1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Valuation
Discussion
Symbol
COYA
Event Date
2022-12-29
Sector
Health Care
Subsector
Pharmaceuticals
Offer Range
$5.00
Shares Offered
3.05M
9.95M
$49.7M
30.7%
Implied Upside vs Midpoint
Description
We are a clinical-stage biotechnology company focused on developing proprietary new therapies to enhance the function of regulatory T cells (“Tregs”). Tregs consist of CD4+CD25high hFOXP3+ cells, which are a subpopulation of T-lymphocytes, a type of white blood cell that suppresses inflammatory responses. Tregs were first discovered in 1995 by Dr. Shimon Sakaguchi and since their discovery, multiple lines of research have contributed to elucidate Treg biology and its role in health and disease. Tregs and their transcription factors have been shown to be essential to maintaining cellular homeostasis by regulating autoimmune and inflammatory responses and maintaining self-tolerance in mammals. Self-tolerance is the ability of the immune system to recognize self-produced substances as a non-threat while appropriately mounting a response to foreign substances. Dysfunctional Tregs underlie numerous disease states, and this cellular dysfunction is driven by the chronic inflammatory environment and high levels of oxidative stress, an imbalance between free radicals and antioxidants in the body, commonly observed in certain diseases. Further, the degree of Treg dysfunction is correlated with the severity and progression of serious and life-threatening conditions. These and other recent advances in the understanding of Treg biology have made this subset of T lymphocytes an important therapeutic target, which we believe may provide new treatments for serious diseases. We have built a diversified product candidate pipeline that includes both ex vivo (outside the body) and in vivo (inside the body) therapeutic approaches intended to restore the suppressive and immunomodulatory functions of Tregs. Our product candidate pipeline is based on our three distinct therapeutic modalities: (1) Treg-enhancing biologics; (2) Treg-derived exosomes (tiny sac-like structures that are formed inside a cell and contain some of the cell’s proteins, lipids, and nucleic acids); and (3) autologous (obtained from the same individual) Treg cell therapy. The product candidates utilizing our Treg-enhancing biologics are collectively referred to as the “300 Series.” The product candidates utilizing our Treg-derived exosomes are collectively referred to as the “200 Series.” The product candidates utilizing our autologous Treg cell therapy are collectively referred to as the “100 Series.” Currently, our 300 Series product candidates include COYA 301 and COYA 302, our 200 Series product candidates include COYA 201 and COYA 206, and our 100 Series product candidate is COYA 101. We are initially focused on developing our Treg-based therapies for neurodegenerative, autoimmune and metabolic diseases where Treg dysfunction has been identified to be an important pathophysiological component of the disease and where new and effective therapies are urgently needed. Since our inception in late 2020, we have generated preclinical and clinical data in multiple models and diseases. Our autologous Treg cell therapy program completed a Phase 1 study in 2017 and a Phase 2a study in 2021 in amyotrophic lateral sclerosis, or ALS. At the completion of the Phase 2a trial, we conducted a Pre-Investigational New Drug (“IND”) Application meeting with the U.S. Food and Drug Administration (the “FDA”) in Q4, 2021 in anticipation of a Phase 2b trial. In June 2021, we were granted an orphan drug designation (“ODD”) by the FDA for the active moiety (principal molecular structure) for our autologous Treg cell therapy in the treatment of ALS. The clinical data from these initial studies has served as an important confirmation of the underlying immunomodulatory properties of Tregs and their potential therapeutic benefits. These studies have also significantly expanded our own foundational knowledge of the biological activity of Tregs, which we believe will be critical for the design of our future clinical and preclinical studies, the selection of future targeted diseases and the overall advancement of our development pipeline. We are developing multiple product candidates, COYA 301, COYA 302, COYA 201, COYA 206, and COYA 101, each using one of our three therapeutic modalities: (i) biologics, (ii) Treg-derived exosomes, and (iii) autologous regulatory T-cells. COYA 301 is a biologic for subcutaneous administration, and we are currently conducting chemistry, manufacturing, and controls (“CMC”) activities and investigational new drug (“IND”) enabling toxicology studies to support the filing of an IND application and the initiation of clinical trials for the treatment of frontotemporal dementia (“FTD”). Our other biologic product candidate, COYA 302, is a combination of two large molecules for subcutaneous and/or intravenous administration. We are currently conducting CMC activities and IND enabling toxicology studies to support the filing of an IND application and the initiation of clinical trials for COYA 302 for the treatment of neurodegenerative and autoimmune diseases. Our COYA 201 product candidate utilizes our Treg-derived exosome therapeutic modality. For COYA 201, we are currently completing animal model studies and will conduct pharmacology, toxicology and other IND-enabling studies to support the initiation of clinical trials in neurodegenerative, autoimmune and metabolic diseases. We will test a variety of doses in these models to assess safety, tolerability, and pharmacology. In an early pilot preclinical lupus nephritis mouse study conducted in the first half of 2022, COYA 201 (Treg exosomes) appeared to be well tolerated at the administered dose of 1x1010 exosomes (low dosage level). At the highest dose of 1x1011 administered twice weekly (or ten times the low dosage level), death in six animals (out of a total of 12 animals) was observed. Dose escalation studies are standard in the early development of new treatments and the identification of the “maximum tolerated dose” and the “LD50”, the dose that produces lethality in 50% of animals, are common studies in early preclinical development. The primary endpoint of this study was proteinuria (amount of protein in urine) to assess renal function. The primary endpoint was not met. In a second study conducted in the third quarter of 2022, COYA 201 (Treg-derived exosomes) was studied in a humanized in vitro model of liver inflammation and fibrosis. The primary objectives of the study were to assess the biological activity of COYA 201 by evaluating inflammation, measured by the levels of released pro-inflammatory cytokines, and fibrosis, measured by the release of procollagen by the hepatic cells. We observed a significant decrease in the secretion of pro-inflammatory cytokines and a significant increase in the secretion of anti-inflammatory cytokines following administration of COYA 201, compared to the untreated controls. The study met its primary objectives by demonstrating that COYA 201 was biologically active in this model. To date, we have not observed any signs of toxicity in this cellular model. In a third study of COYA 201, that is currently ongoing, we are evaluating Treg-derived exosomes in an initial preclinical model of scleroderma. The primary endpoint of this study is lung fibrosis, assessed by lung histopathology of exposed animals at the end of the study, compared to controls. We are currently conducting analyses of the tissue from this study. This study is ongoing and it is too early to establish any signals of toxicity in this model. In addition, we are in early stages of development of COYA 206 utilizing licensed proprietary technology from Carnegie Mellon University. We believe this technology has the potential to produce antigen-directed exosomes without performing genetic manipulation, which we believe may result in easier and more efficient manufacturing, compared to genetically modified products. Lastly, COYA 101 is our autologous regulatory T-cell product candidate. COYA 101 completed a Phase 2a clinical trial in ALS in May 2021. The primary endpoint of the Phase 2a study was the change in Treg suppressive function at the end of the study compared to baseline values. COYA101 was well tolerated. No death occurred over the course of the study and no serious adverse event was considered to be related to the investigational product. We currently believe we are best served by utilizing our available cash to advance each of COYA 301, COYA 302, COYA 201 and COYA 206 before commencing a Phase 2b clinical trial of COYA 101. The costs associated with such a Phase 2b trial would significantly impede our ability to advance COYA 301, COYA 302, COYA 201 and COYA 206 before we can reasonably judge which product candidates and which therapeutic modalities may have the most potential. However, to manage these circumstances, we intend to apply for grant funding to advance COYA 101 into a Phase 2b trial. In the event we receive such grant funding, or we receive other non-dilutive financing from some other source, we would expect to begin the Phase 2b of COYA 101 but would incur Phase 2b clinical trial expenses for COYA 101 not otherwise covered by the non-dilutive financing. We believe that the expenses required to advance COYA 101, net of any grant amounts, would be limited and that we may continue to make appropriate progress in advancing COYA 301, COYA 302, COYA 201 and COYA 206. We believe we have optimized our proprietary GMP manufacturing and cryopreservation technologies, the process of cooling and storing the product at very low or freezing temperatures to save them for future use and infusions, to support the development and potential future commercialization of our product candidates. We have developed a proprietary manufacturing process that isolates dysfunctional Tregs and converts and expands them into functional, restorative Tregs. We have also developed the technology that is designed to isolate and expand highly neuroprotective and immunomodulatory Treg-derived exosomes through our proprietary iscEXO™ platform. Additionally, we have developed proprietary preservation technology to cryopreserve the expanded and converted functional Treg cells via the CTreg™ platform. We believe this is the first cryopreservation platform in the Treg cell therapy field that is being clinically tested and validated, which is intended to allow for long-term monthly infusions while maintaining viability and suppressive function. We licensed our initial technology from the Houston Methodist Hospital in October of 2020 and we continue to maintain a significant partnership with them through continued research and collaboration in the fields of Tregs and in ALS and other neurodegenerative diseases. We will seek additional collaborators and partnerships as we seek to advance the understanding of Treg biology and its applications in disease and medicine. --- We were incorporated under the laws of the state of Delaware on November 23, 2020 under the name Coya Therapeutics, Inc. On December 22, 2020, we consummated the Corporate Reorganization pursuant to which all of the issued and outstanding stock of Nicoya Health, Inc., a Delaware corporation formed in 2020, were exchanged for common stock of Coya Therapeutics, Inc. Our principal executive offices are located at 5850 San Felipe St, Suite 500, Houston, TX 77057. Our telephone number is (800) 587 – 8170. Our website address is www.coyatherapeutics.com.
Coya Therapeutics, Inc. annual income statement and balance sheet, FY 2022 to FY 2025, as reported in SEC filings.
| Metric | FY 2022 | FY 2023 | FY 2024 | FY 2025 |
|---|---|---|---|---|
| Revenue | — | $6.0M | $3.6M | $7.9M |
| Operating income | ($9.8M) | ($7.9M) | ($17.2M) | ($22.6M) |
| Net income | ($12.2M) | ($8.0M) | ($14.9M) | ($21.2M) |
| Metric | FY 2022 | FY 2023 | FY 2024 | FY 2025 |
|---|---|---|---|---|
| Total assets | $8.4M | — | $44.3M | — |
| Total liabilities | $16.8M | — | $4.8M | — |
| Total equity | ($8.4M) | — | $39.6M | — |
| Cash & equivalents | $5.9M | — | $38.3M | — |