Moleculin Biotech, Inc.

Moleculin Biotech, Inc. has filed an 8-K report detailing the use of an investor presentation dated August 31, 2026. This presentation is available on the company's website and is being furnished under Regulation FD Disclosure. The filing also includes the investor presentation as an exhibit.

Moleculin Biotech reported a net loss of $7.6 million for Q2 2026 and $20.5 million for the six months ended June 30, 2026. The company's cash and cash equivalents decreased to $7.3 million, which management believes is insufficient to fund operations for the next year, raising substantial doubt about its ability to continue as a going concern. The company continues to focus on its Annamycin Phase 2/3 trial for AML and is planning additional clinical trials for other drug candidates.

Moleculin Biotech, Inc. completed a public offering on August 3, 2026, raising approximately $9.3 million in gross proceeds. The offering included 12,376,667 shares of common stock (or pre-funded warrants) and Series I Common Stock Purchase Warrants to acquire up to 37,130,001 shares. Roth Capital Partners, LLC acted as the placement agent. The net proceeds will be used to advance Annamycin through clinical development and for working capital.

Moleculin Biotech, Inc. announced the pricing of a public offering consisting of 12,376,667 shares of common stock (or pre-funded warrants) and warrants to purchase up to 37,130,001 shares of common stock. The combined public offering price is $0.75 per share and associated warrant. The offering is expected to close around August 3, 2026, with net proceeds intended for advancing Annamycin through clinical development and for general working capital.

Moleculin Biotech announced updated preliminary blinded results from Part A of its pivotal Phase 2/3 MIRACLE trial for Annamycin in relapsed or refractory acute myeloid leukemia (R/R AML). The trial showed a preliminary blinded composite complete remission (CRc) rate of 37% (n=62), with an identical 37% CRc rate in patients who previously failed venetoclax therapy, significantly exceeding published salvage rates. The company also reported no evidence of cardiotoxicity, differentiating Annamycin from conventional anthracyclines. Enrollment is at 74 of 90 patients, with comprehensive unblinded Part A results expected between December 2026 and February 2027.

Moleculin Biotech announced updated preliminary blinded results from Part A of its pivotal Phase 2/3 MIRACLE trial for Annamycin in relapsed or refractory acute myeloid leukemia (R/R AML). With 62 evaluable subjects, the preliminary blinded composite complete remission (CRc) rate was 37%, including 37% in patients who previously failed venetoclax-based regimens, significantly higher than published salvage rates of 13%. The trial continues to show no evidence of cardiotoxicity, and enrollment has reached 74 of 90 patients, with unblinded Part A results expected by early 2027.

Moleculin Biotech, Inc. is conducting a "reasonable best efforts" public offering to raise approximately $9.1 million in net proceeds. The offering includes up to 4,566,210 shares of common stock, up to 4,566,210 pre-funded warrants, and up to 13,698,630 common warrants, with an assumed combined price of $2.19 per share. Proceeds will fund clinical development of Annamycin, including the pivotal Phase 2/3 MIRACLE trial for R/R AML, which recently reported positive interim efficacy results. The company will require significant additional financing beyond this offering.

Moleculin Biotech, Inc. filed an S-1/A for a public offering of up to 4,566,210 shares of common stock, up to 4,566,210 pre-funded warrants, and up to 13,698,630 common warrants. The assumed combined public offering price is $2.19 per share and common warrants, aiming to raise approximately $9.1 million in net proceeds. The company intends to use these funds to advance the clinical development of Annamycin, including the ongoing Phase 2/3 MIRACLE trial for relapsed/refractory AML, and for general working capital. The offering is on a "reasonable best efforts" basis with no guarantee of a minimum amount of proceeds, and it carries significant dilution risk for existing shareholders.

Moleculin Biotech, Inc. filed an S-1 registration statement for a "reasonable best efforts" public offering of up to 4,566,210 shares of common stock, 4,566,210 pre-funded warrants, and 13,698,630 common warrants. The offering is expected to raise approximately $9.1 million in net proceeds, which will be used for clinical development of Annamycin and working capital. The company also announced positive preliminary interim efficacy results from its pivotal Phase 2/3 MIRACLE trial for R/R AML, showing CR rates of 43% and 36% in treatment arms versus 12% in the control arm, and CRc rates of 50% and 57% versus 29% in the control arm.

Moleculin Biotech, Inc. announced that its Chairman and CEO, Walter Klemp, discussed positive preliminary unblinded efficacy results from the first 45 patients in Part A of the pivotal Phase 2/3 MIRACLE trial. The trial is evaluating Annamycin for relapsed or refractory acute myeloid leukemia (R/R AML). Mr. Klemp provided insights into the early efficacy trends, key data, and the commercial opportunity for Annamycin.