Company Overview - Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on developing drug candidates for hard-to-treat tumors and viruses [6] - The company's lead program, Annamycin, is a next-generation anthracycline aimed at avoiding multidrug resistance and cardiotoxicity associated with current treatments [6] Clinical Trials and Results - The company has completed its End of Phase 2 (EOP2) meeting with the FDA regarding the Phase 1B/2 clinical trial of Annamycin in combination with Cytarabine for treating acute myeloid leukemia (AML) [8] - In the ongoing MB-106 clinical trial, 22 subjects have been enrolled, with 20 completing efficacy evaluations; 9 subjects (45%) achieved a composite complete remission (CRc) [12] - Among the 10 subjects treated with AnnAraC in the second-line setting, 5 achieved a complete remission (CR) [1] Drug Development Pipeline - The company is also developing WP1066, an Immune/Transcription Modulator targeting brain tumors and other cancers [2] - Moleculin is working on a portfolio of antimetabolites, including WP1122, for potential treatment of viruses and certain cancer indications [2] Regulatory Status - 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 European Medicines Agency [9]

– Current median durability of response (mDOR) of CRc's = 6 months and increasing (n=9) – Recruitment increased to 22 subjects and CRc's in all subjects evaluable for efficacy (n=20) was 45% – Data presented at European Hematology Association (EHA) 2024 Hybrid Congress and Company KOL Meeting in Madrid Preliminary Results Across All Lines of TreatmentPreliminary Results Across All Lines of Treatment Median Durability of ResponseMedian Durability of Response Response by Genotype and Mutations Response by Gen ...

As part of the event, Walter Klemp, Chairman and Chief Executive Officer of Moleculin, will provide an "elevator pitch" and outline the Company's upcoming milestones. Additionally, investors and interested parties will have the opportunity to submit questions live during the event. Participating companies will answer as many questions as possible in the time allowed. Live video webcast on Tuesday, June 18th at 3:00 PM ET A live video webcast of the event will be available on the Events page under the Invest ...

A live video webcast of the event will be available on the Events page under the Investors section of the Company's website (moleculin.com). A webcast replay will be available two hours following the live event and will be accessible for 90 days. Investor Contact: About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses. The Company's lead program, Annamycin is a next- g ...

HOUSTON, May 16, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard- to-treat tumors and viruses, today announced its abstract has been accepted for poster presentation at the EHA2024 Hybrid Congress being held June 13-16, 2024 in Madrid, Spain and virtually. Details for the poster presentation are as follows: For more information about the Company, please visit www.mole ...

– Investigator-Initiated Phase 2 study is being conducted at Northwestern University in cooperation with Moleculin – Trial combines WP1066 and radiation, which demonstrated both significant therapeutic response and immune "memory" in glioblastoma animal models HOUSTON, May 15, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company), a clinical-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard- to-treat tumors and viruses, today announced ...

Exhibit 99.1 Moleculin Reports First Quarter 2024 Financial Results and Provides Corporate Update HOUSTON, May 13, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today reported its financial results for the quarter ended March 31, 2024. As previously announced, the Company will host a conference call and live audio webcast to discuss the ...

–     Recently announced interim data from ongoing MB-106 study demonstrating Annamycin in combination with Cytarabine (AnnAraC) achieves CRc rate of 62% (54% CR) in 1st and 2nd line AML subjects (N=13) –     Also announced MB-106 reaches 20 subjects enrolled –     Company to host conference call and webcast today, Monday, May 13th at 8:30 AM ET HOUSTON, May 13, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad p ...

Clinical Trial Results - Annamycin has shown a complete remission (CR) rate of 40% and an overall response rate (ORR) of 55% across all subjects in the Phase 1B/2 trial for AML, with a CR rate of 67% for first-line and 60% for second-line therapies [69]. - The median durability of complete remission (CRc) is approximately 4.9 months, with one death and one relapse reported out of ten CRs [73]. - Annamycin demonstrated no cardiotoxicity in subjects treated, even at doses exceeding the lifetime cumulative anthracycline dose associated with increased cardiomyopathy risk [74]. - The Phase 1B/2 trial for Annamycin in combination with Cytarabine is expected to support a Phase 2 registration-directed clinical trial for New Drug Approval (NDA) [71]. - The company has engaged an independent expert to assess the cardiovascular safety of Annamycin, with ongoing data collection from multiple trials [63]. Regulatory and Patent Information - Annamycin has received Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) for the treatment of AML, enhancing its commercial exclusivity [78]. - The U.S. Patent and Trademark Office issued U.S. Patent number 11,951,118 for Annamycin, with coverage extending until June 2040, subject to regulatory approval timelines [76]. Financial Performance - Revenues for the three months ended March 31, 2024, were $0, consistent with the same period in 2023 [85]. - Research and development expenses decreased to $4.3 million in Q1 2024 from $5.7 million in Q1 2023, a reduction of approximately 24.6% [86]. - General and administrative expenses decreased to $2.4 million in Q1 2024 from $2.6 million in Q1 2023, a reduction of approximately 7.7% [87]. - The net loss for Q1 2024 was $4.97 million, compared to a net loss of $7.92 million in Q1 2023, representing a 37.4% improvement [85]. - Cash used in operating activities increased to $6.72 million in Q1 2024 from $6.02 million in Q1 2023, an increase of approximately 11.7% [91]. - The company recorded a net gain of $1.5 million from the change in fair value of warrant liability in Q1 2024, compared to a gain of $0.04 million in Q1 2023 [88]. - As of March 31, 2024, the company had $0.4 million in cash on hand in Australia, with no known liquidity limitations [90]. - The company expects existing cash and cash equivalents to fund operations into Q4 2024 without additional equity issuance [93]. - The company expensed approximately $0.1 million in general and administrative fees related to an SEC investigation in Q1 2024, down from $0.5 million in Q1 2023 [94]. - The company did not engage in any stock sales during Q1 2024, resulting in no cash provided by financing activities [92]. Research and Development Initiatives - The WP1066 portfolio includes three compounds that have successfully completed Phase 1 clinical trials, with ongoing discussions for further trials in glioblastomas and pediatric brain tumors [81]. - The company is exploring external funding avenues for the WP1122 portfolio, with a final clinical study report submitted in late October 2023 [83]. - Annamycin's unique lipid-based delivery technology aims to improve tissue distribution and reduce toxicity compared to traditional anthracyclines [64].

Patent, once issued, will provide composition protection through 2040, with potential for additional term extension Annamycin is advancing towards pivotal AML study in 2024 and may qualify for an accelerated approval pathway HOUSTON, May 9, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it has received an Issue Notification fr ...