Core Viewpoint - Coya Therapeutics, Inc. (COYA) shows significant upside potential with a mean price target of $16.25, indicating a 144.7% increase from its current price of $6.64 [1] Price Targets and Analyst Estimates - The mean estimate consists of four short-term price targets with a standard deviation of $2.06, suggesting variability among analysts; the lowest estimate of $14 indicates an 110.8% increase, while the highest target is $18, representing a 171.1% increase [2] - A low standard deviation in price targets indicates a high degree of agreement among analysts regarding the stock's price movement direction and magnitude [9] Earnings Estimates and Analyst Consensus - Analysts have shown increasing optimism about COYA's earnings prospects, with a strong consensus in revising EPS estimates higher, which correlates with potential stock price increases [11] - Over the last 30 days, one estimate has increased, leading to a 7.8% rise in the Zacks Consensus Estimate for the current year [12] - COYA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [13]

Coya Therapeutics, Inc. (COYA) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the sy ...

Coya Therapeutics, Inc. (COYA) closed the last trading session at $6.51, gaining 8.5% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $16.25 indicates a 149.6% upside potential.The mean estimate comprises four short-term price targets with a standard deviation of $2.06. While the lowest estimate of $14 indicates an 115.1% increase from the current price level, the most optimistic a ...

Financial Performance - Coya Therapeutics reported net losses of $14.9 million and $8.0 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $40.7 million as of December 31, 2024[20]. - Significant expenses and operating losses are anticipated as the company advances its product candidates through development and clinical trials, with a focus on securing additional capital for operations[21][23]. - Coya Therapeutics' financial statements are prepared on a going-concern basis, indicating potential challenges in securing adequate financing for ongoing operations[23]. - The pharmaceutical industry is highly competitive, with many companies having greater financial flexibility and resources, which may impact the company's ability to pursue certain strategies[108]. Product Development and Pipeline - The company is advancing its lead asset, COYA 302, a Treg-enhancing biologic, which has completed Phase 1 and Phase 2a studies in amyotrophic lateral sclerosis (ALS) and is expected to file an IND for a Phase 2 trial in ALS in Q2 2025[19][27]. - Coya Therapeutics announced the expansion of its pipeline with COYA 303, targeting inflammatory diseases, which demonstrated a dual immunomodulatory mechanism of action in preclinical studies[24]. - The company plans to expand COYA 302's indications beyond ALS to include frontotemporal dementia (FTD) and Parkinson's disease (PD), with clinical data for FTD expected in the second half of 2025[25][28]. - COYA 302 is described as a "Pipeline in a Product," indicating its potential to address multiple neurodegenerative conditions through a combination of therapies[20]. - The company is expanding the COYA 302 pipeline to include FTD, PD, and AD, with plans to file INDs for these conditions following ALS[56]. - COYA 303, a combination of COYA 301 and a GLP-1 receptor agonist, is being developed for inflammatory diseases, with preclinical studies showing additive/synergistic anti-inflammatory effects[86]. Clinical Trials and Results - A proof-of-concept study in ALS patients showed no decline or minimal decline in ALSFRS-R scores at 24 weeks (33.75 ±3.3) and 48 weeks (32 ±7.8) compared to baseline (33.5 ±5.9), indicating clinically meaningful disease progression amelioration[49]. - Treg suppressive function increased significantly during treatment, with percentages of inhibition rising from 62.1±8.1 at baseline to 79.9±9.6 at 24 weeks and 89.5±4.1 at 48 weeks (p<0.01)[51]. - The POC study indicated enhanced Treg function and well-tolerated treatment with no serious adverse events reported over 48 weeks[54]. - COYA 301 demonstrated significant enhancement in Treg function and a clinically meaningful 4.93-point improvement in ADAS-Cog14 score compared to placebo[69]. - The Phase 2 trial showed that LD IL-2 q4wks treatment significantly improved CSF Aβ42 levels (p = 0.045) compared to placebo, indicating a potential mechanism for cognitive benefit[78]. - The study indicated a 27% slower decline in CDR-SOB scores following LD IL-2 q4wks treatment compared to placebo[77]. - Statistically significant reductions in pro-inflammatory markers CCL2 (p < 0.05) and IL-15 (p < 0.001) were observed in patients receiving monthly LD IL-2 cycles[83]. Regulatory and Compliance - Regulatory approvals for biologics require substantial time and financial resources, and failure to comply with regulations may lead to significant sanctions[115]. - The FDA requires extensive preclinical studies and clinical trials before a product candidate can be marketed in the U.S., including compliance with good laboratory practice (GLP) and good clinical practice (GCP) regulations[116]. - An Investigational New Drug (IND) application must be submitted to the FDA, which becomes effective 30 days after receipt unless concerns are raised[117]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh its risks, which can affect marketability[128]. - Companies must submit annual progress reports on clinical trials to the FDA, including safety reports for serious adverse events[122]. - The FDA may inspect manufacturing facilities and clinical trial sites to ensure compliance with regulations before approving a BLA[130]. - The FDA requires post-market testing and surveillance to monitor product safety and effectiveness after commercialization[145]. Intellectual Property and Agreements - The company has filed several patent applications to protect COYA 303, which combines COYA 301 and a glucagon-like-peptide-1 receptor agonist[24]. - The company has a patent estate that includes one U.S. non-provisional patent application and six foreign patent applications, expected to expire between 2040 and 2044, depending on potential extensions[194][196][198]. - The company has entered into a Development and License Agreement with Dr. Reddy's Laboratories, granting exclusive rights to commercialize COYA 302 for ALS in the U.S., Canada, EU, and UK, with a one-time payment of $3.9 million received[200]. - The company is entitled to receive up to approximately $40.0 million in development milestones and approximately $677.3 million in sales milestones related to COYA 302, contingent on achieving specified milestones[203]. - The company has a License and Supply Agreement with Dr. Reddy's for the development of COYA 302, which includes a non-refundable upfront fee of $0.4 million and potential milestone payments totaling approximately $20.0 million[207]. Challenges and Risks - The company may face challenges in obtaining or maintaining required licenses or permits due to complex and frequently changing environmental regulations[182]. - The company is subject to stringent requirements under the GDPR, which includes special protections for sensitive health information and the right for individuals to seek legal remedies[179]. - The company may need to implement additional mechanisms to ensure compliance with new data protection rules due to the GDPR[180]. - The company faces increased scrutiny from federal and state enforcement bodies regarding interactions with healthcare providers, leading to potential investigations and reputational harm[168]. - The company must comply with various federal and state regulations regarding data privacy and security, including HIPAA and GDPR, which impose strict requirements and potential fines of up to 4% of global revenues or €20,000,000 for non-compliance[165][179].

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]

Coya Therapeutics, Inc. (NASDAQ: COYA ) is a US biotech working on neurodegenerative and autoimmune using T cell [Treg] modulation. Their main candidates are COYA 302 and COYA 301. COYA 302 is probably the most promising today, and it’s intended for multiple indicationsMy name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in computer science from Ohio University, Athens, OH, USA, a grad ...

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]