IL-32

HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics and cell therapies intended to enhance the function of Regulatory T Cells (Tregs), today announced its financial results for the third quarter ended September 30, 2023, and provided a clinical and business update. Q3 2023 and Recent Highlights Completed enrollment in a randomized, double-blind, placebo-controlled Phase 2 study of Low Dose IL-2 in patients with mild-to-moderate Alzheimer’s Disease (AD). The study is being conducted by Drs. Stanley Appel and Alireza Faridar at the Houston Methodist Hospital and is funded by the Gates Foundation and Alzheimer’s Association. A total of 38 patients have been randomly assigned to receive subcutaneous Low Dose IL-2 (LD IL-2) at two different dosing regimens, or matching placebo, over 21 weeks. The first patient cohort was randomized to receive LD IL-2 for 5 consecutive days every 4 weeks and the second cohort was randomized to receive LD IL-2 for 5 consecutive days every 2 weeks. This phase 2 well-controlled study is evaluating the safety and tolerability, biological activity, blood and cerebrospinal fluid biomarkers, neuroimaging, and changes in cognitive function of LD IL-2 compared to placebo at pre-specified timepoints over the course of the 21-week treatment period and at 9 weeks after the last dose of study treatment. Topline results of the study are anticipated to be reported Summer 2024. Reported new data supporting the mechanism of action of COYA 302 for the treatment of Amyotrophic Lateral Sclerosis (ALS) at the 22nd Annual Northeast ALS (NEALS) Consortium Meeting on October 4th, 2023. Details of the study can be found here. Results of this study further support the mechanism of action and potential of COYA 302 (LD IL-2 and CTLA4-Ig) to address the multiple immune pathways involved in the progression and severity of ALS. Coya is working expeditiously in the planning and execution of its next clinical study to evaluate the efficacy and safety of COYA 302 in patients with ALS. Secured the exclusive worldwide licensing rights of a proprietary Exosome Engineering Technology (EET) from Carnegie Mellon University (CMU) Applications across multiple indications, including neurodegeneration, autoimmune, and oncology. This proprietary EET platform extends Coya’s pipeline beyond Neurodegenerative disorders to include autoimmune disorders and cancer while expanding Coya’s optionality for potential non-dilutive business development and strategic partnerships with companies seeking ways to deliver cargo/drugs in a targeted fashion. Announced that Dr. Phil Campbell, Professor of Biomedical Engineering at CMU, presented a proof-of-concept application of the licensed exosome engineering technology, “Rapid Functionalization of Treg Exosomes for Targeted Immunotherapy” at the 5th Exosome Based Therapeutic Development Summit in Boston, MA The presentation can be accessed here. Coya and CMU entered into a Research Collaboration Agreement and Option Agreement in 2022 to develop a unique patented technology intended to advance the potential use of exosomes for the treatment of diseases of unmet need. This proprietary technology expands Coya’s pipeline to include autoimmune disorders and cancer. These engineered exosomes are considered a cell-free drug delivery systems without genetic modification that can travel throughout the body unimpeded, including through the blood brain barrier, to provide specific targeted therapies. Published a research article entitled “Immunological, Oxidative, and Structural Factors and Their Responses to Regulatory T Lymphocyte Therapy in Amyotrophic Lateral Sclerosis” in the peer-reviewed journal Ageing and Neurodegenerative Diseases. The publication can be accessed here. Following these encouraging results, Coya plans to assess blood markers of oxidative stress and inflammation systematically and prospectively in the upcoming well powered placebo controlled clinical study of COYA 302 in patients with ALS. Published additional AD clinical data for ld-IL-2 at the Alzheimer’s Association International Conference (AAIC). Showed a significant decrease in biomarker levels known to be associated with neuroinflammation in AD patients, further supporting the initial positive results of the study. Blood levels of CCL4 (CC motif chemokine ligand 4), FLT3LG (FMS-related tyrosine kinase 3 ligand) and TNFα (tumor necrosis factor alpha) were consistently lower following administration of ld IL-2. Announced that Dr. Alireza Faridar, Assistant Professor of Neurology at Houston Methodist and Weill Cornell Medical College, will give an oral presentation at the 18th International Conference on Alzheimer’s and Parkinson’s Disease held in Lisbon, Portugal between March 5-9, 2024. Details and Registration for the conference are found here. Appointed Mr. Dieter Weinand, former Chairman and CEO at Bayer Pharma AG, to its board of directors in August 2023. Coya will continue to leverage Mr. Weinand’s extensive experience, connections, and judgement to guide Coya’s strategic discussions and development programs. Dieter Weinand is an experienced executive with over 25 years of experience in the pharmaceuticals and biotech industries. Engaged Merit Cudkowicz, MD, MSc as expert clinical advisor. Dr. Cudkowicz is a world-renowned neurologist who has dedicated her career to improving the life of patients with ALS and other serious neurological conditions. Dr. Cudkowicz brings decades of experience supporting the development of new therapies for ALS. Appointed Dr. Fred Grossman to its senior management team as President and Chief Medical Officer in July 2023. Prior to joining Coya, Dr. Grossman held executive positions at Eli Lilly, Johnson & Johnson, Bristol Myers Squibb, and Sunovion. Dr. Grossman will leverage his over two decades of clinical development expertise to guide and oversee all of Coya’s development programs, including its lead asset, COYA 302, for the treatment of ALS. Howard Berman, Ph.D., Chief Executive Officer of Coya, commented, “During Q3 and year-to-date, we believe Coya has illustrated substantial value demonstrating a commitment to execution and performance. Coya’s core pipeline is centered around its immunomodulatory biologic drugs, COYA 301 and COYA 302, intended to enhance Treg function and numbers while suppressing other pro-inflammatory pathways. We believe that targeting these critical pathways, both individually and in combination, may provide for an exponential shift in the treatment landscape of neurodegenerative diseases. Focusing our efforts in ALS and AD is warranted given the promising clinical signals that we have observed to date in proof of concept clinical studies. Moreover, running the company efficiently with a careful fiduciary eye to cost containment while delivering significant value to shareholders and patients has been and will continue to be the center of my approach. We are aiming for a busy end to 2023 and productive 2024 with numerous anticipated catalysts and milestones driving the value of the business. Of importance, we plan to release top-line double-blind, placebo-controlled Phase 2 data of LD IL-2 in AD, expected by summer 2024. We also intend to submit an IND application for a randomized double-blind placebo-controlled Phase 2 trial in ALS in 1H 2024. Further, we anticipate publishing multiple peer reviewed publications during this time related to blood biomarker findings in the prior LD IL-2/CTLA4Ig proof of concept clinical trial, as well as clinical data findings for LD IL-2 in AD,” concluded Dr. Berman. Anticipated Events and Milestones COYA 302 (ld IL-2 + CTLA4 Ig) Phase 2 IND Filing in ALS (1H 2024) Initiate Phase 2 trial in ALS (following IND Filing) Proof of Concept Phase 1 investigator-initiated clinical study publication (Q1 2024) Biomarker data and ALS registry publication (Q1 2024) COYA 301 (ld IL-2) Topline data of academic investigator Initiated Phase 2 double blind trial in Alzheimer’s Disease (Summer 2024) Proof of Concept investigator-initiated Phase 1 clinical study publication in Alzheimer’s Disease (Q4 2023 or Q1 2024) Phase 1 proof of concept investigator-initiated clinical study in Alzheimer’s Disease presentation at 18th annual Alzheimer’s and Parkinson’s Disease Conference (Q1 2024) Combination LD IL-2 + Undisclosed Drug AD animal data release (2H 2024) Financial Results (Unaudited) As of September 30, 2023, Coya had cash and cash equivalents of approximately $10.9 million. Research and development (R&D) expenses were $1.6 million for the quarter ended September 30, 2023, compared to $1.3 million for the quarter ended September 30, 2022. The Company believes that R&D spending in 2023 will increase over 2022 spending levels and will be focused primarily on advancing COYA 302. General and administrative expenses were $2.0 million for the quarter ended September 30, 2023, and $1.2 million for the quarter ended September 30, 2022, a change of approximately $0.8 million. The change was primarily due to additional costs associated with being a public company including investor and public relations, director and officer insurance, financial advisory and compliance, as well as an increased headcount. The Company expects general and administrative costs to continue to grow in 2023 as Coya expands its business development activities as well as incur additional public company costs. Net loss was $3.4 million for the quarter ended September 30, 2023, compared to net loss of $4.0 million for the quarter ended September 30, 2022. CONDENSED BALANCE SHEETS September 30, December 31, 2023 2022 (unaudited) Assets Current assets: Cash and cash equivalents $ 10,886,282 $ 5,933,702 Prepaids and other current assets 936,354 1,251,264 Total current assets 11,822,636 7,184,966 Fixed assets, net 72,790 93,310 Deferred financing costs - 1,117,290 Total assets $ 11,895,426 $ 8,395,566 Liabilities and Stockholders' Equity (Deficit) Current liabilities: Accounts payable $ 633,951 $ 1,815,270 Accrued expenses 1,172,674 2,008,361 Total current liabilities 1,806,625 3,823,631 Convertible promissory notes - 12,965,480 Total liabilities 1,806,625 16,789,111 Commitments and contingencies (Note 5) Stockholders' equity (deficit): Series A convertible preferred stock, $0.0001 par value: 10,000,000 shares authorized, none and 7,500,713 issued and outstanding as of September 30, 2023 and December 31, 2022, respectively - 8,793,637 Common stock, $0.0001 par value; 200,000,000 shares authorized; 9,947,915 and 2,590,197 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively 996 259 Additional paid-in capital 37,210,163 681,106 Accumulated deficit (27,122,358 ) (17,868,547 ) Total stockholders' equity (deficit) 10,088,801 (8,393,545 ) Total liabilities and stockholders' equity (deficit) $ 11,895,426 $ 8,395,566 CONDENSED UNAUDITED INTERIM STATEMENTS OF OPERATIONS Three Months Ended September 30, 2023 2022 Operating expenses: Research and development $ 1,592,232 $ 1,278,289 In-process research and development — 135,000 General and administrative 1,964,990 1,236,127 Depreciation 6,841 12,455 Total operating expenses 3,564,063 2,661,871 Loss from operations (3,564,063 ) (2,661,871 ) Other income: Change in fair value of convertible promissory notes — (1,398,375 ) Other income, net 142,089 39,420 Net loss $ (3,421,974 ) $ (4,020,826 ) Per share information: Net loss per share of common stock, basic and diluted $ (0.34 ) $ (1.55 ) Weighted-average shares of common stock outstanding, basic and diluted 9,947,915 2,590,197 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 clinical trials; the safety pro 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.

HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics and cell therapies intended to enhance the function of Regulatory T Cells (Tregs), today announced its financial results for the second quarter ended June 30, 2023, and provided a clinical and business update. Q2 2023 and Recent Highlights Presented positive results from a proof-of-concept (PoC), open-label, investigator-initiated clinical study of low dose interleukin-2 (ld IL-2) + CTLA4 Ig in Amyotrophic Lateral Sclerosis (ALS) illustrating enhancement of Treg function during the treatment period, halting of disease progression at 24 weeks and minimal decline at 48 weeks, with the treatment appearing to be well tolerated. Study data were presented at the 2023 Muscular Dystrophy Association Conference. COYA 302 is our proprietary dual-mechanism investigational biologic combination comprised of ld IL-2 and CTLA4 Ig. The ld IL-2 is intended to enhance anti-inflammatory regulatory T cell function and numbers while the fusion protein CTLA4 Ig is intended to suppress pro-inflammatory cell function. Presented results from an open-label, investigator-initiated clinical study of ld IL-2 in eight patients with mild to moderate Alzheimer’s Disease (AD) evaluating its safety and tolerability, biological activity, blood biomarkers and preliminary efficacy. Study data were presented at the 2023 Keystone Symposia Neurodegeneration: Biology Guiding the Next Generation of Therapeutic Development. During the four-month treatment period, the therapy enhanced Treg function and numbers, appeared to be well tolerated, and resulted in a statistically significant improvement in mean MMSE scores during the treatment phase, compared to mean MMSE score at baseline (p=0.015). COYA 301 is Coya’s proprietary ld IL-2 formulation that is intended to enhance anti-inflammatory regulatory T cell function and numbers. Announced new data illustrating that administration of ld IL-2 in the AD study, as described above, resulted in a statistically significant reduction in the expression of three well characterized proinflammatory cytokines⏤Tumor Necrosis Factor alpha (TNF-α), Interleukin 6 (IL-6), and Interleukin 1- Beta (IL-1β)⏤which correlated with lack of cognitive decline of the patients over the course of the study. Presented a case study of a patient in the ld IL-2 study in AD who had pre-treatment and post-treatment Positron Emission Tomography (PET) brain scans to evaluate neuroinflammation. Meaningful reductions in neuroinflammation were observed throughout the cerebral cortex including hippocampal regions following treatment with ld IL-2, which correlated with improvement in cognitive function in this patient. Reported additional AD clinical data for ld-IL-2 at the Alzheimer’s Association International Conference (AAIC) showing a significant decrease in biomarker levels known to be associated with neuroinflammation in AD patients, further supporting the initial positive results of the study. Blood levels of CCL4 (CC motif chemokine ligand 4), FLT3LG (FMS-related tyrosine kinase 3 ligand) and TNFα (tumor necrosis factor alpha) were consistently lower following administration of ld IL-2. Expanded our patent estate for COYA 301, the Company’s ld IL-2 subcutaneous administration product candidate. Under the terms of an agreement with UNeMed, Coya has been granted the exclusive patent rights and know-how for use of ld IL-2 and ld IL-2 combinations for Parkinson’s Disease. UNeMed will receive payments upon the Company’s achievement of certain milestones and will also be eligible to receive tiered low-single digit royalty payments on net sales. Appointed Dr. Fred Grossman to its senior management team as President and Chief Medical Officer, Arun Swaminathan as Chief Business Officer, Dr. Michelle Frazier, Ph.D. as Senior Vice President of Regulatory Affairs, Merit Cudkowicz, MD, MSc as expert clinical advisor and Dr. Guillaume Dorothée, Ph.D., to the Company’s Scientific Advisory Board. “We had a strong quarter, presenting data that in an open-label, investigator-initiated clinical study, ld IL-2 increased Treg function and halted cognitive decline in patients with Alzheimer’s Disease,” stated Howard Berman, Ph.D., Chief Executive Officer of Coya. “We then announced additional ld IL-2 data in patients with AD, showing a decrease in neuroinflammation, seen in blood biomarkers as well as a case study with PET imaging of the brain. Those results only increase our enthusiasm for COYA 301, as well as our excitement to report top line double-blind, placebo-controlled, Phase 2 data anticipated in 1H 2024 for ld IL-2 in up to 46 patients with mild to moderate AD,” stated Dr. Berman. “Turning to COYA 302 in patients with ALS, we believe our proof-of-concept clinical data was promising, and we are preparing for a pre-IND meeting with the FDA in the fall of 2023. We hope to have our IND application for a phase 2 trial accepted by the FDA early next year and are optimistic the trial can begin soon thereafter. On the tactical front, with the addition of Arun Swaminathan as Chief Business Officer in April, we are actively engaged in exploring potential strategic opportunities across our portfolio of assets,” continued Dr. Berman. “Taken altogether, it was a great quarter from a data and strategic standpoint. Moving ahead, we are focused on driving safe, effective treatments for patients, efficiently leveraging and monetizing our assets, and creating long-term value for our stockholders,” concluded Dr. Berman. Anticipated Events and Milestones: COYA 302 (ld IL-2 + CTLA4 Ig) ALS PoC IIT data publication in peer reviewed journal (H2 2023) Biomarker data release for PoC study (H2 2023) Pre-IND meeting with FDA (H2 2023) IND Filing (Q1 2024) Initiate Phase 2 trial in ALS (following IND Filing) COYA 301 (ld IL-2) AD PoC IIT data presentation (American Neurological Association, September 2023) AD PoC IIT data publication in peer reviewed journal (H2 2023) Topline data of academic investigator Initiated Phase 2 double blind trial in Alzheimer’s Disease (1H 2024) COYA 200 Series (Exosomes) Target validation (H2 2023) Customized cargo validation (H2 2023) Data presentation at scientific symposia (H2 2023) Financial Results (Unaudited) As of June 30, 2023, Coya had cash and cash equivalents of $13.1 million. Research and development (R&D) expenses were $1.1 million for the quarter ended June 30, 2023, compared to $1.4 million for the quarter ended June 30, 2022. The decrease in research and development expense of approximately $0.3 million was primarily due to a $0.7 million decrease in costs attributable to our sponsored research agreement with Houston Methodist Hospital, partially offset by a $0.4 million increase in our preclinical expenses. The Company believes that R&D spending in 2023 will increase over 2022 spending levels and will be focused primarily on advancing COYA 301 and 302. General and administrative expenses were $1.8 million for the quarter ended June 30, 2023, and $2.0 million for the quarter ended June 30, 2022, a change of approximately $0.2 million. The change was primarily due to $1.0 million in costs attributable to the convertible note financing completed in the second quarter of 2022 that were not incurred in the second quarter of 2023, partially offset by a $0.8 million increase due additional costs associated with being a public company including investor and public relations, director and officer insurance, and audit and compliance. The Company expects general and administrative costs to continue to grow in 2023 as Coya expands its business development activities as well as incur additional public company costs. Net loss was $3.1 million for the quarter ended June 30, 2023, compared to net loss of $3.4 million for the quarter ended June 30, 2022. Net loss reflects the changes in operating expenses discussed above as well as $0.4 million expensed as in process research and development expense and $0.2 million of other income, principally interest, earned on the Coya’s cash balances for the quarter ended June 30, 2023. CONDENSED BALANCE SHEETS June 30, December 31, 2023 2022 (unaudited) Assets Current assets: Cash and cash equivalents $ 13,102,392 $ 5,933,702 Prepaids and other current assets 1,287,213 1,251,264 Total current assets 14,389,605 7,184,966 Fixed assets, net 79,630 93,310 Deferred financing costs - 1,117,290 Total assets $ 14,469,235 $ 8,395,566 Liabilities and Stockholders' Equity (Deficit) Current liabilities: Accounts payable $ 237,579 $ 1,815,270 Accrued expenses 983,633 2,008,361 Total current liabilities 1,221,212 3,823,631 Convertible promissory notes - 12,965,480 Total liabilities 1,221,212 16,789,111 Commitments and contingencies (Note 5) Stockholders' equity (deficit): Series A convertible preferred stock, $0.0001 par value: 10,000,000 shares authorized, none and 7,500,713 issued and outstanding as of June 30, 2023 and December 31, 2022, respectively - 8,793,637 Common stock, $0.0001 par value; 200,000,000 shares authorized; 9,947,915 and 2,590,197 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively 996 259 Additional paid-in capital 36,947,411 681,106 Accumulated deficit (23,700,384 ) (17,868,547 ) Total stockholders' equity (deficit) 13,248,023 (8,393,545 ) Total liabilities and stockholders' equity (deficit) $ 14,469,235 $ 8,395,566 CONDENSED UNAUDITED INTERIM STATEMENTS OF OPERATIONS Three Months Ended June 30, 2023 2022 Operating expenses: Research and development $ 1,067,952 $ 1,447,373 In-process research and development 350,000 — General and administrative 1,829,553 1,994,783 Depreciation 6,840 4,033 Total operating expenses 3,254,345 3,446,189 Loss from operations (3,254,345 ) (3,446,189 ) Other income: Change in fair value of convertible promissory notes — 22,345 Other income, net 158,970 10,940 Net loss $ (3,095,375 ) $ (3,412,904 ) Per share information: Net loss per share of common stock, basic and diluted $ (0.31 ) $ (1.32 ) Weighted-average shares of common stock outstanding, basic and diluted 9,947,915 2,590,197 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 pro 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.

The open-label study evaluated the safety and tolerability, biological activity, blood biomarkers and preliminary efficacy of low-dose interleukin 2 (ld IL-2) in 8 patients with Alzheimer’s disease (AD). The academic study was conducted by Dr. Appel and Dr. Faridar at the Houston Methodist Hospital. The additional clinical data show a significant decrease in biomarker levels known to be associated with neuroinflammation in AD patients further supporting the initial positive results of the study. Blood levels of CCL4 (CC motif chemokine ligand 4), FLT3LG (FMS-related tyrosine kinase 3 ligand) and TNFα (tumor necrosis factor alpha) were consistently lower following administration of ld IL-2. Coya’s investigational ld IL-2 for subcutaneous administration has been designed to enhance the function of regulatory T cells (Tregs) in vivo and it is being developed for the treatment of neurodegenerative and autoimmune diseases, as monotherapy or in combination with other immunomodulatory agents. Previously released data showed that treatment with ld IL-2 resulted in a statistically significant improvement in cognitive function, as measured by the Mini-Mental State Examination test (MMSE). In addition, no cognitive decline was observed when it was measured by the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog), and the Clinical Dementia Rating-Sum of Boxes scale (CDR-SB). Over the course of the study, ld IL-2 demonstrated biological activity by restoring peripheral Treg function and numbers and significantly lowering the blood levels of other well-characterized proinflammatory cytokines and chemokines, such as IL-15 (interleukin 15), CCL2 (monocyte chemoattractant protein-1) and CCL11 (CC motif chemokine ligand 11). Treatment with ld IL-2 administered subcutaneously appeared to be safe and well tolerated in patients with AD. An ongoing phase 2, double blind, placebo controlled trial (funded by the Gates foundation and Alzheimer’s Association) in approximately 46 patients with mild to moderate AD is almost fully enrolled and should report top line results in July, 2024. HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing multiple therapeutic platforms intended to enhance Treg function, including biologics and cell therapies, today reported results from an open-label proof-of-concept clinical study for ld IL-2 in patients with AD. Results of the study were presented July 16, 2023, at the Alzheimer’s Association International Conference (AAIC) in Amsterdam, Netherlands. The poster can be accessed here. The study enrolled 8 patients with confirmed presence of brain amyloid pathology and baseline MMSE scores between 12 and 25. The patients were treated with five-day-courses of subcutaneous ld IL-2 for four monthly cycles and were followed for two months post-treatment. Treg function and numbers, serum biomarkers of inflammation, safety and tolerability, and cognitive functioning as measured by the ADAS-Cog, CDR-SB and MMSE assessment tools were evaluated. The additional blood biomarker data showing a significant decrease in the blood levels of the proinflammatory cytokines and chemokines CCL4, FLT3LG and TNFα in AD patients treated with ld IL-2 strengthen the positive results Coya has previously announced in May 2023. Coya previously reported that the treatment with ld IL-2 significantly expanded Treg population and function. At baseline, the mean (SD) percentage of Tregs was 4.55 (1.97) and was almost double at the end of the treatment [8.68 (2.99), p=0.0004]. Mean (SD) Treg suppressive function was 46.61% (7.74) at baseline, and significantly increased to 79.5 % (20.55) at the end of treatment (p=0.003). In addition, evaluation of cognitive function showed that administration of ld IL-2 resulted in a statistically significant improvement in mean MMSE scores during the treatment phase, compared to mean MMSE score at baseline (p=0.015). Consistent with the positive trend in MMSE score, mean scores in ADAS-Cog and CDR-SB scales did not significantly change at the end of treatment with COYA 301, compared to pre-treatment baseline scores, indicating no cognitive decline as measured by these validated instruments. Overall, administration of ld-IL-2 appeared to be safe and well tolerated. The most common adverse events were mild injection-site reactions and mild leukopenia. No serious adverse events were reported, and no patient discontinued the study. Following the encouraging results of this open-label proof-of-concept study, a Phase 2 double-blind, placebo-controlled study in approximately 46 patients with mild-to-moderate AD is being conducted at the Houston Methodist Hospital and as of today, is almost fully enrolled with 38 patients in the study. The well-controlled clinical study will evaluate the safety and tolerability, Teg function, blood biomarkers of neuroinflammation, and efficacy of two dose regimens of ld IL-2 compared to placebo, over a 30-week period. Top-line results are anticipated in July 2024. The study is funded by the Gates Foundation and the Alzheimer’s Association. Stanley Appel, M.D., Professor at Houston Methodist and Chair of Coya’s Scientific Advisory Board commented, “Our research studies documenting a significant reduction of Treg neuroprotective functions in AD led to our use of low dose IL-2 to enhance Treg numbers and suppressive functions. Our 8 patient study in AD was safe and well tolerated, decreased pro-inflammatory signaling, and suggested a beneficial clinical effect. We are optimistic that this approach, now being tested in a larger double-blind placebo-controlled study, may help address the unmet needs of our deserving AD patients.” About Alzheimer’s Disease Alzheimer's disease is the most common cause of dementia, a general term for memory loss and other cognitive abilities serious enough to interfere with daily life. Alzheimer's disease accounts for up to 80% of dementia cases, affecting an estimated 5.7 million Americans. In more than 90% of people with Alzheimer’s, symptoms do not appear until after age 60. The incidence of the disease increases with age and doubles every 5 years beyond age 65. Alzheimer's is a progressive disease, where dementia symptoms gradually worsen over a number of years. In its early stages, memory loss is mild, but with late-stage Alzheimer's, individuals lose the ability to carry on a conversation and respond to their environment. It is the sixth leading cause of death among all adults and the fifth leading cause for those aged 65 or older. On average, a person with Alzheimer's lives 4 to 8 years after diagnosis but can live as long as 20 years, depending on other factors. 1,2 References Alzheimer’s Association ( ). Centers for Disease Control and Prevention ( ). 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 a 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’s 300 Series product candidates, COYA 301 and COYA 302, are biologic therapies intended to enhance Treg function and expand Treg numbers. COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages. These two mechanisms may be additive or synergistic in suppressing inflammation. For more information about Coya, please visit 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 pro 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.