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: US, NY, NEW YORK CITY, TEXAS, EUROPEAN UNION, EUROPE

European Medicines Agency (EMA) Grants Orphan Drug Designation for Moleculin's Treatment of Acute Myeloid Leukemia (AML)

Retrieved on: 
Thursday, April 18, 2024

HOUSTON, April 18, 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 the European Medicines Agency (EMA) has granted Orphan Drug Designation to Annamycin for the treatment of AML.

Key Points: 
  • Recruitment in MB-106 has ended for 2nd line subjects while recruitment for 1st line and 3rd line subjects continue.
  • The EMA grants orphan drug designation to drugs and biologics intended for the treatment, diagnosis or prevention of rare, life-threatening or chronically debilitating diseases or conditions that affect fewer than five in 10,000 people in the European Union.
  • Orphan designation allows companies certain benefits, including reduced regulatory fees, clinical protocol assistance, research grants and up to 10 years of potential market exclusivity in the European Union if approved.
  • Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets.

Moleculin Announces Presentation of Positive Data Demonstrating High Anti-Cancer Activity of Annamycin and Non-Cardiotoxic Properties

Retrieved on: 
Wednesday, April 10, 2024

HOUSTON, April 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 positive preclinical data regarding the Company's next-generation anthracycline, Annamycin, was presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 5-10, 2024 in San Diego, CA.

Key Points: 
  • The poster titled, Non-cardiotoxic Properties of Annamycin, a Clinically Evaluated Anthracycline and Potent Topoisomerase 2β Poison , was presented in the "Late-Breaking Research: Experimental and Molecular Therapeutics 2" session held on Monday, April 8th.
  • These data, documenting lack of cardiotoxicity of Annamycin and aligned with the data demonstrated to date in our ongoing clinical trials, bolster our confidence in Annamycin potential to offer patients a safe and effective treatment option.
  • Annamycin and doxorubicin cytotoxicity was assessed in a panel of cancer cell lines cardiomyocytes (murine and human).
  • For more information about the ongoing trials, please visit clinicaltrialsregister.eu : EudraCT 2020-005493-10 or clinicaltrials.gov : NCT05319587; and clinicaltrials.gov : NCT04887298, respectively.

Moleculin to Present at the MedInvest Biotech & Pharma Investor Conference

Retrieved on: 
Thursday, March 28, 2024

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 Conference behind held in New York City, NY on Thursday, April 4, 2024 at 4:10 PM ET.

Key Points: 
  • 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 Conference behind held in New York City, NY on Thursday, April 4, 2024 at 4:10 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.
  • For more information about the event, please visit the conference website .

Moleculin to Participate in the Virtual Investor Lunch Break: The Moleculin Opportunity

Retrieved on: 
Wednesday, March 27, 2024

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 Moleculin Opportunity event on Thursday, March 28, 2024 at 12:00 PM ET.

Key Points: 
  • Live webcast with Walter Klemp, Chairman and Chief Executive Officer, on Thursday, March 28th 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 Moleculin Opportunity event on Thursday, March 28, 2024 at 12:00 PM ET.
  • As part of the event, Walter Klemp, Chairman and Chief Executive Officer of Moleculin, will provide a corporate overview, business outlook, and discuss the Moleculin opportunity.
  • 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.

Moleculin Announces U.S. Patent Issue Notification for Annamycin Targeting Unmet Need in AML

Retrieved on: 
Wednesday, March 27, 2024

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 it has received an Issue Notification from the United States Patent and Trademark Office (USPTO) for U.S. Patent number 11,951,118 titled, "Preparation of Preliposomal Annamycin Lyophilizate" (the '118 patent') to be issued on April 9, 2024 to Moleculin and The University of Texas System Board of Regents.

Key Points: 
  • Moleculin's novel candidate for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets) uses a unique lipid-based delivery technology.
  • In addition to the expected '118 patent, Moleculin has additional patent applications pending in the U.S. and in major jurisdictions worldwide.
  • Issuance of this patent underscores the importance and proprietary nature of the innovation that makes this next generation anthracycline possible."
  • Annamycin is Moleculin's next-generation anthracycline, initially expected to fulfill a significant unmet need for the 2nd line treatment of relapsed or refractory AML patients.

Moleculin to Report Full Year 2023 Financial Results on March 22, 2024 and Host Conference Call and Webcast

Retrieved on: 
Wednesday, March 20, 2024

HOUSTON, March 20, 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 year ended December 31, 2023, on Friday afternoon, March 22, 2024. Moleculin management will host a conference call and live webcast to discuss clinical, operational and financial results on Monday morning, March 25, 2024 at 8:30 AM ET.

Key Points: 
  • HOUSTON, March 20, 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 year ended December 31, 2023, on Friday afternoon, March 22, 2024.
  • Moleculin management will host a conference call and live webcast to discuss clinical, operational and financial results on Monday morning, March 25, 2024 at 8:30 AM ET.
  • 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 Announces Reverse Stock Split

Retrieved on: 
Tuesday, March 19, 2024

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.

Key Points: 
  • 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 is part of the Company's plan to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market.
  • No fractional shares will be issued as a result of the reverse stock split.
  • As a result of the reverse stock split, the number of shares of common stock outstanding will be reduced from approximately 33.4 million shares to approximately 2.2 million shares, and the number of authorized shares of common stock will remain at 100 million shares.

Moleculin to Present at the 36th Annual ROTH Conference

Retrieved on: 
Tuesday, March 12, 2024

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 the 36th Annual ROTH Conference on March 18, 2024 at 9:00 AM PT.

Key Points: 
  • Live webcast fireside chat on Monday, March 18th 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 the 36th Annual ROTH Conference on March 18, 2024 at 9:00 AM PT.
  • In addition to the presentation, management will be available to participate in one-on-one in-person meetings with qualified members of the investor community who are registered to attend the conference.
  • For more information about the event, please visit the conference website .
  • A live webcast of the fireside chat will be available on the Events page in the Investors section of the Company's website ( moleculin.com ).

Moleculin Announces 2023 Year-End Annamycin Clinical Trials Preliminary Data and 2024 Expectations for Multiple Data Readouts and Transition to Pivotal Phase 2B/3

Retrieved on: 
Wednesday, January 24, 2024

"Over the course of 2023, we delivered on our promise for a year of important data from our Annamycin clinical development programs.

Key Points: 
  • "Over the course of 2023, we delivered on our promise for a year of important data from our Annamycin clinical development programs.
  • We are well-positioned to continue building upon our encouraging growing body of preliminary clinical data and transition to pivotal Phase 2B/3 clinical trials by year-end 2024.
  • With our recent financing in December 2023, we have extended our runway into the fourth quarter of 2024, as well.
  • WP1122 successfully completed a Phase 1 clinical trial, which established a recommended safe dose for future potential Phase 1B or Phase 2 clinical trials.

Moleculin Reports Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 13, 2023

HOUSTON, Nov. 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 reported its financial results for the quarter ended September 30, 2023. As previously announced, the Company will host a conference call and live audio webcast, today, November 13, 2023, at 8:30 AM ET (details below).

Key Points: 
  • HOUSTON, Nov. 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 reported its financial results for the quarter ended September 30, 2023.
  • As previously announced, the Company will host a conference call and live audio webcast, today, November 13, 2023, at 8:30 AM ET (details below).
  • General and administrative expense was $2.6 million and $3.1 million for the three months ended September 30, 2023 and 2022, respectively.
  • Moleculin management will host its quarterly conference call and webcast for investors, analysts, and other interested parties today, November 13, 2023, at 8:30 AM ET.