Coya Therapeutics, Inc.
For the period ended Jun 30, 2026. Filed Aug 11, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 11, 2026
COYA$2.99+6.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-12.
0001193125-26-218201
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-11.
0001193125-26-343481
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 140 previous paragraphs and 131 current paragraphs.
103 unchanged; 18 reworded; 8 added; 17 removed; 2 previous and 2 current paragraphs rearranged.
Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (8)
Current report
the accuracy of our estimates regarding expenses, future revenues, capital requirements, our need for additional financing and our anticipated cash burn rate;
Current report
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 report
General and administrative expenses decreased by $0.6 million from $2.9 million for the three months ended June 30, 2025 compared to $2.3 million for the three months ended June 30, 2026. The decrease was primarily due to a $0.4 million decrease in professional services and a $0.2 million decrease in employee compensation, including lower stock-based compensation.
Current report
Comparison of the six months ended June 30, 2026 and 2025
Current report
Collaboration revenue was $0.5 million and $0.4 million for both the six months ended June 30, 2026 and 2025, respectively, related to R&D Services revenue.
Current report
Research and development expenses increased by $0.2 million from $8.9 million for the six months ended June 30, 2025 to $9.1 million for the six months ended June 30, 2026. The increase was primarily due to a $0.7 million increase in internal research and development expenses, partially offset by a $0.3 million decrease in sponsored research expense and a $0.2 million decrease in preclinical and clinical product candidate costs.
Current report
Sources of Liquidity
Current report
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.
Removed paragraphs (17)
Previous report
Intellectual Property and Protection
Previous report
As of May 1, 2026, our patent estate derived from our relationship with The Houston Methodist Hospital includes one U.S. provisional patent application, seven U.S. non-provisional patent applications, 43 foreign patent applications, and three pending Patent Cooperation Treaty (“PCT”) applications, each co-owned with or in-licensed from The Houston Methodist Hospital. These patent applications are directed to our Treg and exosome compositions and methods of use, methods of Treg and exosome manufacture, and methods of in vivo Treg expansion via combination therapies, among other things. If any patents issue from or claim priority to these patent applications, the patents are expected to expire in 2040, 2042 and 2044-2046 without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees. All of our pending Houston Methodist Hospital patent applications have composition and method claims, with the exception of a biomarker patent application, which has only method claims.
Previous report
In addition, our patent estate derived from our relationship with ARScience Biotherapeutics, Inc. (described below) includes three pending U.S. non-provisional patent applications, one issued U.S. patent, nine pending foreign patent applications and two issued foreign patents. The issued U.S. patent is expected to expire in 2042, the issued foreign patents are expected to expire in 2039, and any other patents that may issue from or claim priority to one or more of these patents or patent applications, if granted, are expected to expire between 2039 and 2041, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. The ARScience Biotherapeutics, Inc. patents have composition, method, and/or utility claims.
Previous report
In addition, our patent estate derived from our relationship with Dr Reddy’s Laboratories includes two pending U.S. non-provisional patent applications, one issued U.S. patent, 15 pending foreign patent applications and five issued foreign patents. The issued U.S. patent is expected to expire in 2042, the issued foreign patents are expected to expire in 2039, and any other patents that may issue from or claim priority to one or more of these patents or patent applications, if granted, are expected to expire in 2039, 2041, or 2042, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. The Dr. Reddy’s patents and patent applications have composition, method and/or utility claims.
Previous report
In addition, our patent estate derived from our relationship with the University of Nebraska includes two pending non-provisional U.S. patent applications and one pending foreign patent application. If any patents issue from or claim priority to these patent applications, the patents are expected to expire in 2043 and 2044, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. The University of Nebraska patent applications have composition and/or method claims.
Previous report
Finally, our patent estate derived from our relationship with Carnegie Mellon includes two pending U.S. non-provisional patent applications. If any patents issue from or claim priority to these patent applications, the patents would be expected to expire in 2040 and 2044, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. The Carnegie Mellon patent applications have composition and/or method claims.
Previous report
Financings
Previous report
In January of 2026, we entered into a Securities Purchase Agreement with certain accredited investors for the issuance and sale in a private placement of 2,522,727 shares of our common stock, or the January 2026 Offering. The January 2026 Offering closed on January 30, 2026 and each share was offered and sold at an offering price of $4.40 per share. Gross proceeds from the private placement were approximately $11.1 million, before deducting offering costs payable by us.
Previous report
Collaboration Revenue
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Other Income
Previous report
Collaboration Revenue
Previous report
Research and Development Expenses
Previous report
Research and development expenses decreased by $1.1 million from $5.2 million for the three months ended March 31, 2025 to $4.1 million for the three months ended March 31, 2026. The decrease was primarily due to a $1.2 million decrease in external preclinical and clinical product candidates, reflecting the timing of preclinical activities undertaken in early 2025 to support our IND applications for COYA 302 in ALS. The decrease was further driven by a $0.1 million decrease in sponsored research expense, partially offset by a $0.2 million increase in internal research and development expenses. For our clinical product candidate (COYA 302), we track our external research and development expenses on a candidate-by-candidate basis. Coincident with 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 report
General and Administrative Expenses
Reworded paragraphs (18)
Previous wording
You should read the following discussion and analysis of our financial condition and operating results together with our financial statements and the related notes appearing at the end of this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements that involve risks and uncertainties. As a result of many factors, such as those set forth in the section of the Quarterly Report on Form 10-Q captioned “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q, our actual results may differ materially from those anticipated in these forward-looking statements.
Current wording
You should read the following discussion and analysis of our financial condition and operating results together with our financial statements and the related notes appearing at the beginning of this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements that involve risks and uncertainties. As a result of many factors, such as those set forth in the section of the Quarterly Report on Form 10-Q captioned “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q, our actual results may differ materially from those anticipated in these forward-looking statements.
Previous wording
our ability to raise additional capital, which may be adversely impacted by potential worsening of global economic conditions, potential future global pandemics or health crises, and the recent disruptions to, and volatility in, the credit and financial markets in the United States;
Current wording
our ability to raise additional capital, which may be adversely impacted by potential worsening of global economic conditions, potential future global pandemics or health crises, and volatility in the credit and financial markets in the United States;
Previous wording
The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipate in our forward-looking statements.
Current wording
The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements.
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.
Current 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.
Previous wording
We have funded our operations primarily through the private and public sale of our securities. Our net losses were $7.2 million and $7.3 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $69.2 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 $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.
Previous wording
Collaboration revenue was $0.3 million for the three months ended March 31, 2026 and 2025 related to R&D Services revenue.
Current wording
Collaboration revenue was $0.2 million for the three months ended June 30, 2026 and 2025 related to R&D Services revenue.
Previous wording
Other income increased by $0.1 million from the three months ended March 31, 2025 compared to the three months ended March 31, 2026. The increase was primarily due to an increase in interest income earned on cash balances.
Current 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.
Previous wording
General and administrative expenses increased by $1.1 million from $2.7 million for the three months ended March 31, 2025 compared to $3.8 million for the three months ended March 31, 2026. The increase was primarily due to an $1.1 million increase in employee compensation, which included a non-cash charge of $1.0 million related to the modification of stock options held by the our former Executive Chairman in connection with his resignation.
Current 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.
Previous wording
Since our inception, we have incurred operating losses from our operations through March 31, 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 March 31, 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 March 31, 2026, we had $50.7 million in cash and cash equivalents and had an accumulated deficit of $69.2 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 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.”
Previous wording
During the three months ended March 31, 2026, we used $6.2 million of cash in operating activities. Cash used in operating activities reflected our net loss of $7.2 million, a $1.2 million change in operating assets and liabilities, partially offset by noncash charges of $2.2 million primarily related to stock-based compensation..
Current 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.
Previous wording
During the three months ended March 31, 2025, we used $2.8 million of cash in operating activities. Cash used in operating activities reflected our net loss of $7.3 million, partially offset by a $3.4 million change in operating assets and liabilities and noncash charges of $1.1 million primarily related to stock-based compensation.
Current 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.
Previous wording
During the three months ended March 31, 2026, we paid $0.9 million in in-process research and development assets, which we incurred in 2025.
Current wording
During the six months ended June 30, 2026, we paid $0.9 million in in-process research and development assets.
Previous wording
We had no investing activities during the three months ended March 31, 2025.
Current wording
We had no investing activities during the six months ended June 30, 2025.
Previous wording
During the three months ended March 31, 2026, financing activities provided $11.0 million of cash from the net proceeds from the issuance of common stock in the January Offering.
Current 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.
Previous wording
During the three months ended March 31, 2025, financing activities were immaterial.
Current wording
During the six months ended June 30, 2025, financing activities were immaterial.
Previous wording
The Methodist License Agreement provides that in the event we sublicense products and services covered by the Methodist License Agreement, then royalties owed to Houston Methodist would be computed as a percentage of payments received by us from the sublicensee. In addition, the termination provisions provide that Houston Methodist may only terminate the Methodist License Agreement, among other things, in the event that after five years we are not “Actively Attempting to Develop or Commercialize,” as such term is defined in the Methodist License Agreement.
Current wording
The Methodist License Agreement provides that in the event we sublicense products and services covered by the Methodist License Agreement, then royalties owed to Houston Methodist would be computed as a percentage of payments received by us from the sublicensee. In addition, the termination provisions provide that Houston Methodist may terminate the Methodist License Agreement, among other things, in the event that after five years we are not “Actively Attempting to Develop or Commercialize,” as such term is defined in the Methodist License Agreement.
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 March 31, 2026 and 2025, we incurred $0.1 million and $0.2 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 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.
Previous wording
We may owe tiered payments to ARS based on its achievement of certain developmental milestones. Under the ARS License Agreement, the Company will pay an aggregate of $13.3 million in developmental milestone payments for the first Combination Product (as defined in the ARS License Agreement) in a new indication. We will then pay an aggregate of $11.6 million in developmental milestone payments for each Combination Product in each subsequent new indication. Further, for the first Mono Product (as defined In the ARS License Agreement) we will pay an aggregate of $11.8 million in developmental milestone payments. We will then pay an aggregate of $5.9 million in developmental milestone payments for each Mono Product in each subsequent new indication, and an aggregate of $5.9 million if all developmental milestones are achieved for each new indication. We will also owe royalties on net sales of licensed products ranging from low to mid-single digit percentages. In the event we sublicenses its rights under the ARS License Agreement, we will owe royalties on sublicense income within the range of 10% to 20%.
Current wording
We may owe tiered payments to ARS based on its achievement of certain developmental milestones. Under the ARS License Agreement, the Company will pay an aggregate of $13.3 million in developmental milestone payments for the first Combination Product (as defined in the ARS License Agreement) in a new indication. We will then pay an aggregate of $11.6 million in developmental milestone payments for each Combination Product in each subsequent new indication. Further, for the first Mono Product (as defined In the ARS License Agreement) we will pay an aggregate of $11.8 million in developmental milestone payments. We will then pay an aggregate of $5.9 million in developmental milestone payments for each Mono Product in each subsequent new indication, and an aggregate of $5.9 million if all developmental milestones are achieved for each new indication. We will also owe royalties on net sales of licensed products ranging from low to mid-single digit percentages. In the event we sublicense the rights under the ARS License Agreement, we will owe royalties on sublicense income within the range of 10% to 20%.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Research and development expenses disaggregated and classified by preclinical, and external and internal expenses are summarized in the table below:
Current report — wording carried from elsewhere
Other income increased by $0.1 million from $0.7 million for the six months ended June 30, 2025 compared to $0.8 million for the six months ended June 30, 2026. The increase was primarily due to an increase in interest income earned on cash balances.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
We do not further classify or evaluate our internal research and development expenses by product candidate or by Series as these expenses primarily relate to compensation, materials and supplies, and other costs which are deployed across multiple therapeutic modalities, multiple product candidates, and multiple therapeutic areas under development.