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a Therapeutics(COYA) - 2025 Q2 - Quarterly Report
a Therapeuticsa Therapeutics(US:COYA)2025-08-12 12:08

PART I – Financial Information This section presents the company's financial information, including statements and management's discussion Item 1. Financial Statements This section presents the company's unaudited condensed interim financial statements and detailed notes Condensed Balance Sheets 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 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 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 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 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 - 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, 202520 - 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 year21 1. Organization and description of business 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 diseases19 - The company has an accumulated deficit of $54.1 million as of June 30, 2025, and anticipates further losses until significant product sales are generated20 - Current cash of $29.8 million is expected to cover operating expenses for at least one year, but substantial additional financing will be needed21 2. Basis of presentation and significant accounting policies 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 adjustments2425 - Management makes estimates and assumptions, particularly for stock options, DRL Development Agreement transaction price allocation, and R&D expenses2627 - The Company operates as one segment, with the CEO managing operations on a consolidated basis and assessing performance based on net loss and cash burn282930 - Collaboration revenue is primarily from the DRL Development Agreement, recognized by analogizing to ASC 606, including upfront license fees, milestone payments, and royalties3233 - Research and development costs are expensed as incurred, including third-party services, clinical/preclinical development, manufacturing, regulatory compliance, and personnel costs40 - Stock-based compensation is measured at grant-date fair value and expensed over the vesting period, using the Black-Scholes model with subjective assumptions4344 - A full valuation allowance is applied to all net deferred tax assets due to the unlikelihood of realization46 - Potentially dilutive securities (warrants, stock options) are excluded from diluted EPS calculation due to anti-dilutive effect from net loss4748 - The company is evaluating the impact of recently issued FASB ASUs on income tax disclosures (ASU 2023-09) and expense disaggregation (ASU 2024-03)4950 3. Fair value measurements 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 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 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 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 $20.0M56 - 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)5758 - 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)5960 - 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 funded62 7. Stockholders' equity 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 202967 - No warrants were granted during the three and six months ended June 30, 202565 8. Stock-based compensation 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 issuance68 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 years71 - 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 9. DRL Development Agreement 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 UK74 - Received an upfront payment of $7.5 million in January 202478 - 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 trial78 - 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-teens78 - 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 payments7678 - 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 202482117 10. Subsequent events 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 limitations83 - The FDA expects to provide a decision on IND approval no later than August 29, 202583 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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 diseases9091 - 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 ALS9293 - 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, respectively93 - 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 future9395 - Substantial additional capital will be needed to fund operations, advance product candidates, and pursue growth strategies97 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS 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 expectations86 - 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 property87 - The company disclaims any obligation to update or revise forward-looking statements89 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 diseases9091 - 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 ALS9293 - 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 expenses9395 - Future operations will require substantial additional capital, to be financed through equity, debt, or collaborations97 Recent Developments 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 agents98 - 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 rights100 - Re-submitted an IND for COYA 302 in ALS on June 30, 2025, including previously requested non-clinical data for a planned Phase 2 study101 - 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, 2025102 Components of Results of Operations 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 future103 - Research and Development Expenses: Expensed as incurred, covering discovery, preclinical/clinical studies, sponsored research, personnel, manufacturing, regulatory activities, and facility costs104106 - In-Process Research and Development: Costs for technology licenses are expensed if the technology has not reached technological feasibility and has no alternative future use110 - 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 operations111112 - Other Income: Consists of interest earned on excess cash114 - 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 probable115 Results of Operations 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) million116 - 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) million123 Comparison of the three months ended June 30, 2025 and 2024 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 2024117 - 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 research118 - 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 Comparison of the six months ended June 30, 2025 and 2024 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 2024124 - 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 - 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 - Other income decreased by $0.1 million due to a decline in interest and dividend income128 Liquidity and Capital Resources 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 million129 - Cash and cash equivalents were $29.8 million as of June 30, 2025, expected to fund operations for at least one year129 - 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 sources132 - Future funding is expected through equity offerings, debt financings, collaborations, or licensing arrangements, which may dilute ownership or impose restrictions133 Overview (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 million129 - Cash and cash equivalents were $29.8 million as of June 30, 2025, expected to fund operations for at least one year129 Funding Requirements 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 expenditures130 - Significant additional funds are needed for operational needs, clinical trials, R&D, and business development, with no current credit facility or committed capital sources132 - Future funding is expected through equity offerings, debt financings, collaborations, or licensing arrangements, which may dilute ownership or impose restrictions133 Cash Flows 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 charges135136 - 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 exercises140 DRL Development Agreement (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 UK141 - 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 royalties143 - 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 payments143 Commitments and Contingencies, including License and Sponsored Research Agreements (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 DRL144145151152 Patent Know How and License Agreement with The Methodist Hospital 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 sales144145 - A minimum annual payment of $0.1 million is owed once commercialization occurs, effective January 1, 2025146 Sponsored Research Agreement with Houston Methodist Research Institute 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 million148 ARScience License Agreement 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)149150 - 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 percentages151 Dr. Reddy's License and Supply Agreement 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 territories152 - 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 Sales152 Recent Accounting Pronouncements (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 statements154 Item 3. Quantitative and Qualitative Disclosures About Market Risk This section confirms the absence of applicable market risk disclosures for the company - Not applicable155 Item 4. Controls and Procedures 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, 2025156 - No material changes in internal control over financial reporting occurred during the period157 PART II – Other Information This section covers other information, including legal proceedings, risk factors, and exhibits Item 1. Legal Proceedings This section confirms no reportable legal proceedings during the current quarter - No legal proceedings to report160 Item 1A. Risk Factors 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 policies161 - The biopharmaceutical industry is highly regulated and subject to changes, including judicial challenges, which could impact regulatory approval timelines and funding162 - 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 agencies162 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section confirms no unregistered equity sales or use of proceeds to report - None to report163 Item 3. Defaults Upon Senior Securities This section confirms no defaults on senior securities during the reporting period - None to report164 Item 4. Mine Safety Disclosures This section states that mine safety disclosures are not applicable to the company's operations - Not applicable165 Item 5. Other Information 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, 2025166 Item 6. Exhibits 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 Act167 - Includes XBRL Instance Document, Taxonomy Extension Schema, and Cover page formatted as Inline XBRL167 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, 2025173