Welcome to our dedicated page for BioLineRX news (Ticker: BLRX), a resource for investors and traders seeking the latest updates and insights on BioLineRX stock.
BioLineRx Ltd. (NASDAQ: BLRX) is a commercial-stage biopharmaceutical company based in Modi'in, Israel, with operations extending to the United States. The company specializes in developing life-changing therapies for oncology and rare diseases. BioLineRx's flagship product, APHEXDA® (motixafortide), has gained approval in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma patients.
Currently, the company is advancing a robust pipeline of investigational medicines targeting sickle cell disease, pancreatic cancer, and other solid tumors. One of their notable clinical-stage therapeutic candidates is motixafortide (BL-8040), a novel peptide showing promise in stem-cell mobilization and solid tumors. Another key candidate is AGI-134, an immuno-oncology agent dedicated to treating solid tumors.
BioLineRx recently announced definitive agreements with institutional investors for the issuance and sale of its American Depositary Shares (ADSs) and warrants. This equity transaction, combined with financial resources from an existing debt facility, positions the company well for the commercialization of APHEXDA and the advancement of its other pipeline programs. Additionally, the company is exploring motixafortide's potential in supporting gene therapy for sickle cell disease, collaborating with leaders in the gene therapy field such as St. Jude Children's Research Hospital and Washington University School of Medicine.
BioLineRx has also received recent notifications and presented new data at various esteemed conferences such as the American Society of Clinical Oncology (ASCO) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). These efforts underscore the company's commitment to bringing innovative therapies from the bench to the bedside.
To access more information about BioLineRx, visit their official website or follow them on Twitter and LinkedIn.
BioLineRx (NASDAQ: BLRX) has outlined its strategic vision following major licensing agreements with Ayrmid and GloriaBio. The Ayrmid agreement provides a $10M upfront payment plus potential $87M in milestones and 18-23% royalties on APHEXDA® sales, along with a $9M equity investment. The GloriaBio deal includes a $15M upfront payment, potential $250M in milestones, and tiered double-digit royalties, plus a $14.6M equity investment.
The company has transformed into 'BioLineRx 2.0', focusing on lean drug development while retaining solid tumor indication rights for motixafortide. With a strengthened balance sheet of $29.5M and reduced operating costs of ~$12M annually, the company projects cash runway through H2 2026. BioLineRx plans to in-license new oncology/rare disease assets over the next two years and will implement a 1-for-40 reverse stock split effective January 30, 2025, to maintain Nasdaq compliance.
BioLineRx (NASDAQ: BLRX) announced a change in its American Depositary Shares (ADS) ratio from 15 to 600 ordinary shares per ADS, effective January 30, 2025. This change will have the same effect as a 1-for-40 reverse stock split of ADSs, reducing outstanding ADSs from 142,340,133 to 3,558,503.
The company has $29.5 million in cash, providing runway through second half of 2026, with a projected annual operating burn of $12 million. This will fund motixafortide development in pancreatic cancer and pipeline expansion activities. The ratio change aims to address Nasdaq's low-priced stock rule and maintain listing compliance.
The company's total outstanding share capital is 2,135,101,990 ordinary shares. While ADS holders will see changes reflected in their accounts after January 30, ordinary shareholders on Tel Aviv Stock Exchange remain unaffected.
BioLineRx (Nasdaq: BLRX) has announced a $10 million registered direct offering of 50,000,000 American Depositary Shares (ADSs) at $0.20 per ADS. The offering includes accompanying warrants to purchase up to 50,000,000 additional ADSs at an exercise price of $0.20 per share, exercisable immediately and expiring in five years.
Each ADS represents fifteen ordinary shares of BioLineRx. The offering is expected to close around January 7, 2025, with H.C. Wainwright & Co. serving as the exclusive placement agent. The company plans to use the net proceeds for research and development activities, pipeline expansion, working capital, and general corporate purposes.
The offering is being made through a shelf registration statement filed with the SEC on December 29, 2023, and declared effective on January 5, 2024.
BioLineRx reported Q3 2024 financial results and strategic updates. Key highlights include a $10 million upfront license agreement with Ayrmid for APHEXDA®, with potential commercial milestones up to $87 million and 18-23% tiered royalties. The company received a $9 million equity investment from Highbridge Capital Management and restructured $16.5 million of long-term debt. Q3 revenue was $4.9 million, with a net loss of $5.8 million. Annual operational expenses are expected to decline by over 70% following the APHEXDA® commercial program transfer.
BioLineRx has entered into a license agreement with Ayrmid for APHEXDA® (motixafortide), receiving a $10 million upfront payment plus potential $87 million in commercial milestones and 18-23% royalties on net sales. The agreement grants Ayrmid exclusive rights to commercialize APHEXDA in all territories except Asia and solid tumor indications. Additionally, BioLineRx secured a $9 million equity investment from Highbridge Capital Management funds. The deal allows BioLineRx to reduce operational expenses while maintaining development rights for motixafortide in solid tumors, including PDAC studies with Columbia University and Gloria Biosciences.
BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company focused on oncology and rare diseases, has announced it will release its Q3 2024 financial results on November 25, 2024, before U.S. markets open. The company will host a conference call at 8:30 a.m. EST, featuring CEO Philip Serlin. The call will be accessible via phone and webcast through the company's website, with replay available until November 27, 2024.
BioLineRx (NASDAQ: BLRX) announced positive initial results from a Phase 1 clinical trial evaluating motixafortide for stem cell mobilization in sickle cell disease (SCD) gene therapies. The study showed that motixafortide, both alone and combined with natalizumab, was safe and well-tolerated, potentially enabling collection of required stem cells in a single apheresis cycle. Motixafortide alone mobilized 198 CD34+ cells/μl median, while the combination achieved 231 CD34+ cells/μl. Notably, patients experienced 2.8-fold greater stem cell mobilization with motixafortide alone and 3.2-fold greater with the combination compared to current standard plerixafor.
BioLineRx (NASDAQ/TASE: BLRX) has received a Notice of Allowance from the USPTO for a new Composition of Matter patent on motixafortide (APHEXDA®/BL-8040). This patent strengthens BioLineRx's intellectual property estate and extends patent protection for motixafortide in the U.S. through December 2041.
The patent reflects the unique attributes of motixafortide as a mobilization agent for multiple myeloma patients undergoing autologous stem cell transplantation, as well as its potential in other indications like pancreatic cancer and gene therapies for sickle cell disease.
BioLineRx also has Orphan Drug market exclusivity for APHEXDA® until September 2030 and five years of data exclusivity as a New Chemical Entity. Motixafortide has Orphan Drug Designation in the U.S. and Europe for pancreatic cancer treatment and in the U.S. for acute myeloid leukemia treatment.
BioLineRx (NASDAQ: BLRX) has launched 'Mobilization Matters', a digital resource for multiple myeloma patients preparing for stem cell collection. The platform, launched on Apheresis Awareness Day, offers patient stories, educational resources, and a discussion guide to support patients undergoing this critical treatment phase.
In partnership with the HealthTree Foundation, BioLineRx is conducting the Mobilization Matters Stem Cell Collection Survey to gather patient insights about their experiences with stem cell collection and apheresis. Survey results are expected in Q1 2025. The initiative aims to enhance understanding and improve care strategies for multiple myeloma patients undergoing stem cell collection.
BioLineRx (NASDAQ: BLRX) reported its Q2 2024 financial results and recent updates. Key highlights include:
- Secured APHEXDA® formulary placement among top 80 transplant centers representing ~37% of stem cell transplant procedures, surpassing Q2 goal
- Doubled the number of centers ordering APHEXDA during Q2
- Entered clinical trial agreement with St. Jude Children's Research Hospital for motixafortide in sickle cell disease
- Q2 revenue: $5.4 million, including $1.8 million from APHEXDA sales
- Net income: $0.5 million, compared to net loss of $18.5 million in Q2 2023
- Cash position: $40.1 million as of June 30, 2024, expected to fund operations into 2025
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