Coya Therapeutics Provides a Corporate Update and Reports Fiscal 2024 Financial Results

HOUSTON--(BUSINESS WIRE)--March 18, 2025-- 

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 
                                         ===========    =========== 
 

View source version on businesswire.com: https://www.businesswire.com/news/home/20250318688518/en/

 
    CONTACT:    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

(END) Dow Jones Newswires

March 18, 2025 08:15 ET (12:15 GMT)