Going Green At The Jump, Low Float (Nasdaq: MBRX) Seizes Control Of Today's Watchlist

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Going Green At The Jump, Low Float (Nasdaq: MBRX) Seizes Control Of Today's Watchlist


September 9th

Dear Reader,


Moleculin Biotech, Inc. (Nasdaq: MBRX) is making solid green moves and here's what we're focused on...


Monday's news! Check it out here: Moleculin Doses First EU Patient in Phase 3 Pivotal MIRACLE Trial for Treatment of Acute Myeloid Leukemia.


From the article:


We now have active sites recruiting in the US, Spain, Ukraine, Georgia, and Romania with more sites expected to come online by the end of September. For our first site in Spain to have opened up with two subjects enrolled, we believe, indicates the unmet need in treating second line R/R AML,” said Walter Klemp, Chairman and CEO of Moleculin. “All of this, importantly, supports our goal to recruit the first 45 subjects for Part A before the end of 2025 for which efficacy and safety will be unblinded.


On top of this week's major news announcement, it's critical to note that MBRX has a low float.


With fewer than 30Mn shares in its float, volatility potential could be significantly heightened on a daily basis.


Take a moment to review my initial report below and then consider (Nasdaq: MBRX) for your watchlist.

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There’s a company in the biotech space that’s starting to get a lot of attention for its work in oncology.


What makes it especially interesting right now is that one of its lead drug candidates has already advanced into Phase 3 clinical trials—a big milestone that signals both progress and confidence in its potential.


Beyond that, the pipeline features additional candidates aimed at tackling some very tough cancers, which makes their approach stand out even more.


If you’re keeping an eye on breakthrough therapies in development, this is definitely a story worth digging into further.


And with a low float creating a potential for heightened volatilitymultiple analysts with targets pointing to quadruple-digit upside potential, and a critical news update that only just broke Monday AM, this Nasdaq profile has jumped to my top watchlist spot:


*Moleculin Biotech, Inc. (Nasdaq: MBRX)*


Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and vi-rus-es.


And based on multiple potential catalysts, (Nasdaq: MBRX) has taken over the top spot on my watchlist. Check them out:


#1. A Low Float Could Create A Volatile Environment In Moments.


#2. Breaking News Monday: First EU Patient Dosed In Pivotal Phase 3 MIRACLE Trial.


#3. "Exciting Data" Continues To Roll In With Positive AML Overall Survival Update.


#4. Multiple Analyst Targets Point To Quadruple-Digit Potential Upside For MBRX!


#5. MBRX's Global IP Portfolio Aims To Get A Boost As Company Receives Notice Of Intent To Grant New European Patent.


But more on those in a second...


Annamycin: Next Generation Non-Cardiotoxic(1) and Organotropic Anthracycline

Annamycin is a next-generation anthracycline being evaluated in the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial, 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 (AML). If successful, Annamycin has the potential to transform the standard of care for 2nd line AML. Annamycin is also in development for the treatment of soft tissue sarcoma (STS).


The company believes anthracyclines are among the most important treatments for AML and advanced STS. However, cardiotoxicity issues limit their effectiveness with life-time maximum dosing set by the US FDA.


Annamycin has demonstrated in multiple clinical trials a lack of cardiotoxicity(1), allowing Moleculin to exceed the currently set maximum lifetime dosing for an anthracycline and potentially realizing the full therapeutic potential of anthracyclines to treat serious, hard-to-treat cancers.


In addition to demonstrating a lack of cardiotoxicity(1) in patients treated in Moleculin trials to date, Annamycin is demonstrating to have superior efficacy in 2nd line AML compared to currently available treatments.


Key Highlights:


  • Potential to be safer and more effective than current prescribed anthracyclines


  • Non-cardiotoxic1 and avoids cross resistance with doxorubicin, cytarabine (Ara-C) and Venetoclax


  • Delivers more than double the Complete Response (CR) rate of any approved treatment for relapse/refractory acute myeloid leukemia


  • US FDA Orphan Drug Designation for STS Lung Mets and AML U.S. FDA Fast Track Status for STS Lung Mets


MIRACLE: Pivotal, Adaptive Phase 3 Trial in Acute Myeloid Leukemia


The MIRACLE study, subject to appropriate future filings with and potential additional feedback from the FDA and their foreign equivalents, is expected to initially utilize an adaptive design whereby the first 75 to 90 subjects will be randomized in Part A of the trial to receive high dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin, or 230 mg/m2 of Annamycin, such doses were specifically recommended by the FDA in the Company’s end of Phase 1B/2 meeting. The amended protocol will allow for the unblinding of preliminary primary efficacy data (CR) and safety/tolerability of the three arms at 45 subjects. This early unblinding will yield 30 subjects with Annamycin (190mg/m2 and 230/m2) and HiDAC and 15 subjects with just HiDAC. The Company expects to reach 45 subjects in the second half of 2025, in addition to the planned unblinding expected in 2026 of the next 30-45 subjects.


For Part B of the trial, approximately 244 additional subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin. The selection of the optimum dose will be based on the overall balance of safety, pharmacokinetics and efficacy, consistent with the FDA’s new Project Optimus initiative. This increase from 240 to 244 subjects represents the statistical “cost” of the additional unblinding.


The amended protocol is currently being reviewed by the Institutional Review Board (IRB). Once approved, the amended protocol will be filed with the amendment for the Company’s Initial New Drug (IND) application in the US with the FDA.


Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the European Medicines Agency (EMA).


Potential Accelerated Timeline

Grab Sources And More: MBRX Website. MBRX Presentation.

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And as I mentioned above, (Nasdaq: MBRX) has several potential catalysts that could provide it with some breakout buzz. Look at these:


#1. MBRX Potential Catalyst - A Low Float Could Create A Volatile Environment In Moments.


According to the Yahoo Finance website, MBRX has a fairly low float.


In fact, the website reports this profile to have approximately 29.42Mn shares in its float.


Why is that important? It's important on one crucial level. Volatility potential.


If the company provides more positive company news in the 2nd half of 2025, could it create a near term spark?

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#2. MBRX Potential Catalyst - Breaking News Monday: First EU Patient Dosed In Pivotal Phase 3 MIRACLE Trial.


Moleculin Doses First EU Patient in Phase 3 Pivotal MIRACLE Trial for Treatment of Acute Myeloid Leukemia


Spain site opens with two R/R AML subjects enrolled; One treated


On track to recruit 45 subjects in 4Q25 for initial data unblinding


HOUSTON, Sept. 08, 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 announced that it has enrolled the first two subjects, and treated one, in the European Union (EU) in its pivotal Phase 2B/3, multi-center, randomized, double-blind, placebo-controlled, adaptive design study 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”) 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). This Phase 3 “MIRACLE” trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) is a global approval trial, including sites in the US, the EU, and other parts of Europe.


We now have active sites recruiting in the US, Spain, Ukraine, Georgia, and Romania with more sites expected to come online by the end of September. For our first site in Spain to have opened up with two subjects enrolled, we believe, indicates the unmet need in treating second line R/R AML,” said Walter Klemp, Chairman and CEO of Moleculin. “All of this, importantly, supports our goal to recruit the first 45 subjects for Part A before the end of 2025 for which efficacy and safety will be unblinded.


...


Read the full article here.

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#3. MBRX Potential Catalyst - "Exciting Data" Continues To Roll In With Positive AML Overall Survival Update.


Moleculin Issues New Positive AML Overall Survival Data


Median Overall Survival (OS) of 15 months for subjects with complete remission (n=8)


Median OS of 2nd Line efficacy evaluable population of 12 months (n=9)


Median OS of Intent to Treat population (1L-7L) of 9 months (n=22)


OS demonstrated by Annamycin in the MB-106 trial is significantly above industry expectations for relapsed AML (4-6 months)


Clinical study report anticipated in Q1 2026


Company continues to execute Part A of the pivotal MIRACLE Phase 3 trial


HOUSTON, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), ..., today announced the completion of its 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). Database lock for the trial is expected by the end of September, with the final clinical study report (CSR) projected to be published in early Q1 2026.


In total, 22 subjects were enrolled in the trial, with all subjects (1L-7L) who received AnnAraC per protocol having completed their efficacy evaluations (n=20). The updated overall survival (OS) data reveal the following:


  • Median OS for Complete Remissions (CR): 15 months (n=8) with 4 subjects alive at study close


  • Median OS for the intent to treat (ITT) Population (1L-7L): 9 months (n=22; 13 subjects experienced an event, 9 subjects censored)


  • Median OS for 2L Efficacy Evaluable Population: 12 months (n=9)


Industry publications1 note that the typical OS for relapsed AML patients is roughly 4-6 months, these results highlight a remarkable improvement, exceeding expectations by 30% or more,” said Walter Klemp, Chairman and CEO of Moleculin Biotech.


...


We are glad to finally be in a position to close out our last Phase 2 AML trial, MB-106 by having completed follow-up on all subjects – some with durable CRs continuing – with database lock expected by the end of next month. While still technically preliminary, we are extremely pleased with the results of the MB-106 trial and look forward to the final CSR. These 2L data formed the basis for the design of the Phase 2B/3 pivotal MIRACLE trial with which we aim to gain eventual approval of Annamycin to serve the unmet need in 2L AML,” added Walter Klemp, Chairman and CEO of Moleculin. “We continue to see meaningful, positive trends across all data points, particularly in overall survival and durability. Of note, an 80+ yr old subject who achieved a CR with one cycle of Annamycin and then received two maintenance cycles of Annamycin finally relapsed after 600+ days. He then received a fourth round of Annamycin under compassionate use and is now back in remission. These data are very exciting and continue to give us hope that Annamycin has the potential to address the significant unmet need for safe and effective therapies for R/R AML. We also need to reemphasize that we have not seen any cardiotoxicity in any of the subjects to date, a key aspect of Annamycin.


We can now also report that 50% of subjects achieving CR moved on to a curative bone marrow transplant, which is the most sought-after goal of any induction therapy in AML,” Mr. Klemp continued. “The results we have seen in 2L patients are better than any drug ever approved for second line AML and more than double the average for the last five drugs approved for 2L use.


Looking ahead, we are focused on driving Part A of our Phase 3 MIRACLE trial forward and remain on track recruit the first 45 enrolled patients before the end of this year on which safety and efficacy will be unblinded. The final data from MB-106, coupled with the expected data from the MIRACLE trial will be invaluable as we continue to unlock the full potential of Annamycin for the treatment of AML,” concluded Mr. Klemp.


...


Read the full article here.

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#4. MBRX Potential Catalyst - Multiple Analyst Targets Point To Quadruple-Digit Potential Upside For MBRX!


Check out what we found over at TipRanks:

The TipRanks website is currently sharing that at least 3 different analysts over the last 12 months have slapped significant price targets on MBRX.


On average, these targets amount to $7.00. From Monday's closing valuation, that average target suggests as much as 1,600+% potential upside.


And with a top $13.00 target, MBRX may have as much as 3,200+% potential upside.

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#5. MBRX Potential Catalyst - MBRX's Global IP Portfolio Aims To Get A Boost As Company Receives Notice Of Intent To Grant New European Patent.


Moleculin Receives Notice of Intent to Grant New European Patent for Annamycin


– New patent enhances market position in Europe


HOUSTON, July 30, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), ..., today announced it has received a Notice of Intent to Grant for the European patent application titled, “PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE.“ Such grant should solidify the Company’s European Union exclusivity of Annamycin, also known by its non-proprietary name of naxtarubicin, with the potential to become the first non-cardiotoxic anthracycline.


The grant is subject to payment of fees and completion of final amendments and formalities. When issued, the patent claims will cover methods of making a preliposomal Annamycin lyophilizate with improved stability and high purity, with a base patent term currently extending until into 2040, subject to extension to account for time required to fulfill requirements for regulatory approval. Moleculin’s novel drug candidate is being positioned to become the first ever non-cardiotoxic anthracycline to be approved and is currently being developed for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets). Additional preclinical studies performed at a world-renowned cancer center indicate Annamycin may be a potential treatment for many other types of cancers. The new chemical entity uses a unique lipid-based delivery technology and has shown the potential to be used in a wide range of cancers. In addition to the newly expected European patent and previously issued U.S. patents, Moleculin has additional patent applications related to Annamycin pending in the U.S., Europe and in major jurisdictions worldwide.


Walter Klemp, Chairman and CEO of Moleculin, said, “Our preliposomal formulation for Annamycin not only improves the stability and usability of Annamycin, but also creates a scalable platform that has the potential to be a catalyst for how lipophilic oncology drugs are delivered. We are pleased to add this newly granted European patent to our global intellectual property portfolio and believe it provides further validation of Annamycin’s potential. The current patent portfolio includes patents and patent applications with claims to methods of making our preliposomal Annamycin and liposomal Annamycin suspension as well as the resulting compositions for use in the treatment of cancers in the US, Europe, China, and India, among others. We remain committed to fortifying our global patent protection for Annamycin and advancing the development of this potentially transformative therapeutic candidate for hard-to-treat tumors.


...


Read the full article here.

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(Nasdaq: MBRX) Recap - These 5 Potential Catalysts Lead The Way!


#1. A Low Float Could Create A Volatile Environment In Moments.


#2. Breaking News Monday: First EU Patient Dosed In Pivotal Phase 3 MIRACLE Trial.


#3. "Exciting Data" Continues To Roll In With Positive AML Overall Survival Update.


#4. Multiple Analyst Targets Point To Quadruple-Digit Potential Upside For MBRX!


#5. MBRX's Global IP Portfolio Aims To Get A Boost As Company Receives Notice Of Intent To Grant New European Patent.

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Coverage is now officially underway on Moleculin Biotech, Inc. (Nasdaq: MBRX).


Be on the lookout for updates coming soon.


Sincerely,

FierceAnalyst | Jaks Swift

Editorial Writer


Sources:

#1. Current Cardiology Review, Anthracycline Cardiotoxicity1: Prevalence, Pathogenesis and Treatment, Maria Volkova and Raymond Russel III. Referenced from Cancer. 2003 Jun 1;97(11):2869-79. “Congestive heart failure in patients treated with doxorubicin: a retrospective analysis of three trials”. Swain SM, Whaley FS, Ewer MS., PMID: 12767102


(Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.)


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Pursuant to an agreement between SWN Media LLC and TD Media LLC, SWN Media LLC has been hired for a period beginning on 09/09/2025 and ending on 09/09/2025 to publicly disseminate information about (MBRX:US) via digital communications. Under this agreement, SWN Media LLC has been paid seventeen thousand five hundred USD ("Funds"). These Funds were part of the funds that TD Media LLC received from a third party who did receive the Funds directly or indirectly from the Issuer and does not own st-ock in the Issuer but the reader should assume that the clients of the third party own shares in the Issuer, which they will liquidate at or near the time you receive this communication and has the potential to hurt share prices.


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