BioLineRx Ltd.
BLRX · Pharmaceutical Preparations · EDGAR filings ↗
Grade
D43Going-concern clinical-stage biopharma with roughly one quarter of cash, despite an earlier successful Phase 3 that is now out-licensed for royalties.
Strengths
- Pivotal GENESIS Phase 3 met its primary endpoint decisively (92.5% vs 26.2%, p<0.0001), underpinning APHEXDA approval
- Out-licensing deals (Ayrmid, Gloria) provide milestone/royalty potential at a much-reduced cash burn
Risks
- Explicit going-concern doubt; cash ~$3.25M, runway ~1.6 quarters (12th pct); secured BlackRock loan with forfeiture risk
- Pipeline thin and other trials terminated/inconclusive; revenue down 96%; deep accumulated deficit ($401M)
Notable findings
- No interest coverageInterest coverage -8.22 (cannot cover interest)
- Going concern• Management has concluded that there is substantial doubt about our ability to continue as a going concern, which could prevent us from obtaining new financing on reasonable terms or at all
- Net lossNet loss (net margin -171.7%)
- Cash burnNegative free cash flow (-8.1M)
- Fund exitedNotable fund(s) exited this quarter: CITADEL ADVISORS LLC
- Revenue declineRevenue -95.9% YoY
Key metrics
Gross margin
80.5%
Operating margin
-871.8%
Net margin
-171.7%
Return on equity
-8.7%
Return on assets
-5.0%
Revenue growth (QoQ)
-95.9%
Interest coverage
-8.2×
Current ratio
2.0×
Free cash flow
-$8M
Tangible book value
$23M
Cash & investments
$3M
Cash runway
2q
Clinical trials
| Trial | Title | Phase | Status | Primary completion |
|---|---|---|---|---|
| NCT03246529 ↗ | A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyte Colony Stimulating Factor (G-CSF) as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma (MM) Multiple Myeloma | PHASE3 | Active Not Recruiting | 2020-12-22 |
| NCT02826486 ↗ | Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients Metastatic Pancreatic Adenocarcinoma | PHASE2 | Completed | 2022-09-06 |
| NCT05293171 ↗ | Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects Healthy Subjects | PHASE1 | Completed | 2022-06-01 |
| NCT02462252 ↗ | Phase IIA Open Label Study to Evaluate Efficacy and Safety of BL-8040 Followed by (hATG), Cyclosporine and Methyprednisolone in Adult Subjects With Aplastic Anemia or Hypoplastic Myelodysplastic Syndrome Aplastic Anemia, Hypoplastic Myelodysplastic Syndrome | PHASE2 | Completed | 2020-11-01 |
| NCT03154827 ↗ | Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myeloid Leukemia (AML) Acute Myeloid Leukemia | PHASE1/PHASE2 | Terminated | 2020-04-01 |
| NCT01838395 ↗ | Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients Acute Myeloid Leukemia | PHASE2 | Completed | 2016-03-01 |
| NCT02073019 ↗ | A Phase I Study Evaluating Safety, Tolerability, PK and PD of BL-8040 for Stem Cell Mobilization in Healthy Volunteers Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB) | PHASE1 | Completed | 2015-07-01 |
| NCT01990885 ↗ | Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients. Celiac Disease | PHASE1/PHASE2 | Completed | 2014-10-01 |
| NCT01833845 ↗ | Efficacy, Safety and Tolerability of Ribavirin Monotherapy Followed by Combined Treatment With Ribavirin and Hydroxychloroquine in Patients Infected With Hepatitis C Hepatitis C | PHASE1/PHASE2 | Terminated | 2014-04-01 |
| NCT01506362 ↗ | Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis Ulcerative Colitis | PHASE2 | Completed | 2013-05-01 |
| NCT01363349 ↗ | Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia Schizophrenia, Cognitive Effect on Schizophrenic Patients | PHASE2/PHASE3 | Terminated | 2013-03-01 |
| NCT01121380 ↗ | A Study Intended to Evaluate Safety, Tolerability and Pharmacokinetics (PK) Parameters of BL-1021 Healthy, Volunteers | PHASE1 | Terminated | 2011-10-01 |
| NCT00557531 ↗ | Safety and Feasibility of the Injectable BL-1040 Implant Cardiovascular Disease | PHASE1/PHASE2 | Unknown | 2010-01-01 |
| NCT00567710 ↗ | A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study Schizophrenia | PHASE2 | Completed | 2009-07-01 |
| NCT00722176 ↗ | Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Schizophrenia | PHASE2 | Completed | 2009-07-01 |
| NCT00480571 ↗ | Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective Disorder Schizophrenia, Schizoaffective Disorder | PHASE2 | Completed | 2007-12-01 |
| NCT00374881 ↗ | A Study of the Safety and Efficacy of Combination Therapy With Morphine, Phenylephrine and Sorbitol in Human Subjects Acute Pain | PHASE1/PHASE2 | Completed | 2007-06-01 |
| NCT00480246 ↗ | A Positron Emission Tomography (PET) Study to Assess the Degree of Dopamine-2 (D2) Receptor Occupancy in the Human Brain After Single Doses of BL-1020 or Perphenazine in Healthy Male Subjects Using [11C]Raclopride as PET Tracer Healthy | PHASE1 | Completed |
Source: ClinicalTrials.gov (U.S. NIH) · active studies first.
Recent filings
| Form | Filed | Period | Accession |
|---|---|---|---|
| 20-F | 2026-03-23 | 2025-12-31 | 0001178913-26-001581 ↗ |
| 20-F | 2025-03-31 | 2024-12-31 | 0001178913-25-001123 ↗ |
| 20-F | 2024-03-26 | 2023-12-31 | 0001178913-24-001075 ↗ |
| 20-F | 2023-03-22 | 2022-12-31 | 0001178913-23-001091 ↗ |
| 20-F | 2022-03-16 | 2021-12-31 | 0001178913-22-001134 ↗ |
| 20-F | 2021-02-23 | 2020-12-31 | 0001178913-21-000741 ↗ |
| 20-F | 2020-03-12 | 2019-12-31 | 0001178913-20-000790 ↗ |
| 20-F | 2019-03-28 | 2018-12-31 | 0001178913-19-000965 ↗ |
| 20-F | 2018-03-06 | 2017-12-31 | 0001178913-18-000765 ↗ |
| 20-F | 2017-03-23 | 2016-12-31 | 0001178913-17-000871 ↗ |
| 20-F | 2016-03-10 | 2015-12-31 | 0001178913-16-004649 ↗ |
| 20-F | 2015-03-23 | 2014-12-31 | 0001178913-15-000957 ↗ |