Moleculin Biotech (NasdaqCM:MBRX) FY Conference March 24, 2026 03:00 PM ET Company ParticipantsWalter Klemp - Founder, Chairman, and CEOConference Call ParticipantsJonathan Aschoff - Senior Biotechnology AnalystJonathan AschoffWelcome back. This is Jonathan Aschoff, senior biotechnology analyst at Roth Capital Partners. Who we have now is Walter Klemp, the CEO of Moleculin Biotech.Walter KlempHey, Jonathan.Jonathan AschoffUm-Walter KlempThanks for having me.Jonathan AschoffYou're very welcome, Wally. You kn ...

Core Insights - Moleculin Biotech has enrolled the 45th subject in its pivotal Phase 2B/3 MIRACLE trial, evaluating Annamycin in combination with cytarabine for treating relapsed or refractory acute myeloid leukemia (R/R AML), marking a significant milestone for the company [1][2] - The upcoming interim data unblinding is expected in mid-2026 and is viewed as a potential inflection point for the company, with preliminary results indicating a 40% remission rate among the first 30 patients [2][3] Trial Progress - The MIRACLE trial is designed to evaluate AnnAraC across eight countries, with an initial dataset expected to include approximately 30 patients treated with AnnAraC and 15 patients in the control arm [2][4] - The trial's adaptive design aims to support a streamlined global registration pathway, integrating Phase 2B data into the Phase 3 portion, in line with regulatory guidance [4] Efficacy and Safety - Preliminary results from the trial show a composite complete remission rate of 40%, with 30% achieving complete remission and 10% achieving complete remission with partial hematologic recovery, despite many patients having previously failed venetoclax-based therapies [3][5] - The absence of cardiotoxicity in over 100 patients treated to date is a notable achievement for the company [2][5] Future Outlook - The company is advancing toward a total enrollment of 90 subjects, with the completion of Part A of the MIRACLE trial expected in Q3 2026 [2][4] - The successful outcomes from the trial could lead to a potential accelerated approval pathway based on the primary endpoint of complete remission [4][5]

Clinical Trial Results - Moleculin reported a preliminary blinded complete remission composite (CRc) rate of 40% in the first 30 subjects treated in the MIRACLE trial, consisting of a 30% complete remission (CR) rate and a 10% complete remission with partial hematological recovery (CRh) rate[5]. - The MIRACLE trial is expected to unblind data for 45 subjects in mid-2026, with a total of 222 additional subjects to be randomized in Part B of the trial[9][7]. - Approximately 35% of subjects treated to date in the MIRACLE trial are relapsed or refractory from a venetoclax regimen, indicating a challenging patient population[5]. Financial Performance - The company reported a net loss of $33.6 million for the year ended December 31, 2025, compared to a net loss of $26.0 million in 2024, with a net loss per common share of $28.42[23]. - Research and development (R&D) expenses for the year ended December 31, 2025, were $15.9 million, a decrease of $1.8 million from $17.7 million in 2024, primarily due to reduced sponsored research activities[13]. - General and administrative (G&A) expenses increased to $9.2 million in 2025 from $8.9 million in 2024, attributed to higher regulatory, legal, consulting, and investor relations expenses[14]. Assets and Liabilities - As of December 31, 2025, the company had cash and cash equivalents of $8.9 million, with total current assets amounting to $9.7 million, an increase from $5.2 million in 2024[15][23]. - Moleculin's total assets as of December 31, 2025, were $22.1 million, up from $16.9 million in 2024, while total liabilities increased to $7.1 million from $5.7 million[23]. Future Plans - The company anticipates starting a Phase 1B/2 study of Annamycin in third-line pancreatic cancer in the second half of 2026[9][10]. - The company has entered a new research collaboration focused on glioblastoma multiforme (GBM) to evaluate intra-arterial delivery of Annamycin in preclinical models[6].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37758 Moleculin Biotech, Inc. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of (I.R.S. ...

March 19, 2026 Corporate Presentation Disclaimer All statements contained herein other than statements of historical fact, including statements regarding our future results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements. The words "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," and similar expressions are intended to identify forward-looking statements. We have based these for ...

Core Viewpoint - Moleculin Biotech, Inc. is actively participating in the 38th Annual ROTH Conference, showcasing its advancements in therapeutic candidates for hard-to-treat tumors and viruses [1]. Company Overview - Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company focused on developing therapies for difficult-to-treat tumors and viruses. Its lead program, Annamycin, is designed to avoid multidrug resistance and cardiotoxicity associated with current anthracyclines [2]. Clinical Trials - The company has initiated the MIRACLE Trial (MB-108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia (AML). The trial follows a successful Phase 1B/2 study and aims to de-risk the development pathway towards potential approval [3]. Additional Developments - Moleculin is also developing WP1066, an Immune/Transcription Modulator targeting various cancers, and has a portfolio of antimetabolites, including WP1122 for treating pathogenic viruses and certain cancer indications [4].

Core Viewpoint - Moleculin Biotech, Inc. is advancing its pivotal MIRACLE Study evaluating Annamycin in combination with cytarabine for patients with relapsed or refractory Acute Myeloid Leukemia, with promising results expected from the ongoing clinical trial [3][6]. Company Overview - Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company focused on developing therapeutic candidates for hard-to-treat tumors and viruses [5]. - The lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance and cardiotoxicity associated with current treatments [5]. Clinical Development - The MIRACLE Study (MB-108) is an adaptive Phase 3 trial designed with FDA input, involving an initial cohort of 45 patients [3][6]. - The study aims to evaluate the safety and efficacy of Annamycin in combination with cytarabine, with an interim unblinding planned after the initial cohort's treatment completion [3][6]. - The trial builds on positive outcomes from the earlier MB-106 Study, where Annamycin showed overall survival rates exceeding historical benchmarks in a challenging patient population [3]. Additional Pipeline - The company is also developing WP1066, an Immune/Transcription Modulator targeting various cancers, and WP1122, an antimetabolite for potential treatment of pathogenic viruses and certain cancer indications [7].

Group 1 - Moleculin Biotech, Inc. has entered into agreements for the immediate exercise of existing warrants to purchase up to 2,122,652 shares of common stock at an exercise price of $3.90 per share, expected to generate approximately $8.3 million in gross proceeds [1][4] - Roth Capital Partners is acting as the financial advisor for this transaction [2] - The company will issue new unregistered warrants for up to 6,367,956 shares, exercisable at the lesser of $3.90 or the lowest volume weighted average price during the next five trading days, subject to shareholder approval [3] Group 2 - The transaction is expected to close on or about February 20, 2026, pending customary closing conditions, with net proceeds intended for working capital and general corporate purposes [4] - The new warrants were offered in a private placement and have not been registered under the Securities Act of 1933, with the company agreeing to file a registration statement for the resale of shares [5] Group 3 - Moleculin Biotech is a Phase 3 clinical stage pharmaceutical company focused on developing therapeutic candidates for hard-to-treat tumors and viruses, with its lead program Annamycin targeting relapsed or refractory acute myeloid leukemia and soft tissue sarcoma lung metastases [7][8] - The company has initiated the MIRACLE Trial, a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for the treatment of relapsed or refractory acute myeloid leukemia, following a successful Phase 1B/2 study [8] - Additionally, the company is developing WP1066, an immune/transcription modulator targeting various cancers, and has a portfolio of antimetabolites including WP1122 for potential treatment of pathogenic viruses [9]

Preliminary blinded CR rate showed 67% improvement over historical cytarabine response Roughly 35% of the subjects treated to date represent ventoclax regimen failuresFirst 45 subjects treated on track for Q1 2026 milestone with unblinding thereafter; treated 35 subjects to date with another 11 identified Continued absence of cardiotoxicity and high efficacy expected to position Annamycin as a “significant advancement” in AML treatment HOUSTON, Feb. 18, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nas ...

Core Viewpoint - Moleculin Biotech, Inc. has received a notice of allowance for a patent in Japan related to the preparation of liposomal Annamycin, which is expected to enhance its intellectual property position and support the development of its non-cardiotoxic therapy for acute myeloid leukemia [1][2][3] Group 1: Patent and Intellectual Property - The Japan Patent Office has allowed claims for a patent application covering methods for reconstituting liposomal Annamycin, ensuring consistent dosing and stability for intravenous administration [2] - This patent allowance complements existing U.S. and European patent protections, with additional applications pending in major jurisdictions worldwide [2][3] Group 2: Product Development and Clinical Trials - Annamycin, also known as naxtarubicin, is being developed for the treatment of relapsed or refractory acute myeloid leukemia (AML) and is positioned to be the first non-cardiotoxic anthracycline approved for clinical use [2][4] - The company has initiated the MIRACLE Trial (MB-108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory AML [5] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML, as well as Orphan Drug Designation from the EMA [3][5] Group 3: Company Overview - Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company focused on developing therapies for hard-to-treat tumors and viruses, with Annamycin as its lead program [4][6] - The company is also developing WP1066, an immune/transcription modulator targeting various cancers, and has a portfolio of antimetabolites for potential treatment of pathogenic viruses and certain cancer indications [6]