Coya Therapeutics Inc (COYA) Quote

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

Coya News and events page:
https://ir.coyatherapeutics.com/news/default.aspx

Coya will be presenting at at the 18th International Conference on Alzheimer’s & Parkinson’s Disease in Lisbon.
Coya Announces Acceptance of Oral Presentation

This completed P1 trial also tested COYA 301 (not by name) Low-Dose IL-2 administered SubQ.
NCT05821153

Coya is associated with this P2 clinical trial:
NCT06096090
I'm not sure why COYA is not directly tagged on the page.
The drug being tested in Low-Dose IL-2 administered SubQ.

COYA 301 is a new formulation of an existing drug: Proleukin® (aldesleukin).
Proleukin is designed to be administered by intravenous infusion.
COYA 301 is designed to be administered by subcutaneous injection.
Subcutaneous injection is intended for slow sustained absorption.

COYA and other biotechs are focusing on Exosomes as a delivery mechanism.
Exosomes explained:

COYA Cash: $10.9M Burn: $0.9M/Month

COYA targets: Alzheimers and ALS

COYA area of expertise: Neurology

Welcome to the COYA stock message board. 1st test posting.