Group 1: Financial Performance - Coya Therapeutics, Inc. reported a quarterly loss of $0.36 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.22, marking an earnings surprise of -63.64% [1] - The company posted revenues of $0.16 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 96.1%, compared to revenues of $3.42 million a year ago [2] - Over the last four quarters, the company has surpassed consensus EPS estimates only once [2] Group 2: Stock Performance and Outlook - Coya Therapeutics, Inc. shares have increased by approximately 7.3% since the beginning of the year, while the S&P 500 has gained 8.4% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.24 on revenues of $4.2 million, and for the current fiscal year, it is -$1.49 on revenues of $5.53 million [7] - The estimate revisions trend for Coya Therapeutics, Inc. was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] Group 3: Industry Context - The Medical - Biomedical and Genetics industry, to which Coya Therapeutics, Inc. belongs, is currently ranked in the bottom 43% of over 250 Zacks industries, suggesting potential challenges for stock performance [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

[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)

Corporate Update - Coya Therapeutics, Inc. is focused on developing biologics that enhance regulatory T cell function in neurodegenerative disorders [1] - The company is awaiting a decision from the FDA on its IND application for COYA 302 in ALS, expected by the end of August 2025 [4] - Coya plans to submit an IND for Frontotemporal Dementia (FTD) by the end of 2025 [4] Financial Results - As of June 30, 2025, Coya had cash and cash equivalents of $29.8 million, down from $38.3 million at the end of 2024 [5][18] - Collaboration revenues for the quarter were $0.2 million, a decrease of approximately $3.3 million compared to $3.4 million in the same quarter of 2024 [5] - Research and development expenses were $3.7 million, down from $4.6 million in the previous year, primarily due to a decrease in preclinical expenses [6] - General and administrative expenses increased to $2.9 million from $2.1 million year-over-year, attributed to higher stock-based compensation and professional services [8] - The net loss for the quarter was $6.1 million, compared to a net loss of $2.9 million for the same period in 2024 [9][20] Upcoming Catalysts - The company is preparing to initiate a controlled Phase 2 clinical trial in ALS pending FDA clearance for COYA 302 [4] - Coya expects to receive milestone payments of $8.4 million from Dr. Reddy's Laboratories upon IND acceptance and first patient dosing of COYA 302 in ALS [7] - Additional nonclinical data to support the start of the COYA 302 Phase 2 trial was submitted to the FDA on June 30, 2025 [7] Product Pipeline - COYA 302 is an investigational biologic combination therapy aimed at enhancing the anti-inflammatory function of regulatory T cells and is being developed for ALS [10][11] - COYA 303 is another investigational product designed for subcutaneous administration, exhibiting a dual immunomodulatory mechanism of action in preclinical studies [12] Research Developments - Recent scientific research published in Frontiers of Immunology linked inflammation and oxidative stress to the progression of Parkinson's Disease [7] - Coya reported new proteomics data from a completed Phase 2 study of low-dose interleukin-2 in Alzheimer's disease [7]

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].

Financial Data and Key Metrics Changes - COYA Therapeutics is publicly traded on NASDAQ under the ticker symbol COYA, with a buy rating and a twelve-month price target of $18 per share [2] - The company anticipates receiving $8.4 million upon IND approval and trial initiation, with a total deal value of $700 million from the partnership with Dr. Reddy's [18][19] Business Line Data and Key Metrics Changes - The primary focus is on neuroinflammation, which is believed to drive the progression of neurodegenerative diseases [4] - COYA's lead asset, COIA-302, is prioritized for ALS, with an IND filing expected by the end of the current quarter and a Phase IIb trial planned [11][12] Market Data and Key Metrics Changes - The company is targeting niche orphan indications like ALS and frontotemporal dementia, while also pursuing mass market indications like Alzheimer's [9] - The current landscape for ALS trials has become more favorable for recruitment due to the withdrawal of other products, which has created enthusiasm among trial sites [20][22] Company Strategy and Development Direction - COYA aims to maximize value by pursuing both niche and broader market opportunities, with a focus on ALS and frontotemporal dementia for regulatory flexibility [10] - The company plans to continue generating data in frontotemporal dementia and Alzheimer's, while also exploring strategic partnerships to enhance its market position [43][45] Management's Comments on Operating Environment and Future Outlook - Management believes that the FDA remains receptive to ALS drug approvals if data supports it, despite recent challenges in the market [21][23] - The company is confident in its approach to neuroinflammation and its potential to address unmet needs in Alzheimer's disease, which is characterized by a lack of effective treatments [30][31] Other Important Information - COYA is developing a regulatory T cell-derived exosome platform aimed at treating systemic and neurodegenerative diseases driven by chronic neuroinflammation, which complements its existing programs [40][42] - The partnership with Dr. Reddy's provides COYA with a strategic advantage and a steady line of sight to non-dilutive funding [45] Q&A Session Summary Question: What is the current focus for COYA Therapeutics? - The immediate focus is on filing for ALS and starting the ALS study, which is expected to be a significant value driver [43] Question: How has the regulatory environment changed for ALS? - There has been no communicated change from the FDA, and recruitment for ALS trials is expected to be easier due to fewer ongoing trials [21][22] Question: What are the expected outcomes for future clinical development? - Relevant outcome measures will include Treg function and cognitive scales, with a focus on stabilizing or improving cognition in Alzheimer's patients [36][38]

PART I - Financial Information [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company presents unaudited Q1 2025 financials showing a $7.3 million net loss and an accumulated deficit of $48.0 million, raising going concern doubts Condensed Balance Sheet Data (Unaudited) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $35,530,624 | $38,339,762 | | Total current assets | $38,373,248 | $44,308,428 | | Total assets | $38,404,996 | $44,347,016 | | Total current liabilities | $4,341,004 | $3,824,474 | | Total liabilities | $5,035,439 | $4,769,921 | | Accumulated deficit | $(48,043,927) | $(40,737,170) | | Total stockholders' equity | $33,369,557 | $39,577,095 | Condensed Statements of Operations (Unaudited) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Collaboration revenue | $257,884 | $126,838 | | Research and development expenses | $5,214,076 | $3,138,159 | | General and administrative expenses | $2,713,890 | $2,439,841 | | Loss from operations | $(7,676,922) | $(5,483,002) | | Net loss | $(7,306,757) | $(5,051,913) | | Net loss per share, basic and diluted | $(0.44) | $(0.35) | Condensed Statements of Cash Flows (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | $(2,828,275) | $2,145,874 | | Net cash used in investing activities | $0 | $(25,000) | | Net cash provided by financing activities | $19,137 | $1,241,764 | | Net (decrease) increase in cash | $(2,809,138) | $3,362,638 | - The company has incurred losses since inception, with an **accumulated deficit of $48.0 million** as of March 31, 2025; management expects its **$35.5 million in cash** to fund operations for at least one year but requires substantial future financing[18](index=18&type=chunk)[19](index=19&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses a Q1 2025 net loss of $7.3 million, driven by a $2.1 million increase in R&D expenses, and confirms sufficient cash for the next year [Overview](index=26&type=section&id=Overview) The company is a clinical-stage biotech focused on Treg therapies, reporting a Q1 2025 net loss of $7.3 million and an accumulated deficit of $48.0 million - The company's core focus is on developing proprietary therapies to enhance the function of regulatory T cells (Tregs) to address dysfunction in neurodegenerative, autoimmune, and metabolic diseases[90](index=90&type=chunk)[91](index=91&type=chunk) - The lead asset, **COYA 302**, is a combination of proprietary low-dose interleukin-2 and CTLA4-Ig, considered a 'Pipeline in a Product' due to its potential across multiple indications[93](index=93&type=chunk) - The company incurred a **net loss of $7.3 million** in Q1 2025 and had an **accumulated deficit of $48.0 million** as of March 31, 2025[93](index=93&type=chunk) [Recent Developments](index=28&type=section&id=Recent%20Developments) The company expanded its pipeline with COYA 303 in January 2025 and published positive preclinical results in April showing enhanced Treg function - On January 21, 2025, the company expanded its pipeline with a new product candidate, **COYA 303**, a combination of COYA 301 and a GLP-1 receptor agonist for inflammatory diseases[97](index=97&type=chunk) - A preclinical study published on April 21, 2025, showed that COYA 303 produced a statistically significant **increase in Treg suppressive function of 42%** (p < 0.001) and promoted Treg survival[98](index=98&type=chunk)[100](index=100&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) The Q1 2025 net loss widened to $7.3 million from $5.1 million year-over-year, driven by a $2.1 million increase in R&D expenses for COYA 302 Comparison of Operations for the Three Months Ended March 31 | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $257,884 | $126,838 | $131,046 | | Research and development | $5,214,076 | $3,138,159 | $2,075,917 | | General and administrative | $2,713,890 | $2,439,841 | $274,049 | | Loss from operations | $(7,676,922) | $(5,483,002) | $(2,193,920) | | Net loss | $(7,306,757) | $(5,051,913) | $(2,254,844) | - **R&D expenses increased by $2.1 million**, primarily due to a **$1.5 million increase** in preclinical expenses for the advancement of COYA 302 in ALS[116](index=116&type=chunk) - **G&A expenses increased by $0.3 million**, mainly due to a **$0.4 million increase** in stock-based compensation, partially offset by a $0.2 million decrease in board fees and taxes[118](index=118&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $35.5 million in cash, sufficient for at least one year, but will require significant additional capital for future clinical trials - As of March 31, 2025, the company had **$35.5 million in cash** and cash equivalents and an **accumulated deficit of $48.0 million**, with cash expected to fund operations for at least one year[120](index=120&type=chunk) Summary of Cash Flows | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Cash (used in) provided by operating activities | $(2,828,275) | $2,145,874 | | Cash provided by financing activities | $19,137 | $1,241,764 | - The DRL Development Agreement provides for potential future milestone payments, including **$4.2 million upon FDA acceptance of an IND** for COYA 302 and another **$4.2 million upon dosing of the first patient** in a Phase 2 trial[136](index=136&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, this section is not applicable, indicating no significant market risk exposure requiring disclosure - The company states this section is **'Not applicable'**[149](index=149&type=chunk) [Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls - Based on an evaluation as of March 31, 2025, management concluded that the company's disclosure controls and procedures were **effective** at the reasonable assurance level[150](index=150&type=chunk) - There were **no material changes** in internal control over financial reporting during the quarter that are reasonably likely to materially affect the company's internal controls[151](index=151&type=chunk) PART II - Other Information [Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company reports it is not currently involved in any legal proceedings - The company reports **'None'** for legal proceedings[154](index=154&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) The company confirms no material changes to the risk factors previously disclosed in its 2024 Annual Report on Form 10-K - There have been **no material changes** from the risk factors disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[155](index=155&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=42&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - The company reports **'None'** for unregistered sales of equity securities[156](index=156&type=chunk) [Other Information](index=42&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during the first quarter of 2025 - During the quarter ended March 31, 2025, **none of the company's directors or officers adopted or terminated a Rule 10b5-1 trading arrangement**[159](index=159&type=chunk) [Exhibits](index=42&type=section&id=Item%206.%20Exhibits) This section lists filed exhibits, including required officer certifications and Inline XBRL documents - The report includes required certifications from the CEO and CFO (Exhibits 31.1, 31.2, 32.1) and **Inline XBRL data files**[160](index=160&type=chunk)

Financial Performance - As of March 31, 2025, Coya Therapeutics had cash and cash equivalents of $35.5 million, down from $38.3 million at the end of 2024[6][21]. - The net loss for Q1 2025 was $7.3 million, compared to a net loss of $5.1 million for Q1 2024, representing a 43% increase in losses year-over-year[9][23]. - Net loss for the period was $7,306,757, compared to a loss of $5,051,913 in the previous period[27]. - Net cash used in operating activities was $(2,828,275), a decrease from $2,145,874 in the prior period[27]. Expenses - Research and development (R&D) expenses increased to $5.2 million for Q1 2025, compared to $3.1 million for Q1 2024, primarily due to a $1.5 million rise in preclinical expenses related to COYA 302[7]. - General and administrative expenses were $2.7 million for Q1 2025, up from $2.4 million in Q1 2024, reflecting a $0.4 million increase in stock-based compensation[8]. - Stock-based compensation increased significantly to $1,080,082 from $435,663[27]. - Accrued expenses showed a significant change, increasing by $421,523 compared to a decrease of $844,745 in the previous period[27]. Revenue - Collaboration revenue for Q1 2025 was $257,884, compared to $126,838 in Q1 2024, indicating a 103% increase[23]. - Deferred collaboration revenue increased by $257,884 compared to a decrease of $126,838 in the prior period[27]. Assets and Liabilities - Coya's total liabilities as of March 31, 2025, were $5.0 million, compared to $4.8 million at the end of 2024[21]. - Collaboration receivable decreased by $7,500,000[27]. - Accounts payable decreased to $101,879 from $477,265[27]. Clinical Development - Coya anticipates submitting an IND for the COYA 302 Phase 2 trial in ALS during Q2 2025, with potential milestone payments of $8.4 million from Dr. Reddy's Laboratories upon IND acceptance[4][5]. - The company reported significant improvements in inflammatory blood markers from a 21-week Phase 2 study of low-dose IL-2 in Alzheimer's disease patients[4]. - Coya's investigational product candidate pipeline includes COYA 303 and COYA 301, aimed at treating inflammatory diseases, with new intellectual property filings for the combination[4]. - The company plans to submit an IND for Frontotemporal Dementia (FTD) by the end of 2025, followed by a controlled Phase 2 clinical trial[5].

Core Insights - Sibylla Biotech has appointed Dieter Weinand as Chairman of its Board of Directors, bringing over 35 years of experience in the pharmaceutical sector [1][4] - The company aims to advance its innovative PPI-FIT technology and pipeline of folding interference small molecules to address challenging therapeutic areas [1][3] Company Overview - Sibylla Biotech is focused on transforming drug discovery by targeting protein folding intermediates, which represents a new druggable dimension in pharmacology [6] - The proprietary PPI-FIT technology allows the company to predict and target intermediate steps in the protein folding process, leading to targeted protein degradation [6][7] Leadership Background - Dieter Weinand has a distinguished career, having held significant roles at major pharmaceutical companies such as Bayer Pharmaceuticals AG, Sanofi, Bristol-Meyers Squibb, and Pfizer [4][5] - His leadership experience includes overseeing the integration of R&D, manufacturing, and commercial functions, contributing to the launch of several high-impact medicines [4] Strategic Vision - The appointment of Mr. Weinand is seen as a strategic move to unlock access to previously undruggable targets and drive the next stages of Sibylla's growth [2][3] - The company is building a pipeline of treatments for high medical need diseases across multiple therapeutic areas, with a mission to bring protein folding interference therapeutics to patients [7]