COYA-302

HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, provides a corporate update and announces its financial results for the year ended December 31, 2024. Corporate Highlights FY2024 to Date Announced significant improvements of inflammatory blood markers from an investigator-initiated, 21-week, double-blind, placebo-controlled, exploratory Phase 2 study of low-dose interleukin-2 (LD IL-2) in patients with Alzheimer’s disease (AD) Announced that five of eight patients have been enrolled in the investigator-initiated academic study of LD IL-2 + CTLA4-Ig combination in patients with Frontotemporal Dementia (FTD) Announced positive results from an investigator initiated double-blind study of low-dose interleukin-2 (LD IL-2) in patients with mild to moderate Alzheimer’s Disease (AD) at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) in Madrid. The study was titled, “A Phase II Clinical Trial of Interleukin-2 (IL-2) in Patients with Mild to Moderate Alzheimer's Disease” Aligned with FDA on the non-clinical data needed to support the planned randomized, double-blind, placebo-controlled, Phase 2b trial of COYA-302 in patients with Amyotrophic Lateral Sclerosis (ALS) Announced expansion of pipeline- COYA 303; COYA 301 in combination with GLP-1 Receptor Agonist for treatment of inflammatory diseases and filing of new intellectual property portfolio for the combination Financial Highlights FY 2024 Raised $10.0M in a private placement of 1.38M shares of common stock. The majority of investors in the offering were existing institutional shareholders of company Received $5.0 million strategic investment by the Alzheimer’s Drug Discovery Foundation (ADDF) to help support the development of COYA 302 for the treatment of Frontotemporal Dementia (FTD) Received $3.85 million from the previously announced First Amendment and License Agreement with Dr. Reddy’s Laboratories, Inc., which is earmarked for funding the first Phase 2 clinical trial of COYA 302 in ALS in the United States. The original agreement was entered into on December 5, 2023. Upcoming Expected Catalysts for 2025 Q2 2025: Submission of additional nonclinical data to support the start of the COYA-302 Phase 2 trial in patients with ALS Upon IND acceptance and first patient dosing of COYA-302 in ALS, eligible to receive milestone payments of $8.4 million from strategic partner, Dr. Reddy’s Laboratories (DRL) Q2 2025: Publication of COYA-303 combination mechanistic data Q2 2025: Publication of data documenting role of inflammation in Parkinson’s Disease Q2 2025: ALS Biomarker data. Publication of longitudinal data on Neurofilament Light Chain (NfL) and oxidative stress markers in patients with ALS 2H 2025: Additional single cell proteomics data from the completed investigator-initiated, 21-week, double-blind, placebo-controlled, exploratory Phase 2 study of low-dose interleukin-2 (LD IL-2) in patients with Alzheimer’s disease (AD) 2H 2025: Top-line clinical data release for an investigator-initiated trial combining LD IL-2 + CTLA4-Ig in patients with FTD 2H 2025: Filing of IND for the COYA-302 Phase 2 trial in patients with FTD* (*Clinical trial initiated upon FDA IND approval) Coya CEO Arun Swaminathan, Ph.D. commented, “We remain encouraged by the progress we made in 2024 and are well positioned for continued success in 2025. We continue to expand our pipeline while making significant progress on our ongoing programs in neurodegenerative diseases with high unmet need, and we are on track to initiate the randomized, double-blind controlled Phase 2b trial in patients with ALS upon IND acceptance. “Our drug candidates all target neuroinflammation, which we see as a key driving factor towards disease progression in the neurological conditions we are addressing. Moreover, our approach to potential combination therapies for treatment of these neurodegenerative diseases differentiates us from other companies and offers, what we believe, a more potent treatment paradigm that could potentially lead to new options for patients and create meaningful shareholder value. “The strong scientific and clinical rationale, our strong cash position and potential for new business development opportunities all together strengthens our optimism about our ability to execute on our corporate, clinical and regulatory goals and continue to build value. I look forward to sharing additional corporate, clinical, and regulatory progress as appropriate,” concluded Swaminathan. Coya CMO, Dr. Fred Grossman said, “As we have indicated in the past, we expect 2025 to hold important milestones for the Company, including initiating the phase 2b trial of COYA 302, which is the combination of LD-IL2 and CTLA 4 IG, in ALS patients. We are on track for submission of all required nonclinical data to the FDA to support the initiation of the Phase 2 trial in patients with ALS. Additionally, we will be submitting an IND for a phase 2b study of COYA 302 in FTD patients. Clinical data from an investigator initiated clinical trial of combination of LD IL-2 and CTLA 4 IG will be reported and will support the planned phase 2b trial of COYA 302 n FTD.” Financial Results As of December 31, 2024, Coya had cash and cash equivalents of $38.3 million. Research and development (R&D) expenses were $11.9 million for the year ended December 31, 2024, compared to $5.5 million for the year ended December 31, 2023. The change was primarily due to a $5.0 million increase in our preclinical expenses, a $1.1 million increase in internal research and development expenses, and a $0.3 million increase in costs attributable to our sponsored research agreement with Houston Methodist Hospital. General and administrative expenses were $8.9 million for the year ended December 31, 2024, and $7.8 million for the year ended December 31, 2023, a change of approximately $1.1 million. The increase was primarily due to a $1.2 million increase in payroll and employee related benefits, a $0.3 million increase in franchise taxes and license fees and $0.2 million increase in our investor and public relations costs, partially offset by a $0.2 million decrease in insurance fees and a $0.4 million decrease in professional service fees. Net loss was $14.9 million for the year ended December 31, 2024, compared to net loss of $8.0 million for the year ended December 31, 2023. About Coya Therapeutics, Inc. Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. COYA 302 – the Company’s lead biologic investigational product or "Pipeline in a Product" – is a proprietary combination of COYA 301 (Coya’s proprietary LD IL-2) and CTLA4-Ig for subcutaneous administration with a unique dual mechanism of action that is now being developed for the treatment of Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Parkinson’s Disease, and Alzheimer’s Disease. Its multi-targeted approach enhances the number and anti-inflammatory function of Tregs and simultaneously lowers the expression of activated microglia and the secretion of pro-inflammatory mediators. This synergistic mechanism may lead to the re-establishment of immune balance and amelioration of inflammation in a sustained and durable manner that may not be achieved by either low-dose IL-2 or CTLA4-Ig alone. For more information about Coya, please visit www.coyatherapeutics.com. Forward-Looking Statements This press release contains “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or will occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. BALANCE SHEETS (Audited) December 31, 2024 2023 Assets Current assets: Cash and cash equivalents $ 38,339,762 $ 32,626,768 Collaboration receivables - 7,500,000 Prepaids and other current assets 5,968,666 1,069,557 Total current assets 44,308,428 41,196,325 Fixed assets, net 38,588 65,949 Total assets $ 44,347,016 $ 41,262,274 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 1,588,128 $ 1,155,656 Accrued expenses 1,388,060 2,973,215 Deferred collaboration revenue 848,286 923,109 Total current liabilities 3,824,474 5,051,980 Deferred collaboration revenue 945,447 574,685 Total liabilities 4,769,921 5,626,665 Stockholders' equity: Series A convertible preferred stock, $0.0001 par value: 10,000,000 shares authorized, none issued and outstanding as of December 31, 2024 and 2023 - - Common stock, $0.0001 par value; 200,000,000 shares authorized; 16,707,441 and 14,405,325 shares issued and outstanding as of December 31, 2024 and 2023, respectively 1,671 1,441 Additional paid-in capital 80,312,594 61,501,801 Subscription receivable - (11,250 ) Accumulated deficit (40,737,170 ) (25,856,383 ) Total stockholders' equity 39,577,095 35,635,609 Total liabilities and stockholders' equity $ 44,347,016 $ 41,262,274 STATEMENTS OF OPERATIONS (Audited) Years Ended December 31, 2024 2023 Collaboration revenue $ 3,554,061 $ 6,002,206 Operating expenses: Research and development 11,865,654 5,501,527 In-process research and development 25,000 543,186 General and administrative 8,885,757 7,833,481 Depreciation 27,361 27,361 Total operating expenses 20,803,772 13,905,555 Loss from operations (17,249,711 ) (7,903,349 ) Other income: Other income, net 1,648,637 639,365 Pre-tax loss (15,601,074 ) (7,263,984 ) Income tax benefit (expense) 720,287 (723,852 ) Net loss $ (14,880,787 ) $ (7,987,836 ) Share information: Net loss per share of common stock, basic and diluted $ (0.98 ) $ (0.79 ) Weighted-average shares of common stock outstanding, basic and diluted 15,238,919 10,163,850 STATEMENTS OF CASH FLOWS (Audited) Years Ended December 31, 2024 2023 Cash flows from operating activities: Net loss $ (14,880,787 ) $ (7,987,836 ) Adjustment to reconcile net loss to net cash used in operating activities: Depreciation 27,361 27,361 Stock-based compensation, including the issuance of restricted stock 2,663,539 872,248 Acquired in-process research and development 25,000 543,186 Changes in operating assets and liabilities: Collaboration receivable 7,500,000 (7,500,000 ) Prepaids and other current assets (4,899,109 ) 181,707 Accounts payable 477,450 298,816 Accrued expenses (1,498,215 ) 877,913 Deferred collaboration revenue 295,939 1,497,794 Net cash used in operating activities (10,288,822 ) (11,188,811 ) Cash flows from investing activities: Purchase of in-process research and development assets (25,000 ) (543,186 ) Net cash used in investing activities (25,000 ) (543,186 ) Cash flows from financing activities: Proceeds from sale of common stock from 2023 Private Placement, net of offering costs - 24,084,805 Proceeds from issuance of common stock upon IPO, net of offering costs - 14,250,311 Payment of financing costs related to the 2023 Private Placement (131,918 ) - Proceeds from subscription receivable 11,250 - Proceeds from the exercise of stock options 1,975 89,947 Proceeds from the exercise of warrants 2,141,128 - Proceeds from sale of common stock, net of offering costs 14,004,381 - Net cash provided by financing activities 16,026,816 38,425,063 Net increase in cash and cash equivalents 5,712,994 26,693,066 Cash and cash equivalents as of beginning of the year 32,626,768 5,933,702 Cash and cash equivalents as of end of the year $ 38,339,762 $ 32,626,768 Supplemental disclosures of non-cash financing activities: Conversion of convertible preferred stock upon IPO $ - $ 8,793,637 Conversion of convertible promissory notes upon IPO $ - $ 12,965,480 Subscription receivable related to warrant exercise $ - $ 11,250 Financing costs related to the 2023 Private Placement in accrued expenses and accounts payable $ - $ 131,918 Investor Contact David Snyder david@coyatherapeutics.com CORE IR Bret Shapiro brets@coreir.com 561-479-8566 Media Contact Kati Waldenburg media@coyatherapeutics.com 212-655-0924