Coya Therapeutics Inc (COYA) 銘柄情報

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

1,379,314 shares Private placement @$7.25
8K https://www.sec.gov/ix?doc=/Archives/edgar/data/0001835022/000119312524240775/d877895d8k.htm

Positive piece from H.C.Wainwright
https://coyatherapeutics.wordpress.com/2024/09/16/coya-therapeutics-coya-h-c-wainwright-buy-18-pt-engaging-immunomudulation-in-nuerology/

Positive piece published by Seeking Alpha
https://seekingalpha.com/article/4726428-coya-therapeutics-several-near-term-share-price-appreciation-catalysts

Coya announces that CEO Howard Berman, Ph.D. and Chief Business Officer and incoming Chief Executive Officer Arun Swaminathan, Ph.D, will participate in a fireside chat at the Chardan 8th Annual Genetic Medicines Conference on Tuesday, October 1, 2024 at 2:00pm ET.

COYA under $7

Rarely do I see pre-market volume. 2K so far today. Nice.

Officers come and go. 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.
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001835022/000119312524202551/d861081d8k.htm

Coya Therapeutics Expands Pipeline and Intellectual Property Portfolio with Filing of New U.S. Patents
https://ir.coyatherapeutics.com/news/news-details/2024/Coya-Therapeutics-Expands-Pipeline-and-Intellectual-Property-Portfolio-with-Filing-of-New-U.S.-Patents-for-COYA-301-in-Combination-with-Glucagon-Like-Peptide-1-GLP-1-Receptor-Agonists/default.aspx

COYA to present AD results at CTAD24
https://ir.coyatherapeutics.com/news/news-details/2024/Coya-Therapeutics-Announces-that-Results-from-a-Double-Blind-Placebo-Controlled-Study-in-Alzheimers-Disease-will-be-presented-on-October-29-2024-at-the-Clinical-Trials-on-Alzheimers-Disease-Conference-CTAD24-in-Madrid/default.aspx

Coya 8K July 15
On June 14, 2024, Coya Therapeutics, Inc. (the “Company”) submitted to the U.S. Food and Drug Administration (the “FDA”) an Investigational New Drug Application (the “IND”) seeking to initiate a study entitled “Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study with Additional 24-Week Open Label Extension (OLE) to Evaluate the Safety and Efficacy of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)” (the “Study”). 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

The WOW signal!
Prior to initiating treatment, patients were declining at an average rate of -1.1 points per month on the ALSFRS-R rating scale- At the end of 6 months of treatment, the mean rate of change on the ALSFRS-R was +0.04 points per month.

$COYA ALS Peer-Reviewed Publication:
https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1415106/full

Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologic intended to enhance regulatory T cell (Treg) function, announces the acceptance of a peer-reviewed manuscript titled, “A Phase 1 Proof-of-Concept Study Evaluating Safety, Tolerability, and Biological Marker Responses with Combination Therapy of CTLA4-Ig and Interleukin-2 in Amyotrophic Lateral Sclerosis,” in the medical journal Frontiers in Neurology. A portion of the data from the manuscript was previously presented at the 2023 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference and the 2024 Society of Neuroimmune Pharmacology Conference.
https://ih.advfn.com/stock-market/NASDAQ/coya-therapeutics-COYA/stock-news/93970259/coya-therapeutics-announces-acceptance-of-peer-rev

Today 2 Jun is #LouGehrigDay #EndALS

It’s T+1 time

On May 17, 2024, Coya Therapeutics, Inc. (the “Company”) entered into a Securities Purchase Agreement (the “Purchase Agreement”) with the Alzheimer’s Drug Discovery Foundation (the “ADDF”) for the issuance and sale in a private placement (the “Private Placement”) of 603,136 shares (the “Shares”) of the Company’s common stock, par value $0.0001 per share (“Common Stock”), at a purchase price of $8.29 per share for gross proceeds to the Company of $5.0 million.
ADDF >>>> https://www.alzdiscovery.org/
8K >>>>>>> https://www.sec.gov/ix?doc=/Archives/edgar/data/0001835022/000119312524142950/d820823d8k.htm

Validating A Better ALS Biomarker With Coya's Fred Grossman
Fred discusses $COYA's 1H2024 plans for a IND application and the 2H2024 P2 trial.
https://www.clinicalleader.com/doc/validating-a-better-als-biomarker-with-coya-s-fred-grossman-0001

Coya Therapeutics to Participate in the 3rd Annual ALS Drug Development Summit
https://ir.coyatherapeutics.com/news/news-details/2024/Coya-Therapeutics-to-Participate-in-the-3rd-Annual-ALS-Drug-Development-Summit/default.aspx

And in the world of ALS.
Amylyx Pharmaceuticals said it would voluntarily remove its drug for amyotrophic lateral sclerosis from the market, a rare move that comes less than a month after a clinical trial showed its once-promising treatment for the fatal disease doesn’t work.
https://www.washingtonpost.com/business/2024/04/04/amylyx-als-drug/

Investing in the fight against ALS. Hosted by Schwab Network.
https://schwabnetwork.com/video/investing-in-the-fight-against-als

COYA 2023 10-K
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001835022/000095017024033161/coya-20231231.htm

Coya Therapeutics Provides a Corporate Update and Reports Fiscal 2023 Financial Results
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001835022/000095017024033159/coya-20240319.htm

Neuroimmune Pharmacology Conference Powerpoint
https://s201.q4cdn.com/307844724/files/doc_news/2024/NeuroimmunePharmacology3-12-2024-4.pdf

Dr. Stan Appel will be presenting during a 30-minute segment at the The 28th Society of Neuroimmune Pharmacology Conference.
March 10-13, 2024 The Francis Marion Hotel, Charleston
https://s-nip.org/documents/2024/SNIP_2024_Schedule.pdf

Empowering Patient Story and Coya’s Fight Against Neurodegenerative Diseases
Coya’s VP of Operations and Patient Advocacy, Daniel Barvin, had the opportunity to shed light on the world of his empowering patient story and Coya’s fight against neurodegenerative diseases in Houston for the Reel Abilities, UP Abilities event.

21 Feb: COYA letter to stockholders.
Today, we announce that we are further expanding the pipeline for COYA 302, adding Alzheimer’s disease (AD) to its growing list of indications
https://ih.advfn.com/stock-market/NASDAQ/coya-therapeutics-COYA/stock-news/93327358/coya-therapeutics-issues-letter-to-stockholders-hi

About ALS:
ALS is a progressive disease, meaning the symptoms get worse over time. The functional status of ALS patients declines about 1 point per month on average, as measured by the Revised ALS Function Rating Scale1, or ALSFRS-R, a validated tool to monitor the progression of the disease.

COYA results:
Patients' disease progression was measured using the ALSFRS-R scale. The mean scores after initiation of treatment were not statistically different compared to the score at baseline, suggesting significant amelioration in the progression of the disease over the 48-week treatment period.

https://ih.advfn.com/stock-market/NASDAQ/coya-therapeutics-COYA/stock-news/93265319/coya-therapeutics-licenses-intellectual-property-r

SEC Form 4's
$COYA announced small option grants (5000 shr @ $7.41) for 3 BOD members. I expect more announcements to come.

8K 19 Jan 2024
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001835022/000119312524010775/d732822d8k.htm
As of December 31, 2023, Coya Therapeutics, Inc. (the “Company”) had cash and cash equivalents (unaudited) of $32.6 million. In January 2024, the Company received $7.5 million from Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”), as required under the terms of the Development and License Agreement entered into with Dr. Reddy’s on December 5, 2023, which was previously disclosed in our Current Report on Form 8-K filed with the Securities and Exchange Commission on December 6, 2023 (the “Form 8-K”).

The Company’s cash and cash equivalents as of December 31, 2023, pro forma for receipt of the $7.5 million from Dr. Reddy’s (as if such amount was received on December 31, 2023) would be $40.1 million.

In addition, as previously disclosed in the Form 8-K, (i) upon the first Food and Drug Administration (FDA) acceptance of an investigational new drug (IND) application for COYA 302 for the treatment of amyotrophic lateral sclerosis (ALS), Dr. Reddy’s will pay the Company an additional $4.2 million, and (ii) upon dosing of the first patient in the first Phase 2 trial of COYA 302 for the treatment of ALS in the United States, Dr. Reddy’s will pay the Company an additional $4.2 million.

The Company anticipates that the IND filing will be made in the first half of 2024 and the dosing of the first patient in the first Phase 2 trial of COYA 302 for the treatment of ALS in the United States will occur in the second half of 2024.

The Company expects its cash and cash equivalents described above will be sufficient to meet its operating needs into 2026.

$COYA current shares in issue: 10M
A Private placement announced DEC 5 2023 added 4.4M shares + 319K warrants.
Prospectus announced today will allow those shares to trade. The 319K warrants may also be exercised.
Currently most shares are held tightly.

I'm not much of a predictor. And most of the shares are tightly held.
But the company does have my respect and a good outlook long term.

Where do you see the PPS heading by year end

Coya has a clear path towards submission of the IND application to the FDA in the second quarter of 2024, with a planned initiation of a well-controlled, double-blind clinical trial of COYA 302 in patients with ALS upon acceptance of the IND

Scientists solve 18-year-old mystery and find the once-elusive source of a critical T cell population
https://medicalxpress.com/news/2023-12-scientists-year-old-mystery-once-elusive-source.html

2023, $COYA has secured a private placement agreement plus a partnership agreement with $RDY. These two deals will provide non-dilutive financing thru 2026.

T-Cells are a focus of COYA research. Understanding the language is helpful.
CAR-T cells are Chimeric Antigen Receptors. (T-Cells)
Tregs are Regulatory T-Cells.
T-Cells have great potential.
‘It’s all gone’: CAR-T therapy forces autoimmune diseases into remission

COYA updated Pipeline.

$COYA $26.5M private placement.
A very newsy 8-K

$COYA + $RDY

New collab announced.

$COYA Therapeutics has posted several YT videos.
https://www.youtube.com/@coyatherapeutics7911/videos

Brief Hometown Houston interview with $COYA CEO Howard Berman.
https://cw39.com/news/health/new-study-at-houston-methodist-hospital-for-alzheimers-disease/

$COYA's web site does not provide a clear picture of on-going clinical trials. And the studies at clinicaltrials.net don't tie back to the company or COYA-301. Dear COYA, why not?
COYA 301 Phase 1 Trial NCT05821153
COYA 301 Phase 2 Trial NCT06096090

It's obvious $COYA is not in the hands of traders.

COYA trading volume:
Friday recorded 60 trades for a total volume of 3.7K
Shares in issue 10.56m