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 ...

(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 ...