COYA 303 is an investigational proprietary combination of LD-IL-2 and GLP-1RA for subcutaneous administration, under development for the treatment of diseases, including Alzheimer's Disease, driven by chronic and sustained inflammation; COYA 303 demonstrated significant attenuation of neuroinflammation in cortex and hippocampus brain regions and upregulation of anti-inflammatory markers, and significant improvement of systemic Treg function and pro- inflammatory cytokines; Accessibility StatementSkip Naviga ...

Coya Therapeutics (NasdaqCM:COYA) FY Conference September 10, 2025 10:00 AM ET Speaker0Alright. Hello, everyone, and welcome to the H. C. Wainwright twenty seventh Annual Global Investment Conference. My name is Maya, and I'm a research associate here.I'm here with Arun Swaminathan, CEO of Koya Therapeutics. Welcome, and I yield you the floor now to introduce yourself and the company.Speaker1Thank you, Maya. Appreciate it. Good morning, everyone, and thank you for the opportunity to share the innovative wor ...

Core Insights - Coya Therapeutics is positioned for a transformative year in 2025 with FDA clearance of its first IND and the initiation of a pivotal ALS trial [3][6] - The company is focused on developing Treg-modulating therapies to address ALS and other neurodegenerative diseases [4][6] Company Overview - Coya Therapeutics, Inc. is a clinical-stage biotechnology company headquartered in Houston, TX, specializing in treatments that target systemic inflammation and neuroinflammation through regulatory T cells (Tregs) [4][6] - The company’s pipeline includes Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy [5][6] Recent Developments - The FDA accepted the IND application for COYA 302 in ALS, allowing the start of a Phase 2 clinical trial [6] - Strategic partnerships, notably with Dr. Reddy's Laboratories, provide financial support and expertise in manufacturing and commercialization [6] Future Plans - Coya plans to expand its pipeline beyond ALS, with an IND filing for frontotemporal dementia expected in late 2025 [6] - Key upcoming milestones include the initiation of the ALS trial, data readouts for frontotemporal dementia, and new preclinical results across multiple programs [6]

Core Viewpoint - Coya Therapeutics, Inc. is actively engaging with investors through participation in two upcoming conferences, highlighting its focus on developing biologics for neurodegenerative disorders [1][2]. Company Overview - Coya Therapeutics, Inc. is a clinical-stage biotechnology company based in Houston, TX, specializing in treatments that enhance regulatory T cell (Treg) function to address systemic inflammation and neuroinflammation [4]. - The company’s investigational product pipeline includes Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy, aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs [5]. Upcoming Events - Coya will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025, at 10 am ET, with a presentation by CEO Arun Swaminathan [2]. - The company will also participate in the Lake Street Capital Markets 9th Annual Best Ideas Growth Conference on September 11, 2025, where management will be available for one-on-one meetings [2]. Webcast Information - Live and archived webcasts of the presentations will be accessible on the company's website under the Investor Relations section, with replays available for 90 days [3].

Coya Therapeutics, Inc. (COYA) came out with a quarterly loss of $0.36 per share versus the Zacks Consensus Estimate of a loss of $0.22. This compares to a loss of $0.19 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -63.64%. A quarter ago, it was expected that this company would post a loss of $0.44 per share when it actually produced a loss of $0.44, delivering no surprise. Over the last four quarters, the company has surp ...

[PART I – Financial Information](index=3&type=section&id=PART%20I%20%E2%80%93%20Financial%20Information) This section presents the company's financial information, including statements and management's discussion [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the company's unaudited condensed interim financial statements and detailed notes [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) This table provides a snapshot of the company's financial position, including assets, liabilities, and equity Condensed Balance Sheets (as of June 30, 2025, and December 31, 2024) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $29,757,328 | $38,339,762 | | Total current assets | $33,427,647 | $44,308,428 | | Total assets | $33,452,555 | $44,347,016 | | Total current liabilities | $4,501,104 | $3,824,474 | | Total liabilities | $5,142,262 | $4,769,921 | | Total stockholders' equity | $28,310,293 | $39,577,095 | [Condensed Unaudited Interim Statements of Operations](index=4&type=section&id=Condensed%20Unaudited%20Interim%20Statements%20of%20Operations) This section details the company's revenues, expenses, and net loss over specific interim periods Condensed Unaudited Interim Statements of Operations | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Collaboration revenue | $163,616 | $3,425,271 | $421,500 | $3,552,109 | | Research and development expenses | $3,663,103 | $4,566,152 | $8,877,179 | $7,704,311 | | General and administrative expenses | $2,908,191 | $2,088,404 | $5,622,081 | $4,528,245 | | Total operating expenses | $6,578,134 | $6,661,396 | $14,512,940 | $12,271,236 | | Loss from operations | $(6,414,518) | $(3,236,125) | $(14,091,440) | $(8,719,127) | | Net loss | $(6,094,977) | $(2,891,680) | $(13,401,734) | $(7,943,593) | | Net loss per share, basic and diluted | $(0.36) | $(0.19) | $(0.80) | $(0.54) | [Condensed Unaudited Interim Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Unaudited%20Interim%20Statements%20of%20Stockholders'%20Equity) This statement outlines changes in the company's equity, including stock-based compensation and net loss Condensed Unaudited Interim Statements of Stockholders' Equity | Metric | Balance as of Dec 31, 2024 | Stock-based compensation expense | Exercise of stock options | Net loss | Balance as of June 30, 2025 | | :-------------------------------- | :------------------------- | :------------------------------- | :---------------------- | :--------- | :-------------------------- | | Common Stock Shares | 16,707,441 | - | 17,557 | - | 16,724,998 | | Common Stock Amount | $1,671 | - | $2 | - | $1,673 | | Additional Paid-In Capital | $80,312,594 | $2,115,795 | $19,135 | - | $82,447,524 | | Accumulated Deficit | $(40,737,170) | - | - | $(13,401,734) | $(54,138,904) | | Total Stockholders' Equity | $39,577,095 | $2,115,795 | $19,137 | $(13,401,734) | $28,310,293 | [Condensed Unaudited Interim Statements of Cash Flows](index=6&type=section&id=Condensed%20Unaudited%20Interim%20Statements%20of%20Cash%20Flows) This statement summarizes the company's cash inflows and outflows from operating, investing, and financing activities Condensed Unaudited Interim Statements of Cash Flows | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(8,601,571) | $(2,417,693) | | Net cash used in investing activities | $- | $(25,000) | | Net cash provided by financing activities | $19,137 | $6,391,014 | | Net (decrease) increase in cash and cash equivalents | $(8,582,434) | $3,948,321 | | Cash and cash equivalents as of end of period | $29,757,328 | $36,575,089 | [Notes to the Condensed Unaudited Interim Financial Statements](index=7&type=section&id=Notes%20to%20the%20Condensed%20Unaudited%20Interim%20Financial%20Statements) This section provides detailed explanations of the company's accounting policies, commitments, and recent events - The Company is a clinical-stage biotechnology company focused on developing proprietary new therapies to enhance the function of Regulatory T cells ("Tregs")[19](index=19&type=chunk) - The Company has incurred losses since inception, negative cash flows from operations, and has an **accumulated deficit** of **$54.1 million** as of June 30, 2025[20](index=20&type=chunk) - **Cash and cash equivalents** of **$29.8 million** as of June 30, 2025, are expected to enable the Company to fund its operating expenses and capital expenditure requirements for at least one year[21](index=21&type=chunk) [1. Organization and description of business](index=7&type=section&id=1.%20Organization%20and%20description%20of%20business) This note describes the company's core business, financial status, and future funding requirements - Coya Therapeutics, Inc. is a clinical-stage biotechnology company developing therapies to enhance Regulatory T cells (Tregs) for neurodegenerative, chronic inflammatory, autoimmune, and metabolic diseases[19](index=19&type=chunk) - The company has an **accumulated deficit** of **$54.1 million** as of June 30, 2025, and anticipates further losses until significant product sales are generated[20](index=20&type=chunk) - **Current cash** of **$29.8 million** is expected to cover operating expenses for at least one year, but substantial additional financing will be needed[21](index=21&type=chunk) [2. Basis of presentation and significant accounting policies](index=7&type=section&id=2.%20Basis%20of%20presentation%20and%20significant%20accounting%20policies) This note outlines the accounting principles, estimates, and revenue recognition policies applied in the financial statements - Financial statements are prepared in conformity with U.S. GAAP and include all normal and recurring adjustments[24](index=24&type=chunk)[25](index=25&type=chunk) - Management makes estimates and assumptions, particularly for stock options, DRL Development Agreement transaction price allocation, and R&D expenses[26](index=26&type=chunk)[27](index=27&type=chunk) - The Company operates as one segment, with the CEO managing operations on a consolidated basis and assessing performance based on **net loss** and cash burn[28](index=28&type=chunk)[29](index=29&type=chunk)[30](index=30&type=chunk) - Collaboration revenue is primarily from the DRL Development Agreement, recognized by analogizing to ASC 606, including **upfront license fees**, **milestone payments**, and **royalties**[32](index=32&type=chunk)[33](index=33&type=chunk) - Research and development costs are expensed as incurred, including third-party services, clinical/preclinical development, manufacturing, regulatory compliance, and personnel costs[40](index=40&type=chunk) - Stock-based compensation is measured at grant-date fair value and expensed over the vesting period, using the Black-Scholes model with subjective assumptions[43](index=43&type=chunk)[44](index=44&type=chunk) - A full valuation allowance is applied to all net deferred tax assets due to the unlikelihood of realization[46](index=46&type=chunk) - Potentially dilutive securities (warrants, stock options) are excluded from diluted EPS calculation due to anti-dilutive effect from **net loss**[47](index=47&type=chunk)[48](index=48&type=chunk) - The company is evaluating the impact of recently issued FASB ASUs on income tax disclosures (ASU 2023-09) and expense disaggregation (ASU 2024-03)[49](index=49&type=chunk)[50](index=50&type=chunk) [3. Fair value measurements](index=11&type=section&id=3.%20Fair%20value%20measurements) This note details the fair value hierarchy and measurements for the company's financial instruments Fair Value of Financial Instruments (Cash and Cash Equivalents) | Asset | Input Level | Fair Value (June 30, 2025) | Carrying Value (June 30, 2025) | Fair Value (Dec 31, 2024) | Carrying Value (Dec 31, 2024) | | :-------------------------------- | :---------- | :------------------------- | :--------------------------- | :------------------------ | :-------------------------- | | Cash and cash equivalents (money market funds) | Level 1 | $29,757,328 | $29,757,328 | $38,339,762 | $38,339,762 | [4. Prepaids and other current assets](index=12&type=section&id=4.%20Prepaids%20and%20other%20current%20assets) This table presents a breakdown of the company's prepaid expenses and other current assets Prepaids and Other Current Assets | Asset | June 30, 2025 | December 31, 2024 | | :-------------------------- | :-------------- | :---------------- | | Prepaid research and development | $3,141,396 | $4,005,246 | | Prepaid insurance | $409,101 | $805,469 | | Prepaid other | $119,822 | $427,370 | | Income tax receivable | $- | $730,581 | | Total | $3,670,319 | $5,968,666 | [5. Accrued expenses](index=12&type=section&id=5.%20Accrued%20expenses) This table provides a summary of the company's accrued liabilities, including R&D and payroll Accrued Expenses | Expense | June 30, 2025 | December 31, 2024 | | :------------------------ | :-------------- | :---------------- | | Accrued research and development | $1,999,432 | $46,667 | | Accrued payroll | $591,464 | $1,132,422 | | Accrued professional fees | $247,789 | $208,971 | | Total | $2,838,685 | $1,388,060 | [6. Commitments and contingencies, including license and sponsored research agreements](index=13&type=section&id=6.%20Commitments%20and%20contingencies,%20including%20license%20and%20sponsored%20research%20agreements) This note describes the company's contractual obligations and potential liabilities from various agreements - DRL Agreement: In-licensed DRL's abatacept biosimilar for COYA 302 development, paid **$0.4M upfront**, with potential pre-approval regulatory milestones up to **$2.9M** and other development/sales milestones up to **$20.0M**[56](index=56&type=chunk) - ARS License Agreement: Exercised option for exclusive license for two patents, with potential developmental **milestone payments** up to **$13.3M** for the first Combination Product in a new indication, and **royalties** on net sales (low to mid-single digit percentages)[57](index=57&type=chunk)[58](index=58&type=chunk) - Methodist License Agreement: Pays annual license maintenance fee, potential **milestone payments** up to **$0.4M** per product candidate, and tiered **royalties** (high-single digit to low-double digit percentages) on net sales. Minimum annual payment of **$0.1M** once commercialization occurs (effective Jan 1, 2025)[59](index=59&type=chunk)[60](index=60&type=chunk) - Sponsored Research Agreement (SRA) with HMRI: Amended in Oct 2024 to increase **total funding** to **$1.2M**. As of June 30, 2025, **$1.0M** has been funded[62](index=62&type=chunk) [7. Stockholders' equity](index=15&type=section&id=7.%20Stockholders'%20equity) This note details the company's common stock, warrants, and equity incentive plan - As of June 30, 2025, the Company had 815,677 common stock warrants outstanding with **exercise prices** ranging from **$6.00** to **$9.15** and expiration dates between December 2025 and November 2029[67](index=67&type=chunk) - No warrants were granted during the three and six months ended June 30, 2025[65](index=65&type=chunk) [8. Stock-based compensation](index=16&type=section&id=8.%20Stock-based%20compensation) This note explains the company's stock option plan and the related compensation expense recognition - The 2021 Equity Incentive Plan authorized 3,239,368 shares as of June 30, 2025, with 170,221 shares available for future issuance[68](index=68&type=chunk) Stock-based Compensation Expense | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | General and administrative | $677,926 | $373,919 | $1,373,319 | $641,357 | | Research and development | $357,787 | $288,402 | $742,476 | $456,627 | | Total | $1,035,713 | $662,321 | $2,115,795 | $1,097,984 | - As of June 30, 2025, **unrecognized compensation cost** for stock options was **$7.1 million**, to be recognized over an estimated weighted-average amortization period of **1.9 years**[71](index=71&type=chunk) - The fair value of options is estimated using the Black-Scholes model with a **risk-free interest rate** of **4.5%** (2025) vs **4.2%** (2024), **expected term** of **5.75 years** (2025) vs **5.74 years** (2024), and **expected volatility** of **96.82%** (2025) vs **106.20%** (2024)[73](index=73&type=chunk) [9. DRL Development Agreement](index=17&type=section&id=9.%20DRL%20Development%20Agreement) This note outlines the key terms, payments, and revenue recognition related to the DRL collaboration agreement - In December 2023, Coya granted Dr. Reddy's an exclusive license to commercialize COYA 302 for ALS in the US, Canada, EU, and UK[74](index=74&type=chunk) - Received an **upfront payment** of **$7.5 million** in January 2024[78](index=78&type=chunk) - Entitled to additional payments of **$4.2 million** upon FDA IND acceptance for COYA 302 in ALS and another **$4.2 million** upon dosing the first patient in the Phase 2 clinical trial[78](index=78&type=chunk) - Potential **development milestones** up to **$40.0 million** and **sales milestones** up to **$677.3 million**, plus **royalties** on Net Sales in the low to mid-teens[78](index=78&type=chunk) - In June 2024, an amendment resulted in a one-time payment of **$3.9 million** to Coya, in exchange for Dr. Reddy's not having to pay the first **$6.0 million** in **royalty payments**[76](index=76&type=chunk)[78](index=78&type=chunk) - **Collaboration revenue** from R&D Services and License was **$0.2 million** for Q2 2025, a significant decrease from **$3.4 million** in Q2 2024, primarily due to immediate recognition of License revenue in Q2 2024[82](index=82&type=chunk)[117](index=117&type=chunk) [10. Subsequent events](index=21&type=section&id=10.%20Subsequent%20events) This note discloses significant events that occurred after the reporting period, impacting future operations - On July 14, 2025, the **FDA informed the Company** that it would not meet the initial review goal date for the re-submitted IND for COYA 302 in ALS due to workload and resource limitations[83](index=83&type=chunk) - The **FDA expects to provide a decision** on **IND approval** no later than August 29, 2025[83](index=83&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, operations, and liquidity - Coya Therapeutics is a clinical-stage biotechnology company focused on developing therapies to enhance Regulatory T cells (Tregs) for neurodegenerative, autoimmune, and metabolic diseases[90](index=90&type=chunk)[91](index=91&type=chunk) - The lead asset, COYA 302 (low dose IL-2 and CTLA4-Ig), is a Treg-enhancing biologic, with a Phase 1 and Phase 2a study completed for ALS[92](index=92&type=chunk)[93](index=93&type=chunk) - **Net losses** were **$6.1 million** and **$2.9 million** for the three months ended June 30, 2025 and 2024, respectively, and **$13.4 million** and **$7.9 million** for the six months ended June 30, 2025 and 2024, respectively[93](index=93&type=chunk) - As of June 30, 2025, the company had an **accumulated deficit** of **$54.1 million** and expects to incur significant expenses and operating losses for the foreseeable future[93](index=93&type=chunk)[95](index=95&type=chunk) - Substantial additional capital will be needed to fund operations, advance product candidates, and pursue growth strategies[97](index=97&type=chunk) [CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS](index=22&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section warns readers about the inherent risks and uncertainties associated with forward-looking statements - The report contains forward-looking statements subject to risks and uncertainties, which may cause actual results to differ materially from expectations[86](index=86&type=chunk) - Factors include ability to develop/commercialize products, timing of clinical trials, success of preclinical studies, impact of global health events, and ability to obtain/protect intellectual property[87](index=87&type=chunk) - The company disclaims any obligation to update or revise forward-looking statements[89](index=89&type=chunk) [Overview](index=23&type=section&id=Overview) This overview introduces Coya Therapeutics' focus on Treg-enhancing therapies and its financial position - Coya Therapeutics is a clinical-stage biotechnology company focused on developing therapies to enhance Regulatory T cells (Tregs) for neurodegenerative, chronic inflammatory, autoimmune, and metabolic diseases[90](index=90&type=chunk)[91](index=91&type=chunk) - The lead asset, COYA 302, is a Treg-enhancing biologic combining low dose interleukin-2 (COYA 301) and CTLA4-Ig, intended for neurodegenerative disorders like ALS[92](index=92&type=chunk)[93](index=93&type=chunk) - The company has incurred **net losses** of **$13.4 million** for the six months ended June 30, 2025, and has an **accumulated deficit** of **$54.1 million**, expecting continued significant expenses[93](index=93&type=chunk)[95](index=95&type=chunk) - Future operations will require substantial additional capital, to be financed through equity, debt, or collaborations[97](index=97&type=chunk) [Recent Developments](index=25&type=section&id=Recent%20Developments) This section highlights key clinical and patent developments, including IND resubmission and FDA feedback - Published results for COYA 303 (LD IL-2 and GLP-1RA) in April 2025, showing a **statistically significant 42% increase** in Treg suppressive function in inflammatory microenvironments, compared to single agents[98](index=98&type=chunk) - Announced issuance of a U.S. patent on June 2, 2025, for a highly stable liquid formulation of IL-2 (aldesleukin), for which Coya has **exclusive in-vivo rights**[100](index=100&type=chunk) - Re-submitted an IND for COYA 302 in ALS on June 30, 2025, including previously requested non-clinical data for a planned Phase 2 study[101](index=101&type=chunk) - **FDA informed the company** on July 29, 2025, that it would not meet the initial IND review goal date for COYA 302 in ALS due to workload, expecting a decision by August 29, 2025[102](index=102&type=chunk) [Components of Results of Operations](index=26&type=section&id=Components%20of%20Results%20of%20Operations) This section explains the key revenue and expense categories contributing to the company's operating results - Collaboration Revenue: Currently derived solely from the DRL Development Agreement, with no product sales revenue expected in the foreseeable future[103](index=103&type=chunk) - Research and Development Expenses: Expensed as incurred, covering discovery, preclinical/clinical studies, sponsored research, personnel, manufacturing, regulatory activities, and facility costs[104](index=104&type=chunk)[106](index=106&type=chunk) - In-Process Research and Development: Costs for technology licenses are expensed if the technology has not reached technological feasibility and has no alternative future use[110](index=110&type=chunk) - General and Administrative Expenses: Includes personnel, facility costs, legal, accounting, and consulting services, expected to increase with continued R&D, potential commercialization, and public company operations[111](index=111&type=chunk)[112](index=112&type=chunk) - Other Income: Consists of interest earned on excess cash[114](index=114&type=chunk) - Income Taxes: No income tax benefits recorded for net operating losses (NOLs) or R&D tax credits due to a full valuation allowance, as realization is not considered probable[115](index=115&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) This section compares the company's financial performance across different interim periods, highlighting key changes - **Net loss** for the three months ended June 30, 2025, was **$(6.1) million**, compared to **$(2.9) million** for the same period in 2024, an increase of **$(3.2) million**[116](index=116&type=chunk) - **Net loss** for the six months ended June 30, 2025, was **$(13.4) million**, compared to **$(7.9) million** for the same period in 2024, an increase of **$(5.5) million**[123](index=123&type=chunk) [Comparison of the three months ended June 30, 2025 and 2024](index=29&type=section&id=Comparison%20of%20the%20three%20months%20ended%20June%2030,%202025%20and%202024) This section analyzes the financial performance for the three-month periods, detailing revenue and expense changes Financial Performance (Three Months Ended June 30, 2025 vs 2024) | Metric | 2025 | 2024 | Change | | :-------------------------- | :----------- | :----------- | :----------- | | Collaboration revenue | $163,616 | $3,425,271 | $(3,261,655) | | Research and development | $3,663,103 | $4,566,152 | $(903,049) | | General and administrative | $2,908,191 | $2,088,404 | $819,787 | | Total operating expenses | $6,578,134 | $6,661,396 | $(83,262) | | Loss from operations | $(6,414,518) | $(3,236,125) | $(3,178,393) | | Net loss | $(6,094,977) | $(2,891,680) | $(3,203,297) | - **Collaboration revenue decreased** by **$3.2 million**, primarily due to the immediate recognition of License revenue from the DRL Development Agreement amendment in Q2 2024[117](index=117&type=chunk) - **R&D expenses decreased** by **$0.9 million**, mainly due to a **$1.2 million** decrease in preclinical expenses, partially offset by increases in internal R&D and sponsored research[118](index=118&type=chunk) - **General and administrative expenses increased** by **$0.8 million**, driven by higher stock-based compensation (**$0.3M**), professional services (**$0.4M**), and investor relations expenses (**$0.1M**)[121](index=121&type=chunk) [Comparison of the six months ended June 30, 2025 and 2024](index=30&type=section&id=Comparison%20of%20the%20six%20months%20ended%20June%2030,%202025%20and%202024) This section analyzes the financial performance for the six-month periods, detailing revenue and expense changes Financial Performance (Six Months Ended June 30, 2025 vs 2024) | Metric | 2025 | 2024 | Change | | :-------------------------------- | :------------- | :------------- | :------------- | | Collaboration revenue | $421,500 | $3,552,109 | $(3,130,609) | | Research and development | $8,877,179 | $7,704,311 | $1,172,868 | | In-process research and development | $- | $25,000 | $(25,000) | | General and administrative | $5,622,081 | $4,528,245 | $1,093,836 | | Total operating expenses | $14,512,940 | $12,271,236 | $2,241,704 | | Loss from operations | $(14,091,440) | $(8,719,127) | $(5,372,313) | | Net loss | $(13,401,734) | $(7,943,593) | $(5,458,141) | - **Collaboration revenue decreased** by **$3.2 million**, primarily due to the immediate recognition of License revenue from the DRL Development Agreement amendment in H1 2024[124](index=124&type=chunk) - **R&D expenses increased** by **$1.2 million**, driven by increases in preclinical expenses (**$0.3M**), internal R&D (**$0.6M**), and sponsored research (**$0.3M**)[125](index=125&type=chunk) - **General and administrative expenses increased** by **$1.1 million**, mainly due to higher stock-based compensation (**$0.8M**), professional services (**$0.4M**), and investor relations expenses (**$0.2M**), partially offset by a decrease in board fees and taxes (**$0.2M**)[127](index=127&type=chunk) - Other income decreased by **$0.1 million** due to a decline in interest and dividend income[128](index=128&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, funding requirements, and cash flow activities - Since inception through June 30, 2025, the company has incurred operating losses and an **accumulated deficit** of **$54.1 million**[129](index=129&type=chunk) - **Cash and cash equivalents** were **$29.8 million** as of June 30, 2025, expected to fund operations for at least one year[129](index=129&type=chunk) - The company will need significant additional funds for operational needs, clinical trials, R&D, and business development, with no current credit facility or committed capital sources[132](index=132&type=chunk) - Future funding is expected through equity offerings, debt financings, collaborations, or licensing arrangements, which may dilute ownership or impose restrictions[133](index=133&type=chunk) [Overview (Liquidity)](index=32&type=section&id=Overview%20(Liquidity)) This section summarizes the company's financial position and expected funding duration - Since inception through June 30, 2025, the company has incurred operating losses and an **accumulated deficit** of **$54.1 million**[129](index=129&type=chunk) - **Cash and cash equivalents** were **$29.8 million** as of June 30, 2025, expected to fund operations for at least one year[129](index=129&type=chunk) [Funding Requirements](index=32&type=section&id=Funding%20Requirements) This section outlines the company's need for additional capital to support its ongoing operations and development - The company's primary use of cash is to fund operating expenses, mainly research and development expenditures[130](index=130&type=chunk) - Significant additional funds are needed for operational needs, clinical trials, R&D, and business development, with no current credit facility or committed capital sources[132](index=132&type=chunk) - Future funding is expected through equity offerings, debt financings, collaborations, or licensing arrangements, which may dilute ownership or impose restrictions[133](index=133&type=chunk) [Cash Flows](index=34&type=section&id=Cash%20Flows) This section provides a detailed breakdown of cash flows from operating, investing, and financing activities Summary of Cash Flows (Six Months Ended June 30, 2025 vs 2024) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :----------------------------- | :----------------------------- | | Cash used in operating activities | $(8,601,571) | $(2,417,693) | | Cash used in investing activities | $- | $(25,000) | | Cash provided by financing activities | $19,137 | $6,391,014 | | Net (decrease) increase in cash and cash equivalents | $(8,582,434) | $3,948,321 | - **Cash used in operating activities increased** to **$8.6 million** in H1 2025 from **$2.4 million** in H1 2024, reflecting a higher **net loss** partially offset by changes in operating assets/liabilities and non-cash charges[135](index=135&type=chunk)[136](index=136&type=chunk) - **Financing activities provided** **$19,137** in H1 2025, significantly down from **$6.4 million** in H1 2024, which included proceeds from common stock sales and warrant exercises[140](index=140&type=chunk) [DRL Development Agreement (Liquidity)](index=36&type=section&id=DRL%20Development%20Agreement%20(Liquidity)) This section reiterates the financial implications of the DRL agreement on the company's liquidity - The DRL Development Agreement grants Dr. Reddy's an exclusive license to commercialize COYA 302 for ALS in the US, Canada, EU, and UK[141](index=141&type=chunk) - The agreement includes an **upfront payment** of **$7.5 million** (received Jan 2024), potential **development milestones** up to **$40.0 million**, **sales milestones** up to **$677.3 million**, and **royalties**[143](index=143&type=chunk) - A June 2024 amendment involved a **$3.9 million** payment to Coya, in exchange for Dr. Reddy's not having to pay the first **$6.0 million** in **royalty payments**[143](index=143&type=chunk) [Commitments and Contingencies, including License and Sponsored Research Agreements (Liquidity)](index=36&type=section&id=Commitments%20and%20Contingencies,%20including%20License%20and%20Sponsored%20Research%20Agreements%20(Liquidity)) This section summarizes the company's contractual obligations and potential liabilities impacting future cash flows - Commitments include annual license fees, **milestone payments**, and **royalties** under agreements with Methodist, ARScience, and DRL[144](index=144&type=chunk)[145](index=145&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk) [Patent Know How and License Agreement with The Methodist Hospital](index=36&type=section&id=Patent%20Know%20How%20and%20License%20Agreement%20with%20The%20Methodist%20Hospital) This agreement outlines the company's licensing terms, including fees, milestones, and royalties with Methodist Hospital - The Methodist License Agreement requires annual license maintenance fees, potential **milestone payments** up to **$0.4 million** per product candidate, and tiered **royalties** (**1%** to **10%**) on net sales[144](index=144&type=chunk)[145](index=145&type=chunk) - A minimum annual payment of **$0.1 million** is owed once commercialization occurs, effective January 1, 2025[146](index=146&type=chunk) [Sponsored Research Agreement with Houston Methodist Research Institute](index=38&type=section&id=Sponsored%20Research%20Agreement%20with%20Houston%20Methodist%20Research%20Institute) This agreement details the funding and scope of the sponsored research collaboration with HMRI - The Sponsored Research Agreement (SRA) with HMRI was amended in October 2024 to increase **total funding** from **$1.0 million** to **$1.2 million**[148](index=148&type=chunk) [ARScience License Agreement](index=38&type=section&id=ARScience%20License%20Agreement) This agreement grants Coya exclusive rights to IL-2 formulations, including milestone and royalty payments - The ARS License Agreement grants Coya an exclusive, royalty-bearing license for two patents related to IL-2 formulations (COYA 301)[149](index=149&type=chunk)[150](index=150&type=chunk) - Potential developmental **milestone payments** include up to **$13.3 million** for the first Combination Product in a new indication, and **royalties** on net sales ranging from low to mid-single digit percentages[151](index=151&type=chunk) [Dr. Reddy's License and Supply Agreement](index=38&type=section&id=Dr.%20Reddy's%20License%20and%20Supply%20Agreement) This agreement details the in-licensing of DRL's biosimilar for COYA 302 development and commercialization - The DRL Agreement, effective April 1, 2023, involves in-licensing DRL_AB for COYA 302 development and commercialization in various territories[152](index=152&type=chunk) - Coya paid a **$0.4 million upfront fee** and may pay up to **$2.9 million** in pre-approval regulatory milestones and an additional **$20.0 million** for other development/sales milestones, plus single-digit **royalties** on Net Sales[152](index=152&type=chunk) [Recent Accounting Pronouncements (Liquidity)](index=38&type=section&id=Recent%20Accounting%20Pronouncements%20(Liquidity)) This section refers to the notes for details on recently issued accounting standards and their potential impact - The company refers to Note 2 of its financial statements for a description of recent accounting pronouncements applicable to its financial statements[154](index=154&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section confirms the absence of applicable market risk disclosures for the company - **Not applicable**[155](index=155&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) This section reports on the effectiveness of the company's disclosure controls and internal financial reporting controls - Disclosure controls and procedures were evaluated as **effective at the reasonable assurance level** as of June 30, 2025[156](index=156&type=chunk) - **No material changes** in internal control over financial reporting occurred during the period[157](index=157&type=chunk) [PART II – Other Information](index=40&type=section&id=PART%20II%20%E2%80%93%20Other%20Information) This section covers other information, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) This section confirms no reportable legal proceedings during the current quarter - **No legal proceedings to report**[160](index=160&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) This section updates previously disclosed risk factors, particularly regarding regulatory changes in the biopharmaceutical industry - **No material changes** to risk factors from the Annual Report on Form 10-K, except for an updated discussion on regulatory obligations and policies[161](index=161&type=chunk) - The biopharmaceutical industry is **highly regulated** and subject to changes, including judicial challenges, which could impact regulatory approval timelines and funding[162](index=162&type=chunk) - A recent U.S. Supreme Court decision (June 28, 2024) may increase **increased litigation and judicial scrutiny** of agency interpretations of law, potentially affecting FDA and other regulatory agencies[162](index=162&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section confirms no unregistered equity sales or use of proceeds to report - **None to report**[163](index=163&type=chunk) [Item 3. Defaults Upon Senior Securities](index=40&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section confirms no defaults on senior securities during the reporting period - **None to report**[164](index=164&type=chunk) [Item 4. Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that mine safety disclosures are not applicable to the company's operations - **Not applicable**[165](index=165&type=chunk) [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information) This section reports on director and officer trading arrangements during the quarter - **No directors or officers adopted or terminated** Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended June 30, 2025[166](index=166&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section lists the certifications and XBRL documents filed as exhibits to the report - **Includes certifications** from Principal Executive Officer (31.1) and Principal Financial Officer (31.2) pursuant to Sarbanes-Oxley Act[167](index=167&type=chunk) - **Includes XBRL Instance Document**, Taxonomy Extension Schema, and Cover page formatted as Inline XBRL[167](index=167&type=chunk) [Signatures](index=42&type=section&id=Signatures) This section contains the required certifications and signatures from the company's executive officers - Report **Signed by** Arun Swaminathan Ph.D., **Chief Executive Officer**, and David Snyder, **Chief Financial Officer** and **Chief Operating Officer**, on August 12, 2025[173](index=173&type=chunk)

[Corporate Update and Business Highlights](index=1&type=section&id=Corporate%20Update%20and%20Business%20Highlights) Coya Therapeutics highlights recent achievements, including an FDA submission for COYA 302 in ALS and a new patent, anticipating key catalysts and an **$8.4 million** milestone payment [Recent Corporate Highlights](index=1&type=section&id=Recent%20Corporate%20Highlights) Coya submitted additional nonclinical data for COYA 302 in ALS, published Parkinson's research, and secured a U.S. patent for an IL-2 formulation - Submitted additional nonclinical data to the FDA on June 30, 2025, to support the initiation of the COYA 302 Phase 2 trial for Amyotrophic Lateral Sclerosis (ALS)[4](index=4&type=chunk) - Published research in *Frontiers of Immunology* demonstrating a correlation between peripheral pro-inflammatory mechanisms and the progression and severity of Parkinson's Disease (PD)[4](index=4&type=chunk) - Announced U.S. patent (US 12,312,389 B2) for a stable ready-to-use liquid IL-2 formulation, for which Coya holds exclusive in-vivo rights across multiple indications[4](index=4&type=chunk) [Upcoming Expected Catalysts for 2025](index=1&type=section&id=Upcoming%20Expected%20Catalysts%20for%202025) Coya anticipates an FDA decision on COYA 302 IND for ALS by August 29, 2025, triggering an **$8.4 million** milestone payment, alongside other key data releases and IND filings - An FDA decision on the IND for COYA 302 in ALS is expected by or before August 29, 2025[4](index=4&type=chunk) - Upon IND acceptance and first patient dosing for COYA 302 in ALS, Coya is set to receive **$8.4 million** in milestone payments from its strategic partner, Dr. Reddy's Laboratories (DRL)[4](index=4&type=chunk) - Key data releases expected include ALS biomarker data, new proteomics data from a Phase 2 study in Alzheimer's disease, and top-line clinical data from a trial in Frontotemporal Dementia (FTD)[4](index=4&type=chunk) - The company plans to file an IND for a Phase 2 trial of COYA-302 in patients with FTD[9](index=9&type=chunk) [Management Commentary](index=2&type=section&id=Management%20Commentary) Management emphasizes the upcoming FDA decision for COYA 302 in ALS as a key catalyst, confirming readiness for the Phase 2 trial and planning an FTD IND submission - Management is focused on the FDA's decision for the COYA 302 IND in ALS, anticipated by the end of August, as a primary upcoming catalyst[5](index=5&type=chunk) - The company is prepared to initiate its controlled Phase 2 clinical trial in ALS pending IND clearance from the FDA[5](index=5&type=chunk) - An IND for Frontotemporal Dementia (FTD) is planned for submission by the end of the year[5](index=5&type=chunk) [Q2 2025 Financial Performance](index=2&type=section&id=Financial%20Results) Coya Therapeutics reported a significant decrease in Q2 2025 collaboration revenue to **$0.2 million**, a net loss of **$6.1 million**, and ended the quarter with **$29.8 million** in cash - As of June 30, 2025, Coya had cash and cash equivalents of **$29.8 million**[6](index=6&type=chunk) Q2 2025 vs. Q2 2024 Financial Highlights (in millions) | Financial Metric | Q2 2025 | Q2 2024 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Collaboration Revenue | $0.2 | $3.4 | -$3.2 | Decrease due to immediate revenue recognition from DRL agreement in Q2 2024 | | R&D Expenses | $3.7 | $4.6 | -$0.9 | Primarily a $1.2M decrease in preclinical expenses for COYA 302 | | G&A Expenses | $2.9 | $2.1 | +$0.8 | Increases in stock-based compensation, professional services, and investor relations | | Net Loss | $6.1 | $2.9 | +$3.2 | Driven by lower revenue and higher G&A expenses | [Product Pipeline Overview](index=3&type=section&id=Product%20Pipeline%20Overview) Coya's pipeline focuses on enhancing regulatory T cell function, with lead candidate COYA 302 for ALS and COYA 303 showing additive anti-inflammatory effects [About COYA 302](index=3&type=section&id=About%20COYA%20302) COYA 302 is an investigational subcutaneous biologic for ALS, combining LD IL-2 and CTLA-4 Ig for dual immunomodulatory effects to enhance Treg function and suppress inflammation - COYA 302 is a combination therapy of low dose interleukin-2 (LD IL-2) and CTLA-4 Ig[11](index=11&type=chunk) - It has a dual mechanism of action: enhancing anti-inflammatory Treg function and suppressing inflammation from activated monocytes and macrophages[11](index=11&type=chunk) - The therapy is being developed for subcutaneous administration to treat patients with ALS and is not yet approved by the FDA[11](index=11&type=chunk)[12](index=12&type=chunk) [About COYA 303](index=3&type=section&id=About%20COYA%20303) COYA 303 is an investigational biologic combining COYA 301 and a GLP-1 RA, showing additive or synergistic anti-inflammatory effects in preclinical studies - COYA 303 combines COYA 301 with a glucagon-like-peptide-1 receptor agonist (GLP-1 RA) for subcutaneous administration[13](index=13&type=chunk) - Preclinical studies showed a dual immunomodulatory mechanism with additive/synergistic anti-inflammatory effects[13](index=13&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) Unaudited financial statements for Q2 2025 show decreased cash and total assets, a higher net loss due to lower collaboration revenue, and significant cash used in operating activities [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2025, Coya Therapeutics reported total assets of **$33.5 million**, a decrease from year-end 2024, primarily due to lower cash and cash equivalents of **$29.8 million** Balance Sheet Summary (as of June 30, 2025) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $29,757,328 | $38,339,762 | | Total Assets | $33,452,555 | $44,347,016 | | Total Liabilities | $5,142,262 | $4,769,921 | | Total Stockholders' Equity | $28,310,293 | $39,577,095 | [Condensed Unaudited Interim Statements of Operations](index=7&type=section&id=Condensed%20Unaudited%20Interim%20Statements%20of%20Operations) For Q2 2025, Coya reported collaboration revenue of **$163,616**, a significant decline, leading to a widened net loss of **$6.1 million** or **($0.36)** per share Statement of Operations Summary (Three Months Ended June 30) | Account | 2025 | 2024 | | :--- | :--- | :--- | | Collaboration revenue | $163,616 | $3,425,271 | | Research and development | $3,663,103 | $4,566,152 | | General and administrative | $2,908,191 | $2,088,404 | | Total operating expenses | $6,578,134 | $6,661,396 | | Net loss | $(6,094,977) | $(2,891,680) | | Net loss per share | $(0.36) | $(0.19) | [Condensed Unaudited Interim Statements of Cash Flows](index=8&type=section&id=Condensed%20Unaudited%20Interim%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities was **$8.6 million**, resulting in a net decrease in cash and cash equivalents to **$29.8 million** Statement of Cash Flows Summary (Six Months Ended June 30) | Account | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,601,571) | $(2,417,693) | | Net cash provided by financing activities | $19,137 | $6,391,014 | | Net (decrease) increase in cash | $(8,582,434) | $3,948,321 | | Cash and cash equivalents at end of period | $29,757,328 | $36,575,089 | [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This report contains forward-looking statements regarding Coya's financial performance, business plans, and clinical development, which are subject to various risks and uncertainties - The report includes forward-looking statements concerning financial performance, business plans, clinical trial timing and success, regulatory approvals, and market opportunities[16](index=16&type=chunk) - These statements are subject to significant risks and uncertainties, including those related to clinical trial outcomes, funding, regulatory approvals, market acceptance, and competition[17](index=17&type=chunk)

HOUSTON, Aug. 12, 2025 /PRNewswire/ -- Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, provides a corporate update and announces its financial results for the quarter ended June 30, 2025. Recent Corporate Highlights Upcoming Expected Catalysts for 2025 Coya's Chief Executive Officer Arun Swaminathan, Ph.D. commented, "As we look ...

Group 1 - Coya Therapeutics, Inc. (COYA) shares increased by 10.7% to close at $6.72, driven by notable trading volume [1] - The rise in stock price is linked to positive investor expectations regarding Coya Therapeutics' pipeline for neurodegenerative diseases, particularly the upcoming phase II study of COYA-302 for amyotrophic lateral sclerosis [2] - The company is projected to report a quarterly loss of $0.22 per share, a year-over-year decline of 15.8%, while revenues are expected to reach $4.2 million, reflecting a 22.8% increase from the previous year [3] Group 2 - The consensus EPS estimate for Coya Therapeutics has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without earnings estimate revisions [4] - Coya Therapeutics is classified under the Zacks Medical - Biomedical and Genetics industry, where another company, Absci Corporation (ABSI), experienced a 0.3% decline in its stock price [4] - Absci Corporation's consensus EPS estimate has decreased by 10% over the past month, with a year-over-year change of +9.1%, and it currently holds a Zacks Rank of 4 (Sell) [5]

Summary of Coia Therapeutics Inc. Presentation Company Overview - **Company**: Coia Therapeutics Inc. - **Focus**: Development of therapies for neurodegenerative diseases such as ALS, frontotemporal dementia, Alzheimer's disease, and Parkinson's disease [4][6][10]. Core Points and Arguments - **Vision**: To improve the quality of life for patients with neurodegenerative diseases, shifting the narrative from their illness to their life stories [4]. - **Target Diseases**: - **ALS**: High unmet need with few treatment options; patients typically have a life expectancy of 3-4 years post-diagnosis [5]. - **Frontotemporal Dementia**: No FDA-approved therapies available [5]. - **Alzheimer's and Parkinson's Diseases**: Significant societal impact, affecting both patients and caregivers [6]. - **Scientific Approach**: Focus on neuroinflammation and regulatory T cell dysfunction as a mechanism to potentially halt disease progression [6][13]. - **Pipeline**: - **COIA-302**: A proprietary combination therapy targeting ALS and other neurodegenerative diseases [16]. - **Combination Strategy**: Utilizes low-dose interleukin-2 and CTLA-4 to enhance Treg function and combat neuroinflammation [16][18]. Financial and Strategic Position - **Partnership**: Strategic collaboration with Dr. Reddy's, valued at over $700 million, providing non-dilutive funding and expertise [8][19]. - **Investor Base**: Strong backing from notable investors including Greenlight Capital and David Einhorn [7]. - **Cash Runway**: Strong financial position with a clean cap table [7]. Clinical Data and Milestones - **Promising Results**: Initial trials show potential to stop progression of ALS, with patients maintaining stable ALSFRS scores over six months [22][23]. - **Upcoming Milestones**: - Submission of data for a Phase 2b study in ALS to the FDA [10]. - Anticipated IND filing for frontotemporal dementia [11]. - Ongoing studies in Alzheimer's disease showing ability to halt cognitive decline [25][26]. Market Potential - **Commercial Opportunity**: High sales potential in orphan diseases like ALS and frontotemporal dementia due to lack of existing therapies, estimated in billions of dollars [13]. - **Regulatory Flexibility**: Orphan disease designation may facilitate faster market entry [6]. Additional Insights - **Combination Therapy Potential**: Research indicates that combining COIA-302 with GLP-1 agonists may enhance efficacy in treating Alzheimer's disease [28][29]. - **External Validation**: Support from the Alzheimer's Drug Discovery Foundation reinforces the credibility of Coia's approach [12]. Conclusion - **Future Outlook**: Coia Therapeutics is positioned for significant advancements in the treatment of neurodegenerative diseases, with multiple key milestones expected in the near future [30].