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).
Moleculin Biotech reports warrant exercise for $2.7M; shares outstanding rise to 7.07M
Warrants to purchase 1,361,500 shares exercised, generating gross proceeds of ~$2.7 million.
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 posts corporate presentation on website; no new material details disclosed
Presentation dated May 2026 made available on company website.
Moleculin Biotech ASCO abstract on Annamycin cardiac safety shows no cardiotoxicity in 90 patients
Abstract accepted for poster at 2026 ASCO Annual Meeting (May 29–June 2, Chicago).
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.
Shareholders approve issuance of up to 6.4M warrant shares; name change rejected
Shareholders approved issuance of up to 6,367,956 shares upon exercise of warrants issued Feb 20, 2026.
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.
Moleculin Biotech posts investor presentation; no material new information
Presentation furnished under Item 7.01 on March 19, 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 posts new investor presentation on website
Filed under Item 7.01 as Regulation FD disclosure with Exhibit 99.1.
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 Biotech shareholders approve warrant share issuance, reject name change to Moleculin Inc.
Approved issuance of up to 2,610,823 shares upon exercise of warrants issued Dec 11, 2025; 578,385 For, 68,176 Against.
Moleculin Biotech posts corporate presentation on website; no material new details disclosed
Company furnished investor presentation dated January 2026 as Exhibit 99.1.
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 partners with CIC biomaGUNE for preclinical Annamycin glioblastoma study
Agreement supplies Annamycin for investigator-initiated preclinical research at CIC biomaGUNE, Spain.
Moleculin Biotech announces 1-for-25 reverse stock split effective Dec 1, 2025
Reverse stock split at 1:25 ratio effective 12:01 a.m. ET on December 1, 2025.
Filing under Item 7.01: corporate presentation posted on company website as Exhibit 99.1.
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 Biotech files 8-K with investor presentation; content not extractable from filing
Company posted October 2025 investor presentation on its website.
Moleculin granted Australian patent for Annamycin lyophilizate; term until 2040
Australian Patent No. 2024203598 covers preliposomal Annamycin lyophilizates with improved stability and high purity.
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.
Moleculin Biotech special meeting: name change proposal fails; warrant issuance approved
Stockholders rejected name change to Moleculin Inc.; needed majority of 36.7M outstanding shares but only 11.3M voted For.
Moleculin gets Canadian patent allowance for Annamycin manufacturing process; term to 2040
CIPO issued notice of allowance for patent application 3,142,510 covering preliposomal Annamycin lyophilizate preparation.
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 posts corporate presentation; no material new information extractable from filing
Investor presentation dated September 2025 posted on company website, but exhibit is an image file with no extractable text.
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).
Moleculin Biotech posts August 2025 investor presentation; content not disclosed in filing
Filed 8-K on August 18, 2025, attaching investor presentation as Exhibit 99.1.
Cash and equivalents $7.6M at June 30, 2025, expected to fund operations only into Q4 2025.
Moleculin preclin data: Annamycin shows efficacy in liver cancers; AML readout H2 2025
Annamycin demonstrated anti-tumor activity in orthotopic HCC models, colorectal liver metastases, and PDAC liver metastases.
Moleculin Biotech furnishes July 2025 corporate presentation; no specific financial data extractable
Presentation posted on company website under Item 7.01 FD Disclosure.
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