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.

– 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.

Moleculin Reports Higher AML Complete Remission (CR) Rates and Significant Durability with Additional Interim Subject Data

Live video webcast roundtable with members from the Moleculin Management Team and Dr. Tallman to discuss the unmet medical needs in the treatment of acute myeloid leukemia (AML), Annamycin and the Company's AML clinical development program as well as data demonstrated to date Ongoing development progress of Annamycin toward pivotal AML study in 2024 with potential qualification for an accelerated approval pathway HOUSTON , May 2, 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 host a virtual AML Clinical Day on Tuesday, May 7, 2024 at 11:00 AM 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 leader, Dr. Martin Tallman.

Moleculin to Host Virtual AML Clinical Day Featuring Internationally Renowned Clinician, Martin S. Tallman, MD, on May 7, 2024

–     Company appoints internationally renowned clinician, Martin S. Tallman, MD as inaugural clinician member HOUSTON, May 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 formation of its Annamycin Scientific Advisory Board and inaugural appointment of Dr. Martin Tallman.

Moleculin Announces Formation of Scientific Advisory Board to Support Development of Annamycin

Moleculin CEO, Walter Klemp highlights Annamycin differentiation in the current AML treatment landscape and potential opportunity FRENCHTOWN, NJ / ACCESSWIRE / April 25, 2024 / JTC Team ("JTC"), a fully integrated corporate communications and investor relations firm, today released a Virtual Investor "What This Means" segment featuring Moleculin Biotech (NASDAQ:MBRX), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses. Watch the "What This Means" video here As part of this "What This Means" segment, Walter Klemp, Chairman and Chief Executive Officer of Moleculin, discusses highlights from the Company's recently announced positive interim data from its ongoing clinical trial evaluating Annamycin for the treatment of subjects with Acute Myeloid Leukemia (AML), how Annamycin is differentiated in the current treatment landscape, and the Moleculin investment opportunity.

Moleculin Biotech (NASDAQ:MBRX) Participates in Virtual Investor "What This Means" Segment Hosted by JTC Team

Roche's Alecensa Gets FDA Green Light; ImmunityBio Gains as PDUFA Date Approaches for Bladder Cancer Drug; Key Drug Trial Failures in 2024 New York, N.Y., April 22, 2024 – PRISM MarketView – Healthcare equities finished mostly higher after a very quiet trading session on Friday.

PRISM MarketView – Biotech Breakfast

–     Next-generation non-cardiotoxic anthracycline Annamycin with notable signs of clinical efficacy in AML in combination with Cytarabine achieves preliminary CRc rate of 60% in 2nd line AML subjects in a European clinical trial –     There are approximately 160,000 people with AML worldwide  –     Annamycin continues to show no signs of cardiotoxicity (N=82 across multiple studies); Lower toxicity profile than traditional intensive therapy –     Annamycin is advancing towards pivotal AML study in 2024 and may qualify for an accelerated approval pathway 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. Annamycin is the Company's next-generation anthracycline that has been designed to be non-cardiotoxic (unlike currently prescribed anthracyclines) and has shown to be non-cardiotoxic in the 82 subjects treated in multiple studies in the U.S. and in Europe.

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

Annamycin demonstrated to be a more potent inhibitor of topoisomerase II-alpha and II-beta while remaining inactive against established cardiomyocyte cultures Results clearly aligned with lack of drug-related cardiotoxic events in patients treated with Annamycin in ongoing clinical trials; 100% of Annamycin subjects in multiple studies (N=82) continue to show no signs of cardiotoxicity during study A prominent treatment for many adult cancers and approximately 50% of all pediatric cancer patients are treated with a cardiotoxic anthracycline Annamycin composition of matter patent issued April 9 th; Patent enables expansion into greater patient populations where cardiotoxicity remains an unmet need 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. 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 8 th.

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

Live webcast on Thursday, April 4 th at 4:10 PM ET 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.

Moleculin to Present at the MedInvest Biotech & Pharma Investor Conference

Live webcast with Walter Klemp, Chairman and Chief Executive Officer, on Thursday, March 28 th 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.

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

Patent, once issued, will provide composition of matter protection through 2040, with potential for additional term extension Next-generation anthracycline uses unique lipid-based delivery technology to bring hope to the estimated 58% of AML patients for whom no approved therapy exists 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. When issued, the patent will provide claims to compositions that contain Annamycin with a base patent term 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 Annamycin Targeting Unmet Need in AML

Moleculin Biotech, Inc. (MBRX) Q4 2023 Earnings Call Transcript

–     Annamycin in combination with Cytarabine (AnnAraC) achieves CRc rate of 60% (50% CR) in 2nd line AML subjects –     AnnAraC has potential to fill significant unmet need and expected to increase 2nd line AML CRs more than double over existing 2nd line therapies –     All 82 Annamycin subjects (in multiple studies) continue to show no signs of cardiotoxicity during study; Lower toxicity profile than traditional intensive therapy –     Annamycin is advancing towards pivotal AML study in 2024 and may qualify for an accelerated approval pathway –     Company to host conference call and webcast today, March 25 th at 8:30 AM ET HOUSTON , March 25, 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, provided a preliminary update on recent clinical activity and expected near term milestones for its lead program MB-106 for the treatment of Acute Myeloid Leukemia (AML) following its Fiscal Year 2023 filing with the Securities and Exchange Commission. As previously announced, the Company will host a conference call and live audio webcast, today, March 25, 2024, at 8:30 AM ET (details below).

Moleculin Announces Positive Interim Data in Annamycin MB-106 Phase 1B/2 AML Trial

–    Year marked by growing body of positive Annamycin efficacy and safety clinical data expected to support advancement into a pivotal study for AML –   Company to host conference call and webcast Monday, March 25 th at 8:30 AM ET –   Company to issue separate clinical trial update press release Monday prior to the conference call HOUSTON , March 22, 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 fiscal year ended December 31, 2023. As previously announced, the Company will host a conference call and live audio webcast, Monday, March 25, 2024, at 8:30 AM ET (details below), issuing a separate clinical trial update press release just prior.

Moleculin Reports Full Year 2023 Financial Results

In-depth discussion of stratification of Company's 2nd line data of Annamycin as a therapy for acute myeloid leukemia (AML) Guidance to be provided for clinical development strategy for advancement of Annamycin into potential AML pivotal registration study 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.

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

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 will take effect at 11:59 pm (Eastern Time) on March 21, 2024, and the Company's common stock will open for trading on The Nasdaq Capital Market on March 22, 2024 on a post-split basis, under the existing ticker symbol "MBRX" but with a new CUSIP number 60855D309.

Moleculin Announces Reverse Stock Split

Live webcast fireside chat on Monday, March 18 th 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.

Moleculin to Present at the 36th Annual ROTH Conference

– MB-106 AML Phase 1B/2 trial (MB-106) preliminary data readout: Reached 67% recruitment – MB-106 preliminary results: Intent to Treat CR rate of 40% plus a CR/ CRi rate of 47% (N=15); Dosed Per Protocol CR rate of 46% plus a CR/CRi rate of 54% (N=13) – First 1st line AML subject treated and resulted in a CR in MB-106 – No CR/CRi's in MB-106 have relapsed to date – MB-107 STS Lung Mets Phase 1B/2 trial preliminary data readout: Phase 1B median extended overall survival of 11 months for heavily pre-treated subjects (N=15); Phase 2 data continues to develop – 100% of Annamycin subjects in multiple studies (N=62) continue to show no signs of cardiotoxicity during study as evidenced by an independent expert's reports – Company provides 2024 business outlook and updates its upcoming milestones HOUSTON , Jan. 24, 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 2023 year-end Annamycin clinical trials preliminary data and 2024 expectations for multiple data readouts and a transition to pivotal Phase 2B/3 clinical studies. The Company also updated its upcoming milestones.

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

HOUSTON , Dec. 20, 2023 /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 has entered into a securities purchase agreement with a single healthcare-focused institutional investor and certain of the Company's executive officers and directors to purchase 7,044,836 shares of common stock (or pre-funded warrants in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company also agreed to issue unregistered warrants to purchase up to an aggregate of 14,089,672 shares of common stock.

Moleculin Announces Pricing of $4.5 Million Registered Direct Offering and Concurrent Private Placement Priced At-the-Market

- CR rate of 36% in Intent to Treat or ITT (n=11) subjects with durability - CR rate of 44% in subjects treated with Annamycin (n=9) - Durability of CR's up to 8 months & climbing (no relapses to date) - Recruitment in MB-106 Phase 1B/2 clinical trial reaches 59% - Announces Publication for 65th ASH Annual Meeting and Exposition - Annamycin continues to be 100% non-cardiotoxic HOUSTON , Dec. 11, 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 announced the presentation of preliminary efficacy findings from the Company's ongoing European Phase 1B/2 clinical trial evaluating Annamycin for the treatment of acute myeloid leukemia or AML (MB-106) to key opinion leaders and current investigators at a meeting held in conjunction with the 65th American Society of Hematology Meeting and Exposition (ASH) in San Diego on December 10, 2023. Additionally, the Company will have a paper published on its MB-106 clinical trial as part of ASH.

Moleculin Presents Positive Interim Data from Phase 1B/2 Clinical Trial in AML at Meeting with KOL's in Conjunction with ASH Annual Meeting

Moleculin (MBRX) announces positive interim data from its early-mid-stage studies of Annamycin in blood and lung cancer indications, along with encouraging third-quarter results. The stock rises 7%.

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