Coya Therapeutics (NasdaqCM: COYA) - **Focus**: Development of therapies for neurodegenerative diseases, particularly through Treg (regulatory T cells) biology Key Accomplishments in 2025 - Progress in lead asset entering clinical trials, potentially moving towards registration trials [3][9] - Promising interim data from an investigator-initiated trial in frontotemporal dementia [9] - Positive preclinical data on the combination of GLP-1s with proprietary low-dose interleukin-2 (COYA 301) [9] - Recognition of scientific contributions, including a Nobel Prize awarded to a scientific advisory board member [9] Scientific Approach and Platform - **Focus**: Addressing neurodegenerative diseases by restoring Treg numbers and functions to reduce inflammation [10][11] - **Three Pillars of Confidence**: 1. **Scientific Basis**: Emphasis on Treg functionality to halt disease progression [11] 2. **Combination Biologics**: Utilizing a combination of low-dose interleukin-2 and CTLA-4 to enhance Treg efficacy [12] 3. **Consistent Results**: Positive outcomes observed across multiple investigator-initiated trials in ALS, FTD, and Alzheimer's [12] Clinical Trials and Regulatory Strategy - **Lead Program**: COYA 302 targeting ALS, currently in a randomized double-blind placebo-controlled trial with 120 patients [15] - **Primary Endpoint**: ALSFRS score at six months, with secondary endpoints including neurofilament light as a biomarker [15][19] - **Regulatory Environment**: FDA prioritizing ALS and FTD due to limited treatment options; Coya is optimistic about regulatory success based on preclinical and trial data [21][22] Future Indications and Prioritization - Next priority is frontotemporal dementia, with plans to submit an IND for a Phase 2A study in early 2026 [25] - Larger indications like Alzheimer's and Parkinson's are capital-intensive; Coya is seeking partnerships or grants to advance these programs [27] Financial Overview - **Partnership with Dr. Reddy's**: Total deal value of approximately $700 million, with milestone payments already received and future payments tied to patient dosing and product approval [32][33] - **Cash Position**: Approximately $28 million reported as of September 30, with an additional $23 million raised in late October [34] Key Objectives for 2026 - Focus on advancing the ALS trial, initiating the FTD trial, and progressing the GLP-1 COYA 303 program [35]

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]