# EDGAR Filing Document

**Accession Number:** 0001835022
**File Stem:** 0001193125-23-075260
**Filing Date:** 2023-3
**Character Count:** 13466
**Document Hash:** 7624e6ca5395d09a5bf36084934c1013
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-23-075260.hdr.sgml**: 20230321

**ACCESSION NUMBER**: 0001193125-23-075260

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 31

**CONFORMED PERIOD OF REPORT**: 20230321

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230321

**DATE AS OF CHANGE**: 20230321

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Coya Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001835022
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41583
- **FILM NUMBER:** 23747854

**BUSINESS ADDRESS:**
- **STREET 1:** 12645 MEMORIAL DR., SUITE F1 #305
- **CITY:** HOUSTON
- **STATE:** TX
- **ZIP:** 77024
- **BUSINESS PHONE:** 650.739.3939

**MAIL ADDRESS:**
- **STREET 1:** 12645 MEMORIAL DR., SUITE F1 #305
- **CITY:** HOUSTON
- **STATE:** TX
- **ZIP:** 77024

?xml version="1.0" encoding="utf-8" ? 8-K

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### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### Washington, D.C. 20549

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### FORM 8-K

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#### CURRENT REPORT

#### Pursuant to Section 13 or 15(d)

#### of The Securities Exchange Act of 1934

#### Date of Report (Date of earliest event reported): March 21, 2023

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## Coya Therapeutics, Inc.

#### (Exact name of registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| **Delaware** | **001-41583** | **85-4017781** |
| **(State or other jurisdiction** <br> **of incorporation)** | **(Commission**<br> **File Number)** | **(IRS Employer**<br> **Identification No.)** |

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| | |
|:---|:---|
| **5850 San Felipe St., Suite 500**<br> **Houston, Texas** | **77057** |
| **(Address of principal executive offices)** | **(Zip Code)** |

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#### Registrant's telephone number, including area code: (800) 587-8170

#### N/A

#### (Former name or former address, if changed since last report.)

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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 (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| **Title of Each Class** | **Trading<br>Symbol** | **Name of Each Exchange**<br> **on Which Registered** |
| Common Stock, par value $0.0001 per share | COYA | The Nasdaq Stock Market LLC |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1 933 (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. ☐

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| | |
|:---|:---|
| **Item 7.01** | **Regulation FD.**  |

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On March 21, 2023, Coya Therapeutics, Inc. (the "Company") will host a conference call to present clinical data of the Company's proprietary investigational biologic combination, COYA 302, in patients with Amyotrophic Lateral Sclerosis ("ALS"). The Company is using the slides attached hereto as Exhibit 99.1 to this Current Report on Form 8-K in connection with the presentations to describe its clinical data.

#### Forward-Looking Statements
This report, including Exhibit 99.1 furnished herewith, contains forward-looking statements within the meaning of the federal securities laws. Forward-looking statements typically are identified by use of terms such as "may," "will," "should," "plan," "expect," "anticipate," "estimate" and similar words, and the opposites of such words, although some forward-looking statements are expressed differently. Forward-looking statements involve known and unknown risks and uncertainties that exist in the Company's operations and business environment, which may be beyond the Company's control, and which may cause actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward- looking statements. For example, forward-looking statements include, without limitation: statements pertaining to Coya Therapeutics, Inc.'s expectations regarding future financial and/or operating results, the efficacy of our drug screening and discovery process, potential for our services, future revenues or growth and plans, strategies and objectives of management for future operations or transactions. The risks and uncertainties referred to above include, but are not limited to, risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. These risks could cause actual results to differ materially from those expressed in any forward-looking statements made by, or on behalf of, the Company. Forward-looking statements represent the judgment of management of the Company regarding future events. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable at the time that they are made, the Company can give no assurance that such expectations will prove to be correct. Unless otherwise required by applicable law, the Company assumes no obligation to update any forward-looking statements, and expressly disclaims any obligation to do so, whether as a result of new information, future events or otherwise.

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| | |
|:---|:---|
| **Item 9.01.** | **Financial Statements and Exhibits.**  |

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(d) The following exhibits are furnished with this report:

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| | |
|:---|:---|
| Exhibit No. | Description |
| 99.1 | [Presentation of Coya Therapeutics, Inc.](d464304dex991.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

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#### SIGNATURES
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.

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| | | |
|:---|:---|:---|
|  | **COYA THERAPEUTICS, INC.** | **COYA THERAPEUTICS, INC.** |
| Dated: March 21, 2023 | By: | /s/ Howard Berman |
|  | Name: | Howard Berman |
|  | Title: | Chief Executive Officer |

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## Exhibit 99.1

![Slide 1](g464304ex99_1s1g1.jpg)

Stanley H. Appel, MD Jason Thonhoff, MD, PhD David Beers, PhD Houston Methodist Research Institute 2023 MDA Clinical & Scientific Conference Novel Treg-modulating Immunotherapy Targets Inflammation in ALS Exhibit 99.1

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![Slide 2](g464304ex99_1s2g1.jpg)

Disclosures Mitsubishi Tanabe Pharma – Member of Clinical Advisory Board; Eledon Pharmaceuticals - Consultant; Implicit Bioscience - Consultant; Coya Therapeutics - Chair of Scientific Advisory Board

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![Slide 3](g464304ex99_1s3g1.jpg)

Disclosures The Houston Methodist Hospital has entered into an exclusive license agreement with Coya Therapeutics, Inc. for the know-how and patents related to its investigational product COYA 302 (IL-2/CTLA4-Ig). The development of this technology and the clinical study has been funded in part by Coya Therapeutics.

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![Slide 4](g464304ex99_1s4g1.jpg)

- Neuroinflammation - Propagating Neuronal Injury in Amyotrophic Lateral Sclerosis

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![Slide 5](g464304ex99_1s5g1.jpg)

Blood monocytes/macrophages and CNS microglia are proinflammatory. Th1 and Th17 lymphocytes are activated and proinflammatory Neuroprotective FoxP3 regulatory T lymphocytes are decreased and dysfunctional. Systemic Immune Alterations Promote Inflammation in ALS Augmenting Burden of Disease and Rates of Progression M1 FoxP3

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![Slide 6](g464304ex99_1s6g1.jpg)

Activated Macrophage Regulatory T Cell FoxP3 x Activated Th1-Th17 IL-1β NO, O2- IL-18 4-HNE IL-6 H2O2 TNFa Activated Macrophages Promote Dysfunction of Treg Numbers + Suppressive Functions Releasing Proinflammatory Cytokines and Markers of Oxidative Stress Proinflammatory cytokines and oxidative stress and lipid peroxides contribute to the pathophysiology of neuronal injury and cell death in ALS.

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![Slide 7](g464304ex99_1s7g1.jpg)

In vivo expansion of Tregs in ALS In vivo Treg expansion strategy with IL-2/CTLA4-Ig was applied for 48 weeks Four ALS patients were enrolled Changes in Treg Suppressive function, Treg numbers, ALSFRS, and biomarkers of lipid peroxides and proinflammatory cytokines were monitored 30-40% 80-90%

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![Slide 8](g464304ex99_1s8g1.jpg)

Lipid Peroxide Biomarkers of Inflammation in ALS \* p<0.05 \*\* p<0.01 n.s.: not significant \*\* \* \* \*\* n.s. \*\* \*\* 4-Hydroxynonenal (4-HNE) Oxidized Low-Density Lipoprotein (ox-LDL)

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![Slide 9](g464304ex99_1s9g1.jpg)

Expanded Treg Combination Therapy for ALS - IL-2/CTLA4-Ig Th1,Th17 80-90% IL-1β NO, O2- IL-18 4-HNE IL-6 H2O2 TNFa CTLA4Ig Proinflammatory Macrophages 30-40% CD80 FoxP3 FoxP3 FoxP3 FoxP3 IL-2

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![Slide 10](g464304ex99_1s10g1.jpg)

Proof-of-Concept Clinical Study Open-label, single-arm in 4 patients with ALS IL-2/CTL4-Ig was administered via subcutaneous injection over 48 weeks

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![Slide 11](g464304ex99_1s11g1.jpg)

Patients' Demographics and Baseline Characteristics Age (years) Sex Type Onset ALS Progression Prior to Baseline (ALSFRS-R score) Respiratory Status Respiratory Support Patient 1 47 Female Familial Limb -1.6 points / month No Respiratory Insufficiency None Patient 2 54 Male Sporadic Limb -1 points / month Respiratory Insufficiency Non-invasive Ventilation Patient 3 57 Female Sporadic Bulbar -1 point / month Respiratory Insufficiency Non-invasive Ventilation Patient 4 84 Female Sporadic Bulbar -0.7 points / month Respiratory Insufficiency None

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![Slide 12](g464304ex99_1s12g1.jpg)

IL-2 and CTLA4-Ig significantly increased Treg suppressive function in vivo Treatment Period Follow-Up IL-2 and CTLA4-Ig significantly upregulates Treg suppressive function as early as 4 weeks after initiation of treatment and maintained a significantly increased Treg function over the course of treatment. \* p<0.05 \*\* p <0.01 (paired t test) \*\* \*\* \*

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![Slide 13](g464304ex99_1s13g1.jpg)

IL-2/CTL4-Ig Significantly Increased Treg Numbers in vivo Consistent with the significant increase in Treg function, IL-2 and CTLA4-Ig increased Treg numbers as early as 4 weeks after initiation of treatment and maintained a higher number over the course of treatment. \*\* \* n.s. n.s. \* p<0.05 \*\* p <0.01 n.s.: not significant (paired t test) Treatment Period Follow-Up

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![Slide 14](g464304ex99_1s14g1.jpg)

IL-2/CTLA-Ig - Lipid Peroxide Biomarkers (interim data) \* n.s. \* p<0.05 n.s.: not significant (paired t test)

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![Slide 15](g464304ex99_1s15g1.jpg)

IL-2/CTLA4-Ig - Biomarkers by Patient (interim data)

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![Slide 16](g464304ex99_1s16g1.jpg)

The mean ALSFRS-R scores at 24 and 48 weeks after initiation of treatment were not statistically different, compared to the baseline score n.s. 48-Week Treatment Follow-Up B: baseline n.s.: not significant (paired t test) IL-2 and CTLA4-Ig appeared to ameliorate disease progression over the course of the 48-week treatment n.s.

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![Slide 17](g464304ex99_1s17g1.jpg)

Safety Summary Overall, treatment with IL-2 and CTL4-Ig was well tolerated over 48 weeks. Most common adverse event was mild injection site reaction. All patients completed the study. No death or other serious adverse event occurred over the course of the study.

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![Slide 18](g464304ex99_1s18g1.jpg)

Conclusions: Biomarkers and Therapeutic Targets in ALS In ALS Treg's normal neuroprotective functions are impaired and macrophages/microglia are proinflammatory. Macrophage/myeloid–mediated inflammatory cytokines, oxidative stress, and lipid peroxides are increased promoting neuronal injury and cell death in ALS. IL-2 expands Tregs and suppresses the proliferation of T effector cells and to a much lesser extent the proinflammatory macrophages responsible for oxidative stress and cytotoxic cytokines. The deleterious effects of heightened proinflammatory secretions mandates the use of CTLA4-Ig in combination with IL-2 to provide suppression of activated macrophages as well as Tcells, not accomplished by IL-2 alone. In the present study in ALS, administration of IL-2 and CTLA4Ig over 48 weeks enhanced suppression of biomarkers of macrophage-mediated oxidative stress and proinflammatory cytokines as well as T cells. Overall, IL-2 and CTLA4-Ig administration was well tolerated. IL-2 and CTLA4-Ig appeared to ameliorate disease progression for 48 weeks. These data suggest that IL-2 and CTLA4-Ig together provide a potentially meaningful approach for the "unmet therapeutic need" in ALS.