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.

– Preliminary results of third cohort in the first-in-human Phase 1a allows Company to proceed to next single ascending dose (SAD) of 64 mg/kg dose and the first multiple ascending dose (MAD) cohort to commence with 32 mg/kg dose of WP1122 – HOUSTON , Aug. 19, 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 preliminary results from the third cohort of the Company's first-in-human Phase 1a study of WP1122. This cohort consisted of 10 subjects dosed with 32 mg/kg or placebo in the dose escalation trial evaluating the safety and pharmacokinetics (PK) of WP1122 in healthy volunteers in the United Kingdom (UK).

Moleculin Announces Completion of Third Single Ascending Dose (SAD) Cohort in Phase 1a Clinical Trial of WP1122 in the UK

- Continued advancement across clinical and preclinical programs; on track with multiple milestones and key data readouts expected through the second half of 2022 - Company has sufficient capital to fund operations beyond mid-2024 HOUSTON , Aug. 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 reported its financial results for the quarter ended June 30, 2022. 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 2022 Financial Results and Provides Programs Update

– Preliminary Phase 1b data demonstrated clinical activity, defined as stable disease or better – Company determines RP2D to be 360 mg/m2 and will begin Phase 2 recruitment – Annamycin has Fast Track Status and Orphan Drug Designation from FDA for the treatment of soft tissue sarcoma HOUSTON , July 28, 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 completed the safety review of the fourth cohort in a dose escalation clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma (STS) lung metastases, thus concluding the Phase 1b portion of its U.S. Phase 1b/2 clinical trial. Preliminary results from the study continue to document clinical activity for Annamycin in the treatment of STS.

Moleculin Concludes Phase 1b and Opens Recruitment in Phase 2 Clinical Trial of Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases

– Preliminary results of second cohort in the first-in-human Phase 1a allow Company to proceed to 32 mg/kg dose of WP1122 in third cohort toward establishing maximum tolerated dose (MTD) – – Multiple ascending dose (MAD) cohort to commence after completion of at least 3 successful SAD dosing cohorts – HOUSTON , July 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 reported preliminary results from the second cohort of the Company's first-in-human Phase 1a study of WP1122. This cohort consisted of 8 subjects dosed with 16 mg/kg or placebo in the dose escalation trial evaluating the safety and pharmacokinetics (PK) of WP1122 in healthy volunteers in the United Kingdom (UK).

Moleculin Announces Completion of Second Single Ascending Dose (SAD) Cohort in Phase 1a Clinical Trial of WP1122 in the UK

NEW YORK , July 5, 2022 /PRNewswire/ -- Purcell & Lefkowitz LLP, a class action law firm dedicated to representing shareholders nationwide, is investigating a potential breach of fiduciary duty claim involving the board of directors of Moleculin Biotech, Inc. (NASDAQ: MBRX). If you are a shareholder of Moleculin Biotech, Inc. and are interested in obtaining additional information regarding this investigation, free of charge, please visit us at: http://pjlfirm.com/moleculin-biotech-inc/ You may also contact Robert H.

SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Is Investigating Moleculin Biotech, Inc. for Potential Breaches of Fiduciary Duty By Its Board of Directors

– Preliminary results of first cohort in the first-in-human Phase 1a allows Company to proceed to 16 mg/kg dose of WP1122 in second cohort toward establishing maximum tolerated dose (MTD) –   – Multiple ascending dose (MAD) cohort to commence after completion of at least 3 successful SAD dosing cohorts – HOUSTON , June 16, 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 preliminary results from the first cohort of the Company's first-in-human Phase 1a study of WP1122. This cohort consisted of 9 subjects dosed with 8 mg/kg or placebo in the dose escalation trial evaluating the safety and pharmacokinetics (PK) of WP1122 in healthy volunteers in the United Kingdom (UK).

Moleculin Announces Completion of First Single Ascending Dose (SAD) Cohort in Phase 1a Clinical Trial of WP1122 in the UK

– Single ascending dose (SAD) cohort of first-in-human Phase 1a study to evaluate safety and pharmacokinetics of WP1122 and establish maximum tolerated dose – – Multiple ascending dose (MAD) cohort to commence after completion of at least 3 SAD dosing cohorts in which WP1122 is found to be safe and well-tolerated – HOUSTON , May 26, 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 the commencement of dosing in its first-in-human Phase 1a study to evaluate the safety and pharmacokinetics (PK) of WP1122 in healthy volunteers for the treatment of COVID-19 (MB-301). WP1122, the Company's lead metabolism/glycosylation inhibitor, is a prodrug of a well-known glucose decoy called 2-deoxy-D-glucose (2-DG).

Moleculin Commences Dosing in Healthy Volunteers in Phase 1a Clinical Trial of WP1122 for the Treatment of COVID-19

HOUSTON, May 19, 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 Global Investment Conference being held May 23-26, 2022 in Miami, FL and virtually.

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

– Positive advancements, encouraging preclinical and clinical data, and development activity in all three core technologies – – Multiple key clinical and regulatory milestones expected throughout 2022 –  – Company has sufficient capital to fund operations into 2024 –  HOUSTON , May 12, 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 March 31, 2022. 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 2022 Financial Results and Provides Programs Update

– Dosing for first-in-human Phase 1a study to evaluate safety and pharmacokinetics of WP1122 in healthy volunteers and establish maximum tolerated dose expected to commence imminently – HOUSTON , May 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 announced that it has received approval from the United Kingdom's (UK) MHRA to proceed with a first-in-human Phase 1a study to evaluate the safety and pharmacokinetics of WP1122 in healthy volunteers for the treatment of COVID-19 (MB-301). The approval follows Moleculin's having submitted a protocol amendment allowing for a higher ratio of diluting excipients to drug substance to facilitate a faster and simpler mixing procedure before drug administration.

Moleculin Receives Approval from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for Protocol Amendment to Phase 1a Clinical Trial of WP1122 for the Treatment of COVID-19

– Preliminary positive safety and efficacy data from second Phase 1 AML study validate advancement to Phase 1/2 of Annamycin in combination with Cytarabine – Preclinical animal research demonstrated a 68% increase in OS with Annamycin and Cytarabine combined compared to Annamycin as a single agent and a 241% increase in OS compared to Cytarabine alone – Trial expected to commence this quarter HOUSTON , May 5, 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 has received allowance from the Polish Department of Registration of Medicinal Products (URPL), as well as the requisite Ethics Committee approval, to proceed with its Phase 1/2 clinical trial in Poland of Annamycin (L-ANN) in combination with Cytarabine (Ara-C) in the treatment of subjects with acute myeloid leukemia (AML) who are refractory to or relapsed after induction therapy. The Phase 1/2 L-ANN /ARA-C combination (AnnAraC) trial (MB-106), an open label trial, builds on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials (MB-104 and MB-105) in the U.S. and Europe and the preclinical data discussed below.

Moleculin Receives Allowance to Proceed with Phase 1/2 Study of Annamycin in Combination with Cytarabine for the Treatment of Acute Myeloid Leukemia (AML)

Global leader with a distinguished 30-year career in oncology, hematology, and academia with significant contributions in clinical developments in ovarian cancer, lung cancer, and leukemias and lymphomas Company continues to advance clinical development across priority development pipeline with expected launch of 2 clinical trials in Europe in 2022 HOUSTON, May 4, 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 Company has engaged Wolfram C. M. Dempke, MD, PhD, MBA, MRCP as its EU Chief Medical Officer and part-time contractor for its European clinical trials.

Moleculin Engages Wolfram C. M. Dempke, MD, PhD, MBA as its European Chief Medical Officer

Investigational New Drug (IND) application clearance from FDA opens up potential for additional investigator funded and led clinical studies   HOUSTON , April 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 that the US Food and Drug Administration (FDA) is allowing the Company's Investigational New Drug (IND) application to study WP1066 for the treatment of recurrent malignant glioma. With this IND now cleared, Moleculin plans to evaluate strategic partnerships and collaborations to conduct a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1066 in adult patients with recurrent malignant glioma.

Moleculin Receives IND Clearance to Conduct Phase 1 Study of WP1066 for the Treatment of Recurrent Malignant Glioma

Company reiterates commitment to solving some of the toughest challenges in highly resistant cancers and viruses and developing better treatments that can make a real impact in people's lives HOUSTON, April 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 announced the launch its new corporate branding and website www.moleculin.com. "As we drive clinical development across our broad portfolio of drug candidates, expand our growing body of clinical data and build value among all stakeholders, we believed it was an important step to refresh our corporate branding identity and website to align with the true potential and vision we have for Moleculin.

Moleculin Announces Corporate Rebranding and Launch of New Website

Annamycin exhibited robust antitumor activity in experimental colorectal cancer liver and lung metastasis models Results support advancement of preclinical development toward initiating clinical studies in metastatic colorectal cancer patients HOUSTON , April 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 preclinical data of Annamycin tested in syngeneic models of metastatic colorectal cancer established in lungs or liver was accepted for poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2022, being held April 8-13, 2022, in New Orleans, Louisiana. Details of the poster presentation are as follows: Title: New approach to target metastatic colorectal cancer organotropism with L-Annamycin Track: Experimental and Molecular Therapeutics  Poster Number: 4048 Session: PO.ET06.05 - New Chemotherapy Agents Presentation Type: E-Poster presentation Session Date and Time: Wednesday, April 13, 2022, from 9:00 am – 12:30 p.m.

Moleculin Announces Presentation of Positive Preclinical Annamycin Data at the AACR 2022 Annual Meeting

– Preliminary positive safety and efficacy data from second Phase 1 AML study supports plans to explore a Phase 1/2 of Annamycin in combination with Cytarabine – – Preliminary interim data for Annamycin in three Phase 1 clinical trials for Acute Myeloid Leukemia (AML) and metastases of Soft Tissue Sarcoma (STS) continues to demonstrate the absence of cardiotoxicity, representing a significant advancement in patient safety –  – WP1122 advancing with parallel development toward first-in-human Phase 1a study to evaluate safety and pharmacokinetics in healthy volunteers for the treatment of COVID-19 and potential treatment of glioblastoma multiforme (GBM) – – Multiple key clinical and regulatory milestones expected throughout 2022 –  – Company has sufficient capital to fund operations into 2024 –  HOUSTON , March 25, 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 year ended December 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 Full Year Financial Results and Provides Programs Update

HOUSTON , March 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 Klemp, Chairman and CEO of Moleculin Biotech, will participate at the 2022 Virtual Growth Conference presented by Maxim Group LLC and hosted by M-Vest, taking place March 28-30, 2022. As part of the conference, a video webcast of the Company's presentation will be available for viewing on-demand for those who are registered to attend.

Moleculin to Participate in the 2022 Virtual Growth Conference Presented by Maxim Group LLC and Hosted by M-Vest

HOUSTON, March 11, 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, Chairman and CEO of Moleculin Biotech, will present at the virtual Oppenheimer 32nd Annual Healthcare Conference on Thursday, March 17, 2022 at 9:20 AM 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 to Present at the Oppenheimer 32nd Annual Healthcare Conference

HOUSTON, March 1, 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 the appointment of Joy Yan, M.D., Ph.D. to its Board of Directors.

Moleculin Announces Appointment of Joy Yan, M.D., Ph.D. to Board of Directors

Moleculin Biotech Inc (NASDAQ: MBRX) has announced preliminary results supporting the successful conclusion of its second Phase 1 trial in Poland, evaluating Annamycin for relapsed and refractory acute myeloid leukemia (AML). Moleculin determined a dose of 240 mg/m2 as the Recommended Phase 2 Dose (RP2D), subject to final approval of the Safety Review Committee, and indicated no signs of cardiotoxicity.

Moleculin Biotech Annamycin Doublet Therapy Shows 68% Overall Survival In Animal Study

HOUSTON, Feb. 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 announced preliminary results supporting the successful conclusion of its second Phase 1 trial (MB-105) in Poland evaluating Annamycin for the treatment of relapsed and refractory acute myeloid leukemia (AML), where Moleculin determined a dose of 240 mg/m2 as the Recommended Phase 2 Dose (RP2D), subject to final approval of the Safety Review Committee, and indicated no signs of cardiotoxicity (a common problem with currently prescribed anthracyclines). Based on preclinical animal data from sponsored research conducted simultaneous with its clinical trials, Annamycin in combination with Cytarabine demonstrated a 68% improvement in the median overall survival (OS) compared to Annamycin as a single agent and a 241% increase in OS compared to Cytarabine alone.

Moleculin Provides Annamycin AML Program Update and Outlines Next Steps to Advance Towards Late-Stage Development

VANCOUVER, British Columbia, Jan. 25, 2022 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (the “Company” or “WPD”) (CSE: WBIO) (FSE: 8SV1), is pleased to announce that it has entered into an amended and restated sublicense agreement (the “Sublicense Agreement”) with Moleculin Biotech Inc. (“Moleculin”). On December 20, 2021, WPD Pharmaceuticals Sp. z o.o. (“WPD Poland”), the Polish subsidiary of the Company, entered into an amendment of its February 2019 sublicense (as amended previously in 2019 and 2021) from Moleculin of certain intellectual property rights, including certain rights to Moleculin's Annamycin, WP1066 and WP1122 portfolios to research, develop, manufacture, use, import, offer and sell products derived from these portfolios in the field of human therapeutics (“Products”) in 29 countries, including some countries in Europe (the “Territories”).

WPD Pharmaceuticals Enters into Amended and Restated Sublicense Agreement with Moleculin Biotech

HOUSTON, Jan. 20, 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. Klemp, Founder, President, CEO and Chairman, will participate in the Virtual Investor 2022 Top Picks Conference on Thursday, January 27, 2022 at 9:00 AM ET.

Moleculin Biotech, Inc. to Present at the Virtual Investor 2022 Top Picks Conference

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.

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