MOLECULIN BIOTECH, INC.


Associated tags: Neoplasm, Acute myeloid leukemia, Virus, STS, Biotechnology, AML, Pharmaceutical industry, Cancer, Brain, T-cell lymphoma, COVID-19, Antimetabolite, Conference, Patient, Safety

Locations: TEXAS, EUROPE, UNITED STATES, EUROPEAN UNION, US, SLOAN, NEW YORK

Moleculin to Present at the Oppenheimer 33rd Annual Healthcare Conference

Retrieved on: 
Monday, March 13, 2023

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.

Key Points: 
  • Presentation with live video webcast on Tuesday, March 14th 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.
  • In addition to the presentation, management will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.
  • 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 ).
  • A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

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)

Retrieved on: 
Monday, February 13, 2023

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. Additionally in the last cohort where all subjects were at least 60 years of age, Annamycin demonstrated an overall response rate (ORR) of 80%.

Key Points: 
  • 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.
  • "We also are encouraged by the absence of cardiotoxicity with Annamycin to date," Mr. Klemp added.
  • 20 subjects were enrolled in the trial with the age range of 24-76 years with a median age of 64.5.
  • As announced in February 2022, upon safely reaching the RP2D of 240 mg/m2 in the MB-105 trial, the Company concluded recruitment for the trial.

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

Retrieved on: 
Thursday, January 5, 2023

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.

Key Points: 
  • Live video webcast on Tuesday, January 17th 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 ).
  • A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

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

Retrieved on: 
Wednesday, December 7, 2022

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").

Key Points: 
  • 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").
  • With the Fast Track designation, Moleculin is potentially eligible for more frequent regulatory meetings and communications with the FDA.
  • "We believe receiving Fast Track designation validates the serious unmet medical need for the treatment of GBM, the most aggressive form of malignant primary brain cancer," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin.
  • In September of 2022, Moleculin was granted Orphan Drug Designation of WP1122 for the treatment of GBM from the FDA.

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

Retrieved on: 
Monday, November 7, 2022

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.

Key Points: 
  • 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.
  • The call will be led by Walter Klemp, Chairman and Chief Executive Officer of Moleculin and Jonathan Foster, Executive VP & Chief Financial Officer of Moleculin.
  • Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing the Moleculin Biotech Conference Call.
  • The live webcast will be accessible on the Events page of the Investors section of the Moleculin website, moleculin.com , and will be archived for 90 days.

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

Retrieved on: 
Friday, October 14, 2022

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). In conjunction with the study safety review committee, the Company stopped the second MAD cohort when 2 subjects experienced adverse events that, although asymptomatic, met the stoppage criteria in the protocol. The Company has opened MAD cohort 2a, in which a minimum of 8 subjects will receive a daily dose of 48 mg/kg. The Company expects this to be the final dose escalation cohort in this trial, which is designed to establish a maximum tolerated dose (MTD).

Key Points: 
  • The Company expects this to be the final dose escalation cohort in this trial, which is designed to establish a maximum tolerated dose (MTD).
  • This Phase 1a, first-in-human, randomized, double-blind, placebo-controlled, overlapping single ascending dose (SAD) and MAD study is investigating the safety of WP1122 administered as an oral solution in healthy human volunteers.
  • The Company expects to enroll approximately 70 subjects in this Phase 1a clinical trial.
  • As we progress with this new MAD cohort, we continue to be encouraged by the safety data demonstrated by WP1122 in our first-in-human Phase 1a study.

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

Retrieved on: 
Friday, September 23, 2022

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. Kemp, Founder, President, CEO and Chairman, and Wolfram C. M. Dempke, MD, PhD, MBA, European Chief Medical Officer of Moleculin will participate in the Virtual Investor Innovations in Acute Myeloid Leukemia Spotlight Event on Wednesday, September 28, 2022 at 11:00 AM ET.

Key Points: 
  • In addition to the moderated portion of the event, investors and interested parties will have the opportunity to submit questions.
  • A live video webcast of the Event will be available on the Events page of the Investors section of the Company's website ( moleculin.com ).
  • The Company's lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity.
  • Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

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

Retrieved on: 
Thursday, September 8, 2022

Details of the presentations are as follows:

Key Points: 
  • Details of the presentations are as follows:
    Title: The Value of Collaboration in Clinical Development: Experience from Poland
    For more information about the conference, visit: www.roswellpark.org/msc-symposium .
  • is a clinical stage pharmaceutical company focused on the development of a broad portfolio of drug candidates for the treatment of highly resistant tumors and viruses.
  • The Company's lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity.
  • Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

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

Retrieved on: 
Wednesday, September 7, 2022

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. Wainwright 24th Annual Global Investment Conference being held in New York, NY and virtually on September 12-14, 2022.

Key Points: 
  • 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. Wainwright 24th Annual Global Investment Conference being held in New York, NY and virtually on September 12-14, 2022.
  • In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference.
  • For more information about the conference, please visit the conference website .
  • The Company's lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity.

Moleculin Receives FDA Orphan Drug Designation of WP1122 for the Treatment of Glioblastoma Multiforme

Retrieved on: 
Tuesday, September 6, 2022

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").

Key Points: 
  • 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").
  • "The receipt of Orphan Drug Designation represents an important milestone for our promising WP1122 development program," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin.
  • Based on preclinical data indicating the potential for WP1122 as a treatment for GBM, Moleculin received Investigational New Drug status and is evaluating opportunities for collaboration in clinical development.
  • The FDA grants Orphan Drug Designation to drugs and biologics intended for the treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States.