Moleculin MIRACLE Trial Delivers 40% Preliminary Blinded CRc Rate (n=30)

Rhea-AI Summary

Moleculin (Nasdaq: MBRX) reported a preliminary blinded CRc rate of 40% (CR 30%, CRh 10%) in the first 30 subjects of the Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine for R/R AML.

The company has treated 35 subjects, targets unblinding after 45 subjects in Q1 2026, and expects first-arm unblinding in late Q2 2026; safety data to date show absence of cardiotoxicity.

Positive

• Preliminary CRc 40% in first 30 subjects
• CR 30% and CRh 10% components reported
• Treated 35 subjects with target unblinding at 45 in Q1 2026
• Prior safety data from 90 subjects show no cardiotoxicity
• Annamycin holds Fast Track and Orphan Drug designations

Negative

• Preliminary data are blinded and subject to final data lock and audit
• Enrollment challenges: higher-than-expected screen failures due to prior inductions
• Control arm inclusion may depress blinded efficacy signal until unblinding

Market Reaction

+5.26% $4.80 1.5x vol

15m delay 6 alerts

+5.26% Since News

+1.4% Peak in 2 min

$4.80 Last Price

$4.71 $5.14 Day Range

+$646K Valuation Impact

$13M Market Cap

1.5x Rel. Volume

Following this news, MBRX has gained 5.26%, reflecting a notable positive market reaction. Argus tracked a peak move of +1.4% during the session. Our momentum scanner has triggered 6 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $4.80. This price movement has added approximately $646K to the company's valuation. Trading volume is above average at 1.5x the average, suggesting increased trading activity.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.

Key Figures

CRc rate: 40% Sample size: 30 subjects CR rate: 30% +5 more

8 metrics

CRc rate 40% Preliminary blinded composite complete remission in first 30 MIRACLE subjects

Sample size 30 subjects First MIRACLE cohort with preliminary blinded efficacy data

CR rate 30% Complete remission component of MIRACLE CRc rate

CRh rate 10% Complete remission with partial hematological recovery in MIRACLE

Venetoclax failures 35% Approximate share of treated subjects relapsed/refractory after venetoclax

First unblinding target 45 subjects Planned MIRACLE Part A early unblinding cohort size

Prior safety population 90 subjects Previous Annamycin trials with no cardiotoxicity reported

Patent protection Through 2040–2045 Annamycin composition of matter patent life and potential extension

Market Reality Check

Price: $4.56 Vol: Volume 66,903 vs 20-day a...

normal vol

$4.56 Last Close

Volume Volume 66,903 vs 20-day average 91,117 (relative volume 0.73) ahead of this efficacy update. normal

Technical Shares at $4.56, trading below the $11.92 200-day moving average.

Peers on Argus

MBRX gained 5.07%, while only one high‑affinity peer (KZIA) appeared in the mome...

1 Up

MBRX gained 5.07%, while only one high‑affinity peer (KZIA) appeared in the momentum scanner, up 10.67%. Other biotech peers showed mixed moves, suggesting the reaction skewed toward company‑specific trial optimism rather than a broad sector rotation.

Historical Context

5 past events · Latest: Feb 13 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 13	Investor communication	Positive	+2.9%	Launch of CEO Corner platform to share strategic and clinical insights.
Feb 05	Conference participation	Neutral	-6.5%	Announcement of participation in a Webull Corporate Connect webinar.
Jan 15	Other company news	Neutral	+3.1%	Operational expansion update for Fab-Form Industries’ U.S. fulfillment hub.
Jan 13	Safety data update	Positive	+5.9%	Independent assessment confirmed no cardiotoxicity in 90 Annamycin subjects.
Jan 12	Pipeline and milestones	Positive	+1.8%	Outlined MIRACLE trial timelines and broader 2026–2028 clinical milestones.

Pattern Detected

Recent Moleculin news, especially around Annamycin’s safety and pivotal trial progress, has generally coincided with positive price reactions, with only an investor‑event announcement showing a negative divergence.

Recent Company History

Over the past months, Moleculin has highlighted advancing Annamycin toward pivotal development and reinforcing its safety. On Jan 12, the company detailed MIRACLE’s global expansion and 2026–2028 milestones, followed by a Jan 13 update confirming no cardiotoxicity in 90 Annamycin‑treated subjects, both with positive price reactions. Subsequent communications, including webinar and CEO Corner announcements, focused on visibility and investor engagement. Today’s MIRACLE efficacy update builds directly on that safety and execution narrative by adding blinded response data and clearer timing for unblinding.

Regulatory & Risk Context

Active S-3 Shelf · $35.7 million

Shelf Active

Active S-3 Shelf Registration 2025-09-19

$35.7 million registered capacity

An effective shelf registration dated Sep 19, 2025 covers up to 64,864,864 common shares for resale tied to Series F warrants. Moleculin would only receive cash if these warrants are exercised, which at full exercise would total gross proceeds of $35.7 million.

Market Pulse Summary

The stock is up +5.3% following this news. A strong positive reaction aligns with the encouraging bl...

Analysis

The stock is up +5.3% following this news. A strong positive reaction aligns with the encouraging blinded efficacy signals from MIRACLE, notably the 40% CRc rate in 30 subjects and ongoing absence of cardiotoxicity across 90 prior patients. Historically, Moleculin’s stock often responded favorably to Annamycin safety and trial‑progress updates. Investors later weighed these data alongside high pre‑news volatility, warrant overhang from registered shares, and the multi‑step unblinding schedule, factors that could have influenced how durable the reaction became over time.

Key Terms

phase 2b/3, randomized, double-blind, placebo-controlled, primary efficacy endpoint, fast track status, +1 more

5 terms

phase 2b/3 medical

"its pivotal Phase 2B/3 “MIRACLE” study of Annamycin in combination"

A phase 2b/3 trial is a combined late-stage clinical study that first refines the best dose and measures how well a treatment works (phase 2b) then expands to a larger, definitive test of safety and effectiveness needed for regulatory approval (phase 3). For investors, results from a phase 2b/3 act like a dress rehearsal that turns into opening night: positive, well-controlled outcomes substantially raise the chance of approval and future sales, while failures can sharply reduce a drug’s value.

randomized, double-blind, placebo-controlled medical

"global multi-center, randomized, double-blind, placebo-controlled, adaptive designed clinical trial"

A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.

primary efficacy endpoint medical

"combined with the Phase 3 (Part B) portion for purposes of measuring its primary efficacy endpoint"

The primary efficacy endpoint is the single main result a clinical trial is designed to measure to decide whether a treatment works, chosen before the study starts. Think of it as the official scoreboard metric judges use to declare a win or loss; investors watch it because meeting or missing this pre-set goal usually drives regulatory approval odds, market expectations, and a company’s stock value.

fast track status regulatory

"Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA"

A regulatory agency’s “fast track” designation gives a development program priority treatment to speed review and encourage more frequent communication between the company and regulators, like an express lane at airport security that aims to get promising treatments evaluated sooner. For investors, this matters because faster review can shorten the time to potential approval, reduce certain development risks and create earlier value inflection points—though it does not guarantee a successful outcome.

orphan drug designation regulatory

"in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

AI-generated analysis. Not financial advice.

Preliminary blinded CR rate showed 67% improvement over historical cytarabine response

Roughly 35% of the subjects treated to date represent ventoclax regimen failures

First 45 subjects treated on track for Q1 2026 milestone with unblinding thereafter; treated 35 subjects to date with another 11 identified

Continued absence of cardiotoxicity and high efficacy expected to position Annamycin as a “significant advancement” in AML treatment

HOUSTON, Feb. 18, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that it is approaching the first unblinding of data in its pivotal Phase 2B/3 “MIRACLE” study 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), having treated 35 subjects to date with another 11 in screening or identified. Additional subjects continue to be identified by site investigators. The targeted number for the first unblinding of data is 45 subjects with the Company believing it is on track to treat the 45^th subject in Q1 2026 with unblinding of data thereafter. This update is as of February 10, 2026, as treatment, identification and recruitment are ongoing.

Additionally, the Company reports a preliminary composite complete remission (CRc) rate of 40% in the MIRACLE trial’s first 30 subjects treated and with blinded, preliminary efficacy data. This CRc rate is comprised of a complete remission (CR) rate of 30% and complete remission with partial hematological recovery (CRh) of 10%.

“The blinded efficacy rates we’re seeing in MIRACLE are exceptionally encouraging,” said Walter Klemp, Chairman and CEO of Moleculin. “And, of course, this includes the control arm of cytarabine plus placebo, which suggests that the Annamycin results should be better. Even with the control arm included, these preliminary, blinded results substantially outperform historical outcomes for CR with cytarabine alone and reinforce our expectations of what Annamycin can become in the treatment of R/R AML. Of particular note is that roughly 35% of the subjects treated to date are relapsed or refractory (R/R) from a venetoclax regimen, a subject population that is generally considered among the most challenging to address with 2^nd line therapies. With the first unblinding now clearly in sight, we are entering what we believe is a transformational period for the Company.”

Dr. Mohamad Cherry, a prominent thought leader in hematological oncology, remarked, “Seeing blinded efficacy rates at this level in the MIRACLE trial is encouraging for the trial’s overall robustness and suggests a hopeful clinical future for Annamycin as a non-cardiotoxic anthracycline. This could mark a significant advancement in the treatment landscape for relapsed/refractory AML.”

“In another encouraging sign, the subjects treated to date presented with a high degree of genetic markers that are considered predictive of poor treatment response, which makes these results even more impressive. The efficacy rates, observed across six countries to date in MIRACLE, form the basis of our optimism for our outlook in 2026,” Mr. Klemp continued. “Our current blinded CR rate is 67% in excess of the historical response rates seen in two recent HiDAC trials with cytarabine alone, which were around 17-18% CR, and also 50% greater than the median CR rate used for approval of all currently prescribed therapies for second line AML patients. What’s more, when you factor in that we estimate that one third of the subjects treated so far did not receive Annamycin, we believe it is likely that Annamycin is performing at or near the impressive level we saw in our last Phase 2 trial. Coupling this with the recently released safety data from 90 total subjects in prior clinical trials demonstrating Annamycin’s lack of cardiotoxicity, we believe Annamycin has the potential to offer a new avenue for patients battling this challenging disease. We are looking forward to the upcoming significant milestone for the Company and the MIRACLE trial of the unblinding of each arm’s efficacy for the first 45 subjects.”

Mr. Klemp concluded, “Given the importance of this trial and its potential to drive future partnerships and value inflection points, we know there is a great focus on the timing of data unblinding. We are committed to frequent market updates to keep investors informed as visibility on more precise timing for unblinding becomes available.”

MIRACLE Trial Progress and Next Steps

The MIRACLE study (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) is a Phase 2B/3, global multi-center, randomized, double-blind, placebo-controlled, adaptive designed clinical trial whereby data from the 2B (Part A) portion will be combined with the Phase 3 (Part B) portion for purposes of measuring its primary efficacy endpoint. Part A of the MIRACLE trial is designed to evaluate the effectiveness of Annamycin in two dosing arms (190 mg/m² and 230 mg/m²) in combination with cytarabine (also referred to as Ara-C) as compared to a control arm of cytarabine plus placebo. 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 Part A, in addition to the conclusion of Part A (at 90 total subjects). The first early unblinding should yield approximately 30 subjects treated with Annamycin (190 mg/m² and 230 mg/m²) in combination with cytarabine and 15 subjects treated with just cytarabine plus placebo.

The MIRACLE trial is being offered only to AML patients who have had a single prior induction therapy (2^nd line patients or 2L). 49 subjects have provided consent to participate in this important investigation; however the number of subjects who have failed to qualify has been higher than expected, in large part because of a high number of applicants attempting to qualify who had more than one prior induction therapy. The Company views this as an indication of the significant unmet medical need among R/R AML patients.

The currently enrolled subjects, including those who have been treated but have not yet been evaluated for efficacy, are from sites across seven countries, providing a diverse base of subjects. 24 sites have had site initiation visits as the Company targets at least 30 sites for Part B. The Company is focused on improving recruitment in the US as recruitment in Europe has been robust to date.

The Company expects to reach the recruitment and treatment of the first 45 subjects in the first quarter of 2026. The unblinding of the first 45 subjects with efficacy data should occur in late Q2 2026, as the data are subject to final data entry, audit and subsequent data lock. As such, these preliminary data may differ from the final locked efficacy and safety results. The second group of 45 subjects in Part A are expected to be fully recruited in the third quarter of 2026 with unblinding expected in the second half of 2026. Recruitment of the second group of 45 subjects in Part A will continue uninterrupted while the first 45 subjects with efficacy are being unblinded. Unblinding for the full 90 subjects in Part A may require more time than for the first 45 as it involves more data to support the transition from Part A to Part B.

For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756. Additionally, the clinical trial in the EU can be found on euclinicaltrials.eu and the reference identifier 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. Annamycin also benefits from composition of matter patent protection through 2040 with the potential to extend that protection as far as 2045. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the EMA.

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 (the combination of Annamycin and cytarabine, also referred to as “Ara-C”) and, 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 also has in its pipeline 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.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, statements regarding the progress and outcome of clinical trials, including the continued recruitment, treatment, and receipt of the unblinded data for the first 45 subjects of the MIRACLE clinical trial as described, the potential for regulatory approval for Annamycin, the timing of future milestones, and the Company's ability to secure necessary financing. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company’s ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
MBRX@jtcir.com

FAQ

What preliminary efficacy did Moleculin (MBRX) report for Annamycin in the MIRACLE trial on Feb 18, 2026?

A preliminary blinded CRc rate of 40% was reported (CR 30%, CRh 10%). According to the company, this rate covers the first 30 treated subjects and includes control-arm data, so results remain blinded until unblinding.

How many subjects has MBRX treated in the MIRACLE trial and when is the first unblinding planned?

MBRX has treated 35 subjects and targets completing 45 subjects in Q1 2026. According to the company, first-arm unblinding is expected in late Q2 2026 after final data entry, audit, and data lock.

What does the 40% CRc in MIRACLE mean compared with historical cytarabine results for R/R AML?

The 40% CRc is reported as materially higher than historical cytarabine CR rates (~17-18%). According to the company, the preliminary blinded rate is about 67% above those historical HiDAC trial response rates.

Does Annamycin show cardiotoxicity concerns in current and prior data cited by Moleculin (MBRX)?

No cardiotoxicity has been reported to date; prior safety data from 90 subjects showed absence of cardiotoxicity. According to the company, this supports Annamycin's profile as a potentially non-cardiotoxic anthracycline.

Who is eligible for the MIRACLE trial (MBRX) and what is the study design and next recruitment steps?

MIRACLE enrolls adult R/R AML patients after a single prior induction (2L patients) in a randomized, double-blind, placebo-controlled Phase 2B/3 design. According to the company, Part A targets two Annamycin doses versus control and aims for 90 subjects to complete Part A.