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.

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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 , Nov. 5, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-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 quarter ended September 30, 2024, on Friday, November 8, 2024. Moleculin management will host a conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET on Monday, November 11, 2024.

Moleculin to Report Third Quarter 2024 Financial Results on November 8, 2024 and Host Conference Call and Webcast

Strong preclinical evidence of Annamycin's potential for treating pancreatic cancer presented at AACR expands collaboration HOUSTON , Nov. 4, 2024 /PRNewswire/ -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (Moleculin or the Company), a late stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the appointment of Daniel D. Von Hoff, M.D.

Moleculin Appoints Leading Expert in Pancreatic Cancer to its Scientific Advisory Board to Support Development of Annamycin

Access the transcript here HOUSTON , Oct. 17, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the transcript from its recently hosted Virtual Acute Myeloid Leukemia KOL event is now available. The transcript is accessible under the Virtual AML KOL event on the Event page under the Investors section of the Company's website (moleculin.com) and on the SEC Filings page.

Transcript from Moleculin's Recent Virtual Acute Myeloid Leukemia KOL Event Now Available

Live webcast discussion featuring internationally renowned Acute Myeloid Leukemia (AML) Key Opinion Leaders Ongoing progress of pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML HOUSTON , Oct. 7, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it will host a Virtual Acute Myeloid Leukemia KOL event on Monday, October 14 th from 11:00 AM – 1:00 PM ET. For the event, Walter Klemp, Chairman and Chief Executive Officer, and Dr. Paul Waymack, Senior Chief Medical Officer of Moleculin will be joined by key opinion leaders: Michael Andreef, MD, PhD, Professor of Medicine, Department of Stem Cell Transplantation, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center; Dr. Giovanni Martinelli, Associate Professor; Department of Medical and Surgical Sciences, Bologna University; and Mohamad Cherry, MD, Medical Director of Hematology at Atlantic Health System.

Moleculin to Host Virtual Acute Myeloid Leukemia KOL Event on October 14, 2024

HOUSTON , Oct. 4, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced its participation at two upcoming investor conferences. Details of the upcoming presentations are as follows: 3rd Annual ROTH Healthcare Opportunities Conference Format: Panel - Innovative Therapies for Liquid Tumors The panel will cover the drugs in development by the presenting companies and where they fit competitively for the initial indication as well as for potential subsequent indications, and upcoming data readouts.

Moleculin to Present at Two Upcoming Investor Conferences

Data recently presented at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer Treatment with Annamycin results in statistically significant inhibition of tumor growth and extension of survival in orthotopic lung cancer models Annamycin continues to be 100% non-cardiotoxic HOUSTON , Sept. 23, 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 the recent presentation of positive in vivo efficacy data of Annamycin in orthotopic and experimental lung metastatic models of sarcoma.

Moleculin Announces Positive In Vivo Efficacy Data of Annamycin in Orthotopic and Experimental Lung Metastatic Models of Sarcoma

Wally Klemp, CEO of Moleculin, discusses the Company's recent update on the Phase 2 clinical trial of STAT3 inhibitor in combination with radiation for the treatment of glioblastoma Watch the "What This Means" video here HOUSTON , Sept. 16, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company), a Phase 3 clinical-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that Walter Klemp, Chairman and Chief Executive Officer of Moleculin participated in a Virtual Investor "What this Means" segment.

Moleculin Participates in Virtual Investor "What this Means" Segment

– Investigator-initiated Phase 2 study is being conducted at Northwestern University in cooperation with Moleculin – Funding for study provided by NIH and BrainUp® – Trial combines WP1066 and radiation, which demonstrated both significant therapeutic response and immune memory in glioblastoma animal models HOUSTON , Sept. 9, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company), a Phase 3 clinical-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the enrollment and treatment of patients in an Investigator-initiated Phase 2 study evaluating WP1066 in combination with radiation therapy for the treatment of adults with glioblastoma (NU 21C06).

Moleculin Announces First Patients Treated in Phase 2 Clinical Trial of STAT3 Inhibitor in Combination with Radiation for the Treatment of Glioblastoma

HOUSTON , Sept. 3, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a Phase 3 clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that Walter Klemp, Chairman and Chief Executive Officer of Moleculin will present at the H.C.

Moleculin to Present at the H.C. Wainwright 26th Annual Global Investment Conference

Live webcast on Wednesday, August 28 th at 3:40 PM ET HOUSTON , Aug. 26, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a Phase 3 clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that Walter Klemp, Chairman and Chief Executive Officer of Moleculin will present at LIVE! with Webull Corporate Connect: Healthcare Investment Webinar on Wednesday, August 28, 2024 at 3:40 PM ET.

Moleculin to Present at LIVE! with Webull Corporate Connect: Healthcare Investment Webinar

$5.5 million financing upfront with up to an additional $11.0 million of potential aggregate gross proceeds upon the exercise in full of milestone-linked warrants HOUSTON , Aug. 19, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a Phase 3 clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the closing of its previously announced public offering of an aggregate of 2,466,368 shares of its common stock (or common stock equivalents in lieu thereof), Series A warrants to purchase up to 2,466,368 shares of common stock and Series B warrants to purchase up to 2,466,368 shares of common stock, at a combined public offering price of $2.23 per share (or per common stock equivalent in lieu thereof) and accompanying warrants. The Series A warrants have an exercise price of $2.23, are exercisable immediately upon Shareholder Approval (as defined below) and will expire upon the earlier of (i) the 2 year anniversary of the date of Stockholder Approval (as defined below) and (ii) the 60th day following the date the Company releases interim data for the first subject group from the MIRACLE trial whereby the complete remission rate for either doses of the Company's study drug is greater than placebo.

Moleculin Announces Closing of up to $16.5 Million Public Offering

-         Positive outcome from End of Phase 1B/2 Meeting with FDA -         Company proceeding with a pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of R/R AML -         Webcast replay of the Company's recent MIRACLE trial update available here HOUSTON , Aug. 14, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a Phase 3 clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today reported its financial results for the quarter ended June 30, 2024. "I am extremely pleased with our recent clinical and regulatory achievements.

Moleculin Reports Second Quarter 2024 Financial Results and Provides Corporate Update

HOUSTON , Aug. 5, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), Phase 3 clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it will host a corporate update webcast presentation on Tuesday, August 6, 2024 at 8:30 AM ET to discuss its recently announced plans to advance Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") to a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). This Phase 3 "MIRACLE" trial (derived from M olecul i n R /R AML A nnAraC Cl inical E valuation) will be a global trial, including sites in the US.

Moleculin to Host Webcast Presentation to Discuss Recently Announced Plans for MIRACLE Phase 3 Pivotal Trial Tuesday, August 6, 2024 at 8:30 AM ET

Based on an encouraging discussion in the End of Phase 1B/2 Meeting with FDA the Company plans to: Proceed with a pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML; Run such future studies globally and in the US above the lifetime maximum allowable anthracycline dose; and Provide the FDA with additional data supporting the selection of the optimal dosing level via the adaptive design in the MIRACLE trial HOUSTON , Aug. 1, 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 the positive discussion in and outcome of its End of Phase 1B/2 (EOP1B/2) meeting with the US Food and Drug Administration (FDA) supporting the advancement of Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") to a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). This Phase 3 "MIRACLE" trial (derived from M olecul i n R /R AML A nnAraC Cl inical E valuation) will be a global trial, including sites in the US.

Moleculin Announces Plans for MIRACLE Phase 3 Pivotal Trial

HOUSTON , July 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 the completion of its End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy (MB-106). The Company expects to report outcomes from the EOP2 meeting upon receipt of official minutes from FDA which is expected by the end of Q3 2024.

Moleculin Completes End of Phase 2 Meeting with FDA for Annamycin in AML

– 89% of CRc's were subjects with "poor prognosis" cytogenetics and/or mutations  – Current median durability of response (mDOR) of CRc's = 6 months and increasing (n=9)  – In 2nd line subjects (n=10) Annamycin in combination with Cytarabine (AnnAraC) achieved an estimated median overall survival (mOS) of 6 months and increasing plus 5 CR's (50%) and 6 CRc's (60%) – Recruitment increased to 22 subjects and CRc's in all subjects evaluable for efficacy (n=20) was 45% – Annamycin continues to demonstrate no cardiotoxicity – Data presented at European Hematology Association (EHA) 2024 Hybrid Congress and Company KOL Meeting in Madrid HOUSTON , June 14, 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 reported additional efficacy findings from the Company's ongoing Phase 1B/2 (MB-106) clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with acute myeloid leukemia (AML). The preliminary data was presented at the European Hematology Association (EHA) 2024 Hybrid Congress.

Moleculin Announces Additional Positive Preliminary Interim Data from AML Clinical Trial

Live video webcast on Tuesday, June 18 th at 3:00 PM ET HOUSTON , June 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 that it will present at the Virtual Investor Pitch Conference on June 18, 2024 at 3:00 PM ET. As part of the event, Walter Klemp, Chairman and Chief Executive Officer of Moleculin, will provide an "elevator pitch" and outline the Company's upcoming milestones.

Moleculin to Present at the Virtual Investor Pitch Conference

Live webcast with Walter Klemp, Chairman and Chief Executive Officer, on Wednesday, June 12 th at 12:00 PM ET  HOUSTON , June 5, 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 Wednesday, June 12, 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 and business outlook.

Moleculin to Participate in the Virtual Investor Lunch Break Series

HOUSTON , May 16, 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 its abstract has been accepted for poster presentation at the EHA2024 Hybrid Congress being held June 13-16, 2024 in Madrid, Spain and virtually. Details for the poster presentation are as follows: Abstract: P537 Session: Acute myeloid leukemia – Clinical Title: LIPOSOMAL ANNAMYCIN (L-ANN) IN COMBINATION WITH CYTARABINE FOR TREATMENT OF PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML) REFACTORY TO OR RELAPSED (R/R) AFTER INDUCTION THERAPY (MB-106 STUDY) Presenting Author: Wolfram C.

Moleculin Abstract Accepted for Poster Presentation at the European Hematology Association (EHA) 2024 Hybrid Congress

– Investigator-Initiated Phase 2 study is being conducted at Northwestern University in cooperation with Moleculin – Trial combines WP1066 and radiation, which demonstrated both significant therapeutic response and immune "memory" in glioblastoma animal models HOUSTON , May 15, 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 the commencement of an Investigator-initiated Phase 2 study evaluating WP1066 in combination with radiation therapy for the treatment of adults with glioblastoma (NU 21C06) in cooperation with the Company. The study is being conducted under Northwestern University's Investigative New Drug application (IND) which cross references the Company's own IND, which received clearance from the U.S. Food and Drug Administration (FDA) in April 2022.

Moleculin Announces Commencement of NIH-Funded Phase 2 Clinical Trial of STAT3 Inhibitor for the Treatment of Glioblastoma (NU 21C06)

Moleculin Biotech, Inc. [MBRX] Q1 2024 Earnings Conference Call May 13, 2024 8:30 AM ET Company Participants Walter Klemp - Chairman and CEO Jonathan Foster - EVP and CFO Paul Waymack - Senior CMO Jenene Thomas - IR Conference Call Participants Jonathan Aschoff - Roth MKM Chad Yahn - Maxim Group Vernon Bernardino - H.C. Wainwright Operator Hello, and welcome to the Moleculin Biotech first quarter 2024 quarterly update conference call and webcast.

Moleculin Biotech, Inc. (MBRX) Q1 2024 Earnings Call Transcript

–     Recently announced interim data from ongoing MB-106 study demonstrating Annamycin in combination with Cytarabine (AnnAraC) achieves CRc rate of 62% (54% CR) in 1st and 2nd line AML subjects (N=13) –     Also announced MB-106 reaches 20 subjects enrolled –     Company to host conference call and webcast today, Monday, May 13 th at 8:30 AM ET HOUSTON , May 13, 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 reported its financial results for the quarter ended March 31, 2024. As previously announced, the Company will host a conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET on Monday, May 13, 2024.

Moleculin Reports First Quarter 2024 Financial Results and Provides Corporate Update

Patent, once issued, will provide composition protection through 2040, with potential for additional term extension Annamycin is advancing towards pivotal AML study in 2024 and may qualify for an accelerated approval pathway HOUSTON , May 9, 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 11,980,634 titled, "Method of Reconstituting Liposomal Annamycin" (the '634 patent') to be issued on May 14, 2024 to Moleculin and The University of Texas System Board of Regents. When issued, the patent will provide claims to liposomal Annamycin suspension compositions with a base patent term currently extending until June 2040, subject to extension to account for time required to fulfill regulatory requirements for FDA approval.

Moleculin Announces U.S. Patent Issue Notification for Lipid-Based Delivery Technology for Annamycin

HOUSTON , May 8, 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 quarter ended March 31, 2024, on Friday, May 10, 2024. Moleculin management will host a conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET on Monday, May 13, 2024.

Moleculin to Report First Quarter 2024 Financial Results on May 10, 2024 and Host Conference Call and Webcast

Annamycin in combination with Cytarabine (AnnAraC) achieves CRc rate of 62% (54% CR) in 1st and 2nd line AML subjects (N=13) Full MB-106 trial reaches 20 subjects with CRc of 45% in 1st – 7th line, with median durability at 4.9 months and climbing Interim data supports advancement to development of Phase 2 registration-directed clinical trial (MB-108) to further provide data for efficacy to support an eventual application for New Drug Approval (NDA) Virtual AML Clinical Day featuring internationally renowned clinician, Martin S. Tallman, MD, today, May 7 th at 11:00 AM ET - Register Here HOUSTON , May 7, 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 the presentation of positive interim data for Annamycin from its ongoing acute myeloid leukemia (AML) clinical development program.

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