Coya Therapeutics, Inc. Stock Price, News & Analysis

Coya Therapeutics is advancing its research on Treg therapies to combat Alzheimer's disease (AD), which affects approximately 6 million Americans and is expected to nearly double by 2050. The economic impact of AD is projected to rise from $345 billion to $1 trillion.

The biotechnology firm is preparing to release clinical data on its COYA 301 drug candidate, designed to enhance Treg cells and reduce neuroinflammation. This data is anticipated in mid-May, providing insights from trials involving eight AD patients.

With the global AD treatment market expected to reach $6.3 billion by 2029, Coya positions itself as a leader in Treg-based immunotherapy, attracting interest from major biopharma players like Eli Lilly and Novartis.

Coya Therapeutics (NASDAQ: COYA) has announced results from a proof-of-concept study evaluating COYA 301, a low-dose interleukin-2 (IL-2) therapy for Alzheimer’s Disease (AD). Conducted by Dr. Stanley Appel and Dr. Alireza Faridar at the Houston Methodist Hospital, the study involved eight patients over four months, assessing Treg function and safety. Initial findings suggest potential enhancement of anti-inflammatory responses, crucial for tackling neuroinflammation seen in AD. The study results will be presented at the 2023 Keystone Symposia in Whistler, British Columbia, from May 15-19.

Coya Therapeutics (Nasdaq: COYA) reported its fiscal year 2022 results, highlighting key developments in its drug pipeline. The company achieved positive results in a clinical study of COYA 302 for ALS, showing halted disease progression over 6 months. Coya also entered into a worldwide agreement with Dr. Reddy's Laboratories (NYSE: RDY) to out-license its COYA 301 product candidate.

The company raised approximately $16.4 million from its IPO in January 2023, with cash and equivalents of $5.9 million as of December 31, 2022. However, Coya reported a net loss of $12.2 million for 2022, attributed to increased R&D and administrative expenses.

Coya Therapeutics, Inc. (NASDAQ: COYA) has appointed Dr. Arun Swaminathan as Chief Business Officer. With over 20 years of experience, he will drive business development and partnerships in Coya’s clinical-stage biotechnology pipeline. Notably, during his tenure at Alteogen, he facilitated deals worth $6B and at Actinium Pharmaceuticals, he executed a $452M deal. CEO Howard H. Berman expressed confidence in Swaminathan’s ability to enhance Coya's strategic direction, particularly following recent positive clinical data. Coya focuses on treatments targeting systemic inflammation and neuroinflammation through its Treg-enhancing therapeutic platforms.

Coya Therapeutics, Inc. (NASDAQ: COYA), a clinical-stage biotechnology firm, announced its participation in the Virtual Investor Summit on March 29, 2023, at 11:00 AM ET. Interested investors are invited to view the webcast here and request one-on-one meetings here. Coya focuses on enhancing Treg functions to combat systemic inflammation through its product pipeline, including biologics and cell therapies.

Coya Therapeutics, Inc. (NASDAQ: COYA) announced positive results from a proof-of-concept study of COYA 302, aimed at treating ALS. Conducted at Houston Methodist Hospital, the 48-week open-label study involved four patients, showing no significant decline in ALSFRS-R scores, contrasting with a pre-treatment mean decline of -1.1 points/month. The study highlighted improved Treg function and reduced biomarkers of inflammation. COYA 302, a combination of COYA 301 and CTLA4-Ig fusion protein, demonstrated tolerability and potential efficacy, with further insights shared during an upcoming conference call on March 21, 2023.

Coya Therapeutics (NASDAQ: COYA) reported encouraging results from a 48-week proof-of-concept study of COYA 302 in four ALS patients. The study found that COYA 302 appears to enhance regulatory T cell function and may slow disease progression, as evidenced by stable ALSFRS-R scores through treatment. Participants initially declining at -1.1 points/month experienced no decline at 24 weeks and only minimal decline at 48 weeks. The treatment was well tolerated with mild side effects and supportive initial efficacy data, indicating a promising direction for larger studies. An IND filing with the FDA is planned for the second half of 2023.

Coya Therapeutics, Inc. (NASDAQ: COYA) has entered into a worldwide agreement with Dr. Reddy’s Laboratories (NYSE: RDY) to develop COYA 302, an investigational combination biologic for neurodegenerative diseases. This product consists of COYA 301 and CTLA4-Ig (Abatacept), targeting chronic inflammation. Coya retains exclusive rights for commercialization in North America, Europe, and Japan, while Dr. Reddy’s can commercialize outside these territories. Coya plans to file an IND in the second half of 2023, aiming for a phase 1b/2 trial in Amyotrophic Lateral Sclerosis (ALS) shortly thereafter. The partnership is expected to enhance Coya’s development efforts.

Coya Therapeutics (NASDAQ: COYA) announced a conference call on March 21, 2023, at 8:00 AM ET, to present clinical data for its investigational biologic COYA 302, targeting Amyotrophic Lateral Sclerosis (ALS). Notably, Coya is conducting a proof-of-concept open-label study to evaluate a dual-mechanism immunotherapy’s safety and efficacy over 12 months. The research combines Interleukin-2 to enhance regulatory T cells and a fusion protein to suppress inflammation. Additionally, Coya will present findings at the 2023 Muscular Dystrophy Association Conference on the same day.