Secured approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia for Phase 2B/3 MIRACLE trial Recent EU approval from the European Medicines Agency (EMA) boosts trial profile Enrollment in Part A of MIRACLE reaches seven subjects treated and one additional subject in screening 16 additional clinical sites in Europe and the US expected to begin recruitment by the end of August; building... Read More

HOUSTON, June 20, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the pricing of a public offering consisting of 16,080,000 shares of common stock (or pre-funded warrants in lieu thereof) and Series E warrants to purchase up to 48,240,000... Read More

Watch the “What This Means" segment here HOUSTON, June 18, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that it participated in a Virtual Investor “What This Means” segment . As part of the segment, Walter Klemp, Founder, President, CEO... Read More

Annamycin aims to eliminate cardiotoxicity associated with anthracyclines used to treat about 60% of all children with cancer FDA recommends inclusion of patients as young as 6 months – younger than Moleculin had proposed – to be allowed in the pediatric clinical study Enrollment and dosing are ongoing in pivotal, adaptive design Phase 3 MIRACLE trial of Annamycin in adult patients with R/R AML; Initial data readout is on... Read More

Globally recognized Oncology Key Opinion Leader, Brian Andrew Van Tine, MD, PhD, discusses the positive topline results from the U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of Soft Tissue Sarcoma Lung Metastases (MB-107) Watch the “What This Means" segment here HOUSTON, June 11, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage... Read More

Access the on-demand webcast here HOUSTON, June 05, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced the release of its Soft Tissue Sarcoma (STS) Lung Mets KOL Webcast discussing the final data from its U.S. Phase 1B/2 clinical trial... Read More

Annamycin delivering better performance 7 th line than would be expected even in 2 nd line for monotherapy Responders (Stable Disease or Partial Response) after 2 cycles of Annamycin showed improvement in OS and Progression Free Survival (“PFS”) Clinical Benefit Rate (“CBR”) was 59.4% (n=32), comprised of 18 subjects with stable disease and 1 subject with a partial response Potential to address 13,500 new incidents of STS... Read More

Enrollment and dosing underway in Phase 3 clinical trial (the “MIRACLE” trial) evaluating Annamycin (naxtarubicin) for the treatment of R/R AML Regulatory and site selection progress to date supports interim data readout expected in the second half of 2025 Recently received European Medicines Agency (EMA) approval adds nine additional countries to the Company’s ongoing MIRACLE trial; Authorization granted in all EU countries... Read More

Adds nine additional countries to the Company’s ongoing pivotal Phase 3 trial; Authorization granted in all EU countries requested Enrollment and dosing underway in Phase 3 clinical trial (the “MIRACLE” trial) evaluating Annamycin for the treatment of R/R AML; Interim data readout expected in the second half of 2025 Subjects targeted for the “MIRACLE” trial include venetoclax regimen failures where outcomes with currently... Read More

HOUSTON, May 07, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced that it will report its financial results for the first quarter ended March 31, 2025 on Tuesday afternoon, May 13, 2025. Moleculin management will host a conference call and... Read More

Annamycin has the potential to be safer and more effective than current prescribed anthracyclines to treat serious, hard-to-treat cancers Ongoing pivotal, adaptive Phase 3 clinical trial (the “MIRACLE” trial) evaluating Annamycin for the treatment of acute myeloid leukemia (AML); Interim data readout expected in the second half of 2025 HOUSTON, May 06, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. , (Nasdaq: MBRX)... Read More

Company continues to expand global IP coverage and claims to major markets, now extending to June 2040 HOUSTON, May 05, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced the U.S. Patent and Trademark Office (USPTO) has granted two additional... Read More

Data presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 Annamycin is potentially a highly versatile drug capable of working synergistically with numerous mechanistically different FDA approved anticancer first line therapies both in vitro and in vivo HOUSTON, April 29, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage... Read More

HOUSTON, April 17, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced that an abstract regarding the Company’s next-generation anthracycline, Annamycin , has been selected for poster presentation at the American Association for Cancer... Read More

Initial data readout on track for second half of 2025 HOUSTON, April 01, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced the first patient has been dosed in its Phase 3 pivotal trial evaluating Annamycin in combination with Cytarabine... Read More

Continued progress in pivotal, adaptive Phase 3 clinical trial (the “MIRACLE” trial) toward first subject treated, on track to take place in the first quarter of 2025 Multiple subjects currently being screened in first MIRACLE site activated Initial data readout of the Phase 3 MIRACLE trial expected in the second half of 2025 Company to host conference call and webcast today, Monday, March 24 th at 8:30 AM ET HOUSTON, March... Read More

HOUSTON, March 19, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that it will report its financial results for the year ended December 31, 2024, on Friday afternoon, March 21, 2025. Moleculin management will host a conference call and... Read More

On-demand video webcast now available here HOUSTON , March 11, 2025 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company") a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it participated in the Virtual Investor "Top 5 for '25" On-Demand Conference . As part of the event, Walter Klemp , Chairman and Chief... Read More

Live webcast fireside chat on Tuesday, March 18 th at 11:00 AM PT HOUSTON , March 10, 2025 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced Walter Klemp , Chairman and Chief Executive Officer of Moleculin will participate in a fireside chat on... Read More

New patents will extend coverage to major markets outside the U.S., expanding upon existing U.S. claims Affirms expectations for an initial data readout of the phase 3 MIRACLE trial for the second half of 2025 HOUSTON , March 6, 2025 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (Moleculin or the Company), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors... Read More

HOUSTON , March 3, 2025 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-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 Acute Leukemias XIX (ISALXIX) International Symposium being held March 16-19, 2025 in Munich, Germany . Details for... Read More

HOUSTON , Feb. 25, 2025 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it has entered into a securities purchase agreement with an institutional investor for the purchase and sale of 3,271,029 shares of common stock (or pre-funded warrants in lieu... Read More

HOUSTON , Feb. 13, 2025 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it has entered into agreements with certain holders of its existing warrants for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of... Read More

Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) in the first quarter of 2025 HOUSTON , Feb. 13, 2025 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it has received U.S. Food and... Read More

First of many site approvals, including sites in the US, Europe and the Middle East , expected throughout Q1-Q3 2025 Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) in the first quarter of 2025 Recently amended protocol accelerates unblinding of preliminary primary efficacy data (CR) and safety/tolerability of the three arms at first 45 subjects, expected... Read More

Walter Klemp , CEO of Moleculin, provides an update on the Company's Phase 3 pivotal trial of Annamycin for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML) (the "MIRACLE" trial) Watch the "What This Means" segment here HOUSTON , Jan. 27, 2025 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a... Read More

Received US Institutional Review Board (IRB) approval for pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) and engaged leading contract research organization (CRO); On track to begin dosing of Annamycin in combination with cytarabine for the treatment of R/R AML in Q1 2025 Expected timelines for recruitment updates and preliminary readouts of MIRACLE trial accelerated to 2H 2025 (n=45); 1H 2026 (n=~75-90) with... Read More

Abstract published as part of the American Society of Hematology (ASH) Annual Meeting Study shows Annamycin effectively targets both Cytarabine (Ara-C) and Venetoclax resistant acute myeloid leukemia (AML) cell lines from heavily pretreated relapsed/refractory primary AML patients in vitro Lack of apparent cardiotoxicity, improved organotropism, synergy with Ara-C, and possible immune-memory reinforcing properties appear to... Read More

Preclinical data accepted for online publication at ASH Annual Meeting reveal significant activity of Annamycin in Venetoclax resistant AML model New preliminary clinical results show Annamycin plus Ara-C achieved 60% CR/CRi in subjects who were relapsed from or refractory to Venetoclax regimens; more than 4 times greater than published historical rates Annamycin demonstrates an even greater potential than previously... Read More

Amended protocol accelerates unblinding of preliminary primary efficacy data (CR) and safety/tolerability of the three arms at first 45 subjects Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) in the first quarter of 2025 Company releases Virtual Investor "What This Means" segment discussing the amended protocol; Available here HOUSTON , Nov. 14, 2024... Read More

Company on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) in the first quarter of 2025 Trial designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML HOUSTON , Nov. 12, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company... Read More

On track to start dosing in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of R/R AML in Q1 2025 Median durability of CRc in MB-106 Annamycin+ Cytarabine AML clinical trial continues to climb - now past 8 months Recent virtual AML KOL event underscores how Annamycin could significantly change the AML... Read More

HOUSTON , Nov. 5, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that it will report its financial results for the quarter ended September 30, 2024 , on Friday, November 8, 2024 . Moleculin management will host a conference call and live audio... Read More

Strong preclinical evidence of Annamycin's potential for treating pancreatic cancer presented at AACR expands collaboration HOUSTON , Nov. 4, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (Moleculin or the Company), a late stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the appointment of Daniel D. Von Hoff , M.D., F.A.C.P.,... Read More

Access the transcript here HOUSTON , Oct. 17, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the transcript from its recently hosted Virtual Acute Myeloid Leukemia KOL event is now available. The transcript is accessible under the Virtual AML... Read More

Live webcast discussion featuring internationally renowned Acute Myeloid Leukemia (AML) Key Opinion Leaders Ongoing progress of pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML HOUSTON , Oct. 7, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the... Read More

HOUSTON , Oct. 4, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced its participation at two upcoming investor conferences. Details of the upcoming presentations are as follows: 3 rd Annual ROTH Healthcare Opportunities Conference Format: Panel -... Read More

Data recently presented at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer Treatment with Annamycin results in statistically significant inhibition of tumor growth and extension of survival in orthotopic lung cancer models Annamycin continues to be 100% non-cardiotoxic HOUSTON , Sept. 23, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the... Read More

Wally Klemp , CEO of Moleculin, discusses the Company's recent update on the Phase 2 clinical trial of STAT3 inhibitor in combination with radiation for the treatment of glioblastoma Watch the "What This Means" video here HOUSTON , Sept. 16, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company), a Phase 3 clinical-stage pharmaceutical company with a broad portfolio of drug candidates... Read More

Investigator-initiated Phase 2 study is being conducted at Northwestern University in cooperation with Moleculin Funding for study provided by NIH and BrainUp ® Trial combines WP1066 and radiation, which demonstrated both significant therapeutic response and immune memory in glioblastoma animal models HOUSTON , Sept. 9, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company), a Phase 3... Read More

HOUSTON , Sept. 3, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a Phase 3 clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that Walter Klemp , Chairman and Chief Executive Officer of Moleculin will present at the H.C. Wainwright 26 th Annual Global Investment Conference being held... Read More

Live webcast on Wednesday, August 28 th at 3:40 PM ET HOUSTON , Aug. 26, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a Phase 3 clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that Walter Klemp , Chairman and Chief Executive Officer of Moleculin will present at LIVE! with Webull... Read More

$5.5 million financing upfront with up to an additional $11.0 million of potential aggregate gross proceeds upon the exercise in full of milestone-linked warrants HOUSTON , Aug. 19, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a Phase 3 clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced... Read More

$5.5 million financing upfront with up to an additional $11.0 million of potential aggregate gross proceeds upon the exercise in full of milestone-linked warrants HOUSTON , Aug. 16, 2024 /PRNewswire-PRWeb/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a Phase 3 clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today... Read More

Positive outcome from End of Phase 1B /2 Meeting with FDA Company proceeding with a pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of R/R AML Webcast replay of the Company's recent MIRACLE trial update available here HOUSTON , Aug. 14, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX)... Read More

HOUSTON , Aug. 5, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), Phase 3 clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it will host a corporate update webcast presentation on Tuesday, August 6, 2024 at 8:30 AM ET to discuss its recently announced plans to advance Annamycin in... Read More

Based on an encouraging discussion in the End of Phase 1B /2 Meeting with FDA the Company plans to: Proceed with a pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML; Run such... Read More

HOUSTON , July 10, 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 the completion of its End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for its Phase 1B /2 clinical trial evaluating Annamycin in combination... Read More

89% of CRc's were subjects with "poor prognosis" cytogenetics and/or mutations Current median durability of response (mDOR) of CRc's = 6 months and increasing (n=9) In 2 nd line subjects (n=10) Annamycin in combination with Cytarabine (AnnAraC) achieved an estimated median overall survival (mOS) of 6 months and increasing plus... Read More

Live video webcast on Tuesday, June 18 th at 3:00 PM ET HOUSTON , June 12, 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 that it will present at the Virtual Investor Pitch Conference on June 18, 2024 at 3:00 PM ET . As part of the event,... Read More

Live webcast with Walter Klemp , Chairman and Chief Executive Officer, on Wednesday, June 12 th at 12:00 PM ET HOUSTON , June 5, 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 that it will present at the Virtual Investor Lunch Break: The... Read More

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... Read More

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... Read More

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

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... Read More

HOUSTON , May 8, 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 that it will report its financial results for the quarter ended March 31, 2024 , on Friday, May 10, 2024 . Moleculin management will host a conference call and live audio... Read More

Annamycin in combination with Cytarabine (AnnAraC) achieves CRc rate of 62% (54% CR) in 1 st and 2 nd line AML subjects (N=13) Full MB-106 trial reaches 20 subjects with CRc of 45% in 1st – 7th line, with median durability at 4.9 months and climbing 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... Read More

Live video webcast roundtable with members from the Moleculin Management Team and Dr. Tallman to discuss the unmet medical needs in the treatment of acute myeloid leukemia (AML), Annamycin and the Company's AML clinical development program as well as data demonstrated to date Ongoing development progress of Annamycin toward... Read More

Company appoints internationally renowned clinician, Martin S. Tallman , MD as inaugural clinician member HOUSTON , May 1, 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... Read More

Next-generation non-cardiotoxic anthracycline Annamycin with notable signs of clinical efficacy in AML in combination with Cytarabine achieves preliminary CRc rate of 60% in 2 nd line AML subjects in a European clinical trial There are approximately 160,000 people with AML worldwide Annamycin continues to show no signs of cardiotoxicity (N=82 across multiple studies); Lower toxicity profile than traditional intensive therapy... Read More

Annamycin demonstrated to be a more potent inhibitor of topoisomerase II-alpha and II-beta while remaining inactive against established cardiomyocyte cultures Results clearly aligned with lack of drug-related cardiotoxic events in patients treated with Annamycin in ongoing clinical trials; 100% of Annamycin subjects in... Read More

Live webcast on Thursday, April 4 th at 4:10 PM ET HOUSTON , March 28, 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 Walter Klemp , President and Chief Executive Officer of Moleculin will present at the MedInvest Biotech & Pharma Investor... Read More

Live webcast with Walter Klemp , Chairman and Chief Executive Officer, on Thursday, March 28 th at 12:00 PM ET HOUSTON , March 27, 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 that it will present at the Virtual Investor Lunch Break: The... Read More

Patent, once issued, will provide composition of matter protection through 2040, with potential for additional term extension Next-generation anthracycline uses unique lipid-based delivery technology to bring hope to the estimated 58% of AML patients for whom no approved therapy exists HOUSTON , March 27, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical... Read More

Annamycin in combination with Cytarabine (AnnAraC) achieves CRc rate of 60% (50% CR) in 2 nd line AML subjects AnnAraC has potential to fill significant unmet need and expected to increase 2 nd line AML CRs more than double over existing 2 nd line therapies All 82 Annamycin subjects (in multiple studies) continue to show no signs of cardiotoxicity during study; Lower toxicity profile than traditional intensive therapy... Read More

Year marked by growing body of positive Annamycin efficacy and safety clinical data expected to support advancement into a pivotal study for AML Company to host conference call and webcast Monday, March 25 th at 8:30 AM ET Company to issue separate clinical trial update press release Monday prior to the conference call HOUSTON , March 22, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the... Read More

In-depth discussion of stratification of Company's 2 nd line data of Annamycin as a therapy for acute myeloid leukemia (AML) Guidance to be provided for clinical development strategy for advancement of Annamycin into potential AML pivotal registration study HOUSTON , March 20, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad... Read More

HOUSTON , March 19, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced a 1-for-15 reverse stock split of its common stock. The reverse stock split will take effect at 11:59 pm (Eastern Time) on March 21, 2024 , and the Company's... Read More

Live webcast fireside chat on Monday, March 18 th at 9:00 AM PT HOUSTON , March 12, 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 Jonathan Foster , Executive VP and Chief Financial Officer of Moleculin will participate in a fireside chat at... Read More

MB-106 AML Phase 1B /2 trial (MB-106) preliminary data readout: Reached 67% recruitment MB-106 preliminary results: Intent to Treat CR rate of 40% plus a CR/ CRi rate of 47% (N=15); Dosed Per Protocol CR rate of 46% plus a CR/CRi rate of 54% (N=13) First 1 st line AML subject treated and resulted in a CR in MB-106 No CR/CRi's in MB-106 have relapsed to date MB-107 STS Lung Mets Phase 1B /2 trial preliminary data readout:... Read More

HOUSTON , Dec. 20, 2023 /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 that it has entered into a securities purchase agreement with a single healthcare-focused institutional investor and certain of the Company's executive officers and directors to... Read More

CR rate of 36% in Intent to Treat or ITT (n=11) subjects with durability CR rate of 44% in subjects treated with Annamycin (n=9) Durability of CR's up to 8 months & climbing (no relapses to date) Recruitment in MB-106 Phase 1B /2 clinical trial reaches 59% Announces Publication for 65 th ASH Annual Meeting and Exposition Annamycin continues to be 100% non-cardiotoxic HOUSTON , Dec. 11, 2023 /PRNewswire/ -- Moleculin Biotech,... Read More

MB-106: CR rate of 38% (N=8) with durability up to 8 months Builds on CRi rate of 60% in MB-105 monotherapy AML trial last cohort (N=5) MB-107: Phase 1B median extended overall survival of 11 months for heavily pre-treated subjects (N=15) MB-107 Phase 1B /2 median progression free survival (PFS) of 3.4 months for subjects dosed at or below 330 mg/m 2 and less than 3 prior therapies (N=9) 100% of Annamycin subjects in... Read More

Ends Quarter with $24.6 million in Cash with Runway Estimated into Third Quarter of 2024 Third quarter marked by additional positive clinical data from Annamycin lead development programs Growing body of Annamycin efficacy and safety clinical data expected to support advancement into pivotal studies for both AML and STS in 2024 Company to host conference call and webcast today at 8:30 AM ET HOUSTON , Nov. 13, 2023... Read More

HOUSTON , Nov. 7, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced that it will report its financial results for the third quarter ended September 30, 2023 , on Monday November 13, 2023 . Moleculin management will host a... Read More

Poster Presented at the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting Annamycin continues to be 100% non-cardiotoxic Annamycin has Fast Track Status and Orphan Drug Designation from FDA for the treatment of soft tissue sarcoma HOUSTON , Nov. 6, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline,... Read More

Live video webcast with Walter Klemp, CEO and Jonathan Foster , Executive VP and CFO of Moleculin on Tuesday, October 25 th at 12:00 PM ET HOUSTON , Oct. 11, 2023 /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 that Walter Klemp , President and... Read More

Phase 1B portion of Phase 1B /2 study demonstrated preliminary CR/CRi rate of 33% (n=6) Annamycin has Fast Track Status and Orphan Drug Designation from FDA for the treatment of AML HOUSTON , Oct. 2, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat cancers and... Read More

Data readouts expected before year end Previously reported preliminary efficacy data on its Phase 1B /2 clinical trial with Annamycin in monotherapy treatment of STS lung mets with >60% of the subjects exhibiting stable disease after two cycles of treatment Annamycin has Fast Track Status and Orphan Drug Designation from FDA for the treatment of soft tissue sarcoma HOUSTON , Sept. 21, 2023 /PRNewswire/ -- Moleculin Biotech,... Read More

Annamycin continues to demonstrate no evidence of cardiotoxicity to date, now in a total of 62 subjects across three of the Company's Annamycin clinical trials Next generation anthracycline, Annamycin, has demonstrated both safety and promising early activity across multiple clinical studies with potential to be an effective treatment across multiple oncology indications HOUSTON , Sept. 18, 2023 /PRNewswire/ -- Moleculin... Read More

HOUSTON , Sept. 14, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced its abstract has been accepted for poster presentation at the 2023 CTOS Annual Meeting being held November 1-4, 2023 in Dublin, Ireland . Details of the... Read More

HOUSTON , Sept. 5, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced that Walter Klemp , Chairman and Chief Executive Officer of Moleculin will present at the H.C. Wainwright 25 th Annual Global Investment Conference being held... Read More

Ongoing progress across ongoing clinical development programs with growing body of positive preclinical and clinical data Released Clinical Trial Update press release yesterday providing the quarter's update on its clinical activities Company to host conference call and webcast today at 8:30 AM ET HOUSTON , Aug. 11, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage... Read More

Announces successful completion of the Phase 1B portion of its Phase 1B /2 clinical trial Annamycin in combination with Cytarabine for the treatment of AML (MB-106) and opens the Phase 2 portion for recruitment Announces a preliminary CR/CRi rate of 33% (n=6) in the Phase 1B portion of its MB-106 clinical trial Reports preliminary efficacy data on its Phase 1B /2 clinical trial with Annamycin in monotherapy treatment of soft... Read More

HOUSTON , Aug. 7, 2023 /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 that it is investigating potential naked short selling of its stock and has retained well-known analytics firm, Shareholder Intelligence Services, LLC ("ShareIntel").... Read More

HOUSTON , Aug. 3, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that it will report its financial results for the second quarter ended June 30, 2023 , on Friday, August 11, 2023 . Moleculin management will host a conference call and... Read More

Data published in peer-reviewed British Journal of Cancer Research No evidence of cardiotoxicity in any subject treated in this study, including up to 16 subjects whose cumulative anthracycline dose (Annamycin included) exceeded the lifetime cumulative doxorubicin (or equivalent) dose of > 450 mg/m 2 After experiencing an 80%/60% ORR/CRi rates in last single agent cohort, Annamycin is currently being evaluated in a Phase 1b... Read More

Live moderated video webcast on Wednesday, July 12 th at 3:00 PM ET HOUSTON , July 6, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that Walter Klemp , President and Chief Executive Officer and Jon Foster , Executive VP & Chief... Read More

Live webcast fireside chat on Wednesday, June 21 st at 1:30 PM ET HOUSTON , June 13, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced that Walter Klemp , President and Chief Executive Officer and Jonathan Foster , Executive VP and... Read More

Company urges shareholders of record date, March 27, 2023 , to vote your shares immediately if you have not already done so HOUSTON , May 30, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced that its annual meeting of... Read More

Continued clinical and operational execution across ongoing development programs with growing body of positive preclinical and clinical data Sufficient capital to fund operations into the third quarter of 2024 Company to host conference call and webcast today at 8:30 AM ET HOUSTON , May 11, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company... Read More

Actively recruiting in three Phase 1b /2 clinical trials (one of which is in Phase 2) Recently completed first cohort in Phase 1b /2 trial evaluating Annamycin in combination with cytarabine (Ara-C) for the treatment of acute myeloid leukemia (AML); Preliminary results show a durable complete response at starting dose level in an elderly subject Multiple expected milestones and interim data readouts expected in 2023 HOUSTON... Read More

HOUSTON , May 4, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that it will report its financial results for the first quarter ended March 31, 2023 , on Thursday, May 11, 2023 . Moleculin management will host a conference call and live... Read More

Preliminary results demonstrate a durable complete response at starting dose level in elderly subject Positive results from first cohort allows Company to progress to second cohort in Phase 1b portion of the Phase 1b /2 trial with 230 mg/m 2 dose of Annamycin HOUSTON , May 2, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing... Read More

Sponsored research data presented in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023 Annamycin demonstrated increased penetration and accumulation in the liver, which correlated with high antitumor activity in HEPA 1-6 hepatocellular carcinoma and CT26 colon cancer liver metastasis models Ongoing clinical trials evaluating Annamycin for the treatment of STS lung metastases... Read More

2022 marked by continued execution and growing body of positive data across clinical and preclinical development programs Sufficient capital to fund operations into the third quarter of 2024 Company to host conference call and webcast today at 8:30 AM ET HOUSTON , March 23, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing... Read More

Actively recruiting in three Phase 1b /2 clinical trials (with one now in Phase 2) and have recently concluded one trial Reached 50% recruitment of Phase 2 portion of soft tissue sarcoma (STS) lung metastases trial Multiple expected milestones and interim data readouts expected in 2023 HOUSTON , March 22, 2023 /PRNewswire/ --... Read More

HOUSTON , March 21, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced that an abstract regarding the Company's next-generation anthracycline, Annamycin , has been selected for poster presentation at the American Association for... Read More

HOUSTON , March 15, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced that it will report its financial results for the full year December 31, 2022 after market close on Wednesday, March 22, 2023 . Moleculin management will host... Read More

Presentation with live video webcast on Tuesday, March 14 th at 12:40 PM ET HOUSTON , March 13, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced that Jonathan P. Foster , Chief Financial Officer of Moleculin , will present at the... Read More

HOUSTON , March 13, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced that it is aware that the Federal Deposit Insurance Corp. has taken control of Silicon Valley Bank (SVB) due to liquidity concerns. The Company confirms it does... Read More

Annamycin appears to be a highly promising non-cardiotoxic, potent TOPO-II inhibitor able to overcome MDR-1 that, due to its unique organotropism, is also able to target hard-to-treat metastasis In an independent expert cardiology review of 42 subjects evaluated as of the date of the review, Annamycin has demonstrated no evidence of cardiotoxicity Annamycin is currently being evaluated in clinical studies for the treatment... Read More

HOUSTON , March 1, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced the first subject has been treated in Italy in the Company's Phase 1/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) for the treatment of subjects with... Read More

Results align with the overall safety profile of Annamycin Final cohort demonstrated an 80% overall response rate (ORR) in elderly subjects (≥60 years old) No cardiotoxicity demonstrated in any study subject The median number of prior therapies for all subjects was 4 HOUSTON , Feb. 13, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a... Read More

Live video webcast on Tuesday, January 17 th at 9:00 AM ET HOUSTON , Jan. 5, 2023 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that Walter Klemp , President and Chief Executive Officer of Moleculin, will present at the Virtual Investor... Read More

Ongoing efforts to open additional clinical sites in Poland and to gain approval to proceed in other European countries First subject treated in Italy expected in the first quarter of 2023 HOUSTON , Dec. 21, 2022 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses,... Read More

Preliminary efficacy updated to 80% overall response rate (ORR) demonstrated in single agent AML trial following database lock Next generation anthracycline, Annamycin, has demonstrated both safety and promising early activity across multiple clinical studies with potential to be an effective treatment across multiple oncology indications Recent independent report from cardiology expert concluded Annamycin has no evidence of... Read More

HOUSTON , Dec. 7, 2022 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation of WP1122 for the treatment of Glioblastoma Multiforme ("GBM"). The FDA's Fast Track... Read More