Moleculin Biotech, Inc.
MBRX evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for MBRX—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · MBRX
Moleculin Biotech, Inc. is a late-stage pharmaceutical development company focused on a portfolio of drug candidates for hard-to-treat tumors and viruses, with its lead candidate Annamycin in a pivotal Phase 2/3 trial for acute myeloid leukemia (AML).
Key risk: Limited cash runway
BioSniper Score
Based on 6 of 6 signals
Market Cap
$12.7M
Cash Runway
3.5 moLead Asset
annamycin (Phase 2/Phase 3)
Next Catalyst
Phase3_Topline · Aug 1, 2030Financial data as of Jun 30, 2026.
Tracking 2 pipeline candidates · 2 clinical trials · 1 catalyst for Moleculin Biotech, Inc..
Moleculin Biotech, Inc. is a late-stage pharmaceutical development company focused on a portfolio of drug candidates for hard-to-treat tumors and viruses, with its lead candidate Annamycin in a pivotal Phase 2/3 trial for acute myeloid leukemia (AML).
- Lead candidate Annamycin is a next-generation anthracycline designed to improve safety and efficacy for AML and advanced soft tissue sarcoma, with composition-of-matter patent protection through 2040 and potential extension to 2045 [sec_mda · as of 2026-08-13].
- The pivotal Phase 2/3 MIRACLE trial for Annamycin in relapsed/refractory AML is ongoing; an interim unblinding occurred in mid-2026 and an additional unblinding is expected in the second half of 2026 [sec_mda · as of 2026-05-14].
- Cash & equivalents were $7.3M as of 2026-06-30, with no revenue and a net loss of $7.6M for the period [sec].
- The company holds Orphan Drug and Fast Track designations for Annamycin and has completed or initiated 18 clinical trials across its three core technology portfolios [sec · filed 2026-07-29].
What works
- Annamycin has shown a 50% CR rate and 60% CRc rate in combination with cytarabine for second-line R/R AML (n=10), with durable responses and median OS of 15 months [sec_mda · as of 2026-08-13].
- Composition-of-matter patent protection extends to 2040 with potential extension to 2045, plus Orphan Drug and Fast Track designations [sec_mda · as of 2026-08-13].
- The MIRACLE trial design includes early interim unblinding, providing stakeholders preliminary safety and efficacy data before trial conclusion [sec_mda · as of 2026-05-14].
What to weigh
- Cash position of $7.3M as of 2026-06-30 is limited, and the company has no revenue, relying on future funding to continue operations and clinical trials [sec].
- The company faces dependency on third-party manufacturers for supply of drug candidates, which could cause delays [sec_mda · as of 2026-08-13].
- Competition from existing therapies or new therapies that may emerge is a significant risk factor [sec_mda · as of 2026-08-13].
From the filings
Quoted directly from source documents.
Annamycin has composition-of-matter patent protection through 2040 with potential extension to 2045.
“Composition of matter patent protection through 2040 with the potential to extend as far as 2045 as well as Orphan Drug and Fast Track designation.”
SEC MD&A · August 13, 2026
The MIRACLE trial had an interim unblinding in mid-2026 and another expected in H2 2026.
“we expect to have an interim unblinding of data in mid-2026 and an additional unblinding in the second half of 2026”
SEC MD&A · May 14, 2026
Annamycin achieved a 50% CR rate and 60% CRc rate in combination with cytarabine for R/R AML.
“106 trial with a CR rate of 50% and a composite complete remission (CRc) rate of 60% in combination with cytarabine for the treatment of R/R AML as second line therapy (n=10).”
SEC MD&A · August 13, 2026
Catalyst timeline
- 2030-08-01 · Phase3_Topline · cytarabine — Phase 3 Topline: A Pivotal Phase 2/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Stu — Topline results from the pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in combination with cytarabine for relapsed/refractory AML.
Risks & what to watch (3)›
Key risks
- Limited cash runway — Cash of $7.3M as of 2026-06-30 with no revenue; may require additional funding to continue operations and trials [sec].
- Dependence on third-party manufacturers — Relies on third parties to supply drug candidates for preclinical and clinical work, posing risk of delays [sec_mda · as of 2026-08-13].
- Competitive landscape — Competition from existing or emerging therapies could affect market acceptance and commercial success [sec_mda · as of 2026-08-13].
What to watch
- Additional unblinding of MIRACLE trial data expected in the second half of 2026 [sec_mda · as of 2026-05-14].
- Investigator-initiated trials for pancreatic and brain cancer programs [news · published 2026-01-12].
- Ability to secure additional funding given limited cash position [sec].
Sources: News · SEC filings · SEC MD&A · Generated August 28, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 6 of 6 signals · derived from public data
3.5 months
D/E 0.82
Lead: Phase 2/Phase 3
2 candidates
1 upcoming, next in ~1432d
3 buys · 0 sells (180d)
Runway
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
16
Total value held
$326K
| Holder | Shares | Value |
|---|---|---|
| sabby management, llc | 75,021 | $172K |
| geode capital management, llc | 32,329 | $74K |
| vanguard capital management llc | 27,738 | $64K |
| vanguard fiduciary trust co | 6,072 | $14K |
| blackrock, inc. | 491 | $1K |
| pinnacle wealth planning services, inc. | 281 | $643 |
| nfsg corp | 114 | $261 |
| sbi securities co., ltd. | 43 | $98 |
| morgan stanley | 36 | $83 |
| vanguard global advisers, llc | 24 | $55 |
Showing top 10 of 16 institutional holders of Moleculin Biotech, Inc.. Open the full 13F history after sign-in.
Short Interest
as of Apr 30, 2026- % of float
- 2.6%
- Days to cover
- 1.5
- Shares short
- 138,763
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
MBRX short interestGovernance
Frequently asked questions
What is the AI investment thesis for Moleculin Biotech, Inc.?
Moleculin Biotech, Inc. is a late-stage pharmaceutical development company focused on a portfolio of drug candidates for hard-to-treat tumors and viruses, with its lead candidate Annamycin in a pivotal Phase 2/3 trial for acute myeloid leukemia (AML).
What is Moleculin Biotech, Inc.'s lead drug candidate?
Moleculin Biotech, Inc.'s most advanced tracked candidate is annamycin (Phase 2/Phase 3) for Leukemia, Myeloid, Acute.
What is Moleculin Biotech, Inc.'s next catalyst?
Moleculin Biotech, Inc.'s next tracked catalyst is a Phase3_Topline event — "Phase 3 Topline: A Pivotal Phase 2/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Stu" — expected August 1, 2030.
Who is the CEO of Moleculin Biotech, Inc.?
Mr. Walter V. Klemp is the chief executive officer of Moleculin Biotech, Inc. (MBRX).
Where is Moleculin Biotech, Inc. headquartered?
Moleculin Biotech, Inc. (MBRX) is headquartered in Houston, TX, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.