a Therapeutics(COYA) - 2025 Q2 - Quarterly Results

Corporate Update and Business Highlights 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 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] - 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] - 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] Upcoming Expected Catalysts for 2025 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] - 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] - 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] - The company plans to file an IND for a Phase 2 trial of COYA-302 in patients with FTD[9] Management Commentary 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] - The company is prepared to initiate its controlled Phase 2 clinical trial in ALS pending IND clearance from the FDA[5] - An IND for Frontotemporal Dementia (FTD) is planned for submission by the end of the year[5] Q2 2025 Financial Performance 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] 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 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 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] - It has a dual mechanism of action: enhancing anti-inflammatory Treg function and suppressing inflammation from activated monocytes and macrophages[11] - The therapy is being developed for subcutaneous administration to treat patients with ALS and is not yet approved by the FDA[11][12] About COYA 303 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] - Preclinical studies showed a dual immunomodulatory mechanism with additive/synergistic anti-inflammatory effects[13] Financial Statements 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 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 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 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 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] - These statements are subject to significant risks and uncertainties, including those related to clinical trial outcomes, funding, regulatory approvals, market acceptance, and competition[17]