8-K
Coya Therapeutics, Inc. (COYA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 16, 2023
Coya Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-41583 | 85-4017781 |
|---|---|---|
| (State or Other Jurisdiction<br>of Incorporation) | (Commission<br> <br>File Number) | (I.R.S. Employer<br> <br>Identification No.) |
| 5850 San Felipe St., Suite 500 | ||
| --- | ||
| Houston, Texas 77057 | ||
| (Address of principal executive offices, including zip code) |
(800) 587-8170
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class: | Trading<br>Symbol | Name of Each Exchange<br> <br>on which Registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | COYA | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR§230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01 | Regulation FD Disclosure |
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On May 16, 2023, Coya Therapeutics, Inc. (the “Company”) announced the presentation of a poster (the “Poster”) with biomarker and preliminary efficacy clinical data for COYA 301 for the treatment of patients with Alzheimer’s Disease (AD) at the 2023 Keystone Symposia Meeting for Neurodegeneration held over May 15-19th, 2023. A copy of the press release which discusses this matter is furnished hereto as Exhibit 99.1, and incorporated herein by reference. The Poster is filed as Exhibit 99.2 hereto and is incorporated herein by reference.
The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 and 99.2 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| Item 8.01 | Other Events. |
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The Poster presentation, entitled, “Regulatory T Cell Expansion Strategy to Target Inflammation in AD: Phase I feasibility trial,” included data demonstrating low-dose IL-2 immunotherapy restored peripheral Treg function and ameliorated systemic pro-inflammatory mediators in AD patients.
The proof-of-concept open-label clinical study was conducted at the Houston Methodist Research Institute (Houston, Texas) and led by Stanley Appel, M.D. and Alireza Faridar, M.D. Dr. Appel is chair of the Company’s Scientific Advisory Board.
The Poster is filed as Exhibit 99.2 hereto and is incorporated herein by reference.
Forward- Looking Statements
This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical trials, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which the Company operates and management’s current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or the Company’s financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the SEC. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
| Item 9.01 | Financial Statements and Exhibits. | |
|---|---|---|
| (d) | Exhibit<br>No. | Description |
| --- | --- | --- |
| 99.1 | Press Release of Coya Therapeutics, Inc., dated May 16, 2023 | |
| 99.2 | Poster Presentation of Coya Therapeutics, Inc. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
1
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| COYA THERAPEUTICS, INC. | ||
|---|---|---|
| Dated: May 16, 2023 | By: | /s/ Howard Berman |
| Howard Berman | ||
| Chief Executive Officer |
2
EX-99.1
Exhibit 99.1
Coya Therapeutics’ COYA 301 Increased Treg Function and Halted Cognitive Decline in an Open Label Study in Patients with Alzheimer’s Disease
| • | The open-label study evaluated the safety and tolerability, biological activity, blood biomarkers andpreliminary efficacy of COYA 301 in 8 patients with Alzheimer’s disease (AD). The investigator-initiated study was conducted by Dr. Appel and Dr. Faridar at the Houston Methodist Hospital.<br> |
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| • | COYA 301 is Coya’s investigational low-dose interleukin-2 (IL-2) for subcutaneous administration. COYA 301 has been designed to enhance the function of regulatory T cells (Tregs) in vivo. |
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| • | Treatment with COYA 301 resulted in a statistically significant improvement in cognitive function, as measuredby 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), andthe Clinical Dementia Rating-Sum of Boxes scale (CDR-SB). |
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| • | Treatment with COYA 301 appeared to be well tolerated in patients with AD. |
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| • | Over the course of the study, COYA 301 restored peripheral Treg function and numbers, and lowered the levelsof systemic pro-inflammatory chemokines and biomarkers in patients with AD. |
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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 COYA 301 in patients with AD. Results of the study will be presented on May 16, 2023, at the Keystone Conference ‘Neurodegeneration: New Biology Guiding the Next Generation of Therapeutic Development’ in Whistler, B.C. Canada.
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 COYA 301 for four monthly cycles and were followed for two months post-treatment. Treg function and numbers, serum biomarkers of inflammation, and cognitive functioning as measured by the ADAS-Cog, CDR-SB and MMSE assessment tools were evaluated.
Clinically, evaluation of cognitive function showed that administration of COYA 301 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.
During the 4-month treatment period, COYA 301 appeared to be 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.
COYA 301 administration 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, COYA 301 significantly lowered the blood levels of the pro-inflammatory cytokines and chemokines IL-15, CCL2 and CCL11 following each treatment cycle.
Chemokines are among the next generation AD Biomarkers and are important regulators of both the central and peripheral immune response and play a critical role in inflammatory processes of the brain. Many studies have found that chemokines regulate the infiltration of peripheral immune cells into the AD brain, are involved in the accumulation of Aß deposition in microglia cells and tau phosphorylation, and correlate with disease progression and survival. Modulating chemokines and other pro-inflammatory markers with treatments in AD may serve as potential indicators of disease progression and therapeutic response.
Stanley Appel, M.D., Professor at Houston Methodist and Chair of Coya’s Scientific Advisory Board commented,“Ourstudy of low-dose IL-2 in patients with AD provided promising results. The therapy was well tolerated, and most significantly it demonstrated expansion in Tregpopulation, and lowered pro-inflammatory cytokines and chemokines. These positive findings were further supported by lack of decline in cognitive function during the treatment phase, suggesting that low dose IL-2 may provide a potentially meaningful approach for the treatment of AD.”
“We believe the outcomesof this proof-of-concept study of COYA 301 in patients with AD are encouraging and we will continue to analyze the data to decide our next steps. These results and therecent positive data for COYA 302 in the treatment of ALS strengthen Coya’s approach for the development of immunotherapies for the treatment of neurodegenerative diseases.” Adrian Hepner, M.D., Ph.D., President and Chief Medical Officer of Coya commented.
Additional details about the study can be found at www.coyatherapeutics.com
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
| 1. | Alzheimer’s Association (www.alz.org). |
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| 2. | Centers for Disease Control and Prevention (www.cdc.gov). |
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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 www.coyatherapeutics.com
Forward-Looking Statements
This press release contains “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and
future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements.
Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; ; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and
circumstances described in the forward-looking statements will be achieved or occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Investor Contact
David Snyder
david@coyatherapeutics.com
Hayden IR
James Carbonara
(646)-755-7412
James@haydenir.com
Media Contact
Jessica Starman
media@coyatherapeutics.com
Source: Coya Therapeutics, Inc.
EX-99.2
Exhibit 99.2 Regulatory T Cell Expansion Strategy to Target Inflammation in AD: Phase I feasibility trial 1 1 1 1 1 1 1 Alireza Faridar , Abdulmunaim M Eid , Aaron D. Thome , Weihua Zhao , David R. Beers , Maria B Pascual , Mohammad O. Nakawah , 1 2 3,4 1 1 Gustavo C. Roman , Charles S. Davis , Michael Grundman , Joseph C. Masdeu , Stanley H. Appel 1 Stanley H. Appel Department of Neurology, Houston Methodist Research Institute, Houston, Texas, USA; 2 CSD Biostatistics, Inc., Oro Valley, Arizona, USA 3 Global R&D Partners, LLC, San Diego, California, USA; 4 University of California San Diego, San Diego, California, USA BACKGROUND RESULTS 2. Adverse event summary 1. Baseline characteristics of the study participants Regulatory T cells (Tregs) are a subset of T cells that play a All adverse events neuroprotective role by were mild, and all suppressing inflammation. resolved.Allpatients completed the four- Treg immunomodulatory month treatment mechanisms are compromised phase as well as 2- inAlzheimer’s disease (AD) month post- individuals, shifting the treatment follow up immune system toward pro- phase. inflammatory status. We investigated the feasibility of low-dose IL-2 immunotherapy 5xFAD-Rag2KO 5xFAD-RAG2+Treg 4. Low-dose IL-2 immunotherapy suppressed plasma pro-inflammatory 3. Low dose IL-2 administration selectively expanded Treg population on restoring Tregs population cytokines and chemokines and modifying inflammation in anADclinicalsetting. METHODS Eight AD dementia (MMSE:12- 25) individuals were enrolled in a proof-of-concept phase 1, Attenuation in the plasma levels of IL15 (A), CCL2 (B), CCL11 (C), were noted following IL-2 open-label, feasibility study of administration. low-dose IL-2 treatment. The 5. Monitoring cognitive status through low dose IL-2 immunotherapy presence of brain amyloid pathologywasconfirmedinall participants. Enrolled individuals received monthly five-day-courses of subcutaneous low-dose IL-2 for four cycles and were E) followed for an additional two-month post-treatment. Treg immunophenotype and There were improvements in MMSE scores during the low-dose IL-2 treatment phase. On days 120 and 168 at post-treatment phase, MMSE scores were comparable to the baseline level. A trend functional analysis were toward improvement was observed in CDR-SB on day 120 which was reversed toward baseline on assessed at screening and day day168.ADAS-Cogscoresondays120and168ofthestudywerecomparabletothebaselinelevels 1 (before IL-2 treatment), and three days after the fifth dose CONCLUSIONS ofeachtreatmentcycleduring therapy, and then at weeks 17 Low-dose IL-2 immunotherapy restored peripheral Treg function and ameliorated and 24. Two-sided paired t- systemic pro-inflammatory mediators in AD patients. The results of this study warrant test was used to assess the * p<0,05 ** p< 0.01 *** p<0.001 conducting a well-controlled clinical study to further evaluate the safety and efficacy of statistical significance of low-doseIL-2asapotentialtreatmentforAD. A) Percentage of Tregs was amplified following each IL-2 treatment cycle and returned to baseline changes in each analyte or low before the next cycle. B) The percentages of CD4+CD25 Tresps were decreased following IL-2 clinical outcome at each ACKNOWLEDGEMENT administration. C) CD25 MFI in Treg population was increased following IL-2 administration. D) timepoint. FoxP3 MFI was only amplified after first IL-2 cycles administration. E) The suppressive function of This research was supported by theAlzheimer’s Association Part-The-Cloud Award. We TregsoncorrespondingTrespproliferationincreasedthroughoutthe4-monthIL-2treatmentphase. alsoacknowledgethesupportofCoyaTherapeutics.