Coya Therapeutics, Inc.

Previous wording

the impact of any global health events, including endemics or pandemics, on our preclinical studies and any future clinical trials;

Current wording

the impact of any global health events, including endemics or pandemics, on our preclinical studies, ongoing clinical trials and any future clinical trials;

Previous wording

Our core focus is developing therapies to target Treg dysfunction. Treg disfunction has been identified as an important pathophysiological component of neurodegenerative, autoimmune, and metabolic diseases, all areas where we believe new and effective therapies are urgently needed. We believe we have expertise in three distinct potential therapeutic modalities: Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Our expertise includes bothex vivo andin vivo approaches intended to restore the suppressive and immunomodulatory functions of Tregs.

Current wording

Our core focus is developing therapies to target Treg dysfunction. Treg dysfunction has been identified as an important pathophysiological component of neurodegenerative, autoimmune, and metabolic diseases, all areas where we believe new and effective therapies are urgently needed. We believe we have expertise in three distinct potential therapeutic modalities: Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Our expertise includes bothex vivo andin vivo approaches intended to restore the suppressive and immunomodulatory functions of Tregs.

Previous wording

Our lead asset, COYA 302, is a Treg-enhancing biologic, which was developed from key learnings established in our early work and discoveries of our autologous Treg cell therapy asset. Our autologous Treg cell therapy program has completed a Phase 1 and Phase 2a studies in amyotrophic lateral sclerosis, or ALS. The clinical data from these initial studies has served as an important confirmation of the underlying immunomodulatory properties of Tregs and their potential therapeutic benefits. These studies have also significantly expanded our own foundational knowledge of the biological activity of Tregs and key biomarkers of disease progression and drug effect, which we believe will be critical for the design of our future clinical and preclinical studies, the selection of future targeted diseases and the overall advancement of our development pipeline. We believe our findings have also established mechanistic benefits of combination biologics to address Treg dysfunction as well as highlighted important advantages of scalability and cost.

Current wording

Our lead asset, COYA 302, is a Treg-enhancing biologic, which was developed from key learnings established in our early work and discoveries of our autologous Treg cell therapy asset. Our autologous Treg cell therapy program has completed Phase 1 and Phase 2a studies in amyotrophic lateral sclerosis, or ALS. The clinical data from these initial studies has served as an important confirmation of the underlying immunomodulatory properties of Tregs and their potential therapeutic benefits. These studies have also significantly expanded our own foundational knowledge of the biological activity of Tregs and key biomarkers of disease progression and drug effect, which we believe will be critical for the design of our future clinical and preclinical studies, the selection of future targeted diseases and the overall advancement of our development pipeline. We believe our findings have also established mechanistic benefits of combination biologics to address Treg dysfunction as well as highlighted important advantages of scalability and cost.

Previous wording

We are currently conducting the ALSTARS Trial, a Phase 2, randomized, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of COYA 302 for the treatment of ALS (ClinicalTrials.gov Identifier: NCT 07161999). COYA 302 is an investigational product not yet approved by the U.S. Food and Drug Administration, or the FDA, or any other regulatory agency. On May 11, 2026, the FDA granted Fast Track Designation to COYA 302 for the treatment of ALS.

Current wording

We are currently conducting the ALSTARS Trial, a Phase 2/3, randomized, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of COYA 302 for the treatment of ALS (ClinicalTrials.gov Identifier: NCT 07161999). COYA 302 is an investigational product not yet approved by the U.S. Food and Drug Administration, or the FDA, or any other regulatory agency. On May 11, 2026, the FDA granted Fast Track Designation to COYA 302 for the treatment of ALS. Enrollment in the ALSTARS trial is complete, with 137 subjects enrolled. Subjects are randomized in equal proportions to placebo or one of two dosing regimens. In the high-dose regimen, subjects receive both CTLA4-Ig and low-dose IL-2 twice per month, during weeks 1 and 3. In the low-dose regimen, subjects receive CTLA4-Ig in week 1 and low-dose IL-2 during week 3. This low-dose schedule differs from the original design in which both agents were to be administered once per month during week 1. The revised low-dose schedule has been in place from the beginning of the trial. The revised schedule preserves the mechanistic rationale of the original regime and the total monthly drug exposure in this dosing sequence is the same as the originally intended sequence. We believe that this change in dosing sequence will have no impact on any potential efficacy or safety of this dosing regimen. The trial begins with a 24-week placebo-controlled treatment period, followed by a second blinded 24-week period. During the second period, subjects in the high- and low-dose groups continue their assigned regimens, while subjects initially assigned to placebo are randomized in equal proportions to one of the two active regimens. After the second 24-week period, all subjects will be invited to participate in an ongoing open-label extension, in which they will receive the high-dose regimen.

Previous wording

Our operations have consisted of developing our clinical and preclinical product candidates and we have devoted substantially all of our resources to developing product and technology rights, conducting research and development (which includes preclinical and non-clinical studies of our product candidates), organizing and staffing our company, ongoing business operations and raising capital. We have funded our operations primarily through the private and public sale of our securities. Our net losses were $6.6 million and $6.1 million for the three months ended June 30, 2026 and 2025, respectively. Our net losses were $13.8 million and $13.4 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $75.8 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures and general and administrative expenditures. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our current or future product candidates.

Current wording

Our operations have consisted of developing our clinical and preclinical product candidates and we have devoted substantially all of our resources to developing product and technology rights, conducting research and development (which includes preclinical and non-clinical studies of our product candidates), organizing and staffing our company, ongoing business operations and raising capital. We have funded our operations primarily through the private and public sale of our securities. Our net losses were $10.6 million and $2.1 million for the three months ended September 30, 2026 and 2025, respectively. Our net losses were $24.5 million and $15.5 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $86.4 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures and general and administrative expenditures. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our current or future product candidates.

Previous wording

Until such time as a product candidate has received approval of its IND application, we consider it a preclinical product candidate. Each of our preclinical product candidates is being developed on one of our three potential therapeutic modalities: (1) Treg-enhancing biologics; (2) Treg-derived exosomes; and (3) autologous Treg cell therapy. The product candidates utilizing our Treg-enhancing biologics are collectively referred to as the “300 Series.” The product candidates utilizing our Treg-derived exosomes are collectively referred to as the “200 Series.” The product candidates utilizing our autologous Treg cell therapy are collectively referred to as the “100 Series.” Currently, our 300 Series product candidates include COYA 301, COYA 302 and COYA 303, our 200 Series product candidates include COYA 201 and COYA 206, and our 100 Series product candidate is COYA 101. For our preclinical candidates we report external development costs and other external research and development costs collectively by Series. These external development costs include: fees paid to CROs, CMOs and research laboratories, process development, manufacturing and clinical development activities. Preclinical research and development activities often benefit more than one preclinical product candidate within a given Series and so disaggregating the data would neither be practicable or meaningful.

Current wording

Until such time as a product candidate has received approval of its IND application, we consider it a preclinical product candidate. Each of our preclinical product candidates is being developed on one of our three potential therapeutic modalities: (1) Treg-enhancing biologics; (2) Treg-derived exosomes; and (3) autologous Treg cell therapy. The product candidates utilizing our Treg-enhancing biologics are collectively referred to as the “300 Series.” The product candidates utilizing our Treg-derived exosomes are collectively referred to as the “200 Series.” The product candidates utilizing our autologous Treg cell therapy are collectively referred to as the “100 Series.” Currently, our 300 Series product candidates include COYA 301, COYA 302 and COYA 303, our 200 Series product candidates include COYA 201 and COYA 206, and our 100 Series product candidate is COYA 101. For our preclinical candidates we report external development costs and other external research and development costs collectively by Series. These external development costs include: fees paid to CROs, CMOs and research laboratories, process development, manufacturing and clinical development activities. Preclinical research and development activities often benefit more than one preclinical product candidate within a given Series and so disaggregating the data would be neither practicable nor meaningful.

Previous wording

Research and development expenses increased by $1.3 million from $3.7 million for the three months ended June 30, 2025 to $5.0 million for the three months ended June 30, 2026. The increase was primarily due to a $1.1 million increase in preclinical and clinical product candidate costs, reflecting primarily the advancement of the COYA 302 ALS Phase 2 clinical trial. The increase was further driven by a $0.4 million increase in internal research and development expenses, partially offset by a $0.2 million decrease in sponsored research expense.

Current wording

Research and development expenses increased by $5.9 million from $11.8 million for the nine months ended September 30, 2025 to $17.7 million for the nine months ended September 30, 2026. The increase was primarily due to a $5.4 million increase in preclinical and clinical product candidate costs, reflecting primarily the advancement of the COYA 302 ALS Phase 2/3 clinical trial. The increase was further driven by a $0.8 million increase in internal research and development expenses, partially offset by a $0.3 million decrease in sponsored research expense. For our clinical product candidate (COYA 302), we track our external research and development expenses on a candidate-by-candidate basis. Coincident with the FDA's approval of our IND of COYA 302 in patients with ALS and FTD, we characterized expenses related to COYA 302 for ALS and FTD as clinical product candidate expenses. Prior to IND approval, all expenses associated with COYA 302 for ALS and FTD were included among the preclinical product candidate expenses captioned as COYA 300 Series. For our preclinical product candidates, we track our external research and development expenses by Series. External research and development expenses include fees paid to CROs and CMOs and fees paid to regulatory, clinical trial and manufacturing professional service firms largely in connection with preclinical activities necessary to prepare COYA 302 for its initial IND filing and launch of a Phase 2 clinical trial.

Previous wording

General and administrative expenses increased by $0.4 million from $5.6 million for the six months ended June 30, 2025 compared to $6.0 million for the six months ended June 30, 2026. The increase was primarily due to a $0.8 million increase in employee compensation, which included a non-cash charge of $1.0 million related to the modification of stock options held by our former Executive Chairman in connection with his resignation, partially offset by a $0.4 million decrease in professional services.

Current wording

General and administrative expenses increased by $0.4 million from $8.2 million for the nine months ended September 30, 2025 compared to $8.6 million for the nine months ended September 30, 2026. The increase was primarily due to a $0.7 million increase in stock-based compensation, which included a non-cash charge of $1.0 million related to the modification of stock options held by our former Executive Chairman in connection with his resignation, partially offset by a $0.2 million decrease in employee related costs and a $0.1 million decrease in insurance fees.

Previous wording

Other income increased by $0.1 million from $0.3 million for the three months ended June 30, 2025 compared to $0.4 million for the three months ended June 30, 2026. The increase was primarily due to an increase in interest income earned on cash balances.

Current wording

Other income increased by $0.2 million from $1.0 million for the nine months ended September 30, 2025 compared to $1.2 million for the nine months ended September 30, 2026. The increase was primarily due to an increase in interest income earned on cash balances.

Previous wording

Since our inception, we have incurred operating losses from our operations through June 30, 2026. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. Since our inception through June 30, 2026, we have funded our operations through the public and private sale of our equity securities, and payments from Dr. Reddy's in accordance with the DRL Development Agreement. As of June 30, 2026, we had $43.2 million in cash and cash equivalents and had an accumulated deficit of $75.8 million. We expect our existing cash and cash equivalents to enable us to fund our operating expenses and capital expenditure requirements into the second half of 2027. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect. Our total future capital requirements will depend on many factors and is subject to the risks and uncertainties set forth in the section titled “Risk Factors.”

Current wording

Since our inception, we have incurred operating losses from our operations through September 30, 2026. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. Since our inception through September 30, 2026, we have funded our operations through the public and private sale of our equity securities, and payments from Dr. Reddy's in accordance with the DRL Development Agreement. As of September 30, 2026, we had $35.8 million in cash and cash equivalents and had an accumulated deficit of $86.4 million. We expect our existing cash and cash equivalents to enable us to fund our operating expenses and capital expenditure requirements into the second half of 2027. Accordingly, substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that such financial statements are issued.

Previous wording

On May 12, 2026, we entered into a Sales Agreement with Leerink Partners LLC (the “Agent” or “Leerink Partners”), as the sales agent, pursuant to which we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $30.0 million in “at-the-market” offerings (the “ATM Offering Program”) through Leerink Partners. Sales of the shares of common stock will be made at prevailing market prices at the time of sale, or as otherwise agreed with Leerink Partners. We will pay Leerink Partners LLC a commission rate of up to 3.0% of the aggregate gross proceeds from the sale of any shares of common stock pursuant to the Sales Agreement. No shares of common stock had been sold under the ATM Offering Program during the six months ended June 30, 2026 and $30.0 million remained available for sale.

Current wording

On May 12, 2026, we entered into a Sales Agreement with Leerink Partners LLC (the “Agent” or “Leerink Partners”), as the sales agent, pursuant to which we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $30.0 million in “at-the-market” offerings (the “ATM Offering Program”) through Leerink Partners. Sales of the shares of common stock will be made at prevailing market prices at the time of sale, or as otherwise agreed with Leerink Partners. We will pay Leerink Partners LLC a commission rate of up to 3.0% of the aggregate gross proceeds from the sale of any shares of common stock pursuant to the Sales Agreement. No shares of common stock had been sold under the ATM Offering Program during the nine months ended September 30, 2026 and $30.0 million remained available for sale.

Previous wording

During the six months ended June 30, 2026, we used $13.6 million of cash in operating activities. Cash used in operating activities reflected our net loss of $13.8 million, a $2.9 million change in operating assets and liabilities, partially offset by noncash charges of $3.2 million primarily related to stock-based compensation.

Current wording

During the nine months ended September 30, 2026, we used $20.8 million of cash in operating activities. Cash used in operating activities reflected our net loss of $24.5 million, a $0.4 million change in operating assets and liabilities, partially offset by noncash charges of $4.1 million primarily related to stock-based compensation.

Previous wording

During the six months ended June 30, 2025, we used $8.6 million of cash in operating activities. Cash used in operating activities reflected our net loss of $13.4 million, partially offset by a $2.7 million change in operating assets and liabilities and noncash charges of $2.1 million primarily related to stock-based compensation.

Current wording

During the nine months ended September 30, 2025, we used $9.7 million of cash in operating activities. Cash used in operating activities reflected our net loss of $15.5 million, partially offset by a $2.1 million change in operating assets and liabilities and noncash charges of $3.7 million primarily related to stock-based compensation.

Previous wording

During the six months ended June 30, 2026, we paid $0.9 million in in-process research and development assets.

Current wording

During the nine months ended September 30, 2026 and 2025, we paid $0.9 million and $0.5 million for in-process research and development assets, respectively.

Previous wording

During the six months ended June 30, 2026, financing activities provided $11.0 million of cash from the net proceeds from the issuance of common stock in the January Offering, partially offset by $0.1 million in payments of finance costs related to the ATM Offering Program.

Current wording

During the nine months ended September 30, 2026, financing activities provided $11.0 million of cash from the net proceeds from the issuance of common stock in the January 2026 Offering, partially offset by $0.2 million in payments of finance costs related to the ATM Offering Program.

Previous wording

During the six months ended June 30, 2025, financing activities were immaterial.

Current wording

During the nine months ended September 30, 2025, financing activities were immaterial.

Previous wording

In December 2023, we entered into the DRL Development Agreement with Dr. Reddy's, pursuant to which, among other things, we granted to Dr. Reddy's an exclusive, royalty-bearing right and license to commercialize COYA 302 solely for use in patients with ALS in the United States, Canada, the European Union and the United Kingdom, or collectively, the New Territories. We previously granted DRL an exclusive license to obtain regulatory approval and commercialize COYA 302 for ALS and certain other indications in all other countries (other than the New Territories, Japan, Mexico, and in each country in South America), pursuant to the License and Supply Agreement entered between with DRL, or the DRL Agreement, effective as of April 1, 2023. COYA 302 is comprised of two components, COYA 301 and DRL_AB. In accordance with the DRL Agreement, we in-licensed DRL_AB for the development and commercialization of COYA 302. Further, under the DRL Development Agreement, Dr. Reddy’s is responsible for the development of DRL_AB. We will have the responsibility for the clinical development of COYA 302 and for seeking regulatory approval in the United States for COYA 302 in ALS.

Current wording

ALS in the United States, Canada, the European Union and the United Kingdom, or collectively, the New Territories. We previously granted DRL an exclusive license to obtain regulatory approval and commercialize COYA 302 for ALS and certain other indications in all other countries (other than the New Territories, Japan, Mexico, and in each country in South America), pursuant to the License and Supply Agreement entered into with DRL, or the DRL Agreement, effective as of April 1, 2023. COYA 302 is comprised of two components, COYA 301 and DRL_AB. In accordance with the DRL Agreement, we in-licensed DRL_AB for the development and commercialization of COYA 302. Further, under the DRL Development Agreement, Dr. Reddy’s is responsible for the development of DRL_AB. We will have the responsibility for the clinical development of COYA 302 and for seeking regulatory approval in the United States for COYA 302 in ALS.

Previous wording

In May 2023, we entered into an SRA with HMRI in which the Company agreed to fund approximately $0.5 million through May 2024. Along with HMRI, we have subsequently amended the SRA multiple times to increase agreed funding and, at times, extend the term. In January 2026, we entered into another SRA with HMRI in which we agreed to fund research through the earlier of completion of the research or 12 months. The maximum funding commitment is $0.6 million. During the three months ended June 30, 2026 and 2025, we incurred $0.1 million and $0.3 million, respectively, in research and development expenses related to the SRA. During the six months ended June 30, 2026 and 2025, we incurred $0.2 million and $0.5 million, respectively, in research and development expenses related to the SRA.

Current wording

In May 2023, we entered into an SRA with HMRI in which the Company agreed to fund approximately $0.5 million through May 2024. Along with HMRI, we have subsequently amended the SRA multiple times to increase agreed funding and, at times, extend the term. In January 2026, we entered into another SRA with HMRI in which we agreed to fund research through the earlier of completion of the research or 12 months. The maximum funding commitment is $0.6 million. During both the three months ended September 30, 2026 and 2025, we incurred $0.2 million in research and development expenses related to the SRA. During the nine months ended September 30, 2026 and 2025, we incurred $0.4 million and $0.7 million, respectively, in research and development expenses related to the SRA.

Previous wording

In 2023, we entered into an exclusive DRL Agreement with DRL which allowed us to in-license DRL’s abatacept biosimilar for use in the development of COYA 302. COYA 302 is a dual biologic intended to suppress neuroinflammation via multiple immunomodulatory pathways, for the treatment of neurodegenerative conditions. The DRL Agreement also provides for the license of COYA 301 to DRL to permit the commercialization by DRL of COYA 302 in territories not otherwise granted to Coya. In consideration for the license we have paid a non-refundable upfront fee of $0.4 million. We will pay to DRL up to an aggregate of approximately $2.9 million of pre-approval regulatory milestone payments for the first indication in the Field (as defined in the DRL Agreement), and an additional approximately $20.0 million if all other development, regulatory approval and sales milestones are incurred under the DRL Agreement. We will also pay to DRL a low-six figure milestone payment per additional indication. Further, pursuant to the DRL Agreement, we will pay to DRL single-digit royalties on Net Sales (as defined in the DRL Agreement). As of June 30, 2026, we owed DRL $0.3 million in milestone payments in connection with the FDA's approval of our IND of COYA 302 in patients with FTD.

Current wording

In 2023, we entered into an exclusive DRL Agreement with DRL which allowed us to in-license DRL’s abatacept biosimilar for use in the development of COYA 302. COYA 302 is a dual biologic intended to suppress neuroinflammation via multiple immunomodulatory pathways, for the treatment of neurodegenerative conditions. The DRL Agreement also provides for the license of COYA 301 to DRL to permit the commercialization by DRL of COYA 302 in territories not otherwise granted to Coya. In consideration for the license we have paid a non-refundable upfront fee of $0.4 million. We will pay to DRL up to an aggregate of approximately $2.9 million of pre-approval regulatory milestone payments for the first indication in the Field (as defined in the DRL Agreement), and an additional approximately $20.0 million if all other development, regulatory approval and sales milestones are achieved under the DRL Agreement. We will also pay to DRL a low-six figure milestone payment per additional indication. Further, pursuant to the DRL Agreement, we will pay to DRL single-digit royalties on Net Sales (as defined in the DRL Agreement). As of September 30, 2026, we owed DRL $0.3 million in milestone payments in connection with the FDA's approval of our IND of COYA 302 in patients with FTD.