Highest-materiality recent filing
Moleculin reports Annamycin CR rates 3x control in Phase 2/3 MIRACLE interim
CR of 43% and 36% for Annamycin arms vs 12% control; CRc 50% and 57% vs 29% control (n=45, ITT).
Oncologists reported average likelihood-to-prescribe Annamycin of 6 out of 7, citing deep remissions and reduced cardiotoxicity.
Moleculin ASCO data: Annamycin shows no cardiotoxicity at high cumulative doses
Pooled analysis of 90 patients: no significant LVEF change (mean diff -0.12%, p=0.84) across doses up to 2,970 mg/m².
Moleculin Q1: Cash $10.3M; MIRACLE trial 40% CRc; 45 subjects enrolled
Cash and equivalents $10.3M as of March 31, 2026; R&D expense $5.4M (up $2.0M YoY) on MIRACLE trial costs.
Moleculin reports preliminary blinded CR rate ~30% in MIRACLE trial; first unblinding before June 30
Preliminary blinded CRc >40%, CR ~30% vs. historical ~17-18% for cytarabine alone.
Pooled analysis of 90 R/R AML patients across 5 trials; 78 had source-verified pre/post ejection fraction assessments.
Moleculin Biotech secures Hong Kong patent for liposomal Annamycin through 2040
Hong Kong patent No. 40073244 covers proprietary reconstitution method of liposomal Annamycin, expiring June 25, 2040.
Median survival 29 days vs 18 days (p=0.0003) in metastatic PDAC models.
Moleculin enrolls 45th subject in MIRACLE AML trial; interim data unblinding on track for mid-2026
45th subject enrolled in pivotal Phase 2B/3 MIRACLE trial of Annamycin + cytarabine (AnnAraC) for R/R AML.
FY2025 R&D expense $15.9M (down from $17.7M), G&A $9.2M; cash $8.9M at year-end; $8.3M raised in Q1 2026; cash runway into Q3 2026.
Holders exercise 2,122,652 existing warrants at $3.90 per share; gross proceeds ~$8.3M.
Preliminary blinded composite CR rate of 40% (30% CR, 10% CRh) in first 30 subjects; 67% above historical cytarabine CR.
Moleculin gets Japanese patent allowance for Annamycin reconstitution methods
Japan Patent Office issued notice of allowance for Patent App. 2021-577862 covering liposomal Annamycin preparation methods.
Moleculin reports no cardiotoxicity in 90 Annamycin subjects across five trials
Independent expert review of 90 subjects across five clinical trials found no evidence of cardiotoxicity.
Moleculin: MIRACLE trial unblinding on track for Q1 2026; global expansion to 9 countries
First unblinding of 45 subjects in pivotal Phase 2B/3 MIRACLE trial for 2L AML expected Q1 2026.
Moleculin Biotech regains Nasdaq compliance, avoiding delisting
Nasdaq staff notified Panel on Jan 6, 2026 that Moleculin regained compliance with Listing Rule 5550(b)(1) (min $2.5M equity).
Entered warrant amendment agreements on Dec 21, 2025 reducing exercise price of Series E, F, G warrants to $3.90 per share.
Moleculin reports positive Phase 1 results for WP1066 in pediatric malignant brain tumors
WP1066 showed no significant toxicity and determined maximum feasible dose in 10 children with high-grade glioma.
Moleculin Biotech regains Nasdaq bid price compliance after stock closes at $1.00+ for 10 days
Nasdaq confirmed compliance with Listing Rule 5550(a)(2) effective Dec 15, 2025.
Moleculin Biotech raises ~$6.8M via warrant exercise inducement, issues new Series G warrants
Entered inducement letters with holders of Series C/D/F warrants to exercise at $6.63 or $6.3219 per share.
Moleculin reports MIRACLE AML trial enrollment at 78% of 45-subject interim target
Enrollment increased to 78% of target for first interim unblinding (up from 60% in Nov).
Moleculin Biotech receives Nasdaq delisting notice for non-compliance with equity rule
Received delist determination letter on Nov 20, 2025 for failing to meet $2.5M minimum stockholders' equity requirement.
Moleculin reports 60% enrollment for first interim unblinding of Phase 3 AML trial
60% of target 45 subjects for first interim unblinding of MIRACLE (R/R AML) trial have consented (as of Nov 4, 2025).
Moleculin Biotech Enters Research Agreement with UNC to Evaluate Annamycin for Pancreatic Cancer
Agreement with University of North Carolina at Chapel Hill for investigator-initiated preclinical research on Annamycin for pancreatic cancer.
Moleculin announces investigator-initiated Phase 1B/2 study of Annamycin for pancreatic cancer
Phase 1B/2 single-arm study of Annamycin for third-line advanced pancreatic cancer; investigator-initiated by Atlantic Health.
13 subjects recruited (10 dosed); target of 20 by end of September 2025.
Moleculin enrolls first EU patients in pivotal Phase 3 MIRACLE trial for R/R AML
First two subjects enrolled, one treated in Spain; active sites in US, Spain, Ukraine, Georgia, Romania.
Moleculin Biotech raises $6.0M via warrant exercise; issues 64.9M new warrants at $0.55
Gross proceeds of $6.0M from immediate cash exercise of 16.2M existing warrants at $0.37/share.
Moleculin reports positive Annamycin AML trial: median OS 15 mos for CR, 12 mos for 2L
Phase 1b/2 MB-106 trial completed; median OS 15 months for complete remissions (n=8), 12 months for 2L efficacy evaluable (n=9).
Moleculin shareholders approve 5x authorized share increase and reverse split authority
Authorized common shares increased from 100M to 500M (Proposal 8).
Cash and equivalents $7.6M at June 30, 2025, expected to fund operations only into Q4 2025.
On March 1, 2022, the Board of Directors of Moleculin Biotech, Inc. (the “Company”) appointed Joy Yan as an independent member of the Company’s Board of Directors, effective on such date.
Max materiality 0.90 · Median 0.60 · Most common event other_material