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.

HOUSTON, Jan. 18, 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 that it has received an updated independent safety review of certain preliminary data for the first 30 patients in its three Phase 1 clinical trials with Annamycin targeting relapsed or refractory acute myeloid leukemia (AML) and the metastases of soft tissue sarcoma to the lungs (STS Lung), which concluded there was no evidence of cardiotoxicity. The review included analysis of ejection fraction, echo strain and certain troponin levels intended to assess potential for both acute and chronic heart damage.

Moleculin Announces Updated Preliminary Safety Data for Annamycin in Its Three Phase 1 Clinical Trials for Acute Myeloid Leukemia and Metastases of Soft Tissue Sarcoma

HOUSTON, Jan. 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 virtual H.C. Wainwright BioConnect Conference taking place January 10-13, 2022.

Moleculin to Present at the H.C. Wainwright BioConnect Conference

HOUSTON, Dec. 27, 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 reported preliminary interim results from its U.S. Phase 1b/2 clinical trial as it concluded the safety review of the third cohort and opens the fourth cohort in a dose escalation trial evaluating Annamycin for the treatment of soft tissue sarcoma (STS) lung metastases, which continues to document preliminary clinical activity for this drug. The Phase 1b/2 study is a U.S. multi-center, open-label, single-arm study that in Phase 1b will determine the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) and safety of Annamycin.

Moleculin Announces Preliminary Third Cohort Interim Data in Phase 1b/2 Clinical Trial of Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases

Roth Capital notes that the FDA cleared Moleculin Biotech Inc's (NASDAQ:MBRX) WP1122 to start a Phase 1 trial in glioblastoma multiforme, which will be in addition to the drug's impending parallel clinical development in COVID-19.  Analyst Jonathan Aschoff expects several clinical data updates over the next year, with Moleculin Biotech potentially having six ongoing trials by year-end 2021.

Read Why Is Roth Capital Bullish On This Cancer-Focused Stock

HOUSTON, Dec. 1, 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 the US Food and Drug Administration (FDA) is allowing the Company's Investigational New Drug (IND) application to study WP1122 for the treatment of Glioblastoma Multiforme (GBM) to go forward. With this IND now cleared, Moleculin plans to initiate a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.

Moleculin Receives FDA Allowance to Begin a Phase 1 Study of WP1122 for the Treatment of Glioblastoma Multiforme

HOUSTON, Nov. 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 that Walter V. Kemp, Founder, President, CEO and Chairman and Dr. John Paul Waymack, Senior Chief Medical Officer will participate in the Virtual Investor Roundtable Event on Thursday, November 18, 2021 at 11:00 AM ET.

Moleculin Biotech, Inc to Present at the Virtual Investor Roundtable Event

HOUSTON, Nov. 11, 2021 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin, we 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, 2021. The Company also provided an update on its portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses.

Moleculin Reports Third Quarter 2021 Financial Results and Provides Programs Update

The stock price of Moleculin Biotech Inc (NASDAQ: MBRX) increased by over 2% during intraday trading today. This is why it happened.

MBRX Stock: Why It Increased Today

HOUSTON, Oct. 19, 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 it has received authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) to commence a Phase 1a clinical trial of WP1122 in the United Kingdom. WP1122, the Company's lead metabolism/glycosylation inhibitor, is a prodrug of a well-known antimetabolite called 2-deoxy-D-glucose (2-DG) currently being developed for inhibition of viral replication and disease manifestations in humans infected with SARS-CoV-2, the virus responsible for COVID-19.

Moleculin Receives Authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) to Commence Phase 1a Clinical Trial of WP1122 for the Treatment of COVID-19

HOUSTON, Oct. 18, 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 reported interim results from its U.S. Phase 1b/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma (STS) lung metastases, which documented preliminary clinical activity for Annamycin. The Phase 1b/2 study is a U.S. multi-center, open-label, single-arm study that in Phase 1b will determine the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) and safety of Annamycin.

Moleculin Announces Interim Data in Phase 1b/2 Clinical Trial of Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases

HOUSTON, Sept. 27, 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 2021 Cantor Virtual Global Healthcare Conference on September 27, 2021 at 8:40 AM ET.

Moleculin to Present at the 2021 Cantor Virtual Global Healthcare Conference

HOUSTON, Sept. 17, 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 virtual Oppenheimer Fall Healthcare Life Sciences and MedTech Summit on September 20, 2021 at 4:35 PM ET.

Moleculin to Present at the Oppenheimer Fall Healthcare Life Sciences and MedTech Summit

HOUSTON, Sept. 8, 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 virtual H.C.

Moleculin to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

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.

Moleculin Reports Second Quarter 2021 Financial Results and Provides Programs Update

HOUSTON, July 13, 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 it has received approval from the Bioethics Committee of the Medical University of Karol Marcinkiewicz in Poznań (Ethics Committee) as well as an allowance from the Polish Department of Registration of Medicinal Products (URPL) for a protocol amendment for its Phase 1/2 evaluating Annamycin for the treatment of subjects with acute myeloid leukemia (AML) that is refractory to or relapsed after induction therapy. 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.

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

HOUSTON, June 21, 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 it has commenced enrollment and dosed the first subject in its U.S. 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.

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

HOUSTON, June 15, 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 as part of the annual reconstitution of the Russell stock indexes, Moleculin has been selected to be added to the Russell 2000® Index effective after the close of the U.S. equity markets on June 25, 2021. "We are pleased to have been included in this year's reconstitution of the Russell 2000® Index.

Moleculin Announces Inclusion in the Russell 2000® Index

The FDA has signed off Phase 1b/2 trial for Moleculin Biotech Inc's (NASDAQ: MBRX) Annamycin to treat soft tissue sarcoma lung metastases. Annamycin is the company's next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin.

Moleculin Biotech to Start Testing Annamycin in Sarcoma Lung Metastases Patients

HOUSTON, May 25, 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 it has received clearance to initiate its Phase 1b/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma (STS) lung metastases. The first of several planned clinical sites is now open and the Company expects to begin patient enrollment.

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

HOUSTON, May 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 March 31, 2021. The Company also provided an update on its portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses.

Moleculin Reports First Quarter 2021 Financial Results and Provides Programs Update

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 17 th at 12:30 PM ET.   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.

Moleculin Biotech to Present at the Q2 Virtual Investor Summit

VANCOUVER, British Columbia, May 11, 2021 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE: WBIO)(FSE: 8SV1) (the “Company” or “WPD”) a clinical-stage pharmaceutical company, is pleased to announce that it has been conditionally awarded a grant of $6,730,036 (20,394,049.68 PLN) from the Polish National Center for Research and Development (“NCRD”), for the development of Annamycin, the Company's drug candidate used in the treatment of Acute Myeloid Leukemia (“AML”).

WPD Pharmaceuticals to Receive $6.7 Million Grant for Development of Annamycin Drug Candidate

The FDA has granted Rare Pediatric Disease Designation to Moleculin Biotech Inc's (NASDAQ: MBRX) WP1066 to treat ependymoma. Ependymoma is a rare type of tumor in the brain or spinal cord and most often occurs in young children.

Moleculin Biotech Stock Is Trading Higher After WP1066 Scores Rare Pediatric Disease Tag For Type Of Brain Tumor

The stock price of Moleculin Biotech Inc (NASDAQ: MBRX) increased by over 10% pre-market. This is why it happened.

MBRX Stock: Over 10% Pre-Market Explanation

HOUSTON, April 14, 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, announced today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPD) to its p-STAT3 inhibitor, WP1066, for the treatment of ependymoma. Ependymoma is a rare type of tumor that can form in the brain or spinal cord.

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