a Therapeutics(COYA) - 2025 Q1 - Quarterly Report

PART I - Financial Information Financial Statements 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][19] Management's Discussion and Analysis of Financial Condition and Results of Operations 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 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][91] - 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] - 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] Recent Developments 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] - 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][100] Results of Operations 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] - 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] Liquidity and Capital Resources 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] 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] Quantitative and Qualitative Disclosures About Market Risk 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] Controls and Procedures 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] - 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] PART II - Other Information Legal Proceedings The company reports it is not currently involved in any legal proceedings - The company reports 'None' for legal proceedings[154] Risk Factors 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] Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities during the period - The company reports 'None' for unregistered sales of equity securities[156] Other Information 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] Exhibits 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]