Breaking News: Moleculin Biotech (Nasdaq: MBRX) Sets the Stage for a Game-Changing 2025

*Sponsored


After Yesterdat’s Biotech Moved Approximately 72%, Krypton Street Announces Its Next Potential Breakout Idea in 

the Same Sector!


Moleculin Biotech, Inc. (Nasdaq: MBRX) Is #1 On Our Watchlist This Morning.


And Here’s Why…


Moleculin’s Leadership Team Has Achieved 7 FDA Approvals, Showcasing Unmatched Regulatory Expertise.


Analyst’s $8 Target For Moleculin, Suggesting Over A 210% Upside Potential From Yesterday’s $2.58 Opening.


With Fewer Than 3 Million Shares In The Public Float, Moleculin’s Limited Availability Could Drive Significant Swings.


Annamycin, Moleculin’s Flagship, Addresses Cardiotoxicity And Multidr-ug Resistance In Cancer Treatment.


Clinical Trials Show Annamycin Delivers A 50% CR Rate In Second-Line AML, Outperforming Vyxeos And Venetoclax.


Fast Track And Orphan Designations Highlight Annamycin’s Critical Role In Addressing AML And STS Lung Metastases.


Moleculin’s Pipeline Targets Triple-Negative Breast Cancer And Pancreatic Cancer, With Potential Global Impact.









December 11, 2024



Dear Reader,



Moleculin Biotech, Inc. (Nasdaq: MBRX) has just dropped game-changing news, proving once again it’s leagues ahead in the biotech race. 


Annamycin, their revolutionary treatment for AML, is showing groundbreaking preclinical results against Venetoclax-resistant AML—a feat that could reshape treatment outcomes for relapsed/refractory AML patients.


Published at the prestigious ASH Annual Meeting, this study highlights Annamycin’s unmatched potential: synergy with Cytarabine, no cardiotoxicity, and a performance that rivals anything on the market. 


Preliminary clinical data confirm a 60% CRc rate in patients who previously had grim prospects after Venetoclax. 


Add to that immune-memory reinforcing properties, and you have a therapy that's not just innovative but transformative.


With Phase 3 trials for AnnAraC (Annamycin + Ara-C) slated for 2025, Moleculin is poised to deliver on its promise of revolutionizing AML treatment.

 

See the full news release here.



If you’re not watching (MBRX), it’s time to get you up to speed.



Take a look at why Moleculin Biotech, Inc. (Nasdaq: MBRX) is #1 on our watchlist today.


Here’s what makes this next company stand out:


  • A leadership team with 7 FDA approvals and 2 Big Pharma exits, demonstrating unmatched expertise.
  • A flagship compound addressing major barriers in cancer treatment, currently in a pivotal Phase 3 trial.
  • Analysts have set an $8 target, which suggests more than 210% potential upside from yesterday’s $2.58 open.
  • With fewer than 3M shares available, this low float setup could react strongly to upcoming milestones.

Moleculin Biotech, Inc. (Nasdaq: MBRX) isn’t just a biotech company—it’s a leader in innovation, driven by a team with 7 FDA approvals and 2 Big Pharma exits under their belt. 


Taking bold steps to address unmet needs in cancer care, Moleculin is transforming treatment options for acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases with its flagship compound, Annamycin. 


The company’s latest corporate presentation found here underscores a strategic roadmap that’s both ambitious and achievable.


Keep reading to see why (MBRX) is #1 on our watchlist this morning… 



Analyst Target Suggests 210% Potential Upside for Moleculin Biotech, Inc. (Nasdaq: MBRX)

In a report recently published on December 6, 2024, Jason McCarthy, Ph.D., Senior Managing Director and Head of Biotechnology Research at Maxim Group, listed an $8 target for Moleculin Biotech, Inc. (Nasdaq: MBRX), which suggests an upside potential of over 210% from yesterday's opening of $2.58.


With fewer than 3M shares available, Moleculin Biotech, Inc. (Nasdaq: MBRX)’s low float could set the stage for significant swings if demand shifts.


A "low float" means that only a small number of shares are actively available, which can lead to amplified reactions to breaking news or major developments.


For Moleculin Biotech, Inc. (Nasdaq: MBRX), the combination of a limited share count and approaching milestones—such as the start of its Phase 3 MIRACLE trial—creates an environment where even modest increases in attention could result in noticeable shifts. 


Low-float situations like this can create an environment for noticeable swings, especially when tied to significant clinical or regulatory advancements.


As Moleculin Biotech, Inc. (Nasdaq: MBRX) advances its ambitious clinical programs, this setup could make its market performance highly responsive to progress updates and other impactful announcements.


Here’s why Moleculin Biotech, Inc. (Nasdaq: MBRX) is driving progress in the biotech field.


Accelerated Phase 3 MIRACLE Trial: Game-Changing Timeline

The MIRACLE Phase 3 trial (Moleculin R/R AML AnnAraC Clinical Evaluation) focuses on relapsed or refractory AML patients, combining Annamycin with Cytarabine (AnnAraC). 


With a protocol amendment, Moleculin has accelerated the unblinded data readout for efficacy and safety to the second half of 2025. 


This pivotal trial is designed to meet FDA requirements while leveraging an adaptive approach to deliver results faster.


Key points include:


  • Unblinded Data in H2 2025: Moleculin will assess 45 subjects—30 receiving Annamycin and Cytarabine, and 15 receiving Cytarabine plus placebo.
  • Part A and B Structure: Part A randomizes 75-90 subjects to establish the optimal dose, while Part B includes 244 additional subjects to confirm efficacy.
  • Strategic Dosing: FDA-recommended doses of 190 mg/m² and 230 mg/m² of Annamycin are being tested, ensuring regulatory alignment.


This acceleration not only positions Moleculin to gain critical insights earlier but also sets the stage for advanced discussions with potential partners.


Annamycin: Revolutionizing Cancer Treatment


Annamycin is no ordinary compound—it’s a next-generation anthracycline designed to overcome the key limitations of its predecessors.


Key features include:


  • Zero Cardiotoxicity: Unlike traditional anthracyclines, Annamycin has shown no cardiotoxic effects in preclinical and clinical studies.
  • Overcomes Resistance: Engineered to bypass multidr-ug resistance mechanisms, addressing a significant barrier in cancer therapy.
  • Regulatory Advantages: Fast Track and Orphan Designations from the FDA and EMA emphasize Annamycin’s potential to address critical gaps in AML and STS treatment.


With such unique attributes, Annamycin is redefining what’s possible in cancer care.


Moleculin Biotech, Inc. (Nasdaq: MBRX) is strategically positioning itself to become a significant player in the oncology market. 


Annamycin, in combination with Cytarabine (AnnAraC), has demonstrated a remarkable 50% complete response (CR) rate in second-line AML patients, outperforming established treatments like Vyxeos (38%) and Venetoclax (37%). 

This strong clinical efficacy aligns with high-value precedents in the biotech space, such as Jazz Pharmaceuticals’ $1.5B acquisition of Celator (Vyxeos) and Servier’s $2B acquisition of Agios’ oncology business, both of which achieved lower CR rates than Annamycin. 


With superior results and regulatory advantages like Orphan and Fast Track Designations, Moleculin is uniquely positioned as a high-value asset in the fight against AML.


Soft Tissue Sarcoma Lung Metastases: Expanding the Pipeline


Moleculin Biotech, Inc. (Nasdaq: MBRX)’s vision for Annamycin extends beyond AML. 


The compound is also being evaluated for STS lung metastases, where current treatment options are severely limited. 


With promising preclinical and early clinical data, Annamycin’s potential for broader applications is clear.



Unlocking a 20X Growth Potential

Moleculin Biotech, Inc. (Nasdaq: MBRX) isn’t stopping with AML. The company envisions a 20X growth potential for Annamycin as it targets a range of additional indications. 


While the current focus remains on AML and soft tissue sarcoma (STS) lung metastases, Annamycin’s unique attributes—such as its ability to overcome multidr-ug resistance and eliminate cardiotoxicity—make it a strong candidate for broader applications. 


These include triple-negative breast cancer (TNBC), colorectal cancer, and pancreatic cancer, among others.


Together, these indications represent nearly 478,000 annual cases globally, illustrating the significant market Annamycin could capture. 


By addressing multiple high-need cancer types, Moleculin is strategically expanding its reach and redefining the possibilities for targeted oncology therapies.


Fiscal Strength and Strategic Partnerships


Moleculin Biotech, Inc. (Nasdaq: MBRX)’s ability to execute on its ambitious goals is supported by a strong financial foundation and key collaborations:


  • Ca-sh Runway: Moleculin is well-positioned to fund operations into 2025, aligning with key trial milestones.
  • Institutional Support: Partnerships with MD Anderson Cancer Center and other leading institutions bolster the company’s clinical and preclinical programs.


What’s Ahead


Moleculin Biotech, Inc. (Nasdaq: MBRX) is gearing up for a transformational year. With its first patient for the MIRACLE trial set to be dosed in Q1 2025, the company is on the brink of delivering pivotal results that could redefine AML treatment standards. 


The accelerated timeline for unblinded data, combined with Annamycin’s groundbreaking attributes, positions Moleculin as a leader in the fight against cancer.


This isn’t just about following industry trends—it’s about setting them.


7 reasons why Moleculin Biotech, Inc. (Nasdaq: MBRX) is #1 on

our watchlist this morning…


1. FDA Expertise in Action: Moleculin’s team has achieved 7 FDA approvals, reinforcing their ability to navigate regulatory pathways and bring therapies to market.


2. High Growth Potential: Analysts like Jason McCarthy, Ph.D., of Maxim Group, have set an $8 target, which reflects over a 210% potential upside from yesterday’s opening of $2.58.


3. Low Float : With fewer than 3M shares in the public float, the limited availability of (MBRX) shares sets the stage for significant swing potential.


4. Breakthrough Therapy: Annamycin, Moleculin’s flagship compound, addresses two major limitations in cancer treatments—cardiotoxicity and multidr-ug resistance—potentionally raising the bar in oncology care.


5. Impressive Clinical Results: Annamycin has achieved a 50% complete response (CR) rate in second-line AML patients, outperforming established treatments like Vyxeos and Venetoclax.


6. Regulatory Backing: Fast Track and Orphan Designations from the FDA and EMA underscore the significance of Annamycin in tackling AML and STS lung metastases.


7. Ambitious Pipeline Expansion: Moleculin is targeting additional indications, including triple-negative breast cancer and pancreatic cancer, representing nearly 478,000 annual cases globally and signaling broader applications for Annamycin.


Consider adding Moleculin Biotech, Inc. (Nasdaq: MBRX)

to Your Radar This Week…


Moleculin Biotech, Inc. (Nasdaq: MBRX) is proving itself as a force to be reckoned with in the biotech sector. Backed by a leadership team with 7 FDA approvals, the company is demonstrating its expertise in navigating complex regulatory pathways and delivering impactful therapies. Analysts have taken notice, with Jason McCarthy, Ph.D., of Maxim Group setting an $8 target, reflecting a potential upside of over 210% from yesterday’s opening.


With fewer than 3M shares in the public float, Moleculin Biotech, Inc. (Nasdaq: MBRX)’s limited availability sets the stage for potential price movement as milestones approach. Its flagship compound, Annamycin, is not only addressing significant barriers in cancer therapy, such as cardiotoxicity and multidr-ug resistance, but is also achieving impressive clinical results—including a 50% CR rate in second-line AML patients, surpassing competitors like Vyxeos and Venetoclax.


Supported by Fast Track and Orphan Designations from both the FDA and EMA, Annamycin’s progress in AML and soft tissue sarcoma lung metastases is complemented by Moleculin’s ambition to expand its pipeline to tackle high-need cancers like triple-negative breast cancer and pancreatic cancer. With the potential to address nearly 478,000 annual cases globally, Moleculin is positioned to make a profound impact in oncology.


The combination of regulatory expertise, clinical breakthroughs, and a well-defined growth strategy makes Moleculin Biotech, Inc. (Nasdaq: MBRX) a standout in the field. 


This is more than just a biotech company—it’s an emerging leader redefining what’s possible in cancer care.


Moleculin Biotech, Inc. (Nasdaq: MBRX) just dropped game-changing news, proving once again it is leagues ahead in the biotech race.


Moleculin Biotech, Inc. (Nasdaq: MBRX) is #1 on our watchlist today and we’ll have “all eyes” on this one so keep a lookout for my next update.



I’ll check back in with you shortly.


Sincerely,


Alex Ramsay

Co-Founder / Managing Editor

Krypton Street Newsletter

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