Core Insights - Coya Therapeutics, Inc. released positive results from a Phase 2 trial of low-dose interleukin-2 (LD IL-2) for patients with mild to moderate Alzheimer's Disease, demonstrating safety and tolerability [1][2] - The treatment showed significant improvements in cerebrospinal fluid (CSF) soluble Aβ42 levels, indicating targeted biological activity [2] - The q4wks dosing regimen resulted in a clinically meaningful improvement in cognitive function compared to placebo, while the q2wks group did not show similar benefits [3] Group 1 - The Phase 2 trial met its primary and secondary endpoints, confirming the safety and tolerability of LD IL-2 in Alzheimer's patients [1] - The q4wks regimen led to a 27% slower decline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) scores compared to the placebo group [3] - The ADAS-Cog14 scores showed a slight improvement of 4.93 points (P=0.061) in the q4wks group compared to placebo, while the q2wks group did not demonstrate cognitive benefits [3] Group 2 - The company plans to advance the q4wks dosing regimen for further development [3] - Coya Therapeutics has seen a 70% increase in stock price since its IPO, indicating strong market interest [2] - Despite positive trial results, COYA stock experienced a decline of 31.4% to $6.982 following the announcement [4]

I write about and invest in mostly early commercial stage companies that have a large TAM and zero to little direct competition. I will provide updates on companies that I introduce as long as the goalposts set by management are met. Of course, there are always unforeseen developments more often in the microcap world than otherwise and there are macro conditions that are beyond the control of company management. I'm also not always right but I like the risk/reward characteristics of investing in micro-caps. ...

Financial Performance - The company reported net losses of $2.9 million and $3.1 million for the three months ended June 30, 2024 and 2023, respectively, and $7.9 million and $5.8 million for the six months ended June 30, 2024 and 2023, respectively, with an accumulated deficit of $33.8 million as of June 30, 2024[73]. - The net loss for Q2 2024 was $2,891,680, a decrease of $203,695 from a net loss of $3,095,375 in Q2 2023[96]. - Net loss for the six months ended June 30, 2024, was $7.9 million compared to a net loss of $5.8 million for the same period in 2023, representing an increase of $2.1 million[100]. - Cash used in operating activities was $2.4 million for the six months ended June 30, 2024, compared to $6.7 million for the same period in 2023[110]. - As of June 30, 2024, the company had $36.6 million in cash and cash equivalents and an accumulated deficit of $33.8 million[104]. - The company expects existing cash and cash equivalents to fund operating expenses and capital expenditures into 2026[104]. Research and Development - COYA 302, the company's lead asset, is a combination of proprietary low dose interleukin-2 (COYA 301) and the immunomodulatory drug CTLA4-Ig, targeting neurodegenerative disorders[73]. - A proof of concept study for COYA 302 in 4 ALS patients showed no decline or minimal decline in the ALSFRS-R scale at 24 and 48 weeks, indicating safety and tolerability[78]. - The company plans to conduct a well-powered Phase 2 study for COYA 302 based on positive proof of concept data[78]. - The company is focused on developing therapies to target Treg dysfunction, which is linked to neurodegenerative, autoimmune, and metabolic diseases[71]. - The POC study for COYA 301 in 8 AD patients showed improved or stable cognitive function, enhanced Treg function, and reduced pro-inflammatory cytokines[80]. - A Phase II clinical trial for LD IL-2 in Alzheimer's Disease has fully enrolled 38 patients, with data presentation scheduled for CTAD24 in Madrid from October 29 to November 1, 2024[81]. - The company expanded its pipeline to include FTD and PD for COYA 302, in addition to ALS and AD, targeting complex immune pathways in neurodegenerative diseases[82]. - The company expects research and development expenses to continue to grow significantly as it advances clinical trials and prepares regulatory filings[90]. - Research and development expenses rose by $3.5 million from $1.1 million in Q2 2023 to $4.6 million in Q2 2024, primarily due to preclinical advancements for COYA 302[97]. - Research and development expenses rose by $5.4 million from $2.3 million for the six months ended June 30, 2023, to $7.7 million for the six months ended June 30, 2024[101]. Funding and Capital - The company has funded operations primarily through private convertible preferred stock offerings, convertible debt financing, and a public offering that closed in January 2023[73]. - The company will need to raise substantial additional capital to support ongoing operations and growth strategy[76]. - The company entered into a Securities Purchase Agreement for a private placement of 603,136 shares at $8.29 per share, resulting in net proceeds of $4.9 million for a Phase 2 study of COYA 302 in FTD[84]. Collaboration and Revenue - Collaboration revenue for Q2 2024 was $3,425,271, compared to $0 in Q2 2023, marking a significant increase[96]. - Other income, net increased by $0.5 million from the six months ended June 30, 2023, to the same period in 2024, primarily due to interest and dividend income[103]. Agreements and Milestones - The DRL Development Agreement includes potential milestone payments of up to $40.0 million and sales milestones of up to $677.3 million related to COYA 302[116]. - The company received a one-time payment of $3.9 million from Dr. Reddy's under the First Amendment to the DRL Development Agreement[115]. - Company agreed to make contingent milestone payments to Methodist totaling up to $0.3 million for ALS treatment and between $0.2 million and $0.4 million for other indications[119]. - Royalty payments to Methodist range from 1% to 10% of annual worldwide net sales of licensed products, with a minimum of $0.1 million annually starting January 1, 2025[119]. - Sponsored Research Agreement with Houston Methodist Research Institute increased funding from $0.5 million to $1.0 million, extending the term through September 2025[121]. - Company will pay an aggregate of $13.3 million in developmental milestone payments for the first Combination Product in a new indication under the ARS License Agreement[124]. - Under the DRL Agreement, company will pay up to approximately $2.9 million in pre-approval regulatory milestone payments and an additional $20.0 million for other milestones[125]. - Company paid a one-time, non-refundable upfront fee of $0.4 million for the DRL Agreement[125]. - The ARS License Agreement includes tiered payments based on developmental milestones, totaling $11.8 million for the first Mono Product in a new indication[124]. - Company is required to pay royalties on sublicense income ranging from 10% to 20% under the ARS License Agreement[124]. - The Methodist License Agreement allows termination if the company is not "Actively Attempting to Develop or Commercialize" after five years[120].

Coya Therapeutics Provides a Corporate Update and Reports Unaudited Second Quarter 2024 Financial Results Houston, TX, August 12, 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, provides a corporate update and announces its financial results for the quarter ended June 30, 2024. Recent Corporate Highlights • Presented updated biomarker data in late April 2024 at the 2 n ...

(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR | --- | --- | |-----------------------------------------------------------------------------------------------------------|------------------------------------------| | Commission File Number: \nCoya Therapeutics, (Exact Name of Registrant as Specified | 001-41583 \n Inc. in its Charter) | | Delaware | 85-4017781 | | (State or other jurisdiction of incorporati ...

Houston, TX, May 9, 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, provides a corporate update and announces its financial results for the quarter ended March 31, 2024. "During the first quarter of 2024, we expanded our clinical pipeline with our lead asset COYA 302 beyond the initial indication of ALS and into FTD, Parkinson's, and Alzheimer's diseases," stated Howar ...

FORM 10-K | --- | --- | --- | |----------------------------------------------------------------------------|----------------------|------------------------------------------| | Coya (Exact name of Registrant as specified in its Charter) | Therapeutics, Inc. | | | Delaware | | 85-4017781 | | (State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) | | 5850 San Felipe St., Suite 500 | | | | Houston, TX | | 77057 | | (Address of principal executive offices) | | (Z ...

Houston, TX, March 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, provides a corporate update and announces its financial results for the year ended December 31, 2023. to the historical treatment progression seen in oncology and viral disease indications, combination therapy may offer unique opportunities to treat complex, multi-pathway diseases in the neurodegene ...

HOUSTON--(BUSINESS WIRE)--Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, announces that Dr. Stanley Appel, M.D., Chairman of Coya’s Scientific Advisory Board and Chief Medical Officer Dr. Fred Grossman will participate in a fireside discussion with BTIG analyst Tom Shrader on Wednesday, March 13, 2024, at 12pm ET. Topics to be discussed include the role of regulatory T cells ...

HOUSTON--(BUSINESS WIRE)--Coya Therapeutics, Inc. (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics primarily focused on the restoration of regulatory T cell (Treg) immunomodulatory function, announces the presentation of data demonstrating the role of the peripheral immune system in the pathophysiology of Frontotemporal Dementia (FTD) from a biomarker study conducted at the Houston Methodist Hospital by Dr. Stanley Appel and Dr. Alireza Faridar and funded by the Houston ...