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A Quick Take On Coya Therapeutics
Coya Therapeutics (COYA) has filed to raise $22.3 million in an IPO of its common stock, according to an S-1 registration statement.
The biopharma firm is developing drug candidates for the treatment of various neurodegenerative and autoimmune diseases.
Coya is operating in the notoriously difficult area of neurodegenerative diseases for its lead candidate, so the IPO is very high risk.
I’ll provide a final opinion when we learn more IPO details from management.
Coya Overview
Houston, Texas-based Coya Therapeutics was founded to develop Treg-modifying therapeutics for various severe disease conditions.
Management is headed by co-founder, Chairman and CEO Howard Berman, Ph.D., who has been with the firm since inception in 2020 and was previously Medical Science Liason at AbbVie and held leadership positions at Novartis and Eli Lilly and Company.
The firm’s lead candidate, COYA 101, is in Phase 2a trials for the treatment of amyotrophic lateral sclerosis, or ALS.
Management expects to initiate Phase 2b trials ‘with grant funding or collaborative partnership’ by 2024 at the earliest.
The company’s other candidate programs are in various pre-clinical stages of development.
Below is the current status of the company’s drug development pipeline:
Company Pipeline (SEC)
Coya has attracted interest from investors, including Bertex LLC and individuals.
Coya’s Market & Competition
Amyotrophic lateral sclerosis [ALS] is a progressive neurological disorder that affects the nerve cells in the brain and the spinal cord. It is sometimes referred to as Lou Gehrig’s disease, after the famous baseball player who was diagnosed with it in 1939.
ALS causes the muscles to deteriorate over time, leading to paralysis and eventually death. Symptoms of ALS can include muscle weakness, slurred speech, difficulty swallowing, and difficulty breathing. As the disease progresses, patients may become unable to move or even speak.
According to a 2019 market research report by Grand View Research, the global market for amyotrophic lateral sclerosis treatment is forecast to reach $886 million by 2026.
North America accounted for the largest market share in 2018 and will likely continue to dominate the ALS demand in the near future.
The Asia Pacific region is expected to grow at the fastest rate in the coming years among all global regions.
Also, there are only two medications approved to treat ALS in the U.S., Rilutek and Radicava. However, another drug, Nuedexta, is also used for ALS conditions.
Major competitive vendors that provide or are developing related treatments include:
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Mitsubishi Tanabe Pharma
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Otsuka Pharmaceutical
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BrainStorm Therapeutics
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Biogen
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Corestem
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AB Science
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Biohaven Pharmaceutical
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Sun Pharmaceutical
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Ionis Pharmaceuticals
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Others
The company is developing treatments for other serious medical conditions.
Coya Therapeutics Financial Status
The firm’s recent financial results are typical of a clinical-stage biopharma in that they feature no revenue and significant R&D and G&A expenses associated with its development efforts.
Below are the company’s recent comparative financial results:
Statement Of Operations (SEC)
As of September 30, 2022, the company had $8.7 million in cash and $14.4 million in total liabilities.
Coya Therapeutics IPO Details
Coya intends to raise $22.3 million in gross proceeds from an IPO of its common stock, although the final figure may differ.
No existing shareholders have indicated an interest in purchasing shares at the IPO price, although this element may become a feature of the IPO if disclosed in a future filing.
Management says it will use the net proceeds from the IPO as follows:
to advance COYA 301 and COYA 302 through IND-enabling CMC and toxicology studies, and the initiation of a Phase 1 studies;
to advance COYA 201 and COYA 206 through or into, respectively, preclinical studies including target validation and animal studies;
to advance COYA 101 towards a Phase 2b trial in the event we are successful in receiving non-dilutive funding from government grants or from a strategic partner (we currently anticipate that grant funding, or other non-dilutive funding, in the amount of approximately $3 million would be sufficient to begin advancing COYA 101 into a Phase 2b trial; this amount is an estimate and may be subject to change);
to fund expenses to advance research and development activities that relate to all our other preclinical activities, including process development activities related to the advancement of our product candidates and the cost of research and development personnel; and
the remainder for planned general and administrative expenses, the costs of operating as a public company, working capital and general corporate purposes.
(Source – SEC)
Management’s presentation of the company roadshow is not available.
Regarding outstanding legal proceedings, management says the firm is ‘not currently subject to any material legal proceedings.’
Listed bookrunners of the IPO are Chardan and Newbridge Securities.
Commentary About Coya’s IPO
COYA is seeking U.S. public capital market investment to advance its drug candidates through and into clinical trials.
The firm’s lead candidate, COYA 101, is in Phase 2a trials for the treatment of amyotrophic lateral sclerosis, or ALS.
Management expects to initiate Phase 2b trials ‘with grant funding or collaborative partnerships’ by 2024 at the earliest.
The market opportunity for treating the various diseases management is targeting is large and expected to grow as the global population ages and becomes more susceptible to disease over time.
Management hasn’t disclosed any major pharma firm collaboration relationship.
The company’s investor syndicate doesn’t include any well-known life science venture capital firms or strategic investors.
Chardan is the lead underwriter and there is no performance data on its IPO involvement over the last 12-month period.
Coya is operating in the notoriously difficult area of neurodegenerative diseases for its lead candidate, so the IPO is very high risk.
When we learn more about the IPO, I’ll provide an update.
Expected IPO Pricing Date: To be announced.
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