MBRX

Access the segment here HOUSTON, July 06, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that Walter Klemp, Chairman and Chief Executive Officer of Moleculin, participated in a Virtual Investor “What This Means” segment. For the segment, Chairman and CEO Wally Klemp discusses the positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A of the pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in relapsed or refractory acute myeloid leukemia (R/R AML). During the conversation, Mr. Klemp provides his perspective on the significance of the early efficacy trends observed across both Annamycin treatment arms, summarizes the key data, and discusses the commercial opportunity, including insights from the Company's recent market research assessing the potential addressable market for Annamycin if approved. The segment is now available for on-demand viewing here. About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin (also known as naxtarubicin), is a highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. The Company has begun the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design, multi-center, randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC (the combination of Annamycin and cytarabine, also referred to as “Ara-C”) for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study remains subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents. Additionally, the Company is deve...

Moleculin Biotech, Inc. Both Annamycin dose arms outperformed control on the primary endpoint of complete remission (CR): 43% and 36% versus 12% — reported on a full intent-to-treat (ITT) basis with no patient exclusions Composite complete remission (CRc) reached 50% and 57% in the respective Annamycin arms versus 29% for control Enrollment in the MIRACLE trial continues with more than two-thirds (67 of 90 subjects) of Part A target as Company advances toward optimal dose selection HOUSTON, June 30, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A of the Company's pivotal Phase 2/3 MIRACLE trial, analyzed on a full intent-to-treat basis with no patient exclusions. Both Annamycin treatment arms demonstrated favorable efficacy trends compared with the control arm in patients with relapsed or refractory acute myeloid leukemia (R/R AML). The interim analysis demonstrated a clear efficacy advantage for both Annamycin treatment arms, 190 mg/m² plus HiDAC and 230 mg/m² plus HiDAC, over the HiDAC control arm. CR reached 43% and 36% in the respective Annamycin cohorts, compared with 12% for control, while CRc reached 50% and 57%, respectively, versus 29% for the control arm. The n=45 population contained 75.6% over 60 years of age, 55.6% 7+3 and 31.1% venetoclax regimens for first line (1L) therapies. Importantly, the remission rates for all three arms, including the control arm, reflect outcomes measured after only a single cycle of therapy, as specified by the MIRACLE protocol. The most commonly cited historical benchmarks in this setting, including the MIRROS and CLASSIC I studies, as well as Moleculin’s own MB-106 study, permitted multiple cycles of treatment. The Company therefore expected absolute remission rates for both the control and Annamycin arms in this single-cycle interim analysis to be lower than those reported in such multi-cycle datasets and believes the most meaningful comparison is the performance of the Annamycin arms relative to the concurrent, randomized control arm evaluated on the same single-cycle basis. "These interim Phase 2/3 results on such a challenging subject population represent a defining moment for Moleculin and, we believe, the strongest clinical validation of Annamycin we ha...

Early blinded results show 40% composite complete remission rate across difficult-to-treat AML patient population in MIRACLE Trial First interim unblinding expected in June 2026 following 45 subject enrollment milestone achieved in MIRACLE trial Enrollment in MIRACLE trial continues to advance on pace with 90th subject expected in Q3 2026 HOUSTON, May 15, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today reported financial results for the first quarter ended March 31, 2026 and provided a corporate update. “With enrollment now surpassing the first interim analysis threshold in the MIRACLE trial, we are just weeks away from beginning what we believe will be the most transformative period in the Company’s history. The impressive preliminary blinded remission data trend we reported earlier this year continues with the 45 subject blinded data. This trend supports our belief in Annamycin’s potential to meaningfully improve outcomes for patients with relapsed or refractory AML,” said Walter Klemp, Chairman and Chief Executive Officer of Moleculin. “We also believe Annamycin has the potential to redefine the anthracycline class by addressing one of the most significant limitations of these foundational therapies, cardiotoxicity, while potentially expanding access to treatment options for patients who otherwise may not be eligible for standard anthracycline-based therapy due to current life-time dose limits,” Mr. Klemp added. Recent Highlights Achieved enrollment of the first 45 subjects in the pivotal MIRACLE Phase 2B/3 trial evaluating Annamycin in combination with cytarabine (“AnnAraC”) for the treatment of relapsed/refractory acute myeloid leukemia (AML) Continued to observe encouraging blinded efficacy trends in the MIRACLE trial, including a previously reported preliminary blinded composite complete remission (CRc) rate of 40% at the first 30 subjects treated mark and also at the 45th subject mark Completed financing transactions during the first quarter of 2026 resulting in approximately $8.3 million in gross proceeds, strengthening the Company’s near-term operating runway Continued expansion of clinical trial operations across the United States and Europe to support accelerated enrollment and future development activities Bolstered global intellectual property strategy for Annamycin, now covering four conti...

Miracle Trial Preliminary Blinded CRc Rate of 40% in First 30 Patients Suggests Encouraging Early Results in Relapsed/Refractory AML HOUSTON, March 19, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today reported financial results for the year ended December 31, 2025 and provided a clinical update highlighting rapid progress toward a major upcoming milestone in its pivotal MIRACLE trial of Annamycin in combination with cytarabine for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy (R/R AML). “With the MIRACLE trial rapidly progressing and the first MIRACLE interim readout now clearly within reach, we believe 2026 will be a defining year for Moleculin,” said Walter Klemp, Chairman and CEO of Moleculin. “The encouraging blinded efficacy data seen so far, particularly in a pretreated population that includes venetoclax failures, reinforces our belief that Annamycin has the potential to represent a significant advancement in AML therapy.” Recent Highlights Reported (n=30) MIRACLE Trial delivered 40% preliminary blinded CRc rate; Received a new independent assessment for the absence of cardiotoxicity in subjects treated with Annamycin, bringing the total number of Annamycin treated subjects reviewed by its independent expert to 90; Entered a new Annamycin research collaboration focused on glioblastoma multiforme (GBM) with CIC biomaGUNE to evaluate intra‑arterial delivery of Annamycin in preclinical models; Announced positive results from a Phase 1 clinical trial of WP1066 in pediatric recurrent malignant brain tumors, showing safety and signs of antitumor immune responses and supporting potential progression to Phase 2; Announced a grant-funded preclinical research agreement with the University of North Carolina at Chapel Hill to evaluate Annamycin for pancreatic cancer treatment; and Announced a targeted new investigator-initiated Phase 1B/2 study of Annamycin in third-line pancreatic cancer with Atlantic Health, based on preclinical data suggesting activity in advanced pancreatic tumors. Clinical Development Update Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) The Company is currently evaluating Annamycin in combination with cytarabine (Ara-C), collectively referred to as AnnAraC, in its pivotal Phase 3 “MIRACLE” tria...

Emory University physician-sponsored clinical trial conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta Results demonstrated WP1066 induces anti-tumor immune responses and were recently published in the Journal of Clinical Investigation Insight WP1066 found to be safe and effective, warranting a Phase 2 trial HOUSTON, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced positive results from the Emory University physician-sponsored Phase 1 clinical trial conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta led by pediatric oncologist, Tobey MacDonald, MD, who discovered STAT3 is critical to certain childhood brain tumors and currently serves as Professor of Pediatrics and Director of the Pediatric Neuro-Oncology Program. WP1066 is Moleculin’s flagship Immune/Transcription Modulator designed to stimulate the immune response to tumors by inhibiting the errant activity of regulatory T cells while also inhibiting key oncogenic transcription factors, including p-STAT3 (phosphorylated signal transducer and activator of transcription 3), c-Myc (oncogene driving many aggressive cancers) and HIF-1α (hypoxia-inducible factor 1α). These transcription factors are widely sought targets because of their role in cancer cell survival and proliferation, angiogenesis (coopting vasculature for blood supply), invasion, metastasis, and inflammation associated with tumors. “The results of this first-in-child trial show some encouraging signals of activity in a highly aggressive chemotherapy resistant brain cancer, such as partial tumor response in a diffuse intrinsic pontine glioma (DIPG) patient and clear anti-tumor immune changes,” said Dr. MacDonald. For the Phase 1 trial, 10 children were treated with WP1066 twice daily for 14 days to determine the maximum feasible dose. Compassionate use treatment in three children with high-grade glioma was also evaluated. Results showed there was no significant toxicity, and a maximum feasible dose was determined. Importantly, WP1066 suppressed the expression of STAT3, inhibiting its activity and demonstrating anti-tumor immune responses. While the preclinical efficacy of WP1066 had been previously demonstrated, and its effectiveness had been studied among adults, this trial was the first to...

- Continues recruitment and opens US and EU sites for the Phase 2B/3 MIRACLE trial - 20+ additional clinical sites in Europe and the US expected to begin recruitment by the end of Q3 - Anticipated data readout of MIRACLE Part A targeted before end of 2025 HOUSTON, Aug. 13, 2025 (GLOBE NEWSWIRE) -- 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 cancers and viruses, today reported its financial results for the second quarter ended June 30, 2025. “The second quarter of 2025 marked a period of momentum for Moleculin. We continued to make meaningful progress in our MIRACLE trial, including a significant expansion into a number of countries, positioning ourselves to achieve our enrollment targets and, importantly, reach an expected pivotal data readout before the end of this year. In addition to progress in our AML program, we reported compelling topline data in our Phase 1B/2 soft tissue sarcoma lung metastases (STS lung mets) trial and continue to build a growing body of preclinical and clinical data showcasing the depth and breadth of the potential Annamycin has to treat a range of cancer indications,” commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. “I am proud of the dedication our team continues to show, and we look forward to building on this progress in the second half of the year and beyond.” Recent Highlights Annamycin for the Treatment of AML Expanded its Phase 2B/3 MIRACLE trial with secured approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia; Four active MIRACLE sites now screening subjects in Ukraine, Georgia, Spain and the US; Expect to add more than 20 additional sites in the European Union (EU) and the US by the end of Q3 2025; and Received positive FDA feedback on pediatric study plan for Annamycin in children with R/R AML, setting the start of that trial in 2027. Other Annamycin Announced the presentation of encouraging preclinical data for Annamycin, which demonstrated significant efficacy against various primary and metastatic liver cancers; Bolstered Annamycin intellectual property portfolio with notice of intent to grant a new European patent; Engaged industry veteran Adriano Treve to explore Annamycin related strategic partnerships; and Reported...

Annamycin delivering better performance 7th line than would be expected even in 2nd line for monotherapy Responders (Stable Disease or Partial Response) after 2 cycles of Annamycin showed improvement in OS and Progression Free Survival (“PFS”) Clinical Benefit Rate (“CBR”) was 59.4% (n=32), comprised of 18 subjects with stable disease and 1 subject with a partial response Potential to address 13,500 new incidents of STS each year and market opportunity expected to grow to $2.6B by 20301 On-demand video webcast with members of the Moleculin management team and internationally renowned Key Opinion Leaders available Thursday, June 5th HOUSTON, June 04, 2025 (GLOBE NEWSWIRE) -- 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 cancers and viruses, today reported positive topline efficacy results from its completed U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (“STS lung mets”) (MB-107). The MB-107 trial was a multi-center, open-label, single-arm monotherapy study that in Phase 1B determined the Maximum Tolerable Dose and Recommended Phase 2 Dose (“MTD”, “RP2D” respectively) and safety of Annamycin and in Phase 2 explored the efficacy of Annamycin as a single agent for the treatment of subjects with STS lung mets for which chemotherapy was considered appropriate. For more information about the MB-107 trial visit clinicaltrials.gov and reference identifier NCT04887298. “These positive topline results from MB-107 are incredibly encouraging. The impact Annamycin demonstrated on median overall survival, particularly with patients who received multiple prior chemotherapy regimens, exceeded expectations. Additionally, the improvement seen with PFS after two doses represents a real potential for Annamycin to provide a meaningful treatment option for the treatment of STS lung mets,” commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. “Looking ahead, we believe these results strongly support further evaluations of Annamycin for the treatment of STS lung mets and we look forward to exploring opportunities to potentially bring this important treatment option to patients.” Topline Efficacy Results Summary Clinical Benefit Rate (“CBR”) was 59.4% (n=32), comprised of 18...

Release Date: May 14, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Moleculin Biotech Inc (NASDAQ:MBRX) has officially started the Phase 3 Miracle trial for Anamycin, with the first patient already treated and 38 sites selected worldwide. The European Medicines Agency has given complete sign-off for the trial in all nine EU countries, marking a significant milestone. The World Health Organization has recognized a new generic drug name for Anamycin, Naxorubicin, aiding in its future market positioning. Additional patent protection for Anamycin has been secured, extending its composition of matter protection into at least 2040. The company is progressing with WP 1,066, a lead statory inhibitor, which is showing promise in treating brain tumors and is in a new clinical trial at Northwestern University. Moleculin Biotech Inc (NASDAQ:MBRX) ended the quarter with $8 million in cash, which will only sustain operations into the third quarter of the year, necessitating a $15 million raise. The company faces potential delays in EU approval due to additional GLP preclinical data requested by the EMA. There are minor differences between the US and EU protocols for the Phase 3 trial, which could complicate the harmonization process. The company acknowledges that the development of an IV delivery for WP 1,066 could encounter speed bumps, potentially delaying progress. The durability of complete remission in the MB 106 trial is still developing, with some patients relapsing after significant periods. Warning! GuruFocus has detected 1 Warning Sign with MBRX. Q: Does the requirement for additional GLP preclinical data by the EMA affect the timeline for EU approval compared to the US? A: Walter Klimt, CEO: We don't believe it will negatively impact the timeline. The EMA requested additional GLP preclinical data, which we can produce. While this could theoretically delay the EU's progression to Part B, we plan to continue recruiting in the US and non-EU sites during this period. Thus, the trial should not slow down, and we expect to meet EU patient requirements without affecting the approval timeline. Q: How close is Emory University to developing an optimal formulation for WP 1,066? A: Walter Klimt, CEO: We are beyond the discovery phase and are now implementing a strategy for a new formulation suitable for IV delive...

Enrollment and dosing underway in Phase 3 clinical trial (the “MIRACLE” trial) evaluating Annamycin (naxtarubicin) for the treatment of R/R AML Regulatory and site selection progress to date supports interim data readout expected in the second half of 2025 Recently received European Medicines Agency (EMA) approval adds nine additional countries to the Company’s ongoing MIRACLE trial; Authorization granted in all EU countries requested Company to host conference call and webcast today, May 14th at 8:30 AM ET HOUSTON, May 14, 2025 (GLOBE NEWSWIRE) -- 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 cancers and viral infections, today reported its financial results for the first quarter 2025 ended March 31, 2025. As previously announced, the Company will host a conference call and live audio webcast to discuss the operational and financial results today, May 14, 2025 at 8:30 AM ET. “We are pleased with the continued progress of our pivotal, adaptive Phase 3 MIRACLE trial and remain encouraged by the Annamycin data demonstrated to date. In particular, with the sites opening in the US, the recent approval from the EMA, and the individual country committee and/or ethics approvals we have received for Belgium, Czechia, France, Germany, Italy, Lithuania, Poland, Romania, and Spain positions us to continue building momentum and remain on track with our expected enrollment and data milestones,” commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. Mr. Klemp continued, “In addition to the progress with our AML program, we are seeing advancements across our pipeline. We continue to be encouraged by the MB-107 trial data demonstrated by Annamycin for the treatment of STS lung mets and expect to report final data readouts from that trial before the end of June. Additionally, investigator-initiated clinical and preclinical work continues on WP1066, our STAT3 inhibitor.” Recent Highlights Received European Medicines Agency (EMA) approval for its Clinical Trial Application (CTA) to conduct Phase 3 MIRACLE clinical trial in all nine countries submitted in the European Union (EU); Announced the International Nonproprietary Names (INN) Expert Committee of the World Health Organization approved “naxtarubicin” for the non-proprietary na...

HOUSTON, May 07, 2025 (GLOBE NEWSWIRE) -- 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 cancers and viruses, today announced that it will report its financial results for the first quarter ended March 31, 2025 on Tuesday afternoon, May 13, 2025. Moleculin management will host a conference call and live audio webcast to discuss the operational and financial results on Wednesday morning, May 14, 2025 at 8:30 AM ET. Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing the Moleculin Biotech Conference Call. The live audio webcast will be accessible on the Events page of the Investors section of the Moleculin website, moleculin.com, and will be archived for 90 days. About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin, is a next-generation highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to eliminate the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. In March of this year, the Company initiated recruitment of patients into its MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study is subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents. Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune respons...

Cash Balance: Approximately $13 million as of the end of the year, including $9 million raised in February 2025. Operating Expenses: Reduced by about $3 million in 2024 compared to 2023. Market Cap: $16.2 million with 14 million shares outstanding. Phase 2 Clinical Trial Results: 50% complete remission rate in second-line AML patients treated with Annamycin plus high-dose Cytarabine. Overall Survival: 11 months for second-line therapy patients in the Phase 2 trial. Progression-Free Survival: Median of 9 months in the Phase 2 trial. Phase 3 MIRACLE Trial: Designed to compare Annamycin plus high-dose Cytarabine against placebo plus high-dose Cytarabine. Interim Data Unblinding: Planned after 45 and between 75-90 subjects in the Phase 3 trial. Shares Trading Volume: Trailing one-year trading volume of 1.4 million shares per day. Warning! GuruFocus has detected 1 Warning Sign with MBRX. Release Date: March 24, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Moleculin Biotech Inc (NASDAQ:MBRX) has initiated the MIRACLE Phase 3 pivotal trial for Annamycin, targeting relapsed and refractory AML patients, with 25 sites selected globally. The company has regulatory and ethics approval in its first European country and expects more approvals in the second quarter. Annamycin has shown promising Phase 2 data with a 50% complete remission rate in second-line AML patients, outperforming existing therapies. The MIRACLE trial includes multiple unblindings of data, providing stakeholders with visibility into the trial's progress. Moleculin Biotech Inc (NASDAQ:MBRX) has reduced operating expenses by $3 million in 2024 compared to 2023, demonstrating financial discipline. The US is expected to be one of the last countries to begin enrolling in the MIRACLE trial due to longer approval processes. The company faces a significant financial challenge, with the Phase 3 trial potentially costing upwards of $60 million to $70 million. Moleculin Biotech Inc (NASDAQ:MBRX) has a limited cash runway, with funds expected to last only until the third quarter of 2025. There is uncertainty regarding which Annamycin dosing regimen will be most effective, requiring further data analysis. The company acknowledges the complexity of achieving early approval, as it requires a very statistically significant result in Part A of the trial. Q: W...