Financial Performance - The net loss for Q3 2024 was $4.0 million, compared to a net loss of $3.4 million in Q3 2023[13] - Net loss for the nine months ended September 30, 2024, was $11,965,011, compared to a net loss of $9,253,811 in 2023, indicating a 29.3% increase in losses[27] - Net loss per share for the nine months ended September 30, 2024, was $(0.80), compared to $(0.94) for the same period in 2023[26] Cash and Assets - Coya Therapeutics reported cash and cash equivalents of $31.1 million as of September 30, 2024, down from $32.6 million at the end of 2023[11] - Coya's total current assets decreased to $35.5 million as of September 30, 2024, from $41.2 million at the end of 2023[22] - Cash and cash equivalents at the end of the period were $31,057,395, down from $10,886,282 at the end of September 30, 2023[27] Expenses - Research and development expenses increased to $2.2 million for Q3 2024, compared to $1.6 million in Q3 2023, reflecting a $0.3 million rise in preclinical expenses[11] - General and administrative expenses were $2.2 million for Q3 2024, up from $2.0 million in Q3 2023, primarily due to a $0.4 million increase in stock-based compensation[12] - Total operating expenses increased to $16,721,525 for the nine months ended September 30, 2024, from $9,718,504 in 2023, representing a 72.5% increase[25] - Stock-based compensation for the nine months ended September 30, 2024, was $1,872,990, significantly higher than $634,249 in 2023[27] - The company incurred $25,000 in in-process research and development expenses for the nine months ended September 30, 2024, down from $350,000 in 2023[27] Revenue and Collaboration - Collaboration revenue for the nine months ended September 30, 2024, was $3,552,109, compared to $0 in the same period of 2023[25] - The company recorded $7,500,000 in collaboration receivable for the nine months ended September 30, 2024, with no such revenue in the previous year[27] Future Plans and Developments - Coya anticipates receiving milestone payments of $8.4 million from Dr. Reddy's Laboratories upon IND acceptance and first patient dosing of COYA-302 in ALS[4] - The company is aligned with the FDA on non-clinical data needed for the Phase 2 study of COYA-302 in ALS, with IND submission for COYA-302 in FTD expected in the second half of 2025[4] - Coya plans to release additional clinical data from the Phase 2 LD IL-2 trial in Alzheimer's Disease in Q1 2025[3] - The company is developing COYA 302, a combination of COYA 301 and CTLA4-Ig, targeting neurodegenerative diseases such as ALS and FTD[16] Liabilities - Total liabilities were reported at $3.5 million as of September 30, 2024, down from $5.6 million at the end of 2023[23] Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2024, was $(7,879,055), compared to $(8,947,731) in 2023, showing a decrease in cash outflow[27] - The company raised $4,943,668 from the sale of common stock during the nine months ended September 30, 2024, with no such proceeds in the previous year[27]

Group 1 - The analyst has a beneficial long position in the shares of COYA through stock ownership, options, or other derivatives [2] - The article expresses the analyst's own opinions and is not influenced by compensation from any company mentioned [2] - There is no business relationship with any company whose stock is mentioned in the article [2] Group 2 - The financial sector is the primary focus, with interests in technology, biotech, pharmaceutical companies, banks, and shipping [1]

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]

Group 1 - The focus is on early commercial stage companies with a large Total Addressable Market (TAM) and minimal direct competition [1] - Updates on companies will be provided as long as management meets established goals, acknowledging the potential for unforeseen developments [1] - The investment strategy leans towards long positions, with a tendency to avoid negative or short themes [1] Group 2 - There is a beneficial long position in the shares of COYA, indicating confidence in the company's performance [2] - The article reflects personal opinions and is not influenced by compensation from external sources [2] - No business relationships exist with any company mentioned, ensuring an unbiased perspective [2]

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 ...