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Moleculin Biotech, Inc. disclosed that it issued a press release reporting its financial results for the quarter ended June 30, 2025 and recent operational highlights. The press release is attached to the Form 8-K as Exhibit 99.1 and is incorporated by reference into the filing.
The 8-K filing itself does not present numerical revenue, profit, cash flow or balance sheet figures; investors must consult the attached press release for detailed results and metrics. The company’s common stock trades under the ticker MBRX on The NASDAQ Stock Market. The filing also lists an Inline XBRL cover page as Exhibit 104, indicating machine-readable cover data is included with the submission.
Moleculin Biotech, Inc. (MBRX) is a clinical-stage pharmaceutical company advancing its lead drug Annamycin in a global Phase 3 pivotal trial (MIRACLE). As of June 30, 2025, the company reported $7.6 million in cash, $21.6 million in total assets, $28.8 million in total liabilities and an accumulated deficit of $167.4 million. Net loss was $7.64 million for Q2 2025 and $14.08 million for the six months ended June 30, 2025. The company recorded a $20.55 million warrant liability and recognized a $10.4 million loss on issuance related to its June 2025 offering.
The MIRACLE Phase 3 program is active in 35+ sites across the US, EU and Eastern Europe with 8 subjects treated as of July 25, 2025 and planned interim unblinding by end of 2025. Regulators: EMA approved CTAs for nine EU countries; FDA provided positive pediatric study feedback. Nasdaq notified the company of deficiencies on equity and bid-price listing standards; a plan to regain compliance was submitted on July 3, 2025. Management disclosed substantial doubt about going concern and is seeking additional financing.
Item 7.01 – Regulation FD: On 30 Jul 2025 Moleculin Biotech, Inc. (NASDAQ: MBRX) furnished an 8-K announcing it has received a Notice of Intent to Grant for European patent application “Preparation of Pre-liposomal Annamycin Lyophilizate.”
The disclosure, provided via attached Exhibit 99.1, indicates the patent is expected to cover the Company’s Annamycin formulation in Europe once formally issued. No financial statements, earnings data or other operational metrics are included. The information is expressly furnished, not filed, and therefore will not be incorporated into other Exchange Act or Securities Act reports unless later referenced. Exhibit 104 supplies the Inline XBRL cover page.
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