Cell Therapeutics Inc. Securities Lawsuit Investigation

Shamis & Gentile P.A., a law firm that advocates for investors who are victims of securities fraud, is investigating potential claims against Cell Therapeutics Inc. (BCLI).

If you purchased or held Cell Therapeutics Inc. securities and suffered losses, you may be eligible to participate in this investigation and seek potential compensation or reforms.

About Cell Therapeutics

Cell Therapeutics, also known as Brainstorm Cell Therapeutics, is a biotechnology company focused on developing autologous cellular therapies. Its lead product candidate, NurOwn, is designed to treat neurodegenerative diseases, including amyotrophic lateral sclerosis.

The company was previously listed on the Nasdaq but transitioned to the OTCQB market after being delisted in July 2025 due to non-compliance with minimum shareholder equity requirements. As of recent reports, BCLI continues to operate with a market capitalization near $7 million and has reported ongoing net losses.

What's being investigated

Lawyers are investigating potential claims on behalf of shareholders of Brainstorm Cell Therapeutics following developments in an ongoing securities fraud class action lawsuit. The investigation centers on whether certain officers and directors may have breached their fiduciary duties to the company.

Key allegations in the class action survived a motion to dismiss on September 15, 2025. The underlying lawsuit alleges that Brainstorm Cell mischaracterized the FDA’s views on its clinical trial design, inaccurately described certain subgroup analyses as “pre-specified,” and downplayed safety concerns raised by the FDA.

The court allowed these claims to proceed, noting that the plaintiffs had sufficiently alleged false or misleading statements in these areas.

Key timeline

• August 15, 2022: Brainstorm Cell announced submission of its Biologics License Application (BLA) for NurOwn to the FDA. investors allege this marked the start of misleading statements about regulatory progress.
• November 10, 2022: The company disclosed the FDA’s refusal to file the BLA; shares fell 42.21%. Investors contend this revealed risks previously downplayed.
• September 27, 2023: FDA advisory committee voted 17-1 that there was no substantial evidence for NurOwn’s effectiveness; shares dropped 48.72% to $0.20 per share. Investors allege this confirmed concerns about the company’s disclosures.
• September 15, 2025: Judge Ho ruled that key allegations in the amended class action complaint survived the defendants’ motion to dismiss. The court found plaintiffs had sufficiently alleged false or misleading statements regarding FDA feedback, trial design, and safety.

Why investors may be concerned

Investors allege that Brainstorm Cell and certain officers and directors may have made materially false or misleading statements, or omitted key facts, about the regulatory status and efficacy of NurOwn. The complaint contends that the company mischaracterized FDA feedback, described certain clinical analyses inaccurately, and downplayed known safety concerns.

Stockholders further argue that the board and management may have failed to maintain adequate oversight of mission-critical regulatory disclosures, potentially exposing the company to legal and reputational risks.

Your Rights and Next Steps

This is an active investigation into potential breaches of fiduciary duty by certain officers and directors of Cell Therapeutics. If you purchased or acquired Brainstorm Cell Therapeutics prior to September 27, 2023, and still hold shares, you may have certain rights.

Potential next steps include:

• Seek corporate governance reforms to improve oversight and disclosure practices.
• Pursue the return of funds to the company if wrongdoing is proven.
• Request a court-approved incentive award for serving as a representative shareholder.

Shareholders in derivative actions act on behalf of the company itself, rather than seeking individual damages. Participation does not require any upfront costs, and you may remain anonymous if you choose.

You May Be Entitled to Compensation

Securities investigations are time-sensitive. If you purchased Cell Therapeutics (OTC: BCLI) prior to September 27, 2023, and still hold some shares today, you can seek corporate reforms, the return of funds back to the Company, and a court approved incentive award at absolutely no cost to you.

Please complete the form below to join the investigation and protect your rights.