Moleculin Biotech Inc (MBRX)

Buckle up 

We are about to go Parabolic here. Trading will be halted and new SP will open in the $2-$3 range and then it will blast towards $10 Imho

mm arcx moved their big….

..

ask down to .587, someone started to take them out and then they moved lower with another order, but if we take out the biggy, its on!!

wall at .60 to the tune of $117,600, yipes.

burst of buys hitting now, lets do this!!

its inching up now, im hoping for a…

…

run like it did a while back. the recent volume is similar to that last big runner.

Mid day pullback , buying for the flip to .70 

thx for the update there.

Moleculin Expands Phase 3 MIRACLE Clinical Trial into the Country of Georgia, Enrollment Update and Future Plans

July 9, 2025

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 the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in the country of Georgia has approved its Clinical Trial Application (CTA) to conduct 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, Europe and the Middle East. Additionally, the Company expects the first patient to be treated in Georgia to occur by the end of August, if not sooner.

“Building upon our recently announced CTA approval in the European Union (EU) from the European Medicines Agency (EMA), RAMPA approval of the MIRACLE trial protocol represents another important milestone and bolsters our ongoing enrollment efforts,” said Walter Klemp, Chairman and CEO of Moleculin. “We expect to add 16 additional sites in Europe and the US to MIRACLE by the end of August. This will build to more than 30 sites by year-end for Part A of the MIRACLE. Adding to this progress, our recruitment in Part A of MIRACLE has hit seven subjects treated and one in screening with just our first site in Ukraine. All of this, importantly, supports our goal to report initial data on the first 45 subjects from Part A in the second half of 2025.”

Mr. Klemp continued, “This early success in recruitment underscores the capability of our clinical sites, with the first ten screened subjects within just three months of site activation, and it showcases the commitment of ARENSIA Exploratory Medicine’s research clinic in Kyiv, Ukraine (ARENSIA). We are grateful for the continued international regulatory collaboration for this trial and believe it reflects the potential demand for Annamycin and the significant unmet need for better treatment options for R/R AML patients, especially venetoclax regimen failures where the outcomes from currently available therapies are considered dismal. Our team remains focused on driving enrollment and advancing this important program forward.”

The MIRACLE study is a Phase 2B/3 clinical trial whereby data from the 2B portion will be combined with the Phase 3 portion for purposes of measuring its primary efficacy endpoint. MIRACLE is subject to appropriate future filings with and potential additional feedback from the FDA and their foreign equivalents, utilizes an adaptive design whereby the first 75 to 90 subjects will be randomized (1:1:1) 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, which Annamycin doses were specifically recommended by the FDA in the Company’s end of Phase 1B/2 meeting.

The protocol for the MIRACLE trial allows for the unblinding of preliminary primary efficacy data (Complete Remission or CR) and safety/tolerability of the three arms at 45 subjects, in addition to the conclusion of Part A (at 75 to 90 subjects). The first early unblinding will yield 30 subjects treated with Annamycin (190mg/m2 and 230 mg/m2) in combination with HiDAC and 15 subjects treated with just HiDAC plus placebo. The Company expects to reach the first unblinding (45 subjects) in the second half of 2025, in addition to the second unblinding, which is expected in the first half of 2026. This accelerated estimated timeline is due in part to the positive response the Company received in meetings during December with potential investigators regarding recruitment for the trial.

As previously announced with regard to the EU, the clinical trial approval with EMA was granted under the condition that the Company present results of appropriate nonclinical GLP studies before initiating the Phase 3 portion (Part B) of the study. Results will be submitted as a substantial modification to the existing approved CTA.

For Part B of the trial, approximately 220 additional subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin (randomized 1:1). 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.

Patient dosing has commenced, and the initial data readout is on track for the second half of 2025. For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756. Additionally, the clinical trial in the EU is on euclinicaltrials.eu and the reference identifier there is 2024-518359-47-00.

Annamycin, also known by its non-proprietary name of naxtarubicin, 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 EMA.

About ARENSIA Exploratory Medicine GmbH
ARENSIA Exploratory Medicine GmbH is a German operator of proprietary hospital-based research clinics, dedicated to performing complex clinical trials with novel molecules, involving patients across numerous disease areas. ARENSIA aims to speed up patients’ access to innovative therapies by collaborating with cutting-edge pharmaceutical companies and currently operates 13 state-of-the-art research clinics across the United States of America and Eastern Europe.

For more information about ARENSIA and its clinical operations, please visit www.arensia.com.

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 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 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 remains 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 response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications.

For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook.

https://ih.advfn.com/stock-market/NASDAQ/moleculin-biotech-MBRX/stock-news/96399536/moleculin-expands-phase-3-miracle-clinical-trial-i

$MBRX 💹

boomage!!!!

here we go, so far in premarket!

grabbed some premarket.

MBRX..............................................................https://stockcharts.com/h-sc/ui?s=MBRX&p=W&b=5&g=0&id=p86431144783

MBRX under $2

MBRX under $2

MBRX.............................https://stockcharts.com/h-sc/ui?s=MBRX&p=W&b=5&g=0&id=p86431144783

Watching just need those offering shares to be gobbled up above $1.07 holds above a few days .... 6.5m shares of common stock in a concurrent private placement (together with the registered direct offering, the "Offering") at a combined purchase price of 1.07per share and accompanying warrants. The warrants issued pursuant to the concurrent private placement will have an exercise price of 1.07per share,..

MBRX...$1.30...HOD...🥳...Off my $1.04 Alert...

georgie18

Member Level
Re: None

Monday, March 24, 2025 7:45:20 PM

Post#
677861
of 677941
MBRX...$1.04...🥳...https://schrts.co/efYmehcr ...MB-107 trial. 11/13/23- Positive interim data. Final data read-out in Q3 2024 & initiate 1st line STS study in Q3 '24. 3/21/25- CSR finalized but not yet submitted. Final data to be presented by the end of April 2025. ...

https://s3.amazonaws.com/sec.irpass.cc/2705/0001437749-25-008751.pdf

MBRX...$1.04...🥳...https://schrts.co/efYmehcr ...MB-107 trial. 11/13/23- Positive interim data. Final data read-out in Q3 2024 & initiate 1st line STS study in Q3 '24. 3/21/25- CSR finalized but not yet submitted. Final data to be presented by the end of April 2025. ...

https://s3.amazonaws.com/sec.irpass.cc/2705/0001437749-25-008751.pdf

MBRX...........................................................https://stockcharts.com/h-sc/ui?s=MBRX&p=W&b=5&g=0&id=p86431144783

MBRX withdrawal of offering https://ih.advfn.com/stock-market/NASDAQ/moleculin-biotech-MBRX/stock-news/95500799/form-rw-registration-withdrawal-request

MBRX: Indeed!! (It simply had SOARED too hideously, that first day of that news; hopefully now, when their PHASE-3 final results are in, we have an OUTRIGHT CURE for perhaps many types of Cancer.)

MBRX https://ih.advfn.com/stock-market/NASDAQ/moleculin-biotech-MBRX/stock-news/95429160/moleculin-receives-positive-fda-guidance-for-accel
That is no FLUFF pr...

MBRX; I sincerely HOPE so, Bro!! (What a VOLATILE casino Wall Street has become, Dude!! Bottom line, as always, be sure to first 'consult' with my TWO personal 'BROKERS', below!! I.e., my charming San Diego's neighbor's lovely DAUGHTER, & my own personal stock broker for many years now, namely, D. HARRY & SONS, PERSONAL FINANCIAL PLANNERS!!)

#DDAmanda Video: $MBRX: Gain: +257% #1 Early Alert Stock Finder



Z

MBRX...........................................................https://stockcharts.com/h-sc/ui?s=MBRX&p=W&b=5&g=0&id=p86431144783

Gapper Monday.... warrants absorbed w/today's vol. ?

MBRX: This is iHub's "Invest-in-America" to the MBRX High Seas Fleet --- OPEN FIRE!!! Show Wall Street, and the WORLD, what a REAL PHARMA company is all about!!!

MBRX: Maybe not, Dude. (I myself grabbed this at $2.02 --- and COULD have dumped it all for nice profit, within 10-minutes from Open today --- but still holding. YES, we're dealing with the proverbial 'YESTERDAY'S NEWS' here, but we'll see shortly here.)

Im late to game as always

MBRX: Make that $20+ --- good old classic USA Greenbacks (fluck the stupid Bitcoin) --- by day's end today, Homeboys!!!

MBRX: Ten bucks by day's end, Peeps!!! (IMO, that is.) I posit that Planet Earth is just beginning to understand what this Firm is attempting to do for we H. sapiens!!!

MBRX: I grabbed mine about 20-minutes ago via my 'E-Turd' acct., & it wasn't easy to snag. (I'm not enamored of "Direct Offerings", etc., like they did late yesterday --- but we'll see what happens here.)

sweet. i actually managed to scoop up some 1.15 in the AH drop yesterday

MBRX: To dah Moooooooooon!!!

MBRX..................................https://stockcharts.com/h-sc/ui?s=MBRX&p=W&b=5&g=0&id=p86431144783

MBRX: Wrong, Dude!!! Pres. DumbFuck will put a TARIFF on it!!!!

MBRX: Maybe $5-$10, tomorrow anybody????

Bid 

Another halt and Biden shows $4.00

great call.

$3.47!Low float news power .76 to $3s best I can say either it's up to $4.20s next or folks start taking mega profits 

Hey Shorty, how do you like us now??!! 🖕🏽

$MBRX 3.09 halted
https://ih.advfn.com/stock-market/NASDAQ/moleculin-biotech-MBRX/stock-news/95429155/form-8-k-current-report

$MBRX: HOTTTTTTtttttttttt Tamales.............. now $3.10 !!!!!!!!!

A bagger already since my 1st post here


Whatta BANNGER !!!!!!!!!

52wk high on this is $10 going back to last March 1, 2024 !!!!!!!!!!!!

No reason why it can't retest that with this news today.


GO $MBRX

WOOHOOOOOOOOOOOOOOOOOOOO🥳🥳🥳🥳🥳🥳🥳🥳🥳🥳

MBRX....................................https://stockcharts.com/h-sc/ui?s=MBRX&p=W&b=5&g=0&id=p86431144783

$MBRX: WOW............. now $1.66


Massive move from $0.44............ wish I saw it earlier.


GO $MBRX

Short squeeze?!

MBRX...Already out here...🥳