Financial Data and Key Metrics Changes - COYA Therapeutics is publicly traded on NASDAQ under the ticker symbol COYA, with a buy rating and a twelve-month price target of $18 per share [2] - The company anticipates receiving $8.4 million upon IND approval and trial initiation, with a total deal value of $700 million from the partnership with Dr. Reddy's [18][19] Business Line Data and Key Metrics Changes - The primary focus is on neuroinflammation, which is believed to drive the progression of neurodegenerative diseases [4] - COYA's lead asset, COIA-302, is prioritized for ALS, with an IND filing expected by the end of the current quarter and a Phase IIb trial planned [11][12] Market Data and Key Metrics Changes - The company is targeting niche orphan indications like ALS and frontotemporal dementia, while also pursuing mass market indications like Alzheimer's [9] - The current landscape for ALS trials has become more favorable for recruitment due to the withdrawal of other products, which has created enthusiasm among trial sites [20][22] Company Strategy and Development Direction - COYA aims to maximize value by pursuing both niche and broader market opportunities, with a focus on ALS and frontotemporal dementia for regulatory flexibility [10] - The company plans to continue generating data in frontotemporal dementia and Alzheimer's, while also exploring strategic partnerships to enhance its market position [43][45] Management's Comments on Operating Environment and Future Outlook - Management believes that the FDA remains receptive to ALS drug approvals if data supports it, despite recent challenges in the market [21][23] - The company is confident in its approach to neuroinflammation and its potential to address unmet needs in Alzheimer's disease, which is characterized by a lack of effective treatments [30][31] Other Important Information - COYA is developing a regulatory T cell-derived exosome platform aimed at treating systemic and neurodegenerative diseases driven by chronic neuroinflammation, which complements its existing programs [40][42] - The partnership with Dr. Reddy's provides COYA with a strategic advantage and a steady line of sight to non-dilutive funding [45] Q&A Session Summary Question: What is the current focus for COYA Therapeutics? - The immediate focus is on filing for ALS and starting the ALS study, which is expected to be a significant value driver [43] Question: How has the regulatory environment changed for ALS? - There has been no communicated change from the FDA, and recruitment for ALS trials is expected to be easier due to fewer ongoing trials [21][22] Question: What are the expected outcomes for future clinical development? - Relevant outcome measures will include Treg function and cognitive scales, with a focus on stabilizing or improving cognition in Alzheimer's patients [36][38]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (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, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-41583 Coya Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware | 85-4017781 | | --- ...

Coya Therapeutics Reports First Quarter Financial Results and Provides a Corporate Update Houston, TX, May 13, 2025 -- 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, 2025. Recent Corporate Highlights Upcoming Expected Catalysts for 2025 • Announced positive interim results of an in ...

Milan, Italy, May 8, 2025 – Sibylla Biotech today announced the appointment of Dieter Weinand as Chairman of its Board of Directors. Mr. Weinand is an industry veteran, boasting over 35 years in the pharmaceutical sector, including leading business units and drug commercialization initiatives at global organizations. His background includes serving as President, CEO and Chairman of the Board of Bayer Pharmaceuticals AG. At Sibylla, Mr. Weinand’s profound knowledge will guide the Board as the company advance ...

Another stock in the Medical sector, Doximity (DOCS) , has outperformed the sector so far this year. The stock's year-to-date return is 6.2%. In Doximity's case, the consensus EPS estimate for the current year increased 13.2% over the past three months. The stock currently has a Zacks Rank #2 (Buy). Looking more specifically, Coya Therapeutics, Inc. belongs to the Medical - Biomedical and Genetics industry, a group that includes 508 individual stocks and currently sits at #76 in the Zacks Industry Rank. Thi ...

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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]

Core Viewpoint - Coya Therapeutics, Inc. (COYA) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks rating system is based on the changing earnings picture of a company, specifically tracking the Zacks Consensus Estimate for EPS from sell-side analysts [2]. - Coya Therapeutics is projected to earn -$1.36 per share for the fiscal year ending December 2025, reflecting a year-over-year decline of 38.8% [9]. - Over the past three months, the Zacks Consensus Estimate for Coya has increased by 7.8%, indicating a positive trend in earnings estimates [9]. Impact of Institutional Investors - Changes in a company's future earnings potential, as shown through earnings estimate revisions, are strongly correlated with near-term stock price movements, influenced by institutional investors who adjust their valuations based on these estimates [5][6]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [8]. - Coya Therapeutics' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [11].

Core Viewpoint - Coya Therapeutics, Inc. (COYA) shows significant upside potential with a mean price target of $16.25, indicating a 149.6% increase from its current price of $6.51 [1] Price Targets and Analyst Estimates - The mean estimate consists of four short-term price targets with a standard deviation of $2.06, where the lowest estimate of $14 suggests an 115.1% increase, and the highest estimate of $18 indicates a 176.5% increase [2] - A low standard deviation among price targets suggests strong agreement among analysts regarding the stock's price movement direction [9] Earnings Estimates and Analyst Sentiment - Analysts have shown growing optimism regarding COYA's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which correlates with potential stock price movements [11] - The Zacks Consensus Estimate for the current year has increased by 7.8% over the past month, with one estimate rising and no negative revisions [12] Zacks Rank and Investment Potential - 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 in the near term [13]

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].