FooBarAndGrill
5月前
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
FooBarAndGrill
7月前
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
FooBarAndGrill
8月前
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
FooBarAndGrill
8月前
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
FooBarAndGrill
12月前
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
FooBarAndGrill
1年前
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.