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 Reports Second Quarter 2021 Financial Results and Provides Programs Update

Retrieved on: 
Thursday, August 12, 2021

HOUSTON, Aug. 12, 2021 /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 financial results for the quarter ended June 30, 2021.

Key Points: 
  • HOUSTON, Aug. 12, 2021 /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 financial results for the quarter ended June 30, 2021.
  • The Company also provided an update on its portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses.
  • We believe Moleculin is well-positioned to continue building momentum and drive shareholder value in the near- and long-term," commented Walter Klemp, Chairman and CEO of Moleculin.
  • H2 2021: Report cohort topline results from the ongoing Phase 1/2 study for treatment of AML and report the study's topline results.

Moleculin Receives Approval to Extend Dose Escalation in Phase 1/2 European Clinical Trial Evaluating Annamycin for the Treatment of Acute Myeloid Leukemia

Retrieved on: 
Tuesday, July 13, 2021

Annamycin is the Company's next-generation anthracycline that has demonstrated a lack of cardiotoxicity in recently conducted human clinical trials for the treatment of AML.

Key Points: 
  • Annamycin is the Company's next-generation anthracycline that has demonstrated a lack of cardiotoxicity in recently conducted human clinical trials for the treatment of AML.
  • Additionally, Annamycin has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin.
  • This amendment will allow us to continue dose escalation in the Phase 1 portion of the trial and establish the maximum tolerated dose as we work toward the recommended dose for the Phase 2 portion of the study.
  • Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

Moleculin Announces First Subject Enrolled and Dosed in Phase 1b/2 Clinical Trial of Annamycin for the Treatment of Sarcoma Lung Metastases

Retrieved on: 
Monday, June 21, 2021

Phase 1b/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma (STS) lung metastases.

Key Points: 
  • Phase 1b/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma (STS) lung metastases.
  • Soft tissue sarcomas are the most common form of sarcoma, accounting for an estimated 130,000 incident cases per year worldwide.
  • For more information about the Phase 1b/2 study evaluating Annamycin for the treatment of STS lung metastases, please visit clinicaltrials.gov and reference identifier NCT04887298.
  • Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

Moleculin Commences Phase 1b/2 Clinical Trial of Annamycin for the Treatment of Sarcoma Lung Metastases

Retrieved on: 
Tuesday, May 25, 2021

Annamycin is currently in development for the treatment ofAMLand STS lung metastases.

Key Points: 
  • Annamycin is currently in development for the treatment ofAMLand STS lung metastases.
  • Based on a recently announced reimbursement grant awarded in Poland, the Company also expects a second Phase 1b/2 clinical trial of Annamycin in sarcoma lung metastases to be initiated in 2021, which will be primarily investigator-funded in Europe.
  • Annamycin has been granted Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of STS lung metastases.
  • For more information about the Phase 1b/2 study evaluating Annamycin for the treatment of STS lung metastases, please visit clinicaltrials.gov and reference identifier NCT04887298.

Moleculin Reports First Quarter 2021 Financial Results and Provides Programs Update

Retrieved on: 
Wednesday, May 12, 2021

b'HOUSTON, May 12, 2021 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculinor the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced its financial results for the quarter ended March 31, 2021.

Key Points: 
  • b'HOUSTON, May 12, 2021 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculinor the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced its financial results for the quarter ended March 31, 2021.
  • Importantly, we have equipped the Company with the resources to advance our portfolio of drug candidates across a number of oncology indications and viruses.
  • On the clinical front, we have the potential to see up to seven clinical trials this year, including investigator sponsored trials.
  • IND targeted for 2022.\nResearch and development expense was $4.1 million and $3.2 million for the three months ended March 31, 2021 and 2020, respectively.

Moleculin Biotech to Present at the Q2 Virtual Investor Summit

Retrieved on: 
Tuesday, May 11, 2021

b'HOUSTON, May 11, 2021 /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 Q2 Virtual Investor Summit on Monday, May 17th at 12:30 PM ET.\nIn 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.

Key Points: 
  • b'HOUSTON, May 11, 2021 /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 Q2 Virtual Investor Summit on Monday, May 17th at 12:30 PM ET.\nIn 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 .\nA live video webcast will be accessible on the Events page in the Investors section of the Company\'s website ( www.moleculin.com ) and archived for 90 days following the event.\nMoleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses.
  • The Company\'s clinical stage drugs are: Annamycin, a next-generation anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma.
  • Moleculin is also engaged in preclinical development of additional drug candidates, including other Immune/Transcription Modulators, as well as WP1122 and related compounds capable of Metabolism/Glycosylation Inhibition.\nFor more information about the Company, please visit http://www.moleculin.com .\n'

Moleculin Engages IQVIA to Manage Potential COVID-19 Clinical Trial

Retrieved on: 
Tuesday, April 6, 2021

"Our teaming up with IQVIA, a preeminent, global CRO, is intended to facilitate the advancement into possible clinical trials for WP1122 with the objective of determining our drug's potential for treating COVID-19," commented Walter Klemp, Moleculin's Chairman and CEO.

Key Points: 
  • "Our teaming up with IQVIA, a preeminent, global CRO, is intended to facilitate the advancement into possible clinical trials for WP1122 with the objective of determining our drug's potential for treating COVID-19," commented Walter Klemp, Moleculin's Chairman and CEO.
  • Over the last quarter, we completed our pre-clinical data, interviewed CRO's and decided that IQVIA Biotech has the experience and reach to best serve our clinical needs for this project.
  • IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry.
  • IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise.

Moleculin Receives FDA Approval of Fast Track Designation for Annamycin in the Treatment of Sarcoma Lung Metastases

Retrieved on: 
Tuesday, March 30, 2021

"We are pleased to receive our second Fast Track Designation from the FDA for Annamycin.

Key Points: 
  • "We are pleased to receive our second Fast Track Designation from the FDA for Annamycin.
  • We now have potential pathways for accelerated approval in two indications, STS lung metastases, and the treatment of relapsed or refractory acute myeloid leukemia," commented Walter Klemp, Moleculin's Chairman and CEO.
  • "Not only does this make us eligible for accelerated approval and priority review for our NDA submission, but it serves as an important reminder of the unmet need in STS lung metastases.
  • We are now focused on initiating our internally funded clinical trial in the US, possibly prior to mid-year.

Moleculin to Participate in Four Upcoming Healthcare Conferences

Retrieved on: 
Tuesday, March 9, 2021

Replays of the webcasts will be available for 90 days after the date of the presentation.

Key Points: 
  • Replays of the webcasts will be available for 90 days after the date of the presentation.
  • Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses.
  • Moleculin is also engaged in preclinical development of additional drug candidates, including other Immune/Transcription Modulators, as well as WP1122 and related compounds capable of Metabolism/Glycosylation Inhibition.
  • For more information about the Company, please visit http://www.moleculin.com .

Moleculin Announces Full Exercise of Over-Allotment Option

Retrieved on: 
Wednesday, February 10, 2021

Oppenheimer & Co. Inc. acted as the sole book-running manager for the offering and Roth Capital Partners, LLC acted as the co-manager for the offering.

Key Points: 
  • Oppenheimer & Co. Inc. acted as the sole book-running manager for the offering and Roth Capital Partners, LLC acted as the co-manager for the offering.
  • The securities described above were offered by the Company pursuant to a shelf registration statement on Form S-3 (No.
  • 333-235686) originally filed December 23, 2019 with the Securities and Exchange Commission (SEC) and declared effective by the SEC on April 9, 2020.
  • Moleculin is also engaged in preclinical development of additional drug candidates, including other Immune/Transcription Modulators, as well as WP1122 and related compounds capable of Metabolism/Glycosylation Inhibition.