Moleculin Biotech

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company, which engages in the development of treatments for highly resistant cancers and viruses. Its clinical stage drugs include Annamycin, an Anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia (AML), and WP1066, an Immune/Transcription Modulator targeting brain tumors, pancreatic cancer, and AML. The company was founded by Walter V. Klemp, Donald H. Picker, and Waldemar Priebe on July 28, 2015 and is headquartered in Houston, TX.

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Moleculin Biotech reports robust Q1 results, eyes pivotal trials for growth

Moleculin Biotech's Q1 2024 earnings call highlighted strong performance of Annamycin, cost management, and strategic growth initiatives. Despite challenges with patient reactions and recruitment, the company is poised for value creation through upcoming trials and FDA interactions.

Moleculin Biotech excels in Q3 with promising AML drug

Moleculin Biotech's Q3 performance highlighted strong drug potential and financial stability
The company's adaptive trial design and global recruitment efforts position them for success
Challenges include meeting key milestones and addressing analyst inquiries for clarity
Opportunities lie in potential accelerated approval, strategic partnerships, and market expansion

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company. It engages in the business of growing a pipeline including phase 2 clinical programs for hard-to-treat cancers and viruses. The company was founded by Walter V. Klemp, Donald H. Picker, and Waldemar Priebe on July 28, 2015 and is headquartered in Houston, TX.

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 (STS lung mets) and acute myeloid leukemia (AML) HOUSTON , April 18, 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 positive preclinical data regarding the Company's next-generation anthracycline, Annamycin, was presented at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place April 14-19, 2023, at the Orange County Convention Center in Orlando, FL. This research was sponsored by the Company.

Moleculin Announces Presentation of Positive Pharmacokinetics and Tissue-Organ Distribution Data Demonstrating High Antitumor Activity of Annamycin in Preclinical Cancer Models

Moleculin Biotech, Inc. (MBRX) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

Moleculin Biotech, Inc. (MBRX) Upgraded to Buy: What Does It Mean for the Stock?

Moleculin Biotech, Inc. (NASDAQ:MBRX ) Q4 2022 Earnings Conference Call March 23, 2023 8:30 AM ET Company Participants Jenene Thomas - Investor Relations Walter Klemp - Chairman and Chief Executive Officer John Paul Waymack - Senior Chief Medical Officer Jonathan Foster - Executive Vice President and Chief Financial Officer Conference Call Participants Jonathan Aschoff - ROTH MKM Jeff Jones - Oppenheimer Operator Hello and welcome to the Moleculin Biotech Fiscal Year 2022 Quarterly Update Conference Call and Webcast. [Operator Instructions] A question-and-answer session will follow the formal presentation.

Moleculin Biotech, Inc. (MBRX) Q4 2022 Earnings Call Transcript

– 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 pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today reported its financial results for the fiscal year ended December 31, 2022 and provided a pipeline update. As previously announced, the Company will host a conference call and live audio webcast, today, Thursday, March 23, 2023, at 8:30 AM ET (details below).

Moleculin Reports Full Year 2022 Financial Results and Provides Pipeline Update

– 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/ -- 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 viruses, today announced recent activity, new positive data and expected near term milestones across its clinical development pipeline. "We continue to make significant progress on multiple fronts across our development pipeline and ongoing clinical trials.

Moleculin Announces Interim Phase 2 Data in STS Clinical Trial and Update on Recruiting, Preliminary Efficacy and Expected Milestones for AML Clinical Trials

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 Cancer Research (AACR) Annual Meeting 2023, taking place April 14-19, 2023, at the Orange County Convention Center in Orlando, FL. Details of the presentation are as follows: Title: Exploration of Annamycin Organotropism to Target Primary and Metastatic Liver Cancers   Track: Experimental and Molecular TherapeuticsSession: PO.ET09.10 - Novel Antitumor Agents, PI3K/AKT Inhibitors, Proteasome Inhibitors, and TopoisomerasesAbstract Number: 4947 / 25Presenter: Rafal Zielinski, Ph.D.

Moleculin Announces Acceptance of Abstract to be Presented at the American Association for Cancer Research (AACR) Annual Meeting 2023

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 a conference call and live audio webcast to discuss the operational and financial results on Thursday, March 23 rd at 8:30 AM ET.

Moleculin to Report Full Year 2022 Financial Results on March 22, 2023 and Host Conference Call and Webcast

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 virtual Oppenheimer 33rd Annual Healthcare Conference on Tuesday, March 14, 2023 at 12:40 PM ET.

Moleculin to Present at the Oppenheimer 33rd Annual Healthcare Conference

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 not hold any deposits or investments at SVB.

Moleculin Announces it Has No Exposure to Silicon Valley Bank Situation

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 of soft tissue sarcoma (STS) metastatic to the lungs and acute myelogenous leukemia (AML) HOUSTON , March 9, 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 the publication of data evaluating Annamycin's performance as an anthracycline designed to avoid the cardiotoxicity typically associated with currently prescribed anthracyclines. The manuscript titled, " Anthracycline-induced cardiotoxicity – are we about to clear this hurdle?

Moleculin Announces Publication of Data Supporting Development of Non-Cardiotoxic Anthracycline for the Treatment of Cancer in Peer-Reviewed European Journal of Cancer

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 AML who are refractory to or relapsed after induction therapy (MB-106). "We continue to be highly encouraged by the data demonstrated from the successfully concluded Annamycin single agent trials and the no evidence of cardiotoxicity seen to date.

Moleculin Announces Dosing of First Subject in Italy for Phase 1/2 Trial Evaluating Annamycin in Combination with Cytarabine (Ara-C) for the Treatment of Acute Myeloid Leukemia (AML)

–  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 broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced the following topline results from its MB-105 European Phase 1 clinical trial assessing the safety and efficacy of Annamycin as a single agent for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML). The final MB-105 results align with the overall safety profile of Annamycin and observations made in previously completed and ongoing clinical studies evaluating Annamycin.

Moleculin Announces Final Topline Data from Successful European Phase 1 Trial Evaluating Annamycin as Single Agent Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML)

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 2023 Companies to Watch Event on Tuesday, January 17, 2023 at 9:00 AM ET. A live video webcast of the presentation will be available on the Events page of the Investors section of the Company's website (moleculin.com).

Moleculin to Present at the Virtual Investor 2023 Companies to Watch Event

– 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, today announced it has received approval from the Agenzia Italiana del Farmaco (AIFA, the Italian Medicines Agency competent authority) and the Istituto Superiore di Sanità (ISS, the Italian National Institute of Health) for its Phase 1/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) in the treatment of subjects with AML who are refractory to or relapsed after induction therapy (MB-106). This adds to the approval the Company already has in Poland where three sites are currently open and recruiting subjects.

Moleculin Receives Approval in Italy to Conduct Phase 1/2 Trial Evaluating Annamycin in Combination with Cytarabine (Ara-C) for the Treatment of Acute Myeloid Leukemia (AML)

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 cardiotoxicity to date in a total of 42 subjects across three of the Company's Annamycin clinical trials Granted FDA Fast Track and Orphan Drug designation for AML and STS lung mets HOUSTON , Dec. 15, 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 provided an update on its clinical programs evaluating Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. These updates were recently presented during a reception for potential investigators held outside of the 64th American Society of Hematology (ASH) Annual Meeting in New Orleans.

Moleculin Reports 80% Overall Response Rate in Final Cohort of Phase 1 Single Agent Trial of Annamycin for the Treatment of Acute Myeloid Leukemia (AML)

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 designation is intended to potentially facilitate the development and expedite the review of novel therapies to treat serious conditions for which there is unmet medical need.

Moleculin Granted FDA Fast Track Designation of WP1122 for the Treatment of Glioblastoma Multiforme

Moleculin Biotech, Inc. (NASDAQ:MBRX ) Q3 2022 Earnings Conference Call November 10, 2022 5:00 PM ET Company Participants Walter Klemp – Chairman and Chief Executive Officer Jonathan Foster – Executive Vice President and Chief Financial Officer Conference Call Participants Jonathan Aschoff – ROTH Capital Operator Hello, and welcome to the Moleculin Biotech Inaugural Quarterly Update Conference Call and Webcast. As a brief reminder, all participants are currently in a listen-only mode.

Moleculin Biotech, Inc. (MBRX) Q3 2022 Earnings Call Transcript

– Continued execution across clinical and preclinical development programs – Three Phase 1b/2 clinical studies with enrollment or dosing now underway – Sufficient capital to fund operations beyond mid-2024 – Company to host conference call and webcast today at 5:00 PM ET HOUSTON , Nov. 10, 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 reported its financial results for the quarter ended September 30, 2022 and provided a pipeline update. As previously announced, the Company will host its inaugural quarterly conference call and live audio webcast, today, November 10, 2022, at 5:00 PM ET (details below).

Moleculin Reports Third Quarter 2022 Financial Results and Provides Pipeline Update

HOUSTON , Nov. 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 it will report its financial results for the quarter ended September 30, 2022 on Thursday, November 10 th. Moleculin management will host its inaugural quarterly conference call and live audio webcast to discuss the operational and financial results at 5:00 PM ET that same day.

Moleculin to Report Third Quarter 2022 Financial Results on November 10, 2022 and Host Inaugural Quarterly Conference Call and Webcast

Company enters what it expects to be the final MAD cohort in the first-in-human Phase 1a designed to establish a maximum tolerated dose (MTD) HOUSTON , Oct. 14, 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 provided an update on the preliminary results from the second multiple ascending dose (MAD) cohort of the Company's first-in-human Phase 1a study of WP1122. This cohort consisted of an initial 4 subjects, who were scheduled to be dosed daily for 7 days with 64 mg/kg/day of WP1122 or placebo in the dose escalation trial evaluating the safety and pharmacokinetics (PK) of WP1122 in healthy volunteers in the United Kingdom (UK).

Moleculin Provides Update on Second Multiple Ascending Dose (MAD) Cohort in Phase 1a Clinical Trial of WP1122 in the UK

– Preclinical work being conducted is intended to validate in vitro findings in established animal models to determine if further preclinical development and human clinical trials are warranted – Hemorrhagic fever arenaviruses (HFA) represent area of significant unmet need with no FDA- approved arenavirus vaccines or therapies HOUSTON , Sept. 27, 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 its WP1096 molecule (a part of its WP1122 portfolio of D-glucose and D-mannose antimetabolites) will be evaluated in animal studies through the preclinical services offered by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

Moleculin Biotech WP1122 Portfolio Compound, WP1096, Selected for NIAID-Funded Animal Studies as Novel Potential Antiviral

– Live moderated video webcast with members of management to discuss its ongoing Phase 1/2 study of core technology in development, Annamycin for the treatment of Acute Myeloid Leukemia, on Wednesday, September 28 th at 11:00 AM ET HOUSTON , Sept. 23, 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 Walter V.

Moleculin Biotech to Present at the Virtual Investor Innovations in Acute Myeloid Leukemia (AML) Spotlight Event

HOUSTON , Sept. 8, 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 members of management will virtually present at the 2nd Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care being held at the Roswell Park Comprehensive Cancer Center in Buffalo, NY September 8-10, 2022.

Moleculin Selected to Present at the 2nd Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care

HOUSTON , Sept. 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 Walter Klemp, President and Chief Executive Officer of Moleculin, will present at the H.C.

Moleculin to Present at the H.C. Wainwright 24th Annual Global Investment Conference

-  Glioblastoma is the most aggressive malignant primary brain tumor with serious unmet medical need HOUSTON , Sept. 6, 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 Orphan Drug Designation of WP1122 for the treatment of Glioblastoma Multiforme ("GBM").

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