–     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 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 operational and financial results at 8:30 AM ET on Monday, May 13, 2024. (details below). "We recently hosted a virtual AML Clinical Day featuring renowned KOLs, Dr. Martin Tallman and Dr. Michael Andreeff. It was great to hear their support of and thoughts on Annamycin's recent developments in AML. You can hear that discussion here. Combined with the encouraging Annamycin data demonstrated to date and the positive feedback from the KOLs, we continue to believe that our results in 2nd line subjects fill a significant unmet need. We believe this is supported by the exceptional  CRc rate demonstrated by AnnAraC in 2nd line patients, which substantially exceeds the performance reported by any drug currently approved in the U.S. for use in 2nd line AML. We believe we are well-positioned for a highly productive End of Phase 2 meeting with FDA to discuss our planned pivotal study of Annamycin for AML," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. Recent Highlights Bolstered the patent estate with issuance of U.S. patents. We recently received an Issue Notification from the United States Patent and Trademark Office (USPTO) for U.S. Patent number 11,980,634 titled, "Method of Reconstituting Liposomal Annamycin." Earlier, we received an Issue Notification titled, "Preparation of Preliposomal Annamycin Lyophilizate." Both provide claims to compositions that contain Annamycin with a base patent term extending until mid-2040. Hosted a virtual AML clinical day highlighting positive interim data for Annamycin from its ongoing acute myeloid leukemia (AML) clinical development program. Full MB-106 trial reaches 20 subjects with CRc of 45% in 1st – 7th line, with median durability at 4.9 months and climbing. 1st and 2nd line patients reached a CRc rate of 62% and a CR rate of 54%. The 2nd line performance from the combination of Annamycin with Ara-C (AnnAraC) exceeds the approval data for all currently approved 2nd line drugs. Interim data supports advancement to development of Phase 2 registration-directed clinical trial (MB-108) to further provide data for efficacy to support an eventual application for New Drug Approval (NDA). Announced the formation of its Annamycin Scientific Advisory Board and inaugural appointment of Dr. Martin Tallman. Granted Orphan Drug Designation of Annamycin for the treatment of AML from the European Medicines Agency (EMA), adding to US Orphan Drug and Fast Track designations. Presented positive data demonstrating high anti-cancer activity of Annamycin and non-cardiotoxic properties at the American Association for Cancer Research (AACR) Annual Meeting. Ongoing AML Clinical Trial Summary The Company is currently conducting its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy (MB-106). clinicaltrialsregister.eu: EudraCT 2020-005493-10 or clinicaltrials.gov: NCT05319587. A summary table of the MB-106 preliminary results is shown below. These subjects had 0-6 prior therapies. The preliminary data for MB-106 demonstrate a CRc rate of 45% and an overall remission rate (ORR) of 55% for all subjects, regardless of the number of prior treatments (N=20). Segmenting the MB-106 subject population for 1st line (N=3) and, most notably, 2nd line (N=10) therapies in the trial, yields a CRc rate of 67% and 60% and an ORR of 67% and 70%, both respectively. Table 1 - Summary of Annamycin Remissions in MB-106 as of May 2, 2024 Study MB-106 Combination Therapy –Phase 1B/2 with Ara-C + Annamycin "5+3" All Lines (Range1-7) 1st Line 2nd Line 1st and 2nd LineCombined All Subjects Recruited and Evaluable 20 3 10 13 Subjects Evaluable Not Dosed Per Protocol 2 0 1 1 Median Age - Years (Range) 69 (19-78) 49 (19-69) 71 (53 - 78) 67 (19-78) Complete Remissions (CR) 8 2 5 7 CR with ...