INV4
1月前
Independent Market Research Finds Strong Physician Intent to Prescribe Moleculin's Annamycin in Relapsed/Refractory AML
June 5, 2026
Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced results from an independent market landscape assessment evaluating Annamycin in relapsed/refractory acute myeloid leukemia (R/R AML).
The research demonstrated strong physician interest in Annamycin, with oncologists reporting an average likelihood-to-prescribe score of 6 out of 7. Physicians cited Annamycin's reported complete remission rates, MRD-negative responses, potential to bridge patients to bone marrow transplant, biomarker-agnostic applicability and reduced cardiotoxicity as key factors supporting potential adoption.
The study included perspectives from academic and community hematologist-oncologists, medical oncologists and pediatric AML specialists. Respondents consistently identified significant unmet need in R/R AML, particularly for patients without actionable mutations and those who relapse or progress following venetoclax-based therapy. Separately, interviews with hospital administrators and insurers revealed that payers view Annamycin as a potentially meaningful value proposition, driven by its efficacy and safety profile and applicability to a broad patient population.
"These independent research findings are highly encouraging and reinforce the potential role we believe Annamycin can play in addressing one of the most difficult areas of AML treatment," said Walter Klemp, Chairman and Chief Executive Officer of Moleculin Biotech. "A physician likelihood to use score of 6 out of 7 reflects meaningful enthusiasm from clinicians who treat AML patients every day. Importantly, the research highlights that physicians recognize that Annamycin is capable of delivering powerful efficacy, producing deep remissions that position patients for transplant and serving a broader population beyond narrow biomarker-defined subsets. Physicians also recognized Annamycin’s safety profile, with the potential for repeat dosing due to the absence of cardiotoxicity."
Key Research Findings
The independent market assessment found that:
• Hematologist-oncologists reported an average likelihood to prescribe Annamycin of 6 out of 7.
• Physicians expressed strong interest in Annamycin's reported complete remission and MRD-negative remission profile.
• Respondents viewed Annamycin's potential to bridge patients to bone marrow transplant as a meaningful clinical advantage.
• Biomarker-agnostic applicability was viewed as highly relevant given the limitations of mutation-targeted therapies, and physicians noted the potential to combine targeted therapies with Annamycin.
• Reduced cardiotoxicity was identified as an important differentiator, providing the possibility for repeat dosing, particularly given the known cardiac limitations of traditional anthracyclines.
• Pediatric AML specialists viewed reduced cardiotoxicity as especially meaningful due to long-term survivorship concerns.
• Payers indicated that Annamycin's efficacy profile, safety characteristics and broad applicability could support a compelling value proposition.
Significant Unmet Need Remains in R/R AML
Despite recent progress in targeted therapies, respondents reported that the R/R AML treatment landscape remains fundamentally underserved. Physicians noted that targeted therapies have improved treatment for select biomarker-defined patient groups, but many patients still lack effective options, particularly following venetoclax failure or in the absence of actionable mutations.
Durable remission, improved survival and successful transition to potentially curative transplant were consistently identified as the most important treatment goals.
Annamycin Profile Resonates Across Stakeholders
Across respondent groups, Annamycin generated strong interest due to its reported efficacy profile and potential applicability across a broad R/R AML population. Physicians responded favorably to the combination of deep responses, transplant-enabling potential, broad use independent of mutation status and reduced cardiotoxicity.
The research also found that clinicians viewed Annamycin as a differentiated approach that may preserve the established anti-leukemic activity of the anthracycline class while reducing one of the class's most significant historical limitations.
"We believe the findings provide important third-party validation of both the clinical and commercial potential of Annamycin," added Mr. Klemp. "As we continue advancing Annamycin, our focus remains on developing a therapy that may address meaningful unmet needs for AML patients, physicians and healthcare systems."
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 (also known as naxtarubicin), 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 2b/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”) 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.
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$MBRX 🗞️
INV4
1月前
Moleculin CEO, Walter Klemp, Highlights 45 Subject Enrollment Milestone in Recent Virtual Investor “What This Means” Segment
June 4, 2026
Moleculin (Nasdaq: MBRX) announced that CEO Walter Klemp appeared in a Virtual Investor “What This Means” segment.
He discussed reaching enrollment of the 45th subject in the pivotal Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine (AnnAraC) in adult R/R AML, and preparations for interim data unblinding targeted for mid-2026.
HOUSTON, June 04, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that Walter Klemp, Chairman and Chief Executive Officer of Moleculin, participated in a Virtual Investor “What This Means” segment.
As part of the segment, Mr. Klemp discussed the Company’s recent news announcing that the 45th subject has been enrolled in its pivotal Phase 2B/3 MIRACLE trial evaluating Annamycin in combination with cytarabine (AnnAraC) for the treatment of adult subjects with relapsed or refractory acute myeloid leukemia (R/R AML). Mr. Klemp gave insight into how this milestone triggers the final phase of preparation for the trial’s interim 45 subject data unblinding, which remains on track for mid-2026 and represents a potentially defining inflection point for the Company.
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 (also known as naxtarubicin), 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”) 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, the expected timing and results of the 45-subject interim data unblinding in the MIRACLE trial, the anticipated clinical milestones set forth above, and the potential efficacy and safety of Annamycin and AnnAraC in R/R AML and other indications. 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. The Company relies on the reports of its expert with regard to the absence of cardiotoxicity. The dataset referenced in this press release is subject to the review of the data from future subjects in its current and future clinical trials and long-term follow-up with subjects in its current trials. 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
Link article
$MBRX 🗞️
INV4
3月前
Moleculin Releases Next CEO Corner Segment Highlighting Annamycin’s Non-Cardiotoxic Profile
April 7, 2026
Moleculin (Nasdaq: MBRX) released a new CEO Corner segment on April 7, 2026 featuring CEO Walter Klemp discussing Annamycin’s non-cardiotoxic safety profile. The company says Annamycin avoided cardiac damage in preclinical and clinical studies, which could broaden options for relapsed/refractory AML and advanced solid tumor patients.
Mr. Klemp noted potential benefits for physicians, and favorable regulatory and commercial implications as the company advances the MIRACLE Study.
====================
HOUSTON, April 07, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced it has released the next segment on its CEO Corner, a platform featuring Walter Klemp, Chief Executive Officer.
In this segment, Mr. Klemp highlights the differentiated safety profile of Annamycin, emphasizing its lack of cardiotoxicity which is a significant limitation associated with traditional anthracyclines such as doxorubicin. Annamycin was specifically designed to avoid cardiac damage, and has demonstrated this advantage across preclinical and clinical studies. This non-cardiotoxic profile could expand treatment options for patients with relapsed or refractory acute myeloid leukemia (AML) and advanced solid tumors, particularly those previously treated with anthracyclines or with existing cardiac risk factors. Mr. Klemp also notes the potential benefits for physicians in enabling more flexible treatment strategies, as well as the favorable regulatory and commercial implications of a differentiated safety profile. As the Company advances its MIRACLE Study, he underscores that Annamycin’s unique design may position it as a promising new option in oncology, with the potential to reshape the use of anthracyclines in modern cancer care.
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 (also known as naxtarubicin), is a 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 continued recruitment, treatment, and receipt of the unblinded data for the first 45 subjects of the MIRACLE clinical trial as described. 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. The Company relies on the reports of its expert with regard to the absence of cardiotoxicity. The dataset referenced in this press release is subject to the review of the data from future subjects in its current and future clinical trials and long-term follow-up with subjects in its current trials. 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
Link article
$MBRX 🗞️
INV4
4月前
MBRX: HC Wainwright & Co. Reiterates Buy Rating and Price Target | MBRX Stock News
March 24, 2026
Key Takeaways
• HC Wainwright & Co. maintains a Buy rating for Moleculin Biotech MBRX
• The price target remains steady at $22.00.
Today, March 24, 2026, HC Wainwright & Co., led by analyst Sara Nik, has reiterated their Buy rating for Moleculin Biotech (MBRX). The firm maintains its price target at $22.00 USD, unchanged from the prior assessment.
Historical Ratings
• December 11, 2025: Rating - Buy; Price Target raised from $4.00 to $22.00 (450% increase).
• September 10, 2025: Rating - Buy; Price Target maintained at $4.00.
• August 27, 2025: Rating - Buy; Price Target maintained at $4.00.
• June 18, 2025: Rating - Buy; Price Target maintained at $4.00.
• June 9, 2025: Rating - Buy; Price Target announced at $4.00.
Moleculin Biotech Inc is a clinical stage pharmaceutical company focused on the development of a broad portfolio of drug candidates for the treatment of resistant tumors and viruses. The company's Annamycin program is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity.
Based on the one-year price targets offered by 3 analysts, the average target price for Moleculin Biotech Inc MBRX is $21.00 with a high estimate of $31.00 and a low estimate of $10.00. The average target implies an upside of 895.26% from the current price of $2.11. More detailed estimate data can be found on the Moleculin Biotech Inc (MBRX) Forecast page.
Based on the consensus recommendation from 3 brokerage firms, Moleculin Biotech Inc's MBRX average brokerage recommendation is currently 2.0, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
This stock alert was generated using automated technology and GuruFocus financial data to provide readers with timely and accurate market reporting. This content was reviewed by GuruFocus editorial team prior to publication. Please send any questions or comments about this story to editors@gurufocus.com.
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$MBRX 🗞️
INV4
4月前
Moleculin Hits 45 Subject Enrollment Milestone, Triggering Final Countdown to Mid-2026 MIRACLE Trial Data Readout
March 23, 2026
Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that the 45th subject has been enrolled in its pivotal Phase 2B/3 MIRACLE trial evaluating Annamycin in combination with cytarabine (AnnAraC) for the treatment of adult subjects with relapsed or refractory acute myeloid leukemia (R/R AML). This milestone triggers the final phase of preparation for the trial’s interim 45 subject data unblinding, which remains on track for mid-2026 and represents a potentially defining inflection point for the Company.
“We believe this upcoming data readout represents the most important milestone in our history to date,” said Walter Klemp, Chairman and CEO of Moleculin. “This is a critical achievement for Moleculin and, more importantly, for patients facing relapsed or refractory AML. Reaching the 45 subject mark brings us to the threshold of our first meaningful look at MIRACLE data. Based on what we believe to be encouraging blinded results announced in February, we believe we are building real momentum toward what could be a transformative outcome. Our Phase 2 AML MB-106 clinical trial generated greater efficacy than any drug ever approved for relapsed or refractory AML, and it contributed to the more than 100 patients treated to date without any associated cardiotoxicity. What remains now is to demonstrate that a larger Phase 3 trial can produce results that will support new drug approval. The upcoming unblinding of the first 45 subjects should be a strong indicator of that potential. A true next-generation anthracycline has long been sought by medical science and would rightly be considered a gamechanger, not just for AML but for a wide range of cancers. We now appear to be on the threshold of finding out whether this can become a reality.”
Moleculin Biotech continues to advance toward a defining milestone with its ongoing MIRACLE trial, a global, adaptive Phase 2B/3 study designed to evaluate AnnAraC across eight countries to date. The trial protocol provides for early unblinding of data after the first 45 subjects complete treatment, which is expected to yield an initial dataset of approximately 30 patients treated with AnnAraC (at two different dose levels) and 15 patients in the control arm receiving cytarabine plus placebo. This upcoming interim readout is anticipated to provide critical insights into efficacy, safety, and dose optimization as the study progresses toward its Phase 3 portion. Enrollment continues in parallel with the 45th subject unblinding as the Company advances to 90 total subjects thereby concluding Part A of MIRACLE, expected in Q3 2026, with the complete unblinding of Part A thereafter.
Encouraging early signals have already emerged from this difficult-to-treat patient population. In February 2026, Moleculin reported a preliminary blinded composite complete remission rate of 40% among the first 30 patients enrolled in the MIRACLE trial, consisting of 30% complete remission and 10% complete remission with partial hematologic recovery. These findings are particularly notable given that approximately 35% of subjects had previously failed venetoclax-based therapies, and many exhibited adverse genetic markers typically associated with poor outcomes. Additionally, the multinational nature of the trial underscores consistent activity across diverse clinical settings. Even with the inclusion of the control arm, these preliminary blinded aggregate outcomes compare favorably to historical remission rates associated with cytarabine alone in relapsed or refractory acute myeloid leukemia.
The MIRACLE trial’s adaptive design is intended to support a streamlined global registration pathway by integrating data from its Phase 2B portion into the planned Phase 3 portion, in alignment with regulatory guidance, including FDA Project Optimus principles. Following the interim readout, enrollment is expected to continue toward 90 patients to enable a second unblinding, with the Phase 3 portion of the study commencing once the optimum dose is determined. The program remains on track toward a potential accelerated approval pathway based solely on the Complete Remission primary endpoint.
Progress in the MIRACLE trial also reflects broader momentum across Moleculin’s oncology pipeline, which includes ongoing and planned studies targeting pancreatic cancer, brain tumors, and soft tissue sarcoma. With dosing of the 45th subject now complete, the Company is entering a catalyst-rich period leading up to the anticipated mid-2026 interim data readout, a milestone that could significantly influence the future development of Annamycin in the treatment of acute myeloid leukemia.
For additional information on the MIRACLE trial, please visit ClinicalTrials.gov and reference Identifier: NCT06788756.
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 (also known as naxtarubicin), 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”) 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, the expected timing and results of the 45-subject interim data unblinding in the MIRACLE trial, the anticipated clinical milestones set forth above, and the potential efficacy and safety of Annamycin and AnnAraC in R/R AML and other indications. 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. The Company relies on the reports of its expert with regard to the absence of cardiotoxicity. The dataset referenced in this press release is subject to the review of the data from future subjects in its current and future clinical trials and long-term follow-up with subjects in its current trials. 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
Link article
🗞️ 🤓
INV4
4月前
Moleculin to Present at 38th Annual ROTH Conference
March 17, 2026
Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that it will participate in a fireside chat at the 38th Annual ROTH Conference being held March 22-24, 2026 in Dana Point, CA.
Details of the fireside chat presentation are as follows:
Date and Time: Tuesday, March 24, 2026 at 12:00-12:25 PM PT
Location: BROWN - HEALTHCARE - VIRTUAL (SUITE 1051)
Presenters: Walter Klemp, Founder, President, Chairman & CEO; Jon Foster, EVP & CFO
Registration Link: Here
Investors interested in arranging one-on-one meetings should contact their ROTH representative. For more information, please visit the conference website here.
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 (also known as naxtarubicin), 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.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
MBRX@jtcir.com
Link article
🗞️
INV4
4月前
Moleculin Releases Next CEO Corner Segment Highlighting MIRACLE Study
March 11, 2026
Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced it has released the next segment on its CEO Corner, a platform featuring Walter Klemp, Chief Executive Officer. The CEO Corner is designed to provide investors and stakeholders with enhanced insight into the Company’s corporate developments, clinical progress and strategic initiatives.
As part of the segment, Mr. Klemp discussed progress on the Company’s pivotal MIRACLE Study evaluating Annamycin in combination with cytarabine (AnnAraC) for patients with relapsed or refractory Acute Myeloid Leukemia. Mr. Klemp explained that the adaptive Phase 3 trial was designed with input from the U.S. Food and Drug Administration and includes an initial cohort of 45 patients. After treatment of these patients is completed, the study will undergo an interim unblinding to evaluate safety and efficacy and help inform the most efficient regulatory path forward. Enrollment and dosing across clinical sites are progressing as planned, with completion of treatment for the first 45 patients expected in the near term. The study builds on encouraging results from the Company’s earlier MB-106 Study, in which AnnAraC demonstrated overall survival outcomes that exceeded historical benchmarks in this difficult-to-treat patient population.
Access the CEO Corner on the Company’s website here.
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 (also known as naxtarubicin), 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 continued recruitment, treatment, and receipt of the unblinded data for the first 45 subjects of the MIRACLE clinical trial as described. 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. The Company relies on the reports of its expert with regard to the absence of cardiotoxicity. The dataset referenced in this press release is subject to the review of the data from future subjects in its current and future clinical trials and long-term follow-up with subjects in its current trials. 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
Link article
$MBRX 🗞️
INV4
7月前
Form PRE 14A - Other preliminary proxy statements
December 19, 2025
Dear Fellow Stockholder:
On behalf of the Board of Directors (the “Board”) and management of Moleculin Biotech, Inc. (the “Company”), you are cordially invited to attend the Special Meeting of Stockholders of the Company to be held on February 5, 2026 at 10:00 a.m. local time at the corporate offices of Moleculin Biotech, Inc., 5300 Memorial Drive, Suite 950, Houston, TX 77007 (the “Special Meeting”).
The attached Notice of the Special Meeting (the “Notice”) and proxy statement (“Proxy Statement”) describe in greater detail all of the formal business that will be transacted at the Special Meeting. Directors and officers of the Company will be available at the Special Meeting to respond to any questions that you may have regarding the business to be transacted.
The Company’s Board has determined that each of the proposals that will be presented to the stockholders for their consideration at the Special Meeting are in the best interests of the Company and its stockholders, and unanimously recommends and urges you to vote “FOR” the proposals set forth in this Proxy Statement. If any other business is properly presented at the Special Meeting, the proxies will be voted in accordance with the recommendations of the Company’s Board.
We encourage you to attend the Special Meeting in person, but if you are unable to attend, it is important that you vote in advance via the Internet, by telephone, or sign, date and return the enclosed proxy card in the enclosed postage-paid envelope. Your cooperation is appreciated since one-third of the common stock must be represented, either in person or by proxy, to constitute a quorum for the transaction of business at the Special Meeting.
On behalf of the Board and all of the employees of the Company, we thank you for your continued support.
Very truly yours,
MOLECULIN BIOTECH, INC.
NOTICE OF SPECIAL MEETING OF STOCKHOLDERS TO BE HELD FEBRUARY 5, 2026
NOTICE IS HEREBY GIVEN that a Special Meeting of Stockholders (the “Special Meeting”) of Moleculin Biotech, Inc. (the “Company”) will be at the corporate offices at 5300 Memorial Drive, Suite 950, Houston, TX 77007, on February 5, 2026 at 10:00 a.m., local time, for the following purposes:
1. Proposal 1. For purposes of complying with Nasdaq Listing Rule 5635(d), to approve the issuance of up to 2,610,823 shares of Company common stock upon the exercise of certain warrants issued on December 11, 2025 in a private placement (the “Nasdaq Proposal”).
2. Proposal 2. To approve an amendment to the Company’s Amended and Restated Certificate of Incorporation, as amended, to change the Company’s name from Moleculin Biotech, Inc. to Moleculin Inc. (the “Name Change Proposal”)
3. Proposal 3. To approve an adjournment of the Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of the Nasdaq Proposal or the Name Change Proposal (the “Adjournment Proposal”).
Please refer to the proxy statement for the Special Meeting (the “Proxy Statement”) for detailed information on the Nasdaq Proposal, Name Change Proposal and Adjournment Proposal.
The Board of Directors (the “Board”) is not aware of any other business that will be presented for consideration at the Special Meeting. If any other matters should be properly presented at the Special Meeting or any adjournments or postponements of the Special Meeting for action by stockholders, the persons named in the form of proxy will vote the proxy in accordance with their best judgment on that matter.
The Board recommends that you vote “FOR” the Nasdaq Proposal, “FOR” the Name Change Proposal, and “FOR” the Adjournment Proposal.
Only stockholders of record as of the close of business on December 11, 2025 are entitled to receive notice of, to attend and to vote at the Special Meeting. If you are a beneficial owner as of that date, you will receive communications from your broker, bank or other nominee about the Special Meeting and how to direct the vote of your shares, and you are welcome to attend the Special Meeting in person, all as described in more detail in the attached Proxy Statement. The Special Meeting may be adjourned or postponed from time to time without notice other than by announcement at the meeting.
Important Notice Regarding the Availability of Proxy Materials for the Special Meeting to Be Held on February 5, 2026. The Proxy Statement and form of Proxy are available on the Internet at https://materials.proxyvote.com/60855D and on our corporate website at www.moleculin.com under “Investors—SEC Filings.”
WHETHER OR NOT YOU PLAN TO ATTEND THE MEETING, PLEASE SIGN AND DATE THE ENCLOSED PROXY AND RETURN IT IN THE ENVELOPE PROVIDED.
Full article here:
https://investorshub.advfn.com/stock-market/NASDAQ/moleculin-biotech-MBRX/stock-news/97485965/form-pre-14a-other-preliminary-proxy-statements
$MBRX
INV4
7月前
Moleculin Announces Exercise of Warrants for $6.8 Million Gross Proceeds
December 10, 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 tumors and viruses, today announced it has entered into agreements with certain holders of its existing warrants for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 727,969 shares of common stock of the Company originally issued in February 2025 at an exercise price of $6.63 per share and 316,360 shares of common stock of the Company originally issued in August 2025 at an exercise price of $6.3219 per share. The shares of common stock issuable upon exercise of the outstanding warrants are registered pursuant to effective registration statements on Form S-1 (File No. 333-286276) and Form S-3 (File No. 333-290418). The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $6.5 million, before deducting financial advisory fees.
Roth Capital Partners and Maxim Group LLC are acting as the Company’s financial advisors for this transaction.
In consideration for the immediate exercise of the warrants for cash, the Company will issue new unregistered warrants to purchase shares of common stock. The new warrants will be exercisable for an aggregate of up to 2,610,823 shares of common stock, at an exercise price of $6.63 per share and will be exercisable upon shareholder approval and for a term of five years from the date of shareholder approval.
The transaction is expected to close on or about December 11, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.
The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the “1933 Act”) and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (“SEC”) or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.
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.
https://investorshub.advfn.com/stock-market/NASDAQ/moleculin-biotech-MBRX/stock-news/97412739/moleculin-announces-exercise-of-warrants-for-6-8
$MBRX
INV4
8月前
Form 8-K - Current report
Oct 29, 2025
Moleculin Expands Global IP Portfolio with New Australian Patent for Annamycin
HOUSTON, October 29, 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 Australian Patent Office (IP Australia) has granted Patent No. 2024203598 titled, “PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE,” with claims covering certain preliposomal Annamycin lyophilizates with improved stability and high purity, with a base patent term currently extending until June 2040, subject to extension to account for time required to fulfill requirements for regulatory approval. This patent further expands the Company's intellectual property portfolio globally.
Walter Klemp, Chairman and CEO of Moleculin, commented, “As we continue our mission to provide patients with Annamycin, a potentially transformative therapeutic candidate for hard-to-treat tumors, we remain focused on building our global patent protection to strengthen our competitive moat in oncology and bolster our position as a leader in the space. I am proud of our team’s diligent work in securing patent protection across key markets, and adding this Australian patent to our growing global IP portfolio underscores our commitment and belief in the potential of Annamycin. We remain encouraged by the data demonstrated by Annamycin to date and look forward to its continued advancement.”
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 granted Australian patent, this patent family relating to the preparation of preliposomal Annamycin includes an expected Canadian patent and previously issued U.S. and allowed European patents. Moleculin also has additional patent applications related to Annamycin pending in the U.S., Europe and in major jurisdictions worldwide.
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 AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory AML 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, 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.
https://investorshub.advfn.com/stock-market/NASDAQ/moleculin-biotech-MBRX/stock-news/97102682/form-8-k-current-report
$MBRX
INV4
9月前
Moleculin Announces New Investigator-Initiated Study of Annamycin for Treating Pancreatic Cancer
Oct 23, 2025
oleculin 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 it is working with Atlantic Health on an investigator-initiated Phase 1B/2 single-arm study evaluating Annamycin for third-line ("3L") treatment of advanced pancreatic cancer.
Pancreatic cancer continues to present significant treatment challenges, being the cancer with the highest mortality rate globally and the seventh leading cause of cancer death. However, recent preclinical studies indicate that Annamycin may target critical factors associated with this disease, showcasing its potential as a novel therapeutic option.
Walter Klemp, Chairman and CEO of Moleculin, commented, “We are excited to work with Atlantic Health to advance the development of Annamycin for the treatment of pancreatic cancer. Their interest in funding and conducting this study stems from the compelling preclinical data presented at several American Association for Cancer Research conferences showing a high level of activity by Annamycin against pancreatic cancer and associated liver metastases in preclinical studies. We believe this may be related to Annamycin’s demonstrated high affinity for and ability to concentrate in the pancreas, especially considering the well-documented challenge of achieving adequate drug uptake to the pancreas with existing therapies. In addition, recent published data1 now reveal that the upregulation of topoisomerase II, the primary target of Annamycin, is highly correlated with poor survival in pancreatic cancer patients, so we have a highly validated target with pancreatic cancer. Coupled with Annamycin’s demonstrated lack of cardiotoxicity, which could enable, for the first time ever, the use of an anthracycline in chronic or maintenance therapies, we believe pancreatic cancer could be an important additional opportunity for Annamycin. Such maintenance therapy demonstrated promising results in a recently concluded clinical study with Annamycin for the treatment of soft tissue sarcoma metastasized to the lungs (MB-107).”
“This study further bolsters our efforts to advance and develop Annamycin through multiple investigator-initiated studies to unlock its potential as a treatment option for many other types of cancers,” Mr. Klemp continued. “We continue to be encouraged by the preliminary preclinical data seen to date and believe Annamycin is a highly promising candidate for patients where there remains significant unmet need, such as pancreatic cancer.”
“Pancreatic cancer remains one of the most devastating and difficult-to-treat malignancies, with limited options once patients progress beyond first- and second-line therapy,” commented Dr. Angela Alistar, MD, Atlantic Health, the study’s principal investigator. “In particular, for the treatment options in the third-line setting, where survival rates are poor, no approved standard of care exists. We are committed to driving innovation in this space and based on the consistent safety and efficacy data, both clinically and preclinically, seen with Annamycin across a broad range of cancers, we believe this represents a great opportunity to address this high unmet need.”
In connection with the planned study, Moleculin will supply Annamycin and be responsible for submitting and maintaining an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA), and Dr. Alistar of Atlantic Health will be responsible for conducting the Phase 1B/2 study. Moleculin estimates the additional cost to run this trial from 2026 into 2030 (for long-term follow-up) will be approximately $1 million, mainly for drug supply and outside laboratory testing.
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 AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory AML from the EMA.
Moleculin is currently conducting 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.
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.
About Atlantic Health
Atlantic Health is at the forefront of medicine, setting standards for quality health care in New Jersey, Pennsylvania and the New York metropolitan area. Powered by a workforce of 24,000 team members and more than 7,779 affiliated physicians dedicated to building healthier communities, Atlantic Health serves more than half of the state of New Jersey including 14 counties and 7.5 million people.
The not-for-profit system offers more than 550 sites of care, including its eight hospitals: Atlantic Health Morristown Medical Center in Morristown, NJ, Atlantic Health Overlook Medical Center in Summit, NJ, Atlantic Health Newton Medical Center in Newton, NJ, Atlantic Health Chilton Medical Center in Pompton Plains, NJ, Atlantic Health Hackettstown Medical Center in Hackettstown, NJ, Atlantic Health Goryeb Children’s Hospital in Morristown, NJ, Atlantic Rehabilitation Institute in Madison, NJ and Atlantic Health CentraState Medical Center in Freehold, NJ.
For more information, visit www.atlantichealth.org.
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 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.
https://investorshub.advfn.com/stock-market/NASDAQ/moleculin-biotech-MBRX/stock-news/97065505/moleculin-announces-new-investigator-initiated-stu
$MBRX
INV4
9月前
Beyond Traditional Drugs: Novel Platforms Targeting Hard-to-Treat Conditions
Oct 21, 2025
Equity Insider News Commentary
Issued on behalf of Avant Technologies Inc.
VANCOUVER, Oct. 21, 2025 /CNW/ -- Equity InsiderNews Commentary – Conventional small molecule approaches have struggled to address genetic defects and complex disease mechanisms, leaving millions with conditions that traditional pharma cannot cure. New FDA guidances from October 2025 outline streamlined approval pathways for cell and gene therapies targeting severe conditions in small populations[1], signaling regulatory momentum toward advanced platforms that replace, repair, or modify disease-causing genes rather than simply managing symptoms. These companies represent a new generation of biotechs pursuing targeted solutions where traditional drugs have reached their limits: Avant Technologies, Inc. (OTCQB: AVAI), Lexeo Therapeutics, Inc. (NASDAQ: LXEO), Moleculin Biotech, Inc. (NASDAQ: MBRX), Acadia Pharmaceuticals Inc. (NASDAQ: ACAD), and Fractyl Health, Inc. (NASDAQ: GUTS).
Equity Insider Logo (PRNewsfoto/Equity Insider)
According to Precedence Research, the precision medicine market reached $118.52 billion in 2025 and analysts project growth to $463.11 billion by 2034[2], driven by breakthroughs in gene editing technologies and personalized therapeutic approaches that match treatments to individual genetic profiles. October 2025 saw multiple gene therapies receive platform technology designations and rare disease pathway selections from the FDA[3], reflecting regulatory priorities that favor companies developing durable, one-time treatments for high-unmet-need populations including rare genetic disorders, neurodegenerative diseases, and treatment-resistant cancers.
Avant Technologies, Inc. (OTCQB: AVAI) has executed a strategic transformation toward a partnership-driven business model that could position the company at the intersection of disease detection and advanced cell-based therapeutics. Through strategic joint ventures, Avant appears to be building what may become an integrated healthcare platform, identifying genetically modified cell lines to address hard to treat diseases while developing targeted cell-based treatments through innovative biotechnology partnerships.
Back in June 2025, Avant announced plans to create a new company to house a joint venture, partnership, or acquisition as it explores expanding its interests in a diabetes development program offering potential treatment opportunities.
Chris Winter, CEO of Avant, said, "We are exploring several promising opportunities to get involved in the development of a treatment for diabetes globally."
Avant's most clinically advanced partnership, Klothonova, Inc., is a 50/50 joint venture with Singapore-based cell therapy pioneer Austrianova that demonstrates the company's treatment development capabilities. Klothonova focuses on developing cell-based therapies utilizing encapsulated Klotho-producing cells targeting age-related diseases while also developing anti-aging therapies for the promotion of longevity and quality of life.
The program successfully completed its initial R&D proof of concept phase, where Austrianova generated genetically modified human cells that over-produce the Klotho protein. These cells were successfully encapsulated in Austrianova's proprietary Cell-in-a-Box® technology and shown to produce the Klotho protein continuously, demonstrating the feasibility of this approach. The program is now advancing to GMP-grade production for potential preclinical and clinical studies, with preparations underway at Austrianova's ISO9001:2015 compliant facility.
"The R&D level proof of concept study provides a clear rationale for the program, giving a green light to move to GMP studies," said Winter. "By prioritizing GMP compliance from the outset, Klothonova is committed to delivering safe, effective treatments that could transform the landscape of age-related disease management."
The scientific foundation for Klotho-based therapies appears compelling. Studies show higher Klotho levels correlate with up to 30% increased lifespan, while individuals with lower Klotho levels had 31% higher mortality rates. Critically, natural Klotho levels drop by 50% after age 40, potentially creating substantial therapeutic opportunities for this "longevity protein" that affects brain, heart, kidney, and immune function.
Austrianova's cell-encapsulation platform is backed by over 50 peer-reviewed publications and 30+ years of development. The technology represents an approach that has been studied for multiple therapeutic protein applications. While Avant has not disclosed specific details about which approaches it may pursue for its diabetes treatment exploration, the company's partnerships demonstrate capabilities in both disease detection and cell-based therapeutic development.
The potential market opportunity spans multiple therapeutic areas. The global Alzheimer's market is projected to reach $32.8 billion by 2033, cardiovascular disease remains the world's leading cause of death, and kidney disease affects 850 million people worldwide. The cell-based therapy market could reach $44 billion globally.
"Our transition to a partnership-driven model represents a transformative step for Avant," said Winter. "By combining forces with top-tier experts, we're not just identifying diseases. We're actively developing solutions that could change lives."
CONTINUED... Read this and more news for Avant Technologies at:
https://equity-insider.com/2025/03/21/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/
Lexeo Therapeutics, Inc. (NASDAQ: LXEO) has achieved significant progress toward an accelerated approval pathway for LX2006 in Friedreich ataxia cardiomyopathy, with the FDA indicating openness to pooling data from ongoing Phase I/II studies with pivotal trial data to support a Biologics License Application. Participants with abnormal baseline left ventricular mass index achieved a 23% mean reduction at 12 months, exceeding the FDA-aligned target threshold of 10%. Interim data from 16 participants showed sustained improvements across both cardiac and neurologic measures, with 14 of 16 participants achieving over 25% reduction in high-sensitivity troponin I and clinically meaningful improvement in the modified Friedreich Ataxia Rating Scale.
"We are encouraged by our recent dialogue with the FDA on LX2006, and we appreciate the Agency's collaborative spirit as we work to deliver a potentially life-changing therapy to the FA community as efficiently as possible," said R. Nolan Townsend, CEO of Lexeo Therapeutics. "Given the highly compelling data to date that demonstrate clinically meaningful improvements across both cardiac and neurologic measures of FA, we are now pursuing a development strategy that could enable a smaller pivotal study, given the potential to pool data with the ongoing Phase I/II trials, as well as potentially assessing the co-primary endpoint of LVMI earlier than 12 months."
The company plans to initiate the LX2006 pivotal study in the first half of 2026 pending protocol finalization, with LX2006 having received Breakthrough Therapy, Regenerative Medicine Advanced Therapy, Orphan Drug, and Fast Track designations from the FDA. Treatment with LX2006 has been generally well tolerated with no Grade 3+ serious adverse events to date across 17 participants.
Moleculin Biotech, Inc. (NASDAQ: MBRX) has secured a notice of allowance from the Canadian Intellectual Property Office for Patent Application No. 3,142,510 covering methods of making preliposomal Annamycin lyophilizate with improved stability and high purity. The patent claims extend until June 2040, subject to extension for regulatory approval timelines, strengthening the company's intellectual property portfolio for its lead anthracycline candidate Annamycin being developed for acute myeloid leukemia and soft tissue sarcoma lung metastases. This Canadian patent complements previously issued U.S. and allowed European patents, with additional applications pending in major jurisdictions worldwide.
"We remain committed to bolstering our global intellectual property portfolio for Annamycin," said Walter Klemp, Chairman and CEO of Moleculin. "This Canadian patent further strengthens our current IP portfolio which includes claims to methods of making our preliposomal Annamycin, in yet another key territory."
Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML, plus Orphan Drug Designation for soft tissue sarcoma lung metastases from both the FDA and EMA. The company has begun the MIRACLE Trial (MB-108), a pivotal Phase 3 adaptive design study evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia, positioning the candidate as potentially the first non-cardiotoxic anthracycline to receive regulatory approval.
Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) is presenting clinical data across multiple therapeutic programs at the 2025 International Congress of Parkinson's Disease and Movement Disorders, including a late-breaker oral platform presentation on ACP-711, an investigational GABAA subunit a3 selective modulator under development for essential tremor.
The company is showcasing preclinical efficacy, safety, and mechanism of action findings on ACP-711, alongside presenting the Phase 2 study design for ACP-204 in adults with Lewy body dementia psychosis and encore findings from post-hoc analysis evaluating duration of illness and response to NUPLAZID (pimavanserin) in Parkinson's disease psychosis. NUPLAZID, approved by the FDA in April 2016, is a selective serotonin inverse agonist targeting 5-HT2A receptors for treatment of hallucinations and delusions associated with Parkinson's disease psychosis.
The company's robust pipeline demonstrates progress beyond NUPLAZID, with ACP-204 representing a novel 5-HT2A inverse agonist/antagonist advancing through mid-stage development for Lewy body dementia psychosis. Acadia's portfolio reflects commitment to underserved neurological disease communities, developing therapeutic advancements with programs in Alzheimer's disease psychosis and other neuropsychiatric conditions affecting patients with limited treatment options.
Fractyl Health, Inc. (NASDAQ: GUTS) announced potent preclinical results from RJVA-002, a dual GIP/GLP-1 gene therapy candidate for obesity, with data showing approximately 30% weight loss at five weeks in a diet-induced obesity mouse model, with the weight loss trajectory not yet plateaued. The single administration of RJVA-002 led to dose-dependent reductions in body weight, with mid-dose and high-dose cohorts achieving 18% and 29% mean weight loss respectively by day 35, with no adverse effects observed in treated animals. These translational results suggest RJVA-002 has potential to match or exceed best-in-class chronic drug therapy from a single point-in-time treatment, expanding the company's Rejuva Smart GLP-1 platform from durable treatment of type 2 diabetes to obesity.
"These RJVA-002 data further support our Smart GLP-1 gene therapy platform approach and suggest that dual gut hormone expression has the potential to produce powerful metabolic effects," said Harith Rajagopalan, M.D., Ph.D., Co-Founder and CEO of Fractyl Health. "Together with the recently reported REMAIN-1 data, and with RJVA-001 nearing the clinic in 2026, these results underscore the strength and breadth of our portfolio."
The company is advancing a multi-modality strategy with RJVA-001 expected to enter first-in-human clinical trials in 2026 for patients with inadequately controlled type 2 diabetes, while RJVA-002 targets dual incretin biology with the goal of achieving durable, well-tolerated weight loss from a single intervention. Fractyl has submitted the first Clinical Trial Application module for RJVA-001 to regulators and has a robust intellectual property portfolio with 33 granted U.S. patents and approximately 40 pending U.S. applications.
Source: https://equity-insider.com/2025/03/21/unlocking-the-trillion-dollar-ai-market-what-investors- need-to-know/
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https://investorshub.advfn.com/stock-market/NASDAQ/moleculin-biotech-MBRX/stock-news/97047760/beyond-traditional-drugs-novel-platforms-targetin
$MBRX
INV4
9月前
Moleculin Announces Notice of Allowance for Canadian Patent Covering Annamycin
September 25, 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 Canadian Intellectual Property Office (CIPO) has issued a notice of allowance for Patent Application No. 3,142,510 titled, “PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE.” A patent from the application is expected to be issued in the coming months.
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 June 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 Canadian patent and previously issued U.S. and allowed European 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, commented, “We remain committed to bolstering our global intellectual property portfolio for Annamycin. This Canadian patent further strengthens our current IP portfolio which includes claims to methods of making our preliposomal Annamycin, in yet another key territory. As we continue to advance our development of Annamycin as a potentially transformative therapeutic candidate for hard-to-treat tumors, building on our global patent protection remains a focus.”
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 AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory AML 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, 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.
https://investorshub.advfn.com/stock-market/NASDAQ/moleculin-biotech-MBRX/stock-news/96885955/moleculin-announces-notice-of-allowance-for-canadi
$MBRX
INV4
10月前
Moleculin Accelerates Recruitment in Phase 3 Acute Myeloid Leukemia “MIRACLE” Clinical Trial
September 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 updates to its active site status and recruitment for 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.
To advance this trial to recruiting the 45th subject in Q4 2025 for its first unblinding for early data insights into the trial’s efficacy and safety endpoints, the Company has the following expectations for September:
Global Expansion: Expanding recruiting beyond Ukraine to include Spain, Georgia, Poland, Romania, Italy, Lithuania, and the US;
Site Expansion: Adding 8 new active sites by the end of September, increasing the total to 20 sites recruiting;
Recruitment Goals: Treating, enrolling, or screening a total of 20 subjects by the end of September; and
Data Insights: Setting a solid footprint to recruit the 45th subject in Q4 2025, allowing for unblinded preliminary data assessment regarding efficacy and safety upon data lock.
Walter Klemp, Chairman and CEO of Moleculin, commented, “Our team is diligently expanding our active site footprint across the US, EU, and neighboring regions. We are confident in our target to recruit the 45th subject by Q4 2025 and achieve our first data unblinding shortly thereafter, especially since the consistent message we are receiving from investigators is that they are very eager to enroll patients in the MIRACLE trial. Moving from our end of Phase 2 meeting with the FDA to screening 13 subjects in just over a year exemplifies our operational efficiency. Of these 13, 10 have been dosed, further supporting our confidence in the speed of recruitment for MIRACLE.”
Mr. Klemp continued, “We expect to increase to over 30 active sites by year-end, as we move toward a second data unblinding for the conclusion of Part A of the trial. That will only require an additional 30 to 45 subjects, so we expect to conclude Part A in the first half of 2026, before commencing Part B of the trial. This level of early visibility is, we believe, exceptionally rare for a Phase 2B/3 trial and highly advantageous for investors.”
The MIRACLE study is a Phase 2B/3 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. 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 recruitment of the first 45 subjects in the second half of 2025 with unblinding shortly thereafter, 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.
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. 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, 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://investorshub.advfn.com/stock-market/NASDAQ/moleculin-biotech-MBRX/stock-news/96785628/moleculin-accelerates-recruitment-in-phase-3-acute
$MBRX
INV4
10月前
Moleculin Announces Exercise of Warrants for $6.0 Million Gross Proceeds
August 28, 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 tumors and viruses, today announced it has entered into agreements with certain holders of its existing warrants for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 16,216,216 shares of common stock of the Company originally issued in June 2025 at an exercise price of $0.37 per share. The shares of common stock issuable upon exercise of the outstanding warrants are registered pursuant to an effective registration statement on Form S-1 (File No. 333-287727). The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $6.0 million, before deducting financial advisory fees.
Roth Capital Partners is acting as the Company’s financial advisor for this transaction.
In consideration for the immediate exercise of the warrants for cash, the Company will issue new unregistered warrants to purchase shares of common stock. The new warrants will be exercisable for an aggregate of up to 64,864,864 shares of common stock, at an exercise price of $0.55 per share and will be exercisable upon shareholder approval and for a term of five years from the date of shareholder approval.
The transaction is expected to close on or about August 28, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.
The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the “1933 Act”) and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (“SEC”) or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.
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.
https://investorshub.advfn.com/stock-market/NASDAQ/moleculin-biotech-MBRX/stock-news/96718683/moleculin-announces-exercise-of-warrants-for-6-0
$MBRX
INV4
10月前
Moleculin Issues New Positive AML Overall Survival Data
August 27, 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 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.
As previously reported, 8 subjects in the ITT population of 22 (36%) achieved a complete remission (CR) following treatment with AnnAraC. Among the subjects treated in the second line (2L) setting (n=10), the CR rate (the same primary efficacy endpoint as in the ongoing Phase 2B/3 pivotal MIRACLE trial), was 50%. Median durability for the 8 subjects achieving a CR was 10 months and continuing at the end of the study. CR durability ranged from 2 months to 22 months. CRs were achieved in subjects with a variety of prior treatments, including traditional 7+3 and venetoclax regimens.
“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.
The median age of subjects in MB-106 is 68 years. A total of 18 subjects had relapsed/refractory AML and 4 subjects were first line treatment. Two subjects discontinued early due to allergic reactions. All subjects who completed treatment had undergone post therapy disease response assessments (bone marrow assessment and/or peripheral blood evaluation) (Day 15 or later). No clinically significant signs of cardiotoxicity were noted during or after treatment in any of the subjects enrolled. The combination was well tolerated with myelosuppression and infections being the main adverse events (AEs). All data from MB-106 is preliminary and subject to change.
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.
The Company is currently 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”) in a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). This global Phase 3 “MIRACLE” trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) includes sites in the US, Europe and the Middle East. 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.
1 - Bruno C. Medeiros, Is there a standard of care for relapsed AML?, Best Practice & Research Clinical, Haematology, Volume 31, Issue 4, 2018, Pages 384-386, ISSN 1521-6926; Roboz GJ, Sanz G, et al. Guadecitabine vs TC in relapsed/refractory AML after intensive chemotherapy: a randomized phase 3 ASTRAL-2 trial. Blood Adv. 2024 Apr 23;8(8):2020-2029. doi: 10.1182/bloodadvances.2023012062. PMID: 38231126; PMCID: PMC11103175.; Faderl S, Wetzler M, et al. Clofarabine plus cytarabine compared with cytarabine alone in older patients with relapsed or refractory acute myelogenous leukemia: results from the CLASSIC I Trial. J Clin Oncol. 2012 Jul 10;30(20):2492-9. doi: 10.1200/JCO.2011.37.9743. Epub 2012 May 14. PMID: 22585697; PMCID: PMC4874149.
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://investorshub.advfn.com/stock-market/NASDAQ/moleculin-biotech-MBRX/stock-news/96711002/moleculin-issues-new-positive-aml-overall-survival
$MBRX
INV4
11月前
Moleculin Biotech (Nasdaq: MBRX) has received a Notice of Intent to Grant for a European patent application for its drug candidate Annamycin (naxtarubicin). The patent, extending until 2040, covers methods of making preliposomal Annamycin lyophilizate with improved stability and high purity.
Annamycin is positioned to become the first non-cardiotoxic anthracycline for treating acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases. The drug has received Fast Track Status and Orphan Drug Designation from both FDA and EMA, utilizing a unique lipid-based delivery technology with potential applications across various cancer types.
Positive
• Patent protection in Europe extends until 2040, strengthening market exclusivity
• Drug candidate positioned to be first-ever non-cardiotoxic anthracycline
• Fast Track Status and Orphan Drug Designation from both FDA and EMA
• Novel lipid-based delivery technology with potential for multiple cancer applications
===================
Biotech Patent Specialist = positive
Moleculin secures European patent protection for Annamycin until 2040, strengthening its position in cancer therapeutics with potentially first non-cardiotoxic anthracycline.
This European patent notice represents a significant intellectual property milestone for Moleculin's Annamycin (naxtarubicin) program. The patent specifically covers their preliposomal lyophilizate formulation technology, which solves crucial stability and purity challenges common in liposomal drug delivery systems. With protection extending into 2040 (potentially longer with regulatory extensions), this patent substantially strengthens Moleculin's market exclusivity position in Europe.
The patented formulation technology addresses two critical pharmaceutical development hurdles: stability and manufacturing scalability. The preliposomal approach allows for a shelf-stable precursor that converts to the active liposomal form when needed, overcoming the notorious stability limitations of conventional liposomal formulations. This technological advantage creates a dual commercial moat - both for Annamycin specifically and potentially as a platform technology for other lipophilic oncology drugs.
This patent complements Moleculin's regulatory advantages, including Fast Track Status and Orphan Drug Designations from both FDA and EMA. These designations provide additional market exclusivity beyond the patent life and potential accelerated approval pathways. The company's strategic patent estate now spans major pharmaceutical markets including the US, Europe, China, and India - covering both composition and manufacturing methods. This comprehensive approach to intellectual property protection maximizes the commercial potential for Annamycin in both acute myeloid leukemia and soft tissue sarcoma lung metastases indications.
===================
Oncology Drug Development Expert = Positive
Moleculin's patent strengthens its position in developing what could be the first non-cardiotoxic anthracycline, potentially transforming cancer treatment standards.
Anthracyclines represent one of the most potent classes of chemotherapy, but their clinical utility has been severely limited by cumulative, dose-dependent cardiotoxicity that can lead to heart failure. If Annamycin (naxtarubicin) successfully maintains efficacy while eliminating this cardiotoxicity, it would represent a paradigm shift in cancer treatment, particularly for acute myeloid leukemia (AML) where anthracyclines are backbone therapies.
The patented preliposomal formulation technology addresses a fundamental challenge in anthracycline development. Traditional anthracyclines like doxorubicin cause cardiotoxicity partly because they distribute broadly throughout the body, including heart tissue. Moleculin's lipid-based delivery system appears designed to alter this biodistribution profile, potentially achieving preferential tumor accumulation while sparing cardiac tissue.
Moleculin's development strategy targeting both AML and soft tissue sarcoma lung metastases is clinically sound. Both indications have significant unmet needs and represent logical applications for an anthracycline with improved safety. The dual-indication approach also diversifies clinical development risk. The company's reference to preclinical studies at a "world-renowned cancer center" suggesting broader applications implies the potential for label expansion into additional cancer types.
The regulatory designations - Fast Track and Orphan Drug status from both FDA and EMA - provide significant advantages beyond market exclusivity. These designations enable enhanced regulatory interactions, potential for accelerated approval pathways, and reduced development costs. Combined with the patent protection, Moleculin has constructed a comprehensive strategy to maximize Annamycin's potential to reach patients with difficult-to-treat cancers.
Link article
$MBRX
INV4
11月前
Moleculin Receives Notice of Intent to Grant New European Patent for Annamycin
July 30, 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 tumors and viruses, 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.”
Annamycin (naxtarubicin), currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. 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, 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/96523821/moleculin-receives-notice-of-intent-to-grant-new-e
$MBRX
INV4
11月前
Moleculin Engages Industry Veteran Adriano Treve to Explore Accelerated Strategic Partnerships
July 17, 2025
... Mr. Klemp concluded, “With the timeline now visible for our Phase 3 data, interest from potential strategic partners has significantly increased. Adding Mr. Treve alongside our Business Advisor Mr. Dennis McNamara, with over 30 years’ experience with strategic transactions for emerging life sciences companies, is a combination that should significantly expand opportunities for Moleculin going into 2026 and is intended to help accelerate the development of key partnerships that could create a significant value inflection for Moleculin shareholders.” ...
https://ih.advfn.com/stock-market/NASDAQ/moleculin-biotech-MBRX/stock-news/96448941/moleculin-engages-industry-veteran-adriano-treve-t
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Insider Trade | 12 Months
Number of Shares Bought 945,945
Number of Shares Sold 0
Ownership Summary
Institutional Ownership 4.89%
Total Shares Outstanding (millions) 30
Total Value of Holdings (millions) $1
Active Positions | Holders | Shares
Increased Positions | 11 | 1,039,675
Decreased Positions | 6 | 23,214
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Moleculin Biotech Inc is a clinical-stage pharmaceutical company with a focus on the treatment of highly resistant cancers and viruses through the development of its drug candidates. The company has three core technologies: Annamycin which is a next-generation anthracycline; Immune/Transcription Modulators, of which WP1066 is a member; and Metabolism/Glycosylation Inhibitors, of which WP1122 is a member.
https://moleculin.com/pipeline/
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About Us
Core Company Belief:
Anthracyclines are among the most important treatments for acute myeloid leukemia (AML) and advanced soft tissue sarcoma (STS).
Annamycin allows, for the first time ever, a clear majority of patients to benefit from these treatments.
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 anthracycline designed to avoid multidrug resistance mechanisms and to eliminate 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 is initiating 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 approval for Annamycin for the treatment of AML. This study is 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 viruses, as well as certain cancer indications.
https://moleculin.com
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According to the 2 analysts' twelve-month price targets for Moleculin Biotech, the average price target is $4.00. The average price target represents a forecasted upside of 459.91% from the current price of $0.71.
https://www.marketbeat.com/stocks/NASDAQ/MBRX/forecast/
(Targets are not always met)
$MBRX
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