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.

–        MB-106: CR rate of 38% (N=8) with durability up to 8 months –        Builds on CRi rate of 60% in MB-105 monotherapy AML trial last cohort (N=5) –        MB-107: Phase 1B median extended overall survival of 11 months for heavily pre-treated subjects (N=15) –        MB-107 Phase 1B/2 median progression free survival (PFS) of 3.4 months for subjects dosed at or below 330 mg/m2 and less than 3 prior therapies (N=9) –        100% of Annamycin subjects in multiple studies (N=66) continue to show no signs of cardiotoxicity during study HOUSTON , Nov. 13, 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 provided a preliminary update on recent clinical activity and expected near term milestones across its clinical development pipeline in its quarterly filing with the Securities and Exchange Commission. "Despite a host of recent new drug approvals, the most important therapeutic tool for treating AML and advanced STS continues to be an anthracycline.

Moleculin Announces Positive Interim Data in Annamycin Clinical Trials: MB-106 AML Trial Complete Response (CR) Rate of 38% and MB-107 STS Lung Mets Trial Median Phase 1B Extended Overall Survival of 11 Months

– Ends Quarter with $24.6 million in Cash with Runway Estimated into Third Quarter of 2024 – Third quarter marked by additional positive clinical data from Annamycin lead development programs – Growing body of Annamycin efficacy and safety clinical data expected to support advancement into pivotal studies for both AML and STS in 2024 – Company to host conference call and webcast today at 8:30 AM ET HOUSTON , Nov. 13, 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 reported its financial results for the quarter ended September 30, 2023. As previously announced, the Company will host a conference call and live audio webcast, today, November 13, 2023, at 8:30 AM ET (details below).

Moleculin Reports Third Quarter 2023 Financial Results

HOUSTON , Nov. 7, 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 that it will report its financial results for the third quarter ended September 30, 2023, on Monday November 13, 2023. Moleculin management will host a conference call and live webcast to discuss the operational and financial results at 8:30 AM ET that same day.

Moleculin to Report Third Quarter Financial Results on November 13, 2023 and Host Conference Call and Webcast

– Poster Presented at the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting – Annamycin continues to be 100% non-cardiotoxic – Annamycin has Fast Track Status and Orphan Drug Designation from FDA for the treatment of soft tissue sarcoma HOUSTON , Nov. 6, 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 Phase 2 portion of the Company's ongoing U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB107). The abstract titled, "A Phase 1b/2 Study of Liposomal Annamycin (ANN) in Subjects with Previously Treated Soft-Tissue Sarcomas (STS) with Pulmonary Metastases ," was presented by Brian Andrew Van Tine, MD, PhD, Professor of Medicine, Washington University School of Medicine in a poster presentation at the 2023 CTOS Annual Meeting being held November 1-4, 2023 in Dublin, Ireland.

Moleculin Presents Positive Preliminary Efficacy Findings from Phase 1B/2 Clinical Trial Demonstrating 64% Stable Disease Rate Through Two Cycles of Annamycin for the Treatment of Soft Tissue Sarcomas (STS) Lung Metastases

Live video webcast with Walter Klemp, CEO and Jonathan Foster, Executive VP and CFO of Moleculin on Tuesday, October 25 th at 12:00 PM ET HOUSTON , Oct. 11, 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 Walter Klemp, President and Chief Executive Officer and Jonathan Foster, Executive VP and Chief Financial Officer of Moleculin, will participate at the Virtual Investor Ask the CEO Conference on Tuesday, October 25, 2023 at 12:00 PM ET The "Ask the CEO" conference is intended to provide the investment community with access to ask their questions directly to management. Investors and interested parties will have the opportunity to submit questions live during the event.

Moleculin to Participate in the Virtual Investor Ask the CEO Conference

– Phase 1B portion of Phase 1B/2 study demonstrated preliminary CR/CRi rate of 33% (n=6) – Annamycin has Fast Track Status and Orphan Drug Designation from FDA for the treatment of AML HOUSTON , Oct. 2, 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 cancers and viruses, today announced the initial subjects have been treated in the Phase 2 portion of the Company's Phase 1B/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) for the treatment of subjects with AML (MB-106). Walter Klemp, Chairman and Chief Executive Officer of Moleculin commented, "This milestone marks an important step in advancing the development of Annamycin for the treatment of AML.

Moleculin Doses First Subjects in Phase 2 Portion of Clinical Trial Evaluating Annamycin in Combination with Cytarabine (Ara-C) for the Treatment of Acute Myeloid Leukemia (AML)

Moleculin (MBRX) completes enrollment in the phase II portion of the development program for its lead candidate, Annamycin, to treat soft tissue sarcoma lung metastases. The stock rises 10%.

Moleculin (MBRX) Posts Update From Lung Cancer Study, Stock Up

– Data readouts expected before year end – Previously reported preliminary efficacy data on its Phase 1B/2 clinical trial with Annamycin in monotherapy treatment of STS lung mets with >60% of the subjects exhibiting stable disease after two cycles of treatment – Annamycin has Fast Track Status and Orphan Drug Designation from FDA for the treatment of soft tissue sarcoma HOUSTON , Sept. 21, 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 cancers and viruses, today announced the completion of enrollment in the Phase 2 portion of the Company's U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB107).

Moleculin Announces Completion of Enrollment in U.S. Phase 1B/2 Clinical Trial Evaluating Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases (MB107)

– Annamycin continues to demonstrate no evidence of cardiotoxicity to date, now in a total of 62 subjects across three of the Company's Annamycin clinical trials – Next generation anthracycline, Annamycin, has demonstrated both safety and promising early activity across multiple clinical studies with potential to be an effective treatment across multiple oncology indications HOUSTON , Sept. 18, 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 it has received a new independent assessment for the absence of cardiotoxicity in subjects treated with Annamycin.

Moleculin Announces New Positive Independent Report of No Cardiotoxicity in Annamycin

Moleculin Biotech (NASDAQ: MBRX ) stock is on the move Friday after the clinical-stage pharmaceutical company provided an update to investors. According to a press release from Moleculin Biotech, the company is preparing to attend the 2023 CTOS Annual Meeting.

Why Is Moleculin Biotech (MBRX) Stock Is Moving Today?

HOUSTON , Sept. 14, 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 its abstract has been accepted for poster presentation at the 2023 CTOS Annual Meeting being held November 1-4, 2023 in Dublin, Ireland.

Moleculin Announces Abstract Accepted for Poster Presentation at the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting

HOUSTON , Sept. 5, 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 that Walter Klemp, Chairman and Chief Executive Officer of Moleculin will present at the H.C.

Moleculin to Present at the H.C. Wainwright 25th Annual Global Investment Conference

Moleculin Biotech, Inc. (NASDAQ:MBRX ) Q2 2023 Earnings Call Transcript August 11, 2023 8:30 AM ET Company Participants Jenene Thomas - IR Walter Klemp - Chairman & CEO John Paul Waymack - Senior CMO Jonathan Foster - EVP & CFO Conference Call Participants Jonathan Aschoff - ROTH MKM Jeff Jones - Oppenheimer Operator Hello, and welcome to the Moleculin Biotech Quarterly Update Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded.

Moleculin Biotech, Inc. (MBRX) Q2 2023 Earnings Call Transcript

– Ongoing progress across ongoing clinical development programs with growing body of positive preclinical and clinical data – Released Clinical Trial Update press release yesterday providing the quarter's update on its clinical activities – Company to host conference call and webcast today at 8:30 AM ET HOUSTON , Aug. 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 reported its financial results for the quarter ended June 30, 2023. As previously announced, the Company will host a conference call and live audio webcast, today, August 11, 2023, at 8:30 AM ET (details below).

Moleculin Reports Second Quarter 2023 Financial Results

– Announces successful completion of the Phase 1B portion of its Phase 1B/2 clinical trial Annamycin in combination with Cytarabine for the treatment of AML (MB-106) and opens the Phase 2 portion for recruitment – Announces a preliminary CR/CRi rate of 33% (n=6) in the Phase 1B portion of its MB-106 clinical trial – Reports preliminary efficacy data on its Phase 1B/2 clinical trial with Annamycin in monotherapy treatment of soft tissue sarcoma metastasized to the lungs with 73% (n=26) of the subjects exhibiting stable disease after two cycles of treatment – Multiple expected milestones and interim data readouts expected in 2023 HOUSTON , Aug. 10, 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 cancers and viruses, today provided an update on recent activity and expected near term milestones across its clinical development pipeline. "We continue to make solid progress across our development pipeline and ongoing clinical trials and are extremely encouraged by our Annamycin AML and STS programs.

Moleculin Provides Update on Ongoing Clinical Trials and Outlines Expected Upcoming Milestones

HOUSTON , Aug. 7, 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 is investigating potential naked short selling of its stock and has retained well-known analytics firm, Shareholder Intelligence Services, LLC ("ShareIntel"). ShareIntel's investigation will provide shareholder data, including share ownership, purchases, sales and custody by individuals, institutions, broker-dealers, clearing agents and custodians, and other information related to the Company's public shareholders and market activity with respect to sales of publicly traded common stock.

Moleculin Retains Shareholder Intelligence Services, LLC to Investigate Potential Naked Short Selling

HOUSTON , Aug. 3, 2023 /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 will report its financial results for the second quarter ended June 30, 2023, on Friday, August 11, 2023. Moleculin management will host a conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET that same day.

Moleculin to Report Second Quarter Financial Results on August 11, 2023 and Host Conference Call and Webcast

Data published in peer-reviewed British Journal of Cancer Research No evidence of cardiotoxicity in any subject treated in this study, including up to 16 subjects whose cumulative anthracycline dose (Annamycin included) exceeded the lifetime cumulative doxorubicin (or equivalent) dose of > 450 mg/m2  After experiencing an 80%/60% ORR/CRi rates in last single agent cohort, Annamycin is currently being evaluated in a Phase 1b/2 study in combination with Cytarabine for the treatment of AML HOUSTON , July 13, 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 the publication of data from its completed MB-105 European Phase 1 clinical trial assessing the safety and efficacy of Annamycin as a single agent for the treatment of adults with relapsed or refractory AML. The manuscript titled, " Results of a Phase 1 Study of Liposomal Annamycin for the Treatment of Relapsed or Refractory AML Patients After Induction Therapy ," was published in the peer-reviewed British Journal of Cancer Research.

Moleculin Announces Publication of Data from Successful European Phase 1 Trial Evaluating Annamycin as Single Agent Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML)

Live moderated video webcast on Wednesday, July 12 th at 3:00 PM ET HOUSTON , July 6, 2023 /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 and Jon Foster, Executive VP & Chief Financial Officer of Moleculin, will participate in the Virtual Investor Summer Spotlight Series on Wednesday, July 12, 2023 at 3:00 PM ET. A live video webcast of the presentation will be available on the Events page of the Investors section of the Company's website (moleculin.com).

Moleculin to Participate in the Virtual Investor Summer Spotlight Series

Live webcast fireside chat on Wednesday, June 21 st at 1:30 PM ET HOUSTON , June 13, 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 that Walter Klemp, President and Chief Executive Officer and Jonathan Foster, Executive VP and Chief Financial Officer of Moleculin, will present at the Healthcare Virtual Conference Part II, presented by Maxim Group LLC and hosted by M-Vest on Wednesday, June 21, 2023 at 1:30 PM ET. The exponential growth in knowledge and expertise in science and medicine continues to drive opportunities in the healthcare space.

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

- Company urges shareholders of record date, March 27, 2023, to vote your shares immediately if you have not already done so   HOUSTON, May 30, 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 that its annual meeting of stockholders (the "Annual Meeting") scheduled for and convened on Thursday, May 25, 2023 has been partially adjourned to Thursday, June 15, 2023 at 10:30 a.m. Eastern Time.

Moleculin Announces Adjournment of 2023 Annual Meeting to June 15, 2023

Moleculin Biotech, Inc. (NASDAQ:MBRX ) Q1 2023 Earnings Conference Call May 11, 2023 8:30 AM ET Company Participants Jenene Thomas - Investor Relations Walter Klemp - Chairman and Chief Executive Officer John Paul Waymack - Senior Chief Medical Officer Jonathan Foster - Executive Vice President and Chief Financial Officer Conference Call Participants Jonathan Aschoff - ROTH MKM Jeff Jones - Oppenheimer Operator Hello and welcome to the Moleculin Biotech Q1 2023 Quarterly Update Conference Call and Webcast. [Operator Instructions] A question-and-answer session will follow the formal presentation.

Moleculin Biotech, Inc. (MBRX) Q1 2023 Earnings Call Transcript

Moleculin Biotech (NASDAQ: MBRX ) reported first quarter results for 2023. Moleculin Biotech reported a loss per share of 28 cents.

MBRX Stock Earnings: Moleculin Biotech Misses EPS Estimates

– Continued clinical and operational execution across ongoing development programs with growing body of positive preclinical and clinical data – Sufficient capital to fund operations into the third quarter of 2024 – Company to host conference call and webcast today at 8:30 AM ET HOUSTON , May 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 reported its financial results for the quarter ended March 31, 2023. As previously announced, the Company will host a conference call and live audio webcast, today, Thursday, May 11, 2023, at 8:30 AM ET (details below).

Moleculin Reports First Quarter 2023 Financial Results

HOUSTON , May 4, 2023 /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 will report its financial results for the first quarter ended March 31, 2023, on Thursday, May 11, 2023. Moleculin management will host a conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET that same day.

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