Coya Therapeutics Inc (COYA)

Motivation for patients to participate.

The COYA clinical trial offers patients an excellent chance of receiving treatment.

The trial has defined a three-arm treatment plan. Two of those arms involve actual treatment with the actual COYA-302 combo. The one remaining arm is placebo.

The clinical trial offers patients two (2) 24-week periods. Participants are randomized for the first 24-weeks and then randomized again for the next 24-week period. So each 24-week period offers patients a 2/3 chance of receiving the drug.

The probability of receiving actual treatment at least once when given two independent 2/3 chances is 8/9, or approximately 88.89%.

https://clinicaltrials.gov/study/NCT07161999

Coya Therapeutics Has Been Granted U.S. FDA Fast Track Designation for COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)May 12, 2026 7:30 AM
Business Wire Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for COYA 302, a proprietary investigational biologic combination therapy with a dual mechanism of action, for the treatment of amyotrophic lateral sclerosis (ALS). The FDA Fast Track Designation is a program designed to facilitate and expedite the development and review of drugs and biologics intended to treat serious or life-threatening conditions. Its primary purpose is to ensure that promising new therapies reach patients as quickly as possible through several key regulatory advantages, which include more frequent FDA interactions, potential for rolling review, and eligibility for expedited programs such as Accelerated Approval and Priority Review. “We are pleased to announce that COYA 302 has received FDA Fast Track designation for the treatment of ALS,” said Arun Swaminathan, Ph.D., Chief Executive Officer of Coya. “This recognition underscores the devastating nature of ALS and the urgent need for new therapies. At Coya, we remain fully committed to advancing our lead biologic candidate, COYA 302, through the regulatory process with the ultimate goal of delivering—pending FDA approval—a safe and effective treatment for patients living with ALS and their families.” About COYA 302 COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 comprises proprietary low dose interleukin-2 (LD IL-2) and CTLA-4 Ig and is being developed for subcutaneous administration for the treatment of patients with ALS. These mechanisms may have additive or synergistic effects. Coya is currently conducting the ALSTARS Trial, a Phase 2, randomized, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of COYA 302 for the treatment of ALS (ClinicalTrials.gov Identifier: NCT 07161999). COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency. 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. 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. For more information about Coya, please visit www.coyatherapeutics.com Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: expectations of Coya Therapeutics, Inc. (the “Company”) regarding the potential benefits, effectiveness and safety of its product candidates; the significance and potential benefits associated with the FDA’s Fast Track designation for COYA 302; the Company’s ability to advance its product candidates through the preclinical and clinical development processes; the Company’s expectations regarding, quality, timing and availability of data from the Company’s clinical trials; the timing of announcements, updates and results of the Company’s clinical trials and related data; the Company’s future results of operations and financial position, including cash runway; and the potential therapeutic benefits and economic value of the Company’s product candidates. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. These and other factors that may cause the Company’s actual results to differ from current expectations are discussed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. View source version on businesswire.com: https://www.businesswire.com/news/home/20260512522130/en/ Investor Contact
David Snyder, CFO
david@coyatherapeutics.com Media Contacts
Russo Partners
David Schull
David.Schull @HANGIN 31-2310 Rachelle Babb
rachelle.babb @Michael McCrady-7559 Original: Coya Therapeutics Has Been Granted U.S. FDA Fast Track Designation for COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

Coya Therapeutics Reports First Quarter 2026 Financial Results and Provides a Corporate UpdateMay 12, 2026 7:35 AM
Business Wire Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance T-cell (Treg) function in patients with neurodegenerative disorders, announces its financial results for the quarter ended March 31, 2026 and provides a corporate update. “We are off to a strong start in 2026, building on the clinical and scientific progress achieved last year,” said Arun Swaminathan, Ph.D., Chief Executive Officer of Coya. “The ALSTARS trial is now in full recruitment mode, and we maintain our guidance for a 1Q 2027 topline readout. With a solid foundation and balance sheet in place we are well positioned to deliver on our priorities for 2026.” Recent Corporate Highlights FDA granted Fast Track Designation to COYA 302 for the treatment of ALS on May 11, 2026. Fast Track Designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs. Announced U.S. FDA acceptance of Investigation New Drug (IND) Application for COYA 302 for the treatment of frontotemporal dementia (FTD). Reported results of the investigator-initiated study of low-dose IL-2 and CTLA4-Ig combination treatment demonstrating Treg enhancement and cognitive stability in FTD patients. Announced $11.1 million private placement, led by Dr. Reddy’s Laboratories, Inc. ($10 million) and Greenlight Capital ($1.1 million), an existing institutional stockholder of the Company. Announced publication in Brain Communications demonstrating regulatory T-cell dysfunction and system inflammation in frontotemporal dementia, supporting mechanistic rationale for the use of COYA 302 as a therapy in patients with frontotemporal dementia. Announced publication in Annals of Clinical and Translational Neurology demonstrating correlation between longitudinal biomarker data and clinical outcomes supporting the mechanistic rationale for COYA 302 in patients with ALS. The ALSTARS protocol was amended to remove the prior exclusion criteria for patients receiving antihypertensive medications and for those with controlled autoimmune diseases. The amended protocol was cleared through both FDA and Health Canada and is expected to allow for a broader patient population, which we believe will increase the enrollment rate. Upcoming Expected Catalysts for 2026 June 2026: Scientific presentations at upcoming 5th Annual ALS Drug Development Summit and ENCALS (European Network to Cure ALS). 2H 2026: Targeting full enrollment of our ALSTARS Phase 2 trial. 2H 2026: Initiate Phase 2a study evaluating COYA 302 for the treatment of FTD. 2H 2026: Report additional single cell proteomics data from the completed ALS and AD investigator-initiated trials. 2H 2026: Publication of COYA 303 in vivo data in inflammatory animal model of peripheral and CNS inflammation. “The recent revision to our inclusion/exclusion criteria [for our ALSTARS protocol] has expanded the patient population to study this potential therapy for ALS. We expect that this change will also increase the recruitment rate,” said Fred Grossman, DO, FAPA, President and Chief Medical Officer of Coya. “We continue to strengthen the biological foundation of our approach as we believe the investigator-initiated study findings and publications noted above highlight the role of immune dysregulation and systemic inflammation in FTD and ALS, and reinforce the promising potential of COYA 302 to modulate these pathways and impact disease progression.” Financial Results As of March 31, 2026, Coya had cash and cash equivalents of $50.7 million. Collaboration revenue was $0.3 million for each of the three months ended March 31, 2026 and 2025, and related to the Company’s R&D services performance obligation under the Development and License Agreement with DRL. Research and development expenses decreased by $1.1 million, from $5.2 million for the three months ended March 31, 2025, to $4.1 million for the three months ended March 31, 2026. The decrease was primarily due to a $1.2 million decrease in external preclinical and clinical product candidates, reflecting the timing of preclinical activities undertaken in early 2025 to support the Company’s Investigational New Drug applications for COYA 302 in ALS. The decrease was further driven by a $0.1 million decrease in sponsored research expense, partially offset by a $0.2 million increase in internal research and development expenses. General and administrative expenses increased by $1.1 million, from $2.7 million for the three months ended March 31, 2025, compared to $3.8 million for the three months ended March 31, 2026. The increase was primarily due to a $1.1 million increase in employee compensation, which included a non-cash charge of $1.0 million related to the modification of stock options held by the Company’s former Executive Chairman in connection with his resignation. Net loss was $7.2 million for the three months ended March 31, 2026, compared to net loss of $7.3 million for the three months ended March 31, 2025. 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. 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. For more information about Coya, please visit www.coyatherapeutics.com About COYA 302 COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 comprises proprietary low dose interleukin-2 (LD IL-2) and CTLA-4 Ig and is being developed for subcutaneous administration for the treatment of patients with ALS and other neurodegenerative diseases. These mechanisms may have additive or synergistic effects. Coya is currently conducting the ALSTARS Trial, a Phase 2, randomized, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of COYA 302 for the treatment of ALS (Identifier: NCT07161999). COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: expectations of Coya Therapeutics, Inc. (the “Company”) regarding the potential benefits, effectiveness and safety of its product candidates; the significance and potential benefits associated with the FDA’s Fast Track designation for COYA 302; the Company’s ability to advance its product candidates through the preclinical and clinical development processes; the Company’s expectations regarding, quality, timing and availability of data from the Company’s clinical trials; the timing of announcements, updates and results of the Company’s clinical trials and related data; the Company’s future results of operations and financial position, including cash runway; and the potential therapeutic benefits and economic value of the Company’s product candidates. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. These and other factors that may cause the Company’s actual results to differ from current expectations are discussed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.   COYA THERAPEUTICS, INC. CONDENSED BALANCE SHEETS       (unaudited)             March 31,     December 31,       2026     2025   Assets             Current assets:             Cash and cash equivalents   $ 50,724,643     $ 46,822,786   Prepaids and other current assets     2,538,036       3,116,232   Total current assets     53,262,679       49,939,018   Fixed assets, net     8,420       11,227   Total assets   $ 53,271,099     $ 49,950,245                 Liabilities and Stockholders' Equity             Current liabilities:             Accounts payable   $ 948,192     $ 1,061,122   Accrued expenses     1,355,714       3,612,913   Deferred collaboration revenue     1,242,635       1,197,856   Total current liabilities     3,546,541       5,871,891   Deferred collaboration revenue     754,198       1,050,124   Total liabilities     4,300,739       6,922,015                 Stockholders' equity:             Series A convertible preferred stock, $0.0001 par value: 10,000,000 shares authorized, none issued or outstanding as of March 31, 2026 or December 31, 2025     -       -   Common stock, $0.0001 par value; 200,000,000 shares authorized; 23,457,183 and 20,934,456 shares issued and outstanding as of March 31, 2026 or December 31, 2025, respectively     2,346       2,094   Additional paid-in capital     118,138,281       104,989,413   Accumulated deficit     (69,170,267 )     (61,963,277 ) Total stockholders' equity     48,970,360       43,028,230   Total liabilities and stockholders' equity   $ 53,271,099     $ 49,950,245     COYA THERAPEUTICS, INC. CONDENSED UNAUDITED INTERIM STATEMENTS OF OPERATIONS       Three Months Ended March 31,       2026     2025   Collaboration revenue   $ 251,147     $ 257,884   Operating expenses:             Research and development     4,096,580       5,214,076   In-process research and development     10,000       -   General and administrative     3,781,977       2,713,890   Depreciation     2,807       6,840   Total operating expenses     7,891,364       7,934,806   Loss from operations     (7,640,217 )     (7,676,922 ) Other income:             Other income     433,227       370,165   Pre-tax loss     (7,206,990 )     (7,306,757 ) Income tax expense     -       -   Net loss   $ (7,206,990 )   $ (7,306,757 )               Per share information:             Net loss per share of common stock, basic and diluted   $ (0.32 )   $ (0.44 ) Weighted-average shares of common stock outstanding, basic and diluted     22,644,304       16,720,511     COYA THERAPEUTICS, INC. CONDENSED UNAUDITED INTERIM STATEMENTS OF CASH FLOWS       Three Months Ended March 31,       2026     2025   Cash flows from operating activities:             Net loss   $ (7,206,990 )   $ (7,306,757 ) Adjustment to reconcile net loss to net cash used in operating activities:             Depreciation     2,807       6,840   Stock-based compensation, including the issuance of restricted stock     2,195,516       1,080,082   Acquired in-process research and development assets     10,000       -   Changes in operating assets and liabilities:             Collaboration receivable     -       -   Prepaids and other current assets     578,196       3,126,042   Accounts payable     (154,713 )     101,879   Accrued expenses     (1,382,199 )     421,523   Deferred collaboration revenue     (251,147 )     (257,884 ) Net cash used in operating activities     (6,208,530 )     (2,828,275 ) Cash flows from investing activities:             Purchase of in-process research and development assets     (885,000 )     -   Net cash used in investing activities     (885,000 )     -   Cash flows from financing activities:             Proceeds from sale of common stock, net of offering costs     10,995,387       -   Proceeds from the exercise of stock options     -       19,137   Net cash provided by financing activities     10,995,387       19,137   Net increase (decrease) in cash and cash equivalents     3,901,857       (2,809,138 ) Cash and cash equivalents as of beginning of the period     46,822,786       38,339,762   Cash and cash equivalents as of end of the period   $ 50,724,643     $ 35,530,624                 Supplemental disclosures of non-cash investing and financing activities:             Financing costs related to the sale of common stock in accounts payable   $ 41,783     $ -   In-process research and development costs in accrued expenses   $ 250,000     $ -       View source version on businesswire.com: https://www.businesswire.com/news/home/20260512279103/en/ Investor Contact
David Snyder, CFO
david@coyatherapeutics.com Media Contacts
Russo Partners
David Schull
David.Schull @HANGIN 31-2310 Rachelle Babb
rachelle.babb @Michael McCrady-7559 Original: Coya Therapeutics Reports First Quarter 2026 Financial Results and Provides a Corporate Update

“We are pleased to announce that COYA 302 has received FDA Fast Track designation for the treatment of ALS,”
https://ir.coyatherapeutics.com/news/news-details/2026/Coya-Therapeutics-Has-Been-Granted-U-S--FDA-Fast-Track-Designation-for-COYA-302-for-the-Treatment-of-Amyotrophic-Lateral-Sclerosis-ALS/default.aspx

Clinical trial updates
All sites have progressed to "Recruiting".
The next status is "Active, not recruiting".
The site in Lincoln Nebraska has progressed to "Active, not recruiting".
This is a good indicator that patients are willing to enroll in the blinded trial.
https://clinicaltrials.gov/study/NCT07161999

Halting the progress of ALS. Scores at 48 weeks were not statistically different
COYA has published the results of a STUDY

Clinical Trial Updates:
Trial: Study of COYA 302 for the Treatment of ALS (ALSTARS)
All Canadian sites are now recruiting.
New Austin Texas site added, not yet recruiting: Austin Neuromuscular Center

ALS: Eric Dane. "Dr. McSteamy"

Webcast Replay

COYA Webinar Tuesday Feb 17th 2pm Central
Inside the Evolving ALS Landscape: Biology, Innovation, and Clinical Progress
https://russopr.zoom.us/webinar/register/WN_rRgGlKFlTISfw3iSp0Nlmg#/registration

Summary of incentive stock option grants (Form 4)
All numbers are right-to-buy shares at $4.73
Vesting 1/36 monthly over the next 3 years.
David Snyder CFO 140,041
Arun Swaminathan CEO 293,983
Fred Grossman CMO 140,041
Howard Berman COB 15,257

Letter to Shareholders
https://ir.coyatherapeutics.com/news/news-details/2026/Coya-Therapeutics-CEO-Dr--Arun-Swaminathan-Issues-Letter-to-Stockholders/default.aspx

COYA 302 treats ALS by targeting the underlying neuroinflammation through a dual immunomodulatory mechanism of action. It is an investigational combination therapy that is currently in a Phase 2 clinical trial (ALSTARS trial).

Mechanism of Action

Enhances Regulatory T-cells (Tregs): The low-dose interleukin-2 (LD IL-2) component of COYA 302 is intended to increase the number and enhance the anti-inflammatory function of Tregs, which are often dysfunctional in ALS patients.

Suppresses Inflammation: The CTLA-4 Ig component (abatacept biosimilar candidate) is designed to temper the activation of effector T cells and reduce the inflammation caused by activated monocytes and macrophages.

Together, these two mechanisms work to rebalance the immune system, reduce inflammatory cytokines and oxidative stress that damage motor neurons, and thereby potentially slow the progression of the disease.

COYA ALS Clinical Trial Sites Recruiting:

COYA Central Contact 800-587-8170 clinicaltrials@coyatherapeutics.com

CALIFORNIA
Los Angeles 310-423-3277 GroupneuromuscularResearch@cshs.org
San Francisco 415-463-0379 clinicalresearch@sutterhealth.org

FLORIDA
Davie 954-262-6387 Donovan.Mott@nova.edu
Gainesville 352-733-2412 Jennifer.steshyn@neurology.ufl.edu
Miami 305-243-2345 jph93@miami.edu
Tampa 813-974-9413 jessshaw@usf.edu

GEORGIA
Atlanta 404-727-5193, Katherine.cummings@emory.edu

MARYLAND
Baltimore 410-614-1196 dwillie2@jh.edu

MASSACHUSETTS
Boston 617-643-3530 coya302healey@mgb.org

MICHIGAN Ann Arbor University of Michigan

MISSOURI
St Louis, 314-362-6981 als@wustl.edu

NEBRASKA
Lincoln, 402-770-7403 wendy@somnos.com

NEW YORK
New York City 877-426-5637 alsresearch@cumc.columbia.edu

PENNSYLVANIA
Philly 267-582-6061 Gemma.krautzel@jefferson.edu
Philly Kathleen.hatala@tuhs.temple.edu

TEXAS
Dallas 214-827-3610 hrucker@texasneurology.com
Houston 713-441-6955 abalogun@houstonmethodist.org
San Antonio 210.450.8454 kentbaron@uthscsa.edu

NOT YET
Phoenix, Chicago, Vancouver BC, London Ontario, Toronto, Ontario, Montreal, Quebec

https://clinicaltrials.gov/study/NCT07161999?term=coya&rank=1

Positive results for COYA-302 applied to FTD.
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001835022/000119312526007042/d39008d8k.htm

Bruce Willis has Frontotemporal Dementia (FTD)

IND for the Treatment of Frontotemporal Dementia (FTD)
https://ir.coyatherapeutics.com/news/news-details/2026/Coya-Therapeutics-Announces-U-S--FDA-Acceptance-of-Investigational-New-Drug-IND-Application-for-COYA-302-for-the-Treatment-of-Frontotemporal-Dementia-FTD/default.aspx

Interview with $COYA CEO Arun Swaminathan
🚀 The latest episode of The Upside is live!

ALS. Dementia. Alzheimer’s. Diseases that impact over 50 million people - with few treatment options.

But $COYA believes stopping progression is possible.

How? I sat down with @CoyaTx CEO Arun Swaminathan to explain it all...… pic.twitter.com/6hvvkFHgOh— Lou Basenese (@LouBasenese) December 22, 2025

On December 16, 2025, Coya Therapeutics, Inc. (the “Company”) received a $4.2 million milestone payment under the Development and License Agreement, dated December 5, 2023 (the “DRL Development Agreement”), by and amongst the Company, Dr. Reddy’s Laboratories Ltd. and its affiliate, Dr. Reddy’s Laboratories SA. The milestone payment was triggered by dosing of the first patient in the Company’s ALSTARS trial evaluating COYA 302 for the treatment of amyotrophic lateral sclerosis (ALS), which was announced on December 9, 2025.
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001835022/000119312525321737/d729078d8k.htm

First Patients dosed.
https://www.businesswire.com/news/home/20251209366236/en/Coya-Therapeutics-Announces-Patients-Have-Been-Dosed-in-the-ALSTARS-Trial-of-COYA-302-for-the-Treatment-of-ALS

Just as a reminder, the company status is "clinical trial". Mile stones are "recruiting", "1st patient dosed", etc.
So... not much, really, to chat about.

COYA ALS Clinical Trial Sites Recruiting:

COYA Central Contact 800-587-8170 clinicaltrials@coyatherapeutics.com

Lincoln, Nebraska, Neurology Associates, 402-770-7403 wendy@somnos.com
Dallas, Texas Neurology, 214-827-3610 hrucker@texasneurology.com
Boston, Massachusetts General Hospital, 617-643-3530 coya302healey@mgb.org
St Louis, Washington University, (314) 362-6981 als@wustl.edu
Atlanta, Emory University, (404)727-5193, Katherine.cummings@emory.edu

Not Yet Recruiting: Philadelphia, Houston, Miami, San Francisco

https://clinicaltrials.gov/study/NCT07161999?term=coya&rank=1

The $COYA ALS clinical trial is ramping up.
Recruiting, Lincoln, Nebraska, Neurology Associates, 402-770-7403
Recruiting, Dallas, Texas, Texas Neurology, 214-827-3610
More sites not yet recruiting San Francisco, Miami, Atlanta, Boston, Philadelphia, Houston.
https://clinicaltrials.gov/study/NCT07161999?term=coya&rank=1

For students of $COYA. There is much to learn and understand in this write up.
https://biotechhealthx.com/biotech-news/coya-therapeutics-coya-could-be-the-next-5x-biotech/

COYA will raise cash thru the sale of common stock. The August 19th prospectus specified $75M but only listed common stock as a possibility. Today's supplement specifies common stock. Number of shares is TBD.

COYA mentioned in Seeking Alpha blurb.
https://seekingalpha.com/news/4503965-coya-therapeutics-jumps-as-greenlight-discusses-in-q3-letter

Coya Therapeutics (NASDAQ:COYA) surged 17% after David Einhorn's Greenlight hedge fund disclosed it's the company's largest holder in its latest Q3 letter to investors.

Coya's lead drug is aimed at treating ALS and it has just entered clinical trials.

"While results won't be known for about a year, the compound appears very promising, and if the trial succeeds, it has an excellent chance to receive `fast track' approval from the FDA," according to the Greenlight letter viewed by Seeking Alpha.

Greenlight also highlighted that a member of Coya's advisory committee was last week awarded a Nobel Prize in Medicine in an area "consistent with COYA's approach."

"Of course, there is no way to know how the trial will turn out. But at a time when AI-related business plans that are not much more than a Powerpoint presentation are being funded at a multi-billion valuations, we'd prefer to speculate at COYA at a $100 million valuation."

Up 17%. No news. Just some big buys.

$COYA Coya Therapeutics Congratulates Scientific Advisor Dr. Shimon Sakaguchi
https://www.businesswire.com/news/home/20251007513857/en/Coya-Therapeutics-Congratulates-Scientific-Advisor-Dr.-Shimon-Sakaguchi-for-Receiving-The-Nobel-Prize-in-Physiology-or-Medicine-for-Discovery-of-Regulatory-T-Cells-and-Immune-Function

2025 Nobel prize in medicine awarded to COYA SAB member Shimon Sakaguchi
https://www.nobelprize.org/prizes/medicine/2025/press-release/

New ALS Research Vindicates a 92-Year-Old Trailblazer Dr. Stanley Appel
This is a Bloomberg article .... maybe you can read it.
https://www.bloomberg.com/news/newsletters/2025-10-06/new-als-research-backs-trailblazer-s-focus-on-immune-system
I'm posting relevant links from the article.
amyotrophic lateral sclerosis
Stanley Appel
C9ORF72: What It Is, What It Does, and Why It Matters
Coya Therapeutics has licensed the approach

COYA Launches a new Phase 2 Clinical Trial: NCT07161999
Study of COYA 302 for the Treatment of ALS (ALSTARS)
https://clinicaltrials.gov/study/NCT07161999?term=coya&rank=1

Coya Therapeutics' COYA 303 Shows Promising Central Nervous System (CNS) Anti-inflammatory Effects and Systemic Regulatory T Cell (Treg) Enhancing Effects in a Preclinical Animal Inflammation Model
https://ir.coyatherapeutics.com/news/news-details/2025/Coya-Therapeutics-COYA-303-Shows-Promising-Central-Nervous-System-CNS-Anti-inflammatory-Effects-and-Systemic-Regulatory-T-Cell-Treg-Enhancing-Effects-in-a-Preclinical-Animal-Inflammation-Model/default.aspx

COYA 302 P2 trial just got a huge boost.
NEALS Acceptance ... Opens access to 150 clinical trial sites

FDA Accepted COYA's IND
IND Announcement

FDA's approval decision for COYA's submitted IND will be provided no later than August 29, 2025.
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001835022/000119312525168115/d14950d8k.htm

Finally! On June 30, 2025, the Company re-submitted ... (the “IND”)
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001835022/000119312525153465/d17294d8k.htm

Business updates:
Patent protection:
Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya”) today announced the issuance of a U.S. patent relevant to its investigational ready-to-use (RTU) liquid formulation of IL-2. In particular, the U.S. Patent and Trademark Office (USPTO) has granted patent number US 12,312,389 B2, which covers methods of producing highly stable liquid formulations of IL-2 (aldesleukin).

IND Date:
Coya is on track and plans to submit the IND for COYA 302 (a proprietary combination of the low dose-rhIL-2 + CTLA4-Ig) by the end of June supporting the initiation of the Phase 2b study in patients with ALS
https://ir.coyatherapeutics.com/news/news-details/2025/Coya-Therapeutics-Announces-Issuance-of-New-U-S--Patent-Protecting-Methods-of-Producing-Recombinant-Human-rh-Interleukin-2-aldesleukin-Liquid-Formulations/default.aspx

Language I've been waiting for:
"we anticipate is on track for an FDA IND submission in ALS during 2Q 2025 followed by the initiation of a controlled Phase 2 clinical trial."
https://www.sec.gov/Archives/edgar/data/1835022/000095017025069819/coya-ex99_1.htm

Principal Investigator Alireza Faridar, M.D. to provide overview of data for the investigator-initiated “Phase II Clinical Trial of Interleukin-2 (IL-2) in Patients with Mild to Moderate Alzheimer’s disease”

This Calendar

This Session:

I've been on the sidelines here.
$COYA has yet to announce a successful IND filing.
They have not even disclosed what additional information is required. On July 12, 2024, the Company received an email notification from the FDA stating that additional non-clinical data is required prior to the initiation of the Study. The FDA also stated that it would provide the Company with more details about what additional information it requires within the next thirty (30) days. https://www.sec.gov/ix?doc=/Archives/edgar/data/0001835022/000119312524178809/d762748d8k.htm

ALS drug failures and why COYA 302 is different
https://www.digitaljournal.com/tech-science/als-drug-failures-and-why-coya-302-is-different/article

Coya Therapeutics (COYA): BTIG Buy $15 PT March 2nd, 2025
https://coyatherapeutics.wordpress.com/2025/03/02/coya-therapeutics-coya-btig-buy-15-pt-march-2nd-2025/

Coya reports good results.
https://ir.coyatherapeutics.com/news/news-details/2025/Coya-Therapeutics-Reports-Statistically-Significant-Improvement-of-Inflammatory-Blood-Markers-in-Patients-with-Alzheimers-Disease-Following-Monthly-Dosing-with-Low-Dose-IL-2-Further-Supporting-Clinical-Development/default.aspx

Coya announces the expansion of its investigational pipeline and advancement of COYA 303 for the treatment of inflammatory diseases.
https://ih.advfn.com/stock-market/NASDAQ/coya-therapeutics-COYA/stock-news/95283171/coya-therapeutics-announces-pipeline-expansion-c

Coya Therapeutics Provides Enrollment Update of the Investigator-Initiated Phase 1 Study of Low Dose Interleukin-2 (LD IL-2) + CTLA4-Ig Fusion Protein in Patients with Frontotemporal Dementia (FTD)
Dec 18, 2024
https://ir.coyatherapeutics.com/news/news-details/2024/Coya-Therapeutics-Provides-Enrollment-Update-of-the-Investigator-Initiated-Phase-1-Study-of-Low-Dose-Interleukin-2-LD-IL-2--CTLA4-Ig-Fusion-Protein-in-Patients-with-Frontotemporal-Dementia-FTD/default.aspx

Worth a listen:
https://wsw.com/webcast/evercore44/register.aspx?conf=evercore44&page=coya&url=https://wsw.com/webcast/evercore44/coya/2360484

Q&A with Coya's new CEO.
https://houston.innovationmap.com/coya-therapeutics-arun-swaminathan-ceo-2670009696.html

Web/Con Tuesday, October 29, at 8am ET
Webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=xpdYyUGI
or Dial: 1-866-807-9684
https://www.businesswire.com/news/home/20241028411053/en/

Two events next week in Madrid (ADDF followed by CTAD)
Agenda ADDF Summit 2024 COYA presenting.
https://summit.alzdiscovery.org/agenda

Clinical Trials Results Poster P027 by Stanley Appel CTAD 2024
https://www.ctad-alzheimer.com/files/files/PROGRAM_CTAD2024_WEB%20OCTOBER%2018.pdf