false 0001835022 0001835022 2024-08-16 2024-08-16

 

 

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): August 16, 2024

 

 

Coya Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

Delaware   001-41583   85-4017781

(State or Other Jurisdiction

of Incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

5850 San Felipe St., Suite 500  
Houston, Texas     77057
(Address of Principal Executive Offices)     (Zip Code)

Registrant’s Telephone Number, Including Area Code: 800 587-8170

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)

 

☐

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:

 

Title of each class

  

Trading

Symbol(s)

  

Name of each exchange

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 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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 5.02.

Departure of Directors or Certain Officers; Election of Directors, Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On August 19, 2024, Coya Therapeutics, Inc. (the “Company”) announced a planned change in management. Effective November 1, 2024, Arun Swaminathan, the Company’s Chief Business Officer since April 2023, will serve as Chief Executive Officer of the Company. Dr. Swaminathan will succeed Dr. Howard Berman, who, on August 16, 2024, notified the Company that he would be resigning as Chief Executive Officer of the Company effective at the close of business on October 31, 2024. After his resignation, Dr. Berman intends to remain a member of the Company’s board of directors (the “Board”) and serve as Executive Chairman of the Board. Upon his resignation, the Company anticipates that it will enter a consulting agreement with Dr. Berman, with an expected term of 12 months, pursuant to which Dr. Berman will provide consulting services to the Company.

On August 19, 2024, upon recommendation of the Company’s Nominating and Corporate Governance Committee, Dr. Swaminathan was also appointed to the Company’s Board as a Class III director to serve until the Company’s 2025 annual meeting of stockholders and until his successor is duly elected and qualified.

Dr. Swaminathan, age 55, has served as the Company’s Chief Business Officer since April 2023. From September 2021 through March 2023, Dr. Swaminathan served as the Chief Business Officer of Actinium Pharmaceuticals, Inc. From December 2018 through September 2021, he served as the Chief Business Officer of Alteogen Inc. Dr. Swaminathan has 20+ years of experience in the pharmaceutical and biotechnology industries across commercial, business development and research and development roles. Dr. Swaminathan holds a bachelor of pharmacy from University of Madras, a Ph.D. in Pharmaceutical Sciences from University of Pittsburgh and is a graduate of the certificate program in Marketing Management from Wharton, University of Pennsylvania. The Company believes Dr. Swaminathan is qualified to serve on the Board due to his experience as the Company’s Chief Business Officer and his experience in the pharmaceutical and biotechnology industries.

Dr. Swaminathan is party to and currently serves the Company pursuant to the terms of an Executive Employment Agreement dated April 3, 2023 (the “Employment Agreement”). Dr. Swaminathan’s current base salary is $425,000, and Dr. Swaminathan is eligible to receive an annual bonus for the fiscal year ending December 31, 3024 in an amount equal to 40% of his base salary. Pursuant to the terms of the Employment Agreement, in the event Dr. Swaminathan is terminated without cause, he is eligible to receive continued payment of his base salary for 9 months. In connection with the transition of his role to Chief Executive Officer, the Compensation Committee of the Board plans to review and evaluate potential changes to Dr. Swaminathan’s compensation arrangements in light of what will be his new and increased responsibilities with the Company. Any changes to compensation will be subject to final determination and approval of the Compensation Committee upon completion of such review. Dr. Swaminathan is also party to an indemnification agreement on the Company’s standard form with each of its directors and executive officers, a copy of which was previously filed as Exhibit 10.2 to the Company’s Registration Statement on Form S-1 on November 18, 2022.

 

-2-

The foregoing description of the Employment Agreement is not complete, and is subject to the full text of the Employment Agreement, a copy of which is included as Exhibit 10.1 to this Current Report on Form 8-K.

There are no arrangements or understandings between Dr. Swaminathan and any other person pursuant to which he was appointed as an officer or director and Dr. Swaminathan does not have a direct or indirect material interest in any “related party” transaction required to be separately disclosed pursuant to Item 404(a) of Regulation S-K. Dr. Swaminathan does not have any family relationships with any of the Company’s directors or executive officers.

 

Item 7.01.

Regulation FD.

On August 19, 2024, the Company issued a press release announcing Dr. Swaminathan’s promotion to Chief Executive Officer effective November 1, 2024. A copy of the press release is attached hereto as Exhibit 99.1.

The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

Number

   

Description

10.1    Executive Employment Agreement by and between the Company and Arun Swaminathan, dated April 3, 2023.
99.1    Press Release, dated August 19, 2024.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

-3-

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.

 

    COYA THERAPEUTICS, INC.
Date: August 19, 2024     By:  

/s/ Howard Berman

    Name:   Howard Berman
    Title:   Chief Executive Officer

 

-4-

Exhibit 10.1

EXECUTIVE EMPLOYMENT AGREEMENT

This Executive Employment Agreement (“Agreement”), dated April 3, 2023 (“Effective Date”), is between Coya Therapeutics, Inc. (the “Company”) and Arun Swaminathan (“Executive”).

 

1.

Position, Responsibilities, and term

 

  a.

Position. Executive is employed by the Company to render services to the Company in the position of Chief Business Officer. Executive shall perform such duties and responsibilities as are normally related to such position in accordance with the standards of the industry and any additional duties now or hereafter assigned to Executive by the Company’s Board of Directors (“Board”) (“Services”). Executive shall abide by the rules, regulations, and practices as adopted or modified from time to time in the Company’s sole discretion. Executive will devote Executive’s full- time efforts to the provision of Services under this Agreement. If the Executive is transferred to another position within the Company by the Board during the Term, Executive will continue to receive the compensation and benefits set forth in Section 2.

 

  b.

Other Activities. Except upon the prior written consent of the Company, Executive will not, during the term of this Agreement: (i) be employed elsewhere; (ii) engage, directly or indirectly, in any other business activity (whether or not pursued for pecuniary advantage) that might interfere with Executive’s duties and responsibilities hereunder or create a conflict of interest with the Company; or (iii) acquire any interest of any type in any other business which is in competition with the Company, provided, however, that the foregoing shall not be deemed to prohibit the Executive from acquiring solely as an investment up to one percent (1%) of the outstanding equity interests of any publicly-held company.

 

  c.

No Conflict. Executive represents and warrants that Executive’s execution of this Agreement and performance of Services under this Agreement will not violate any obligations Executive may have to any other employer, person or entity, including any obligations to keep in confidence proprietary information, knowledge, or data acquired by Executive in confidence or in trust prior to becoming an employee of the Company.

 

  d.

Term of Employment. The initial term of this Agreement shall be for a period of (i) two (2) years after the Effective Date of this Agreement (“Initial Term”); or (ii) the date upon which Executive’s employment is terminated in accordance with Section 3. This Agreement shall be automatically renewed for additional one (1) year terms (each an “Extension Term”) upon the expiration of the Initial Term and each Extension Term, unless either party gives the other party a written notice of termination not less than thirty (30) days prior to the date of expiration of the Initial Term or any Extension Term (together, the Initial Term and all Extension Terms are referred to herein as the “Term”). Where the Agreement is terminated upon notice and the expiration of the Initial Term or an Extension Term, the Company shall pay to Executive all compensation to which Executive is entitled up through the effective date of termination according to its normal payroll practices, and the Company shall not have any further obligations under this Agreement.

2.

Compensation and Benefits

 

  a.

Base Salary. In consideration of the Services to be rendered under this Agreement, the Company shall pay Executive a gross salary at the rate of $375,000 per year (“Base Salary”), less applicable withholdings. The Base Salary shall be paid in accordance with the Company’s normal payroll practices. Executive’s Base Salary will be reviewed from time to time in accordance with the established procedures of the Company for adjusting salaries for similarly situated employees and may be adjusted in the sole discretion of the Company.

 

  b.

Annual Bonus. In further consideration of the Services to be rendered under this Agreement, Executive shall be eligible to receive an annual bonus of up to 35% of Base Salary, less applicable withholdings, based on achievement of goals and objectives established by the Company (“Annual Bonus”). Any Annual Bonus earned by Executive will be paid within two-and-one-half months of the end of the year in which it was earned. Executive must remain employed with the Company through the end of the calendar year at issue in order to be eligible to receive the Annual Bonus.

 

  c.

Employment Benefits Plans. In further consideration of the Services to be rendered under this Agreement, Executive will be entitled to participate in pension, profit sharing and other retirement plans, incentive compensation plans, group health, hospitalization and disability or other insurance plans, and other employee welfare benefit plans generally made available to other similarly-situated employees of the Company, in accordance with the benefit plans established by the Company, and as may be amended from time to time in the Company’s sole discretion.

 

  d.

Vacation. Executive shall be eligible to receive paid vacation consistent with the policies and procedures adopted by the Company, if any, in its sole discretion.

 

  e.

Equity Plan. Executive shall be granted options 115,000 of Coya’s common stock at a strike price equal to the fair market value on the date of grant. One third of these options will vest at the one-year anniversary of the grant and the remainder shall vest ratably over the subsequent 24 months.

 

  f.

Expenses. The Company will pay or reimburse Executive for all normal and reasonable travel and entertainment expenses incurred by Executive in connection with Executive’s responsibilities to the Company upon submission of proper vouchers and documentation in accordance with the Company’s expense reimbursement policy.

 

3.

At-Will Employment

The employment of Executive shall be “at-will” at all times. The Company or Executive may terminate Executive’s employment with the Company at any time, without any advance notice, for any reason or no reason at all, notwithstanding anything to the contrary contained in or arising from any statements, policies or practices of the Company relating to the employment, discipline or termination of its employees. Following the termination of Executive’s employment, the Company shall pay to Executive all compensation to which Executive is entitled up through the date of termination. Thereafter, all obligations of the Company under this Agreement shall cease other than those set forth in Section 4.

 

2

4.

Company Termination Obligations

 

  a.

Termination by Company for Cause. Where the Company terminates Executive’s employment for Cause, all obligations of the Company under this Agreement shall cease, other than those set forth in Section 3. For purposes of this Agreement, “Cause” shall mean: (i) Executive engages in misconduct, including but not limited to misappropriation of trade secrets, fraud, or embezzlement; (ii) Executive commits a crime involving dishonesty, breach of trust, or physical harm to any person; (iii) Executive breaches this Agreement; (iv) Executive refuses to implement or follow a lawful policy or directive of the Company; (v) Executive engages in misfeasance or malfeasance demonstrated by Executive’s failure to perform Executive’s job duties diligently and/or professionally; or (vi) Executive violates a Company policy or procedure which causes harm to the Company, including violation of the Company’s policy concerning sexual harassment, discrimination or retaliation.

 

  b.

Termination by Company without Cause. For that period commencing as of the Effective Date until the one year anniversary of the Effective date, should the Company terminate Executive’s employment without Cause, and Executive’s employment is not terminated due to death or Disability (as defined below), Executive will be eligible to receive continued payment of Base Salary for three (3) months according to the Company’s normal payroll practices, less applicable withholdings and any remuneration paid to Executive during each applicable Company payroll period because of Executives employment or self- employment during such period. Subsequent to the one year anniversary of the Effective Date, should the Company terminate Executive’s employment without Cause, and Executive’s employment is not terminated due to death or Disability (as defined below), Executive will be eligible to receive continued payment of Base Salary for nine (9) months according to the Company’s normal payroll practices, less applicable withholdings and any remuneration paid to Executive during each applicable Company payroll period because of Executives employment or self- employment during such period.

 

  c.

Termination Due to Disability. Executive’s employment shall terminate automatically if Executive becomes Disabled. Executive shall be deemed Disabled if Executive is unable for medical reasons to perform Executive’s essential job duties for either ninety (90) consecutive calendar days or one hundred twenty (120) business days in a twelve (12) month period and, within thirty (30) days after a notice of termination is given to Executive, Executive has not returned to work. If Executive’s employment is terminated by the Company due to Executive’s Disability, all obligations of the Company under this Agreement shall cease, other than those set forth in Section 3.

 

  d.

Termination Due to Death. Executive’s employment shall terminate automatically upon Executive’s death. If Executive’s employment is terminated due to Executive’s death, all obligations of the Company under this Agreement shall cease, other than those set forth in Section 3.

 

3

  e.

Executive’s Resignation. Executive may resign Executive’s employment at any time during the Term of this Agreement pursuant to Section 3, and thereafter, all obligations of the Company under this Agreement shall cease, other than those set forth in Section 3.

 

  f.

Timing of Payments. In the event that Executive becomes entitled to receive continued payment of Base Salary pursuant to Section 4(b), Executive shall not be entitled to receive any such payments until the Company’s first payroll date that is coincident with or next following the date that is fifty five (55) calendar days following the date of Executive’s termination of employment (or, if applicable, the date of Executive’s Separation from Service) and any payments that otherwise would have been paid to Executive during such period shall be paid to Executive with the first installment paid to Executive following the end of such period. Any pro-rated Annual Bonus that becomes payable to Executive pursuant to Section 4(b) shall be paid to Executive in a lump sum payment on the date that Executive receives the first installment payment of continued Base Salary as provided in the preceding sentence.

 

  g.

Section 409A; Delayed Payments. To the extent applicable, the provisions in this Section 4 are intended to comply with Section 409A of the Internal Revenue Code of 1986, as amended, and guidance promulgated thereunder (“409A”) and this Agreement shall be administered and construed in a manner consistent with this intent. In the event that any compensation that becomes payable to Executive pursuant to this Section 4 qualifies as a deferral of compensation within the meaning of and subject to 409A, then, notwithstanding anything to the contrary in this Agreement (i) such compensation shall be paid to Executive only in the event of Executive’s “separation from service” with the Company within the meaning of 409A (“Separation from Service”) and (ii) payment of that compensation shall be delayed if Executive is a “specified employee,” as defined in 409A(a)(2)(B)(i), and such delayed payment is required by 409A. Such delay shall last six (6) months from the date of Executive’s Separation from Service. On the Company’s first payroll date that occurs after the end of such six-month period, the Company shall make a catch-up payment to Executive equal to the total amount of such payments that would have been made during the six-month period but for this Section 4(g). To the extent applicable, each and every payment to be made pursuant to Section 4(b) shall be treated as a separate payment and not as one of a series of payments treated as a single payment for purposes of Treasury Regulation Section 1.409A-2(b)(2)(iii).

 

5.

Executive Termination Obligations

 

  a.

Return of Property. Executive agrees that all property (including without limitation all equipment, tangible proprietary information, documents, records, notes, contracts and computer-generated materials) furnished to or created or prepared by Executive incident to Executive’s employment belongs to the Company and shall be promptly returned to the Company upon termination of Executive’s employment.

 

4

  b.

Resignation and Cooperation. Upon termination of Executive’s employment, Executive shall be deemed to have resigned from all offices and directorships then held with the Company. Following any termination of employment, Executive shall cooperate with the Company in the winding up of pending work on behalf of the Company and the orderly transfer of work to other employees. Executive shall also cooperate with the Company in the defense of any action brought by any third party against the Company that relates to Executive’s employment by the Company.

This Agreement may not be amended or waived except by a writing signed by Executive and by the Company’s Board. Failure to exercise any right under this Agreement shall not constitute a waiver of such right. Any waiver of any breach of this Agreement shall not operate as a waiver of any subsequent breaches. All rights or remedies specified for a party herein shall be cumulative and in addition to all other rights and remedies of the party hereunder or under applicable law.

 

6.

Assignment; Binding Effect

 

  a.

Assignment. The performance of Executive is personal hereunder, and Executive agrees that Executive shall have no right to assign and shall not assign or purport to assign any rights or obligations under this Agreement. This Agreement may be assigned or transferred by the Company; and nothing in this Agreement shall prevent the consolidation, merger or sale of the Company or a sale of any or all or substantially all of its assets.

 

  b.

Binding Effect. Subject to the foregoing restriction on assignment by Executive, this Agreement shall inure to the benefit of and be binding upon each of the parties; the affiliates, officers, directors, agents, successors and assigns of the Company; and the heirs, devisees, spouses, legal representatives and successors of Executive.

 

7.

Notices

All notices or other communications required or permitted hereunder shall be made in writing and shall be deemed to have been duly given if delivered: (a) by hand; (b) by a nationally recognized overnight courier service; or (c) by United States first class registered or certified mail, return receipt requested, to the principal address of the other party.

 

8.

Severability

If any provision of this Agreement shall be held by a court or arbitrator to be invalid, unenforceable, or void, such provision shall be enforced to the fullest extent permitted by law, and the remainder of this Agreement shall remain in full force and effect. In the event that the time period or scope of any provision is declared by a court or arbitrator of competent jurisdiction to exceed the maximum time period or scope that such court or arbitrator deems enforceable, then such court or arbitrator shall reduce the time period or scope to the maximum time period or scope permitted by law.

 

5

9.

Taxes

All amounts paid under this Agreement shall be paid less all applicable state and federal tax withholdings and any other withholdings required by any applicable jurisdiction.

 

10.

Governing Law

This Agreement shall be governed by and construed in accordance with the laws of the State of Texas.

 

11.

Interpretation

This Agreement shall be construed as a whole, according to its fair meaning, and not in favor of or against any party. Sections and section headings contained in this Agreement are for reference purposes only, and shall not affect in any manner the meaning or interpretation of this Agreement. Whenever the context requires, references to the singular shall include the plural and the plural the singular.

 

12.

Obligations Survive Termination of Employment

Executive agrees that any and all of Executive’s obligations under this Agreement, shall survive the termination of employment and the termination of this Agreement.

 

13.

Counterparts

This Agreement may be executed in any number of counterparts, each of which shall be deemed an original of this Agreement, but all of which together shall constitute one and the same instrument.

 

14.

Authority

Each party represents and warrants that such party has the right, power and authority to enter into and execute this Agreement and to perform and discharge all of the obligations hereunder; and that this Agreement constitutes the valid and legally binding agreement and obligation of such party and is enforceable in accordance with its terms.

 

15.

Entire Agreement

This Agreement is intended to be the final, complete, and exclusive statement of the terms of Executive’s employment by the Company and may not be contradicted by evidence of any prior or contemporaneous statements or agreements, except for agreements specifically referenced herein (including the Award Agreement, Proprietary Information Agreement, and Mutual Arbitration Agreement. To the extent that the practices, policies or procedures of the Company, now or in the future, apply to Executive and are inconsistent with the terms of this Agreement, the provisions of this Agreement shall control. Any subsequent change in Executive’s duties, position, or compensation will not affect the validity or scope of this Agreement.

 

6

16.

Executive Acknowledgement

EXECUTIVE ACKNOWLEDGES EXECUTIVE HAS HAD THE OPPORTUNITY TO CONSULT LEGAL COUNSEL CONCERNING THIS AGREEMENT, THAT EXECUTIVE HAS READ AND UNDERSTANDS THE AGREEMENT, THAT EXECUTIVE IS FULLY AWARE OF ITS LEGAL EFFECT, AND THAT EXECUTIVE HAS ENTERED INTO IT FREELY BASED ON EXECUTIVE’S OWN JUDGMENT AND NOT ON ANY REPRESENTATIONS OR PROMISES OTHER THAN THOSE CONTAINED IN THIS AGREEMENT.

IN WITNESS WHEREOF, the parties have duly executed this Agreement as of the date first written above.

 

COYA THERAPEUTICS, INC.    EXECUTIVE
By:  

 

              By:   

 

Howard Berman, CEO    Arun Swaminathan
Dated:  

 

      Dated:   

 

 

7

Exhibit 99.1

Coya Therapeutics Promotes Arun Swaminathan Ph.D. to Chief Executive Officer Effective November 1st, 2024

Dr. Howard Berman, the founder of Coya, will transition to Executive Chair of the Board effective November 1st, 2024

Dr. Arun Swaminathan is appointed to the Board of Directors effective immediately

HOUSTON, TX, August 19, 2024 — Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function today announced that Arun Swaminathan Ph.D. has been promoted to the role of Chief Executive Officer effective November 1, 2024. He will succeed Dr. Howard Berman who will continue to serve in the capacity of Executive Chair.

As we look forward to and prepare for the release of Alzheimer’s data at the upcoming CTAD24 conference on October 29, 2024 in Madrid and continue to progress COYA 302 in ALS, the company will benefit from leveraging Dr. Swaminathan’s strategic, business development, operational, and deal making experience to guide Coya through its next phase in the company’s growth. Over the last 5 years across multiple companies, Dr. Swaminathan was instrumental in executing several company significant commercial transactions in excess of $6 billion, including Coya’s recent Dr. Reddy’s Laboratory licensing transaction of up to $700 million.

Coya also believes it will benefit from Dr. Swaminathan’s leadership in advancing COYA 302 in related programs such as Frontotemporal Dementia (FTD), Parkinson’s Disease (PD), and other immune mediated diseases.

Howard Berman, Ph.D., commented, “Coya has grown quickly to a clinical stage company and is poised, in partnership with Dr. Reddy’s Laboratories, to potentially bring these therapies to patients who desperately need them. We believe Arun has an incredible skillset to execute on each of these milestones. He has been a foundational member of this team, instrumental in consummating our up to $700 million licensing transaction with Dr. Reddy’s Laboratories. At this stage of our evolution, I can think of no one better skilled and dedicated to take us to the next level, to progress our assets forward in the clinic and execute new business deals, all of which we believe will create value for our shareholders.

Prior to joining Coya as our Chief Business Officer, a role he has served in since April 2023, Dr. Swaminathan executed significant commercial transactions at Alteogen Inc. and Actinium Pharmaceuticals. He also was the founder and CEO of Lynkogen, Inc., a company developing GLP-1 fusion proteins. He began his career in clinical pharmacology and development and commercial roles of increasing responsibility at Bristol Myers Squibb and Covance and obtained his Ph.D. in pharmaceutical sciences from the University of Pittsburgh.

Dr. Swaminathan added, “I’m excited and grateful for the confidence Howard and our board of directors have placed in me. I look forward to expanding our existing partnerships and continuing to leverage my long-standing relationships and knowledge of the industry on behalf of the company and its shareholders, building atop the strong foundation we’ve together created over the last year. It is my mandate to bring our assets to patients as quickly as possible.”

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 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, CFO

david@coyatherapeutics.com

CORE IR

Bret Shapiro

brets@coreir.com

561-479-8566

Media Contacts

For Coya Therapeutics:

Kati Waldenburg

media@coyatherapeutics.com

212-655-0924

v3.24.2.u1
Document and Entity Information
Aug. 16, 2024
Cover [Abstract]  
Amendment Flag false
Entity Central Index Key 0001835022
Document Type 8-K
Document Period End Date Aug. 16, 2024
Entity Registrant Name Coya Therapeutics, Inc.
Entity Incorporation State Country Code DE
Entity File Number 001-41583
Entity Tax Identification Number 85-4017781
Entity Address, Address Line One 5850 San Felipe St.
Entity Address, Address Line Two Suite 500
Entity Address, City or Town Houston
Entity Address, State or Province TX
Entity Address, Postal Zip Code 77057
City Area Code 800
Local Phone Number 587-8170
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Common Stock, par value $0.0001 per share
Trading Symbol COYA
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period false
Coya Therapeutics (NASDAQ:COYA)
Gráfica de Acción Histórica
De Jul 2024 a Ago 2024 Haga Click aquí para más Gráficas Coya Therapeutics.
Coya Therapeutics (NASDAQ:COYA)
Gráfica de Acción Histórica
De Ago 2023 a Ago 2024 Haga Click aquí para más Gráficas Coya Therapeutics.