Protagenic Therapeutics, Inc. has reported significant financial challenges in its latest 10-K filing for the fiscal year ending December 31, 2024. The company incurred a net loss of $5.7 million, an increase from the $4.5 million loss reported in the previous year. This rise in losses is attributed to heightened research and development expenses, which grew to $3.8 million from $3.1 million, alongside increased general and administrative costs. As of the end of 2024, Protagenic had an accumulated deficit of approximately $36.3 million and no product revenue, as it remains in the early stages of clinical development for its lead candidate, PT00114.
In terms of operational developments, Protagenic has made strides in its clinical programs, having commenced its first human trial for PT00114 on September 26, 2023. The company anticipates announcing results from the multiple-dose portion of the Phase I trial in the second quarter of 2025, with Phase II efficacy results expected in early 2026. The company is also in the process of re-filing its Investigational New Drug (IND) application to address regulatory feedback, which is a critical step for advancing its clinical trials.
The company has faced challenges in maintaining compliance with Nasdaq listing requirements, receiving a deficiency letter in July 2024 regarding its stock price. Following a hearing, Nasdaq accepted Protagenic's plan to regain compliance, allowing until April 28, 2025, to meet the necessary criteria. As of the end of 2024, Protagenic had cash reserves of $1.8 million, which it estimates will sustain operations until the third quarter of 2025. The company has indicated that it will need to secure additional funding to continue its operations beyond this period.
Protagenic's workforce remains small, with only three employees and several consultants. The company recognizes the need to expand its team to support its growth and operational demands as it transitions into a clinical-stage entity. The filing also highlights the company's reliance on third-party vendors for clinical trials and manufacturing, which poses additional risks if these partners do not meet their obligations.
Looking ahead, Protagenic aims to advance PT00114 through clinical trials targeting treatment-resistant depression, anxiety disorders, and substance use disorders. The company is also exploring strategic partnerships to enhance its market presence and expand its product pipeline. However, the path to profitability remains uncertain, as the company does not expect to generate revenue from product sales until at least 2027, contingent upon successful clinical outcomes and regulatory approvals.
About Protagenic Therapeutics, Inc.new
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