Financial Performance - Coya Therapeutics reported a net loss of $14.9 million for the year ended December 31, 2024, compared to a net loss of $8.0 million for the year ended December 31, 2023, representing an increase of 86.25%[13] - Net loss for 2024 was $14,880,787, compared to a net loss of $7,987,836 in 2023, reflecting an increase in losses of approximately 86%[26] - Net loss per share increased to $0.98 in 2024 from $0.79 in 2023, indicating a deterioration in per-share performance[26] - The company reported a pre-tax loss of $15,601,074 in 2024, compared to a pre-tax loss of $7,263,984 in 2023, indicating a worsening of about 115%[26] Expenses - Research and development (R&D) expenses increased to $11.9 million in FY 2024 from $5.5 million in FY 2023, primarily due to a $5.0 million rise in preclinical expenses[11] - General and administrative expenses rose to $8.9 million in FY 2024 from $7.8 million in FY 2023, an increase of approximately 14.1%[12] - Total operating expenses increased to $20,803,772 in 2024, up from $13,905,555 in 2023, marking an increase of about 50%[26] - Stock-based compensation increased significantly to $2,663,539 in 2024 from $872,248 in 2023, representing an increase of approximately 205%[28] Cash Flow and Assets - Cash and cash equivalents as of December 31, 2024, were $38.3 million, up from $32.6 million as of December 31, 2023, indicating a growth of 17.5%[10] - Cash and cash equivalents at the end of 2024 were $38,339,762, up from $32,626,768 at the end of 2023, showing an increase of about 17%[28] - The company had a net cash provided by financing activities of $16,026,816 in 2024, down from $38,425,063 in 2023, a decrease of approximately 58%[28] - Coya's total assets increased to $44.3 million as of December 31, 2024, compared to $41.3 million as of December 31, 2023[24] Revenue and Collaboration - Collaboration revenue decreased to $3,554,061 in 2024 from $6,002,206 in 2023, representing a decline of approximately 41%[26] - The company recorded a collaboration receivable of $7,500,000 in 2024, compared to a negative $7,500,000 in 2023, indicating a significant change in cash flow dynamics[28] Strategic Initiatives - Coya raised $10.0 million in a private placement of 1.38 million shares of common stock, primarily from existing institutional shareholders[4] - The company received a strategic investment of $5.0 million from the Alzheimer's Drug Discovery Foundation to support the development of COYA 302 for Frontotemporal Dementia[4] - Coya is on track to initiate a randomized, double-blind controlled Phase 2b trial in patients with Amyotrophic Lateral Sclerosis (ALS) upon IND acceptance[6] - The company plans to submit additional nonclinical data to support the start of the COYA-302 Phase 2 trial in ALS in Q2 2025[9] - The company is expected to publish ALS biomarker data and additional clinical data in the second half of 2025, which may provide insights into the role of inflammation in neurodegenerative diseases[9]

Company Overview - Coya Therapeutics, Inc. (NASDAQ: COYA) is a US biotech company focused on neurodegenerative and autoimmune diseases through T cell (Treg) modulation [1] - The company's main candidates are COYA 302 and COYA 301, with COYA 302 being the most promising for multiple indications [1] Analyst Background - The article includes a brief background of Myriam Hernandez Alvarez, who holds degrees in Electronics and Telecommunication Engineering, Computer Science, Business Management, and a Ph.D. in Computer Applications [1]

Group 1 - Coya Therapeutics (NASDAQ: COYA) experienced a significant setback in 2024 due to the release of data from its phase 2 study on Low-Dose IL-2 COYA-301 for Alzheimer's Disease treatment [2] - The article is authored by Terry Chrisomalis, who operates the Biotech Analysis Central service, providing in-depth analysis of various pharmaceutical companies [2] Group 2 - The Biotech Analysis Central service includes a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks, offering detailed analysis for each [2]

Financial Performance - The company reported net losses of $4.0 million for Q3 2024, compared to $3.4 million for Q3 2023, and $12.0 million for the nine months ended September 30, 2024, compared to $9.3 million for the same period in 2023[85]. - As of September 30, 2024, the company had an accumulated deficit of $37.8 million[85]. - The company has not recognized any revenue from product sales and does not expect to generate revenue in the foreseeable future[117]. - Other income, net increased by $739,712 from $464,693 in the nine months ended September 30, 2023, to $1,204,405 in the same period of 2024[138]. - Collaboration revenue was $3,552,109 for the nine months ended September 30, 2024, with no collaboration revenues earned in Q3 2024 due to increased spending on COYA 302[129]. - Cash provided by financing activities during the nine months ended September 30, 2024, was $6.3 million, down from $14.3 million in the same period of 2023[145][150]. Research and Development - The lead asset, COYA 302, is a combination of low dose interleukin-2 and CTLA4-Ig, targeting neurodegenerative disorders[85]. - The product candidate pipeline includes Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy, focusing on neurodegenerative, autoimmune, and metabolic diseases[83]. - The Phase 2 POC study of LD IL-2 in ALS patients showed no decline or minimal decline in ALSFRS-R scores at 24 and 48 weeks, indicating safety and tolerability[92]. - The Phase 2 trial of LD IL-2 in Alzheimer's disease demonstrated a clinically meaningful 4.93-point improvement in ADAS-Cog14 scores compared to placebo[98]. - The LD IL-2 q4wks regimen significantly improved CSF Aβ42 levels (p = 0.045) compared to placebo, indicating potential benefits in AD pathology[106]. - The Phase 2 trial for FTD is anticipated to report clinical data in the second half of 2025, assessing safety and tolerability of LD IL-2[114]. - Research and development expenses primarily consist of costs related to discovery and development, including clinical trial expenses and regulatory activities[118]. - Research and development expenses increased by $0.6 million from $1.6 million in Q3 2023 to $2.2 million in Q3 2024, driven by preclinical advancement of COYA 302[130]. - Research and development expenses for the nine months ended September 30, 2024, reached $9.9 million, up $6.0 million from $3.9 million in the same period of 2023[135]. - The company expects research and development expenses to continue to grow in Q4 2024 as it advances COYA 301 and COYA 302[122]. Funding and Capital Requirements - The company plans to finance operations through equity sales, debt financings, or collaborations, highlighting the need for substantial additional capital[89]. - The company has funded operations primarily through private convertible preferred stock offerings and public/private securities offerings[85]. - The company expects existing cash and the $10.0 million from the October 2024 Private Placement to fund operations into 2026[139]. - The company has no credit facility or committed sources of capital and will need significant additional funds for operational needs and clinical trials[143]. - The company anticipates financing operations through equity offerings, debt financings, and collaborations, but may face challenges due to global economic conditions[144]. Clinical Trials and Studies - Two proof of concept studies reported positive results for LD IL-2 in amyotrophic lateral sclerosis and Alzheimer's Disease[90]. - The Alzheimer's Disease study involved 8 patients and showed enhanced Treg function and reduced neuroinflammation, with no serious adverse events reported[91]. - The company submitted an IND for a Phase 2 study of COYA 302 in ALS patients, with the FDA requiring additional nonclinical data before initiation[93]. - The LD IL-2 q2wks group did not show benefits in exploratory endpoints, highlighting the importance of appropriate dosing for Treg functionality[99]. - The company plans to expand the COYA 302 pipeline to include FTD and PD, targeting complex immune pathways in neurodegenerative diseases[111]. Expenses and Operational Costs - Total operating expenses rose by $886,226 from $3,564,063 in Q3 2023 to $4,450,289 in Q3 2024[128]. - Net loss increased by $599,444 from $3,421,974 in Q3 2023 to $4,021,418 in Q3 2024[128]. - General and administrative expenses increased by $1.3 million from $5.5 million for the nine months ended September 30, 2023, to $6.7 million for the same period in 2024[138]. - General and administrative expenses are anticipated to rise to support ongoing research and development and potential commercialization efforts[125]. Agreements and Collaborations - The company entered into the DRL Development Agreement, receiving a $7.5 million upfront payment and potential additional payments totaling $44.2 million upon achieving certain milestones[151]. - The company is entitled to up to $40.0 million in development milestones and up to $677.3 million in sales milestones under the DRL Development Agreement[151]. - The company has a license agreement with Methodist Hospital, which includes milestone payments totaling up to $0.3 million for ALS treatment and royalties of 1% to 10% on annual worldwide net sales[154]. - The company executed a Sponsored Research Agreement with Houston Methodist Research Institute, funding approximately $0.5 million through May 2024, later amended to $1.0 million through September 2025[156]. - The company entered into an ARScience License Agreement, paying a one-time option fee of $0.1 million for exclusive rights to two patents related to IL-2 formulations[157]. - The company exercised the ARS Option, resulting in a mid-six-figure up-front fee and the activation of the ARS License Agreement[158]. - Under the ARS License Agreement, the company will pay $13.3 million in milestone payments for the first Combination Product and $11.6 million for each subsequent new indication[159]. - The company will also pay $11.8 million in milestone payments for the first Mono Product and $5.9 million for each subsequent new indication[159]. - The company entered into a License and Supply Agreement with Dr. Reddy's Laboratories, paying a one-time upfront fee of $0.4 million[161]. - The company will pay up to approximately $2.9 million in pre-approval regulatory milestone payments and an additional $20.0 million for other milestones under the DRL Agreement[161]. - The company will pay single-digit royalties on net sales to Dr. Reddy's Laboratories as part of the DRL Agreement[161].

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 ...