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Moleculin Biotech, Inc. (Nasdaq: MBRX) Just Landed On Our Watchlist This Morning—Tuesday, September 29, 2026
Don’t Miss Our Next Update—Get Real-Time Alerts Sent Directly To Your Phone. Up To 10X Faster Than Email. Get (MBRX) On The Radar While It’s Still Early… September 29, 2026 Dear Reader, Breaking news just hit the wire this morning… Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that it has completed and closed enrollment in Part A of its Phase 2/3 MIRACLE trial — with 89 subjects enrolled and one additional subject currently in screening. That means the comprehensive unblinded data readout is now on track for Q1 2027. The timing of this announcement couldn't be more fitting… Because this is the exact company we've been preparing to bring to your attention this morning. And this story centers on a problem that has challenged cancer treatment for decades. The anthracycline class of cancer compounds has been a backbone of oncology for more than fifty years… But one company may have just found a way to address the biggest limitation that has followed the class since its beginning. Moleculin Biotech, Inc. (Nasdaq: MBRX) is topping our watchlist this morning — Tuesday, September 29, 2026. 
The reason comes down to something that has limited anthracyclines for decades: cardiotoxicity. These agents rank among the most effective weapons against blood cancers and solid tumors. But the cumulative cardiac damage they inflict — sometimes permanent, sometimes fatal — has forced dose caps that leave patients undertreated or unable to receive additional cycles of therapy. For anyone watching the oncology space, the question has always been the same: what if someone could build an anthracycline that kept the cancer-killing power but dropped the heart risk? Moleculin Biotech, Inc. (Nasdaq: MBRX) just published a peer-reviewed pooled analysis across five clinical trials in Frontiers in Cardiovascular Medicine showing zero clinical or subclinical evidence of cardiotoxicity from its lead compound, Annamycin — even at cumulative doses exceeding the lifetime limits placed on conventional anthracyclines. Zero. Across 90 patients. Reviewed independently by the Cleveland Clinic's cardio-oncology laboratory. That's the kind of data that could reshape how the medical community thinks about this entire compound class… Keep in mind, (Nasdaq: MBRX) has a float less than 18M listed as available to the public — with a float that small, the potential exists for big moves if demand begins to shift. And the Wall Street coverage reflects the forward-looking potential here. 
Three firms currently cover (MBRX) with bullish momentum ratings, according to TipRanks: Maxim Group — Jason McCarthy, Ph.D. — target: $2 H.C. Wainwright — Sara Nik, Ph.D. — target: $3 Roth Capital — Jonathan Aschoff, Ph.D. — target: $31 The analyst coverage adds another layer to the story, but the real substance begins with the science behind Annamycin itself. To understand why these cardiac-safety findings matter, it helps to look at how the compound was designed and what the clinical data are showing so far. A Compound Engineered to Solve the Anthracycline Problem
Annamycin isn't just another cancer therapeutic. It was fundamentally re-engineered from the ground up to maintain the tumor-killing power of traditional anthracyclines while eliminating the cardiac damage that has limited them for decades. Its proprietary liposomal formulation was designed to optimize tissue distribution and reduce cardiac exposure… And the clinical evidence increasingly suggests it's working. The peer-reviewed publication, titled "Cardiac safety of L-Annamycin: a pooled analysis of five clinical trials," evaluated cardiac data from 90 patients across AML and metastatic soft tissue sarcoma (STS) trials. Mean LVEF — a standard measure of heart function — was 60.6% at baseline and 60.0% following treatment, with no statistically significant difference. No relationship between cumulative dose and cardiac function decline. No relationship between patient age and cardiac function decline. Patients received a median cumulative dose of 660 mg/m², well above conventional anthracycline lifetime limits… And still, the Cleveland Clinic review found no evidence of treatment-related cardiotoxicity. Walter Klemp, Chairman and CEO of Moleculin, noted that the absence of detectable cardiac toxicity in patients receiving doses beyond traditional thresholds supports continued development of Annamycin and its potential to address an important limitation of the anthracycline class. The MIRACLE Trial: Where the Numbers Get Interesting
Cardiac safety is one thing. But the real question for any cancer compound is whether it works against the disease. And the data coming out of Moleculin's MIRACLE trial — a Phase 2/3 study evaluating Annamycin combined with cytarabine (AnnAraC) in relapsed or refractory AML — suggests it does. The most recent blinded interim data from 62 evaluable patients showed a composite complete remission (CRc) rate of 37% and a complete remission rate of 24%. Here's what makes that especially notable… Nearly half of those patients — 30 out of 62 — had previously failed venetoclax-based therapy. Venetoclax failure is one of the hardest settings in AML. Published salvage remission rates after first-line venetoclax failure hover around 13%, with median survival of roughly 2.4 months. In the MIRACLE trial, the blinded CRc among that subgroup was also 37% — essentially identical to the broader population. That's roughly three times the published salvage rate, in a setting where outcomes are typically grim… And when the first 45 patients were unblinded at the interim analysis, CRc reached 50% and 57% in the two Annamycin dosing arms versus 29% for the control arm. One cycle of therapy. No cardiotoxicity. Enrollment stands at 74 of 90 subjects, with final Part A treatment expected in September 2026 and comprehensive unblinded results anticipated in the December 2026 to February 2027 window. The trial is being conducted across 33 sites in seven countries, with the company targeting at least 45 sites for Part B. And it's worth noting what MIRACLE is structurally: a randomized, double-blind, placebo-controlled, adaptive-design study… That's not a single-arm open-label readout. That's the kind of trial design regulators want to see when evaluating a new compound for approval. With Part A data expected to inform the transition into Part B, and the AML treatment market on a trajectory toward $6.1B by 2028 according to BCC Research, the next few months could carry outsized weight for (MBRX). Beyond AML: Expanding the Compound's Reach
The Annamycin story doesn't end with blood cancers… New preclinical data presented at the AACR Conference on Pancreatic Cancer in September 2026 shows that Annamycin's antitumor activity in pancreatic cancer is partially mediated by CD8+ T cells — the immune system's primary tumor-killing cells. This matters because pancreatic cancer is notoriously "cold" from an immunological standpoint, meaning checkpoint inhibitors have largely failed as single agents. The finding that Annamycin may help convert cold tumors into hot ones — making them visible to immune attack — opens the door to potential combination approaches and significantly broadens the compound's addressable pipeline beyond hematologic cancers. Meanwhile, Moleculin Biotech, Inc. (Nasdaq: MBRX) continues expanding its intellectual property footprint globally. The Mexican Patent Office granted Patent No. 436849 in September 2026, protecting Annamycin's proprietary lung-targeted liposomal formulation through 2040. This adds to the company's growing international patent estate and reinforces long-term commercial exclusivity for the technology. The company's pipeline extends beyond Annamycin as well. WP1066 is an Immune/Transcription Modulator designed to inhibit p-STAT3 and other oncogenic transcription factors while stimulating a natural immune response, currently targeting brain tumors, pancreatic cancer, and other solid tumor indications. WP1122, an antimetabolite, is being developed for the potential treatment of pathogenic viruses and certain cancer indications. Together with the Annamycin platform, these programs give Moleculin multiple shots on goal across distinct mechanisms of action. Annamycin also carries FDA Fast Track Status and Orphan Designation for R/R AML, along with EMA Orphan Designation — designations that can accelerate regulatory review and provide additional market exclusivity upon approval… Composition-of-matter patent protection extends through 2040, with the potential to reach as far as 2045. And the broader AML therapeutics sector continues to expand. According to BCC Research, the global AML treatment space is projected to grow from $3.8B in 2023 to $6.1B by 2028 at a CAGR of 10.0%, driven by the launch of differentiated therapies, rising disease incidence among elderly populations, and advances in molecular diagnostics. 7 Reasons We Have (MBRX) On Our Watchlist This Morning—Tuesday, September 29, 2026…
1. Small-Float: According to Yahoo Finance, less than 18M shares exist in the public float, the potential exists for big moves if demand begins to shift. 2. Peer-Reviewed Cardiac Safety: A pooled analysis across five clinical trials, independently reviewed by the Cleveland Clinic, found zero evidence of cardiotoxicity at cumulative Annamycin doses exceeding conventional anthracycline lifetime limits — published in Frontiers in Cardiovascular Medicine. 3. MIRACLE Trial Efficacy: Blinded CRc of 37% across 62 evaluable patients, with unblinded Annamycin arms reaching 50% and 57% CRc versus 29% for control at the interim analysis — after just one cycle of therapy. 4. Venetoclax-Failure Response: Blinded CRc of 37% among 30 patients who had failed first-line venetoclax — roughly 3x the published salvage remission rate of approximately 13% in that difficult-to-treat population. 5. Approaching Data Readout: Comprehensive unblinded Part A results from the full 90-patient MIRACLE cohort are anticipated in the December 2026 to February 2027 timeframe — a potential value-defining window for the company. 6. Pipeline Expansion Beyond AML: Preclinical data presented at AACR showed Annamycin turning immunologically "cold" pancreatic tumors "hot" through CD8+ T cell activation, suggesting a potential immune-mediated mechanism of action alongside direct cytotoxicity. 7. Strengthening IP and Regulatory Position: FDA Fast Track Status, Orphan Designation from both FDA and EMA, a newly granted Mexican patent through 2040, and composition-of-matter patent protection potentially extending to 2045. Get (MBRX) On The Radar While It’s Still Early…
The AML treatment space is moving fast, and the need for effective, tolerable therapies in the relapsed or refractory setting has never been greater… What makes Moleculin Biotech, Inc. (Nasdaq: MBRX) stand out right now is the convergence of several things happening at once. You have a lead compound that just cleared a major safety validation — peer-reviewed, independently evaluated, published in a respected cardiovascular journal. You have a Phase 2/3 trial producing remission numbers that, even on a blinded basis, triple the published salvage benchmarks in one of AML's hardest-to-treat populations. You have an upcoming data readout in the next few months that could confirm those results in a randomized, controlled setting. And you have a market cap, below $15M according to Yahoo Finance, which may not appear to fully reflect the scope of what's being built here… We have all eyes on Moleculin Biotech, Inc. (Nasdaq: MBRX) first thing this morning. Get (MBRX) on the radar while it’s still early. Sincerely, Jeff Ackerman
Managing Editor,
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