Coya Therapeutics Reports Second Quarter Financial Results and Provides a Corporate Update
Coya Therapeutics (NASDAQ: COYA), a clinical-stage biotech company focused on regulatory T cell enhancement for neurodegenerative disorders, reported Q2 2025 financial results and corporate updates. The company ended Q2 with $29.8 million in cash and posted a net loss of $6.1 million, wider than the $2.9 million loss in Q2 2024.
Key developments include the FDA submission for COYA 302 Phase 2 trial in ALS patients, with a decision expected by August 29, 2025. Upon IND acceptance and first patient dosing, Coya will receive $8.4 million in milestone payments from Dr. Reddy's Laboratories. The company also secured a U.S. patent for a stable ready-to-use liquid IL-2 formulation and plans to submit an IND for Frontotemporal Dementia by year-end.
Coya Therapeutics (NASDAQ: COYA), una società biotech in fase clinica focalizzata sul potenziamento delle cellule T regolatorie per le malattie neurodegenerative, ha riportato i risultati finanziari del secondo trimestre 2025 e aggiornamenti aziendali. La società ha chiuso il Q2 con $29,8 milioni di liquidità e ha registrato una perdita netta di $6,1 milioni, in aumento rispetto alla perdita di $2,9 milioni del Q2 2024.
Tra i principali sviluppi figurano la presentazione alla FDA per lo studio di Fase 2 COYA 302 nei pazienti con SLA, con decisione prevista entro il 29 agosto 2025. Al momento dell'accettazione dell'IND e della prima somministrazione al paziente, Coya riceverà $8,4 milioni in pagamenti legati a milestone da Dr. Reddy's Laboratories. La società ha inoltre ottenuto un brevetto statunitense per una formulazione liquida pronta all'uso e stabile di IL-2 e prevede di presentare un IND per la demenza frontotemporale entro la fine dell'anno.
Coya Therapeutics (NASDAQ: COYA), una compañía biotecnológica en fase clínica centrada en el aumento de las células T reguladoras para trastornos neurodegenerativos, informó los resultados financieros del segundo trimestre de 2025 y novedades corporativas. La compañía cerró el Q2 con $29,8 millones en efectivo y registró una pérdida neta de $6,1 millones, superior a la pérdida de $2,9 millones en el Q2 de 2024.
Entre los hitos clave está la presentación a la FDA del ensayo de Fase 2 COYA 302 en pacientes con ELA, con una decisión prevista para el 29 de agosto de 2025. Tras la aceptación del IND y la dosificación del primer paciente, Coya recibirá $8,4 millones en pagos por hitos de Dr. Reddy's Laboratories. La compañía también obtuvo una patente en EE. UU. para una formulación líquida estable y lista para usar de IL-2 y planea presentar un IND para la demencia frontotemporal antes de fin de año.
Coya Therapeutics (NASDAQ: COYA), 신경퇴행성 질환을 위한 조절 T세포 강화에 주력하는 임상 단계의 바이오텍 회사가 2025년 2분기 재무 실적 및 기업 업데이트를 발표했습니다. 회사는 2분기 말에 $29.8 million의 현금을 보유했고, $6.1 million의 순손실을 기록했으며 이는 2024년 2분기의 $2.9 million 손실보다 확대된 수치입니다.
주요 개발 사항으로는 ALS 환자를 대상으로 하는 COYA 302 2상 시험의 FDA 제출이 있으며, 결정은 2025년 8월 29일에 예정되어 있습니다. IND 승인 및 첫 환자 투여 시 Coya는 Dr. Reddy's Laboratories로부터 $8.4 million의 마일스톤 지급을 받게 됩니다. 회사는 또한 사용 준비가 된 안정적인 액체형 IL‑2 제형에 대한 미국 특허를 확보했으며, 연말까지 전두측두엽 치매(Frontotemporal Dementia)용 IND 제출을 계획하고 있습니다.
Coya Therapeutics (NASDAQ: COYA), une biotech en phase clinique axée sur le renforcement des cellules T régulatrices pour les maladies neurodégénératives, a publié ses résultats financiers du deuxième trimestre 2025 et des informations d'entreprise. La société a clôturé le T2 avec $29,8 millions en trésorerie et a enregistré une perte nette de $6,1 millions, plus importante que la perte de $2,9 millions au T2 2024.
Parmi les faits marquants figurent le dépôt auprès de la FDA pour l'essai de phase 2 COYA 302 chez des patients atteints de SLA, décision attendue pour le 29 août 2025. Après acceptation de l'IND et administration au premier patient, Coya recevra $8,4 millions au titre de paiements liés à des jalons de la part de Dr. Reddy's Laboratories. La société a également obtenu un brevet américain pour une formulation liquide d'IL‑2 stable et prête à l'emploi et prévoit de soumettre un IND pour la démence frontotemporale d'ici la fin de l'année.
Coya Therapeutics (NASDAQ: COYA), ein klinisch fortgeschrittenes Biotech-Unternehmen, das sich auf die Verstärkung regulatorischer T‑Zellen bei neurodegenerativen Erkrankungen spezialisiert hat, veröffentlichte die Finanzergebnisse für das 2. Quartal 2025 sowie Unternehmensupdates. Das Unternehmen schloss das Q2 mit $29,8 Millionen an Barmitteln und meldete einen Nettoverlust von $6,1 Millionen, ausgeweitet gegenüber dem Verlust von $2,9 Millionen im Q2 2024.
Zu den wesentlichen Entwicklungen gehört die Einreichung bei der FDA für die COYA 302 Phase‑2‑Studie bei ALS‑Patienten; eine Entscheidung wird bis zum 29. August 2025 erwartet. Bei Annahme des IND und der Dosierung des ersten Patienten erhält Coya $8,4 Millionen an Meilensteinzahlungen von Dr. Reddy's Laboratories. Das Unternehmen sicherte sich außerdem ein US‑Patent für eine stabile, gebrauchsfertige flüssige IL‑2‑Formulierung und plant, bis Jahresende ein IND für die frontotemporale Demenz einzureichen.
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Insights
Coya faces widening losses amid critical FDA decision for COYA 302 in ALS expected by August 29, with $29.8M cash runway supporting near-term catalysts.
Coya Therapeutics reported a significant widening of its quarterly net loss to
The company's
Coya's pipeline development continues with multiple data readouts expected in 2025, including biomarker data for ALS, proteomics data from a Phase 2 Alzheimer's study, and top-line data from trials in Frontotemporal Dementia (FTD). The company is also planning an IND filing for COYA 302 in FTD by year-end, indicating commitment to expanding its therapeutic applications across multiple neurodegenerative disorders.
The company's regulatory T cell enhancement approach represents a potentially novel mechanism for addressing neurodegeneration, with COYA 302 as their lead program. The recent publication linking inflammation and oxidative stress to Parkinson's Disease progression further supports their scientific foundation. The recently announced U.S. patent for a stable ready-to-use liquid IL-2 formulation strengthens their intellectual property position, with exclusive in-vivo rights across multiple indications.
Recent Corporate Highlights
- Submitted to FDA on June 30, 2025, additional nonclinical data to support the start of the COYA 302 Phase 2 trial in patients with ALS
- Published results of scientific research linking inflammation and oxidative stress to the progression of Parkinson's Disease (PD). Study demonstrated correlation between peripheral pro-inflammatory mechanisms, particularly monocytes and oxidative stress, in the progression and severity PD. It was published in the scientific journal Frontiers of Immunology
- Announced
U.S. patent (US 12,312,389 B2) for a stable ready-to-use liquid IL-2 formulation; Coya holds exclusive in-vivo rights across multiple indications
Upcoming Expected Catalysts for 2025
- Decision from the US FDA on the IND for COYA 302 in ALS, expected by or before August 29, 2025
- Upon IND acceptance and first patient dosing of COYA 302 in ALS, Coya will receive milestone payments of
$8.4 million - ALS Biomarker data. Publication of longitudinal data on Neurofilament Light Chain (NfL) and oxidative stress markers in tracking progression and survival in patients with ALS
- Report new 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)
- Top-line clinical data release for an investigator-initiated trial combining LD IL-2 + CTLA4-Ig in patients with Frontotemporal Dementia (FTD)
- Top-line data for COYA 303 in an in-vivo inflammatory animal model
- Filing of IND for the COYA-302 Phase 2 trial in patients with FTD*
(*Clinical trial will be initiated after FDA IND approval for FTD)
Coya's Chief Executive Officer Arun Swaminathan, Ph.D. commented, "As we look ahead, we are focused on several key catalysts, including a decision from the FDA on our IND application for COYA 302 in ALS, anticipated by the end of August. We are encouraged by the growing body of data supporting our regulatory T cell enhancement approach, including the recent findings from the investigator-initiated trial in FTD and promising pre-clinical results with COYA 303. These advances strengthen our confidence in the potential of COYA 302 in neurodegenerative diseases like ALS and FTD."
Coya's Chief Medical Officer Dr. Fred Grossman commented, "We look forward to the FDA's decision on our IND submission for COYA 302 in ALS, which represents a significant milestone for our lead program. Pending clearance, we are prepared to initiate our controlled Phase 2 clinical trial in ALS. We also plan to submit an IND for FTD by the end of the year."
Financial Results
As of June 30, 2025, Coya had cash and cash equivalents of
Collaboration revenues were
Research and development expenses were
General and administrative expenses were
Net loss was
About COYA 302
COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 comprises proprietary low dose interleukin-2 (LD IL-2) and CTLA-4 Ig and is being developed for subcutaneous administration for the treatment of patients with ALS. These mechanisms may have additive or synergistic effects.
COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency.
About COYA 303
COYA 303 is an investigational biologic combination of COYA 301 and a glucagon-like-peptide-1 receptor agonist (GLP-1 RA) designed for subcutaneous administration. In a preclinical study, COYA 303 exhibited a dual immunomodulatory mechanism of action resulting in an additive/synergistic anti-inflammatory effect, which the Company believes was due to increased Treg function and suppressed pro-inflammatory myeloid cells and responder T cells.
About Coya Therapeutics, Inc.
Headquartered in
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.
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 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.
Investor Contact
David
david@coyatherapeutics.com
astr partners
Matthew Beck
matthew.beck@astrpartners.com
917-415-1750
Media Contacts
Russo Partners
Olipriya Das
Olipriya.Das@russopartnersllc.com
646-942-5588
Matthew Purcell
matthew.purcell@russopartnersllc.com
646-942-5595
COYA THERAPEUTICS, INC. CONDENSED BALANCE SHEETS | ||||||||
| ||||||||
(unaudited) | ||||||||
June 30, | December 31, | |||||||
2025 | 2024 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 29,757,328 | $ | 38,339,762 | ||||
Prepaids and other current assets | 3,670,319 | 5,968,666 | ||||||
Total current assets | 33,427,647 | 44,308,428 | ||||||
Fixed assets, net | 24,908 | 38,588 | ||||||
Total assets | $ | 33,452,555 | $ | 44,347,016 | ||||
| ||||||||
Liabilities and Stockholders' Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 931,344 | $ | 1,588,128 | ||||
Accrued expenses | 2,838,685 | 1,388,060 | ||||||
Deferred collaboration revenue | 731,075 | 848,286 | ||||||
Total current liabilities | 4,501,104 | 3,824,474 | ||||||
Deferred collaboration revenue | 641,158 | 945,447 | ||||||
Total liabilities | 5,142,262 | 4,769,921 | ||||||
| ||||||||
Stockholders' equity: | ||||||||
Series A convertible preferred stock, | - | - | ||||||
Common stock, | 1,673 | 1,671 | ||||||
Additional paid-in capital | 82,447,524 | 80,312,594 | ||||||
Accumulated deficit | (54,138,904) | (40,737,170) | ||||||
Total stockholders' equity | 28,310,293 | 39,577,095 | ||||||
Total liabilities and stockholders' equity | $ | 33,452,555 | $ | 44,347,016 | ||||
COYA THERAPEUTICS, INC. CONDENSED UNAUDITED INTERIM STATEMENTS OF OPERATIONS | ||||||||
| ||||||||
Three Months Ended June 30, | ||||||||
2025 | 2024 | |||||||
Collaboration revenue | $ | 163,616 | $ | 3,425,271 | ||||
Operating expenses: | ||||||||
Research and development | 3,663,103 | 4,566,152 | ||||||
In-process research and development | — | — | ||||||
General and administrative | 2,908,191 | 2,088,404 | ||||||
Depreciation | 6,840 | 6,840 | ||||||
Total operating expenses | 6,578,134 | 6,661,396 | ||||||
Loss from operations | (6,414,518) | (3,236,125) | ||||||
Other income: | ||||||||
Other income | 319,541 | 344,445 | ||||||
Pre-tax loss | (6,094,977) | (2,891,680) | ||||||
Income tax expense | — | — | ||||||
Net loss | $ | (6,094,977) | $ | (2,891,680) | ||||
| ||||||||
Per share information: | ||||||||
Net loss per share of common stock, basic and diluted | $ | (0.36) | $ | (0.19) | ||||
Weighted-average shares of common stock outstanding, basic and diluted | 16,724,998 | 14,915,217 | ||||||
COYA THERAPEUTICS, INC. CONDENSED UNAUDITED INTERIM STATEMENTS OF CASH FLOWS | ||||||||
| ||||||||
Six Months Ended June 30, | ||||||||
2025 | 2024 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (13,401,734) | $ | (7,943,593) | ||||
Adjustment to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation | 13,680 | 13,680 | ||||||
Stock-based compensation, including the issuance of restricted stock | 2,115,795 | 1,097,984 | ||||||
Acquired in-process research and development assets | - | 25,000 | ||||||
Changes in operating assets and liabilities: | ||||||||
Collaboration receivable | - | 7,500,000 | ||||||
Prepaids and other current assets | 2,298,347 | (2,241,700) | ||||||
Accounts payable | (656,784) | 716,067 | ||||||
Accrued expenses | 1,450,625 | (1,883,022) | ||||||
Deferred collaboration revenue | (421,500) | 297,891 | ||||||
Net cash used in operating activities | (8,601,571) | (2,417,693) | ||||||
Cash flows from investing activities: | ||||||||
Purchase of in-process research and development assets | - | (25,000) | ||||||
Net cash used in investing activities | - | (25,000) | ||||||
Cash flows from financing activities: | ||||||||
Proceeds from subscription receivable | - | 11,250 | ||||||
Proceeds from sale of common stock | - | 5,000,000 | ||||||
Payment of financing costs related to the 2023 Private Placement | - | (131,918) | ||||||
Proceeds from the exercise of stock options | 19,137 | 1,975 | ||||||
Proceeds from the exercise of warrants | - | 1,509,707 | ||||||
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 beginning of the period | 38,339,762 | 32,626,768 | ||||||
Cash and cash equivalents as of end of the period | $ | 29,757,328 | $ | 36,575,089 | ||||
| ||||||||
Supplemental disclosures of non-cash financing activities: | ||||||||
Financing costs related to the sale of common stock in accounts payable | $ | - | $ | 56,332 | ||||
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SOURCE Coya Therapeutics, Inc.
