midastouch017
2月前
Hemispherian Initiates Phase 1/2a Clinical Trial of GLIX1 in Glioblastoma
https://finance.yahoo.com/sectors/healthcare/articles/hemispherian-initiates-phase-1-2a-063000795.html
First-in-class TET2 activator targets DNA damage response in GBM and other cancers
Strong preclinical efficacy, brain penetration, and safety profile support clinical advancement
Study led by world-leading glioblastoma investigators, including Dr. Roger Stupp
OSLO, Norway, April 08, 2026--(BUSINESS WIRE)--Hemispherian AS, a clinical-stage oncology company developing novel small molecule therapeutics, today announced the initiation of a first-in-human Phase 1/2a clinical trial of GLIX1 in patients with recurrent and progressive glioblastoma (GBM) and other high-grade gliomas (NCT07464925). The study is being conducted in collaboration with BioLineRx Ltd. (NASDAQ/TASE: BLRX).
GLIX1 is an orally available, first-in-class small molecule designed to activate TET2 and drive tumor-selective DNA damage. By restoring TET2 activity, GLIX1 induces DNA damage selectively in cancer cells, representing a differentiated approach to targeting the DNA damage response with potential applicability across a broad range of tumors.
Glioblastoma was selected as the initial indication due to its highly suppressed TET2 activity and significant unmet medical need. Despite existing therapies, GBM remains one of the most aggressive and treatment-resistant cancers.
In extensive preclinical studies, including orthotopic in vivo GBM models, GLIX1 demonstrated:
Potent anti-tumor activity
Robust blood-brain barrier penetration
Favorable safety profile in toxicology studies
The trial will be conducted across three leading academic centers. The first site to initiate patient enrollment is NYU Langone Health, led by Dr. Alexandra Miller. Additional sites include Northwestern University, led by Dr. Roger Stupp and Dr. Ditte Primdahl, and Moffitt Cancer Center, led by Dr. Patrick Grogan.
"The initiation of this Phase 1/2a study marks a defining milestone for Hemispherian and represents the culmination of years of dedicated research and development work by our team and our collaboration partner, BioLineRx. GLIX1 has a compelling preclinical profile and a truly differentiated mechanism of action, and we look forward to bringing this innovative therapy to patients who urgently need new treatment options. We are proud to be advancing this program alongside world-leading glioblastoma investigators and anticipate initial data readout in the first half of 2027," said Zeno Albisser, Chief Executive Officer of Hemispherian AS.
"GLIX1 is built on a fundamentally new understanding of how to exploit DNA repair vulnerabilities in cancer. The strength and consistency of the preclinical data give us confidence as we now transition this mechanism into the clinic," remarks Adam Robertson, Chief Scientific Officer at Hemispherian.
Dr. Alexandra Miller, Chief of Neuro-Oncology and Co-Director of the Brain and Spine Tumor Center at the Perlmutter Cancer Center, NYU Langone Health, stated:
"I am pleased to be the first investigator able to enroll patients into this critical study, which brings new hope to patients who are in desperate need of innovative and novel treatment options."
Dr. Roger Stupp, Medical Director of the Malnati Brain Tumor Institute at Northwestern University in Chicago and lead investigator of the study, added:
"GLIX1 is a promising innovative molecule with impressive pre-clinical data, and I could not be more excited to participate in this study. The protocol will rigorously assess the safety of an agent with an entirely novel mechanism of action, with the potential to ultimately integrate well and synergize with the current treatments. We urgently need breakthrough innovations for our patients suffering from glioblastoma, one of the most aggressive and difficult malignancies to treat."
Clinical Trial Design (NCT07464925)
The Phase 1 portion of the study will enroll up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The primary objective is to establish the maximum tolerated dose (MTD) and/or a recommended dose based on safety, pharmacokinetics/pharmacodynamics (PK/PD), and preliminary efficacy. Data from Phase 1 are anticipated in the first half of 2027.
The Phase 2a expansion is expected to include multiple patient cohorts, including newly diagnosed and recurrent GBM, as well as additional tumor types. Combination approaches, including with PARP inhibitors, will also be evaluated. These cohorts are designed to generate early efficacy signals, inform dose optimization, and support subsequent clinical development.
About Hemispherian
Hemispherian AS is a clinical-stage pharmaceutical company developing first-in-class small-molecule cancer therapies. Its lead program, GLIX1, is being advanced in partnership with BioLineRx for the treatment of glioblastoma and a broad range of solid tumors.
The company is headquartered in Oslo, Norway, and collaborates with leading academic and clinical institutions worldwide.
Learn more at www.hemispherian.com or on LinkedIn.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260407249206/en/
Contacts
Zeno Albisser, CEO – zeno@hemispherian.com
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midastouch017
6月前
BioLineRx Reports Third Quarter 2025 Financial Results and Provides Corporate Update
https://finance.yahoo.com/news/biolinerx-reports-third-quarter-2025-120000966.html
- Establishes joint venture with Hemispherian AS to advance GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other cancers -
- Phase 1/2a clinical trial of GLIX1 expected to commence in Q1 2026 -
- Management to host conference call today, November 24th, at 8:30 am EST -
TEL AVIV, Israel, Nov. 24, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the quarter ended September 30, 2025, and provided a corporate update.
"The clear highlight of the third quarter was our announcement in September that we established a joint venture with Hemispherian, expanding our development pipeline into additional high-need cancer indications, leading with glioblastoma, in addition to our ongoing PDAC program," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Hemispherian's lead asset, GLIX1, is a versatile molecule with a novel mechanism of action that targets the DNA repair mechanism in cancer cells and has demonstrated compelling efficacy in numerous pre-clinical models. Importantly, the development path is straightforward and efficient, and we are eager to initiate a Phase 1/2a first-in-human study in the first quarter of next year while also advancing pre-clinical activities in support of future potential trials of GLIX1 in other cancers."
"At the same time, the ongoing CheMo4METPANC Phase 2b clinical trial of motixafortide in metastatic pancreatic cancer, which is being led by Columbia University and supported by both Regeneron and BioLineRx, continues to progress, giving us a second opportunity to leverage our drug development expertise to bring true innovation to patients with difficult-to-treat cancers," Mr. Serlin concluded.
Corporate Updates
Announced formation of a joint venture to advance privately held Hemispherian's small molecule cancer therapeutic, GLIX1
GLIX1, a Phase 1-ready candidate that is being developed as a potential treatment for glioblastoma, estimated to be a greater than $3.7 billion global addressable market by 2030 that has seen little innovation since the current standard of care was developed in 2005. The compound is also expected to be evaluated in other cancers, with preclinical work beginning in 2026.
Announced that it has received Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a key patent covering GLIX1 for cancers in which cytidine deaminase (CDA) is not over-expressed beyond a specific threshold, estimated to be 90% of all cancers.
Patent preserves BioLineRx's ability to evaluate GLIX1 in other cancers beyond glioblastoma, including both hematological and solid tumor cancer types.
Patent further broadens and strengthens GLIX1's patent protection until 2040, with a possible patent-term extension of up to five years.
Financial Updates
With $25.2 million on its balance sheet as of September 30, 2025, BioLineRx is maintaining its cash runway guidance into the first half of 2027.
Clinical Updates
GLIX1
Continued to advance preparations for initiation of a Phase 1/2a clinical trial of GLIX1 in recurrent and newly diagnosed glioblastoma in the first quarter of 2026.
World leading investigators in the field of glioblastoma, Dr. Roger Stupp and Dr. Ditte Primdahl of the Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center at Northwestern University, will serve as principal investigators for the study.
The Phase 1 part of the trial aims to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy.
The Phase 2a expansion part of the trial is planned to include three population cohorts: (1) GLIX1 as monotherapy in recurrent GBM, (2) GLIX1 on top of standard of care in newly diagnosed GBM patients (likely a "window of opportunity" study, with biopsies before and after treatment for PD assessment), and (3) GLIX1 in combination with PARP inhibitors in other solid tumors.
Pre-clinical activities in support of potential clinical trials of GLIX1 in additional cancers are ongoing.
Motixafortide
Pancreatic Ductal Adenocarcinoma (mPDAC)
Enrollment continues in the CheMo4METPANC Phase 2b clinical trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx. The CheMo4METPANC trial is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapy (gemcitabine and nab-paclitaxel).
A prespecified interim analysis is planned when 40% of progression-free survival (PFS) events are observed.
Sickle Cell Disease (SCD) & Gene Therapy
Announced that a poster featuring final results from a Phase 1 clinical trial (NCT05618301) evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD) was accepted for presentation at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition taking place December 6-9, 2025, in Orlando, FL.
The 10-subject proof-of-concept study, which was conducted in collaboration with Washington University School of Medicine, demonstrated that motixafortide alone, and in combination with natalizumab, were found to be safe and well- tolerated. Common adverse events were transient and included Grade 1-2 injection site and systemic reactions. No Grade 4 adverse events, dose limiting toxicities or complicated vaso-occlusive events occurred. Motixafortide alone, and in combination with natalizumab resulted in robust CD34+ HSC mobilization.
Motixafortide alone mobilized a median of 189 CD34+ cells/µl (range 77-690) to the peripheral blood (PB), with a median yield of 4.22x106 CD34+ cells/kg following a single blood volume collection, projecting the collection of 16.9x106 cells/kg in a four-blood-volume apheresis collection session. Motixafortide in combination with natalizumab mobilized a median of 312 CD34+ cells/µl (range 117-447) to the PB, with a median yield of 4.89x106 CD34+ cells/kg following a single blood volume collection, projecting the collection of 19.6x106 CD34+ cells/kg in a four-blood-volume apheresis collection session. The collection yields of motixafortide alone and in combination with natalizumab are encouraging given that hematopoietic stem cell-based gene therapy for sickle cell disease requires sufficient HSCs (16.5-20x106 CD34+ cells/kg) to generate a product.
In two subjects with prior plerixafor mobilization, motixafortide alone, and in combination with natalizumab, led to 2.7-2.8 fold higher CD34+ cells/µl mobilization to PB and 2.8-3.2 fold higher CD34+ cells/kg collection yield, respectively, than plerixafor.
A second SCD study, sponsored by St. Jude Children's Research Hospital, continues to enroll patients. The study is a multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ HSCs used in the development of gene therapies for patients with SCD.
APHEXDA Performance Update
APHEXDA generated sales of $2.4 million in the third quarter of 2025, providing royalty revenue to the Company of $0.4 million.
Financial Results for the Quarter Ended September 30, 2025
Total revenues for the third quarter of 2025 were $0.4 million, reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Total revenues in 2025 are not comparable to the same period in 2024, which included a portion of the upfront payment from Gloria Biosciences ($3.2 million) as well as direct commercial sales by BioLineRx ($1.7 million) prior to the Ayrmid transaction in November 2024.
Cost of revenues for the third quarter of 2025 was immaterial, compared to cost of revenues of $0.8 million for the third quarter of 2024. The cost of revenues in 2025 reflects sub-license fees on royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The cost of revenues in 2024 primarily reflects amortization of intangible assets, royalties on net product sales of APHEXDA in the U.S. and cost of goods sold on product sales.
Research and development expenses for the third quarter of 2025 were $1.7 million, a decrease of $0.8 million, or 33.0%, compared to $2.6 million for the third quarter of 2024. The decrease resulted primarily from lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount.
There were no sales and marketing expenses for the third quarter of 2025, compared to $5.5 million for the third quarter of 2024. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid out-licensing transaction.
General and administrative expenses for the third quarter of 2025 were $0.8 million, a decrease of $0.6 million, or 40.2%, compared to $1.4 million for the third quarter of 2024. The decrease resulted primarily from lower payroll and share-based compensation, primarily due to a decrease in headcount, as well as small decreases in a number of general and administrative expenses.
Non-operating income (expenses) for the third quarters of 2025 and 2024 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet, as a result of changes in its share price, offset by warrant offering expenses.
Net financial income for the third quarter of 2025 was $0.1 million, compared to net financial expenses of $1.2 million for the third quarter of 2024. Net financial income (expenses) for both periods primarily relate to loan interest paid, partially offset by investment income earned on bank deposits and gains on foreign currency (primarily NIS) cash balances due to the strengthening of the NIS against the US dollar during the period. The significant decrease in financial expenses in the 2025 period results from a substantial paydown of the BlackRock loan balance in November 2024, following the transaction with Ayrmid.
Net loss for the third quarter of 2025 was $1.0 million, compared to net loss of $5.8 million for the third quarter of 2024.
As of September 30, 2025, the Company had cash, cash equivalents, and short-term bank deposits of $25.2 million, sufficient to fund operations, as currently planned, into the first half of 2027.
midastouch017
7月前
BioLineRx Announces Receipt of USPTO Notice of Allowance for Key Patent Covering GLIX1 for Treating a Broad Range of Cancer Types
https://finance.yahoo.com/news/biolinerx-announces-receipt-uspto-notice-120000126.html
Patent covers the use of GLIX1 for treating cancers in which cytidine deaminase (CDA) is not over-expressed (representing over 90% of cancers)
Patent further broadens and strengthens GLIX1 patent protection until 2040, with a possible patent-term extension of up to five years
TEL AVIV, Israel, Nov. 17, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a key patent, entitled, 'Deoxy-Cytidine or Uridine Derivatives for Use in Cancer Therapies' (Pat. Appl. Ser. No. 18/602,969), which covers the use of GLIX1 for treating cancer types in which cytidine deaminase (CDA) is not over-expressed beyond a specific threshold. Corresponding patent applications are pending worldwide. The patent further broadens and strengthens GLIX1's patent protection for the treatment of cancer until 2040, with a possible patent-term extension of up to five years.
It is estimated that over 90% of all cancers do not overexpress CDA beyond the specific threshold, reflecting the importance of this additional intellectual property as BioLineRx expands development of GLIX1 beyond glioblastoma, its initial indication, into other cancer types, once safety and dosing in glioblastoma are established.
"This Notice of Allowance from the USPTO is a critical addition to GLIX1's intellectual property estate, as it protects our opportunity to evaluate this exciting molecule across the majority of cancers," stated Philip Serlin, Chief Executive Officer of BioLineRx. "As we prepare to initiate a first-in-human study of GLIX1 in patients with glioblastoma in the first quarter of 2026, we are in parallel advancing pre-clinical studies in other cancer models. We believe GLIX1, with its unique mechanism of action that targets the DNA damage response in cancer cells, has the potential to offer new hope to patients suffering from a broad range of difficult-to-treat cancers, and we are eager to commence clinical trials early next year."
GLIX1 is covered by a comprehensive portfolio of patents that are both issued and pending. In addition to the allowed U.S. patent referenced above and corresponding patents issued and pending worldwide, GLIX1 is covered by additional issued or pending patents, which broaden the coverage for its use in treating cancer as both monotherapy and in combination with established anti-cancer agents:
GLIX1 for use in treating cancer of the central nervous system, such as glioblastoma, is covered by patents issued in the US, Europe and 13 other countries. The patents are valid until at least 2040 (with a possible patent term extension of up to five years).
GLIX1, in combination with PARP inhibitors, for use in treating homologous recombination (HR) proficient cancers, which represent the majority of cancers, is covered by a pending international patent application. Corresponding national-phase patents, if granted, will be valid until at least 2044 (with a possible patent term extension of up to five years).
midastouch017
8月前
BioLineRx Ltd. and Hemispherian AS Establish Joint Venture to Develop GLIX1, a First-in-Class, Oral, Small Molecule Targeting DNA Damage Response in Glioblastoma and Other Cancers
https://finance.yahoo.com/news/biolinerx-ltd-hemispherian-establish-joint-110000288.html
- GLIX1 restores TET2 activity in cancer, resulting in double stranded DNA breaks in cancer cells only -
- FDA IND clearance received for Phase 1/2a study, expected to initiate in Q1 2026 -
- Glioblastoma market opportunity estimated to be in excess of $3.8 billion annually across the US and EU5 by 2030 -
- BioLineRx affirms its cash runway into the first half of 2027 -
- Management to host conference call today, September 29th, at 8:30 am EDT -
TEL AVIV, Israel and OSLO, Norway, Sept. 29, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Hemispherian AS, a Norwegian biotech company focused on small molecule cancer therapeutics, today announced the establishment of a joint venture (JV) to develop GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma (GBM) and other cancers. GLIX1 agonizes TET2 activity in cancer cells, resulting in the formation of double-stranded DNA breaks and apoptosis specifically in cancer cells.
GLIX1, Hemispherian's lead drug candidate, is being developed as a potential treatment for newly diagnosed and recurrent GBM. GLIX1 has demonstrated potent anti-tumor activity in multiple glioblastoma models, excellent blood-brain barrier penetration and a favorable safety profile in preclinical toxicology studies. An Investigational New Drug (IND) application was cleared by the U.S. Food and Drug Administration (FDA) in August 2025, and a Phase 1/2a study is expected to initiate in Q1 2026. GLIX1 has also been granted Orphan Drug Designation by both the FDA and the European Medicines Agency (EMA), underscoring the substantial unmet need in this indication. In addition, GLIX1 has shown anti-tumor activity in other cancer models, and early data also suggest the potential for strong synergy of GLIX1 with PARP inhibitors, particularly in homologous recombination (HR) proficient cancers. Further development in other solid tumors is being planned.
"This joint venture combines our expertise in DNA damage response research and discovery, with BioLineRx's proven track record of clinical and regulatory success," stated Zeno Albisser, Chief Executive Officer of Hemispherian. "Glioblastoma is a notoriously challenging tumor type in urgent need of new treatment options. GLIX1 is a small molecule that crosses the blood-brain-barrier, has a novel mechanism of action targeting a DNA repair mechanism in cancer cells, and has demonstrated impressive efficacy and a favorable safety profile in pre-clinical models. We are eager to initiate the Phase 1/2a study as expeditiously as possible, and are working with leading neuro-oncology centers and the BioLineRx team to bring this promising asset to patients."
"Following a comprehensive review of pipeline expansion opportunities in oncology and rare diseases, we are thrilled to have identified a highly innovative asset such as GLIX1, with the potential to become an effective and safe treatment option for cancer patients with high unmet needs. I could not be more excited to work alongside the Hemispherian team," said Philip Serlin, Chief Executive Officer of BioLineRx. "This JV brings together highly complementary capabilities in DNA repair research, alongside clinical development and regulatory expertise, to create an entity that I believe is well positioned to bring much-needed innovation to the most challenging cancer types while creating shareholder value. The JV also has a first look at other molecules in Hemispherian's pipeline, but will initially focus on GLIX1."
Terms of the Joint Venture
Pursuant to the terms of the JV agreement, Hemispherian will contribute the global rights of GLIX1 to the JV, and BioLineRx will be responsible for managing, performing and funding all JV development activities. In consideration for their respective contributions, as of the JV's inception, Hemispherian will hold 60% of the JV's share capital, and BioLineRx will hold a 40% stake, with BioLineRx's stake increasing incrementally to a potential maximum of 70% in parallel with its continued investment in the program. The parties agreed that all funding from BioLineRx would go strictly to asset development. The JV also has a first look at other molecules in Hemispherian's pipeline.
Urgent Unmet Need and Significant Commercial Opportunity in Glioblastoma
GBM is the most common and aggressive form of primary brain cancer. The current standard of care (SoC) treatment was established in 2005, with only limited further advancements since. Treatment includes surgical resection, followed by radiotherapy, and concomitant and adjuvant chemotherapy (Temozolomide), yet most patients will succumb to their disease within less than 18 months (median OS of 12-18 months).
GBM occurs at all ages, but peaks in the fifth and sixth decades of life, with an increasing incidence in light of the aging global population. New and better treatments are desperately needed aiming at improving survival, maintaining quality of life and delaying tumor progression and symptoms.
The annual incidence of GBM is expected to be approximately 18,500 patients in the U.S. and approximately 13,400 across the EU5 (France, Germany, Italy, Spain and the United Kingdom) by 2030. Total addressable markets across both the newly diagnosed and recurrent settings are estimated to be approximately $2.5 billion in the U.S., and approximately $1.3 billion across the 5EU at that time.
Phase 1/2a Study to be Conducted by World Leading Investigators in Glioblastoma
Dr. Roger Stupp and Dr. Ditte Primdahl of the Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center at Northwestern University will serve as principal investigators for the study.
The Phase 1 part of the trial is expected to recruit up to 30 patients with recurrent GBM. The objective of this part is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. Data from the Phase 1 part of the trial is anticipated in H1 2027.
The Phase 2a expansion part of the trial is planned to include three population cohorts: (1) GLIX1 as monotherapy in recurrent GBM, (2) GLIX1 in combination with standard of care in newly diagnosed GBM patients (likely a "window of opportunity" study), and (3) GLIX1 in combination with PARP inhibitors in other solid tumors.
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until October 1, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
About Hemispherian AS
Hemispherian AS is a pioneering biotech company developing next-generation therapeutics for aggressive cancers. The company is focused on developing a novel class of small molecule drugs targeting the TET2 enzyme.
The company's lead compound, GLIX1, has a unique mechanism of action that selectively targets DNA repair pathways in tumor cells while sparing healthy tissue. Hemispherian has received IND clearance from the FDA to start clinical development for GLIX1. Hemispherian is based in Oslo, Norway. For more information, visit www.hemispherian.com.
midastouch017
10月前
BioLineRx Reports Second Quarter 2025 Financial Results and Provides Corporate Update
https://finance.yahoo.com/news/biolinerx-reports-second-quarter-2025-110000493.html
- Reports continued progress in the evaluation of assets for potential pipeline expansion in the areas of oncology and rare disease; transaction targeted for 2025 -
- Provides updated and extended cash runway guidance into H1 2027 -
- Management to host conference call today, August 14th, at 8:30 am EDT -
TEL AVIV, Israel, Aug. 14, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the quarter ended June 30, 2025, and provided a corporate update.
"Since our last quarterly update, we have been acutely focused on evaluating a broad range of potential pipeline expansion opportunities where we can leverage our clinical and regulatory expertise, and track record of drug approval success, to drive new innovation in areas of need," said Philip Serlin, Chief Executive Officer of BioLineRx. "Today, I am pleased to report that discussions with potential partners continue to progress. Our balance sheet is strong, our organization is lean, and we are seeing promising opportunities that fit well within our criteria - most notably a clear and efficient development pathway. I remain confident that we could potentially execute a transaction this year that will expand our pipeline and provide fresh opportunities for clinical success and long-term value creation."
Financial Updates
With $28.2 million on its balance sheet as of June 30, 2025, BioLineRx is guiding to a cash runway into the first half of 2027. This represents an improvement as compared to the Company's previous cash runway guidance into the second half of 2026.
Clinical Updates
Motixafortide
Pancreatic Ductal Adenocarcinoma (mPDAC)
Enrollment activities continue in the CheMo4METPANC Phase 2b clinical trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx. The CheMo4METPANC trial is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapy (gemcitabine and nab-paclitaxel).
A prespecified interim analysis is planned when 40% of progression-free survival (PFS) events are observed.
An abstract featuring updated data from the pilot phase of the ongoing CheMo4METPANC clinical trial was presented at the 2025 ASCO Annual Meeting in May. Key highlights include:
- Four of 11 patients remained progression-free after more than one year.
- Two patients underwent definitive treatment for metastatic pancreatic cancer: one had complete resolution of all radiologically detected liver lesions and underwent radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response.
- An analysis of pre- and on-treatment biopsies revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination.
Sickle Cell Disease (SCD) & Gene Therapy
Ongoing Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease continues to progress. The trial is sponsored by Washington University School of Medicine in St. Louis, and results are anticipated in the second half of 2025.
A second study, sponsored by St. Jude Children's Research Hospital, continues to enroll patients. The study is a multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with Sickle Cell Disease (SCD).
APHEXDA Performance Update
APHEXDA generated sales of $1.7 million in the second quarter of 2025, providing royalty revenue to the Company of $0.3 million.
Financial Results for the Quarter Ended June 30, 2025
Total revenues for the second quarter of 2025 were $0.3 million, reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Total revenues in 2025 are not comparable to the same period in 2024, which included direct commercial sales by BioLineRx prior to the Ayrmid transaction in November 2024.
Cost of revenues for the second quarter of 2025 was immaterial, compared to cost of revenues of $0.9 million for the second quarter of 2024. Cost of revenues in 2025 are not comparable to the same period in 2024, which included cost of sales from direct commercial sales by BioLineRx prior to the Ayrmid transaction in November 2024.
Research and development expenses for the second quarter of 2025 were $2.3 million, compared to $2.2 million for the second quarter of 2024. The increase resulted primarily from certain one-time costs associated with the PDAC study at Columbia University, offset by lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount.
There were no sales and marketing expenses for the second quarter of 2025, compared to $6.4 million for the second quarter of 2024. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid transaction.
General and administrative expenses for the second quarter of 2025 were $0.2 million, compared to $1.6 million for the second quarter of 2024. The decrease resulted primarily from the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria, a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, as well as small decreases in a number of general and administrative expenses.
Net non-operating expenses for the second quarter of 2025 were $1.9 million, compared to net non-operating income of $7.8 million for the second quarter of 2024. Non-operating income (expenses) for both periods primarily relate to fair-value adjustments of warrant liabilities on the balance sheet, as a result of changes in the Company's share price
Net financial income for the second quarter of 2025 was $0.2 million, compared to net financial expenses of $1.6 million for the second quarter of 2024. Net financial income (expenses) for both periods primarily relate to loan interest paid, partially offset by investment income earned on bank deposits and gains on foreign currency (primarily NIS) cash balances due to the strengthening of the NIS during the period. The significant decrease in financial expenses in the 2025 period results from a substantial paydown of the BlackRock loan balance in November 2024, following the transaction with Ayrmid.
Net loss for the second quarter of 2025 was $3.9 million, compared to net income of $0.5 million for the second quarter of 2024.
As of June 30, 2025, the Company had cash, cash equivalents, and short-term bank deposits of $28.2 million, sufficient to fund operations, as currently planned, into the first half of 2027.
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until August 16, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
midastouch017
11月前
Form 6- K
BioLineRx Ltd. (the “Company”) today announced the results of the Company’s Annual General Meeting of Shareholders (the “Meeting”), which was held on June 29, 2025, at 3:00 p.m. (Israel time).
At the Meeting, the Company’s shareholders voted upon and approved, by the respective requisite majority in accordance with the Israel Companies Law, 5759-1999 and the Company’s articles of association (the “Articles of Association”), the proposals set forth in the Company’s proxy statement for the Meeting, which was attached as Exhibit 99.1 to the Company’s Report on Form 6-K furnished to the U.S. Securities and Exchange Commission on May 23, 2025. Accordingly, the following proposals were adopted at the Meeting:
Proposal 1 – the re-election of Dr. BJ Bormann and Dr. Raphael Hofstein as Class II directors, each to serve until the Company’s annual general meeting of shareholders to be held in 2028, and until their respective successors have been duly elected and qualified.
Proposal 2 – the increase in the Company’s authorized share capital and to amend the Company’s Articles of Association accordingly.
Proposal 3 – the adoption of the renewed Compensation Policy for the Company’s Executive Officers and Directors.
Proposal 4 – the reappointment of Kesselman & Kesselman, Certified Public Accountants (Isr.), a member firm of PricewaterhouseCoopers International Limited, as the Company’s independent registered public accounting firm for the year ending December 31, 2025, and until the Company’s next annual general meeting of shareholders, and to authorize the Audit Committee of the Board of Directors to fix the compensation of said auditors in accordance with the scope and nature of their services
This Form 6-K is hereby incorporated by reference into all effective registration statements filed by the registrant under the Securities Act of 1933.
midastouch017
1年前
BioLineRx Announces New Pilot Phase Data from Phase 2 Combination Trial of Motixafortide in First-Line Pancreatic Cancer (PDAC) to be Presented at ASCO 2025 Annual Meeting
https://finance.yahoo.com/news/biolinerx-announces-pilot-phase-data-110000297.html
- 4 of 11 PDAC patients in the pilot phase remained progression free at over one year
- Poster presentation on Saturday, May 31st
TEL AVIV, Israel, May 30, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare disease, today announced that a poster including new data from the single-arm pilot phase of the investigator-initiated, randomized CheMo4METPANC Phase 2 combination clinical trial will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30-June 3, 2025 in Chicago, Illinois.
The CheMo4METPANC trial is evaluating the company's CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard-of-care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).
Updated results from the pilot phase indicate that four of eleven patients remained progression free after more than one year. Two patients underwent definitive treatment for mPDAC: one had complete resolution of all radiologically detected liver lesions and underwent definitive radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response. An analysis of pre- and on-treatment biopsies and peripheral blood mononuclear cells (PBMCs) also revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination. In addition, patients achieving a partial response were found to have higher pre-treatment proportions of CXCL12-producing cancer associated fibroblasts, a potential marker of response.
"The data that continue to emerge from the pilot phase of the CheMo4METPANC Phase 2 study are extremely encouraging, with four of eleven patients remaining progression free after more than one year, as well as two patients that underwent definitive treatment, in what has historically been among the most challenging tumor types to treat," stated Philip Serlin, Chief Executive Officer of BioLineRx Ltd. "Notably, these results further suggest that the combination of motixafortide, cemiplimab and standard-of-care chemotherapy can overcome the immunosuppressive mechanisms of the tumor microenvironment (TME) and increase intratumoral CD8+ T-cell infiltration, resulting in improved patient outcomes. We look forward to results from the ongoing randomized portion of this important study."
The pilot clinical trial of motixafortide, cemiplimab, gemcitabine and nab-paclitaxel (N=11) demonstrated an overall response rate (ORR) of 64% (7/11) and a disease control rate (DCR) of 91% (10/11), compared to historical ORR and DCR of 23% and 48%, respectively, with gemcitabine and nab-paclitaxel. Based on these encouraging results, the CheMo4METPANC Phase 2 trial was amended to become a randomized study, with planned enrollment increasing from 30 to 108 patients. The trial is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies. The trial is planned to be fully enrolled in 2027, and a prespecified interim analysis is planned for when 40% of PFS events are observed.
Poster Presentation at ASCO 2025
McCormick Place, Chicago, Illinois
Poster Session Details
Primary Track: Gastrointestinal Cancer—Gastroesophageal, Pancreatic and Hepatobiliary
Title: CheMo4METPANC: Combination Chemotherapy (Gemcitabine and Nab-Paclitaxel), Chemokine (C-X-C) Motif Receptor 4 Inhibitor (Motixafortide), and Immune Checkpoint Blockade (Cemiplimab) in Metastatic Treatment-Naïve Pancreatic Adenocarcinoma
Presenter: Gulam Abbas Manji, MD, PhD, Columbia University Herbert Irving Comprehensive Cancer Center
Abstract: 4167
Poster Bd #: 457
Date: May 31, 2025
Time: 9:00am CDT
Location: Hall A
About CheMo4METPANC Phase 2 Clinical Trial
The multi-center CheMo4METPANC Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04543071) is a randomized, investigator-initiated clinical trial in first line metastatic pancreatic cancer. Sponsored by Columbia University, and supported equally by BioLineRx and Regeneron, the study is evaluating the combination of CXCR4 inhibitor motixafortide, PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in 108 patients. The trial's primary endpoint is progression free survival (PFS). Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival.
About Pancreatic Cancer
Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In the United States in 2024, an estimated 66,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths.1 Worldwide, an estimated 496,000 people were diagnosed with the disease in 2020. In the U.S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative survival rate is 44%. About 12% of people are initially diagnosed at this stage. If the cancer has spread to surrounding tissues or organs, the 5-year relative survival rate is 15%. For the 52% of patients who are initially diagnosed with metastatic cancer, the 5-year relative survival rate is 3%.2 In particular, hepatic (liver) metastases are a critical risk factor driving poor prognoses for patients with metastatic PDAC. These data highlight the need for the development of new therapeutic options.
About Motixafortide in Cancer Immunotherapy
Motixafortide inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC). Motixafortide leverages the expression of the CXCR4 receptor on different immune cells and potentiates the immune system against the tumor. Among CXCR4-expressing immune cells, some exhibit anti-tumoral activity, such as effector T cells and some exhibit pro-tumoral activity and support tumor growth. By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile.
midastouch017
1年前
BioLineRx Reports First Quarter 2025 Financial Results and Provides Corporate Update
https://finance.yahoo.com/news/biolinerx-reports-first-quarter-2025-110000166.html
- Reports continued progress in the evaluation of assets for potential in-licensing and development in the areas of oncology and rare disease -
- New data from pilot phase of ongoing CheMo4METPANC Phase 2b combination trial of motixafortide in PDAC, sponsored by Columbia University, to be presented at upcoming 2025 ASCO Annual Meeting –
- APHEXDA performing well under Ayrmid stewardship -
- Management to host conference call today, May 27th, at 8:30 am EDT -
TEL AVIV, Israel, May 27, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the quarter ended March 31, 2025, and provided a corporate update.
"Following our announcement last November that we out-licensed APHEXDA®, our FDA-approved stem cell mobilization agent, to Ayrmid Ltd., we have been actively evaluating new assets in the areas of oncology and rare disease where we can leverage our drug development and regulatory expertise to bring new medicines to market," said Philip Serlin, Chief Executive Officer of BioLineRx. "I remain optimistic that we will announce a meaningful transaction this year."
"At the same time, APHEXDA is performing well under the stewardship of Ayrmid, and I believe this license agreement will contribute significant long-term value to our company," Mr. Serlin concluded.
Financial Updates
Completed financing in January 2025 raising gross proceeds of $10 million.
Successfully reduced operating expense run rate by over 70% beginning January 1, 2025, through the APHEXDA program transfer to Ayrmid and the resulting shutdown of the Company's U.S. commercial operations in Q4 2024, as well as additional headcount and other operating expense reductions.
Reaffirms cash runway through the second half of 2026.
APHEXDA Performance Update
APHEXDA generated sales of $1.4 million in the first quarter of 2025, providing royalty revenues to the Company of $0.3 million.
Clinical Updates
Motixafortide
Pancreatic Ductal Adenocarcinoma (mPDAC)
Additional trial sites were activated for the CheMo4METPANC Phase 2b clinical trial, which is expected to have a positive impact on patient recruitment. Full enrollment in the randomized trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx, is planned for completion in 2027, with a prespecified interim analysis planned when 40% of progression free survival (PFS) events are observed.
An abstract featuring updated data from the pilot phase of the ongoing CheMo4METPANC clinical trial has been accepted for a poster presentation at the 2025 ASCO Annual Meeting on Saturday, May 31st. Key highlights include:
Two patients underwent definitive treatment for metastatic pancreatic cancer: one had complete resolution of all radiologically detected liver lesions and underwent definitive radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response.
An analysis of pre- and on-treatment biopsies revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination.
Sickle Cell Disease (SCD) & Gene Therapy
Enrollment is continuing into the multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with Sickle Cell Disease (SCD). The trial is sponsored by St. Jude Children's Research Hospital.
Reported continued progress of a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease. The trial is sponsored by Washington University School of Medicine in St. Louis.
Financial Results for the Quarter Ended March 31, 2025
Revenues for the three-month period ended March 31, 2025 were $0.3 million, a decrease of $6.6 million, compared to revenues of $6.9 million for the three-month period ended March 31, 2024. The significant decrease in revenues from 2024 to 2025 reflects the one-time revenues recorded in 2024 relating to the out-licensing transaction with Gloria during the fourth quarter of 2023, as well as the change in the Company's operations following the out-licensing of APHEXDA to Ayrmid during the fourth quarter of 2024. The revenues in 2025 reflect the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The revenues in 2024 primarily reflect a portion of the up-front payment received by the Company and a milestone payment achieved under the license agreement with Gloria, which collectively amounted to $5.9 million, as well as $0.9 million of net revenues from product sales of APHEXDA in the U.S.
Cost of revenues for the three-month period ended March 31, 2025 was immaterial, compared to cost of revenues of $1.5 million for the three-month period ended March 31, 2024. The cost of revenues in 2025 reflects sub-license fees on royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The cost of revenues in 2024 primarily reflects sub-license fees on a milestone payment received under the Gloria license agreement and royalties on net product sales of APHEXDA in the U.S., as well as amortization of intangible assets and cost of goods sold on product sales.
Research and development expenses for the three months ended March 31, 2025 were $1.6 million, a decrease of $0.9 million, or 34.9%, compared to $2.5 million for the three months ended March 31, 2024. The decrease resulted primarily from lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount.
There were no sales and marketing expenses for the three months ended March 31, 2025, compared to $6.3 million for the three months ended March 31, 2024. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid out-licensing transaction.
General and administrative expenses for the three months ended March 31, 2025 were $1.0 million, a decrease of $0.4 million, or 28.6%, compared to $1.4 million for the three months ended March 31, 2024. The decrease resulted primarily from a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, as well as small decreases in a number of general and administrative expenses.
Net non-operating income for the three months ended March 31, 2025 was $7.6 million, compared to net non-operating income of $4.5 million for the three months ended March 31, 2024. Non-operating income for both periods primarily relates to fair-value adjustments of warrant liabilities on the balance sheet, as a result of changes in the Company's share price.
Net financial expenses for the three months ended March 31, 2025 were $0.1 million, compared to net financial expenses of $0.4 million for the three months ended March 31, 2024. Net financial expenses for both periods primarily relate to loan interest paid, partially offset by investment income earned on bank deposits.
Net income for the quarter ended March 31, 2025 was $5.1 million, compared to $0.7 million for the quarter ended March 31, 2024.
As of March 31, 2025, the Company had cash, cash equivalents, and short-term bank deposits of $26.4 million
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until May 29, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
midastouch017
1年前
BioLineRx Reports 2024 Financial Results and Provides Corporate Update
https://finance.yahoo.com/news/biolinerx-reports-2024-financial-results-110000630.html
- Reports meaningful progress in the evaluation of assets for potential in-licensing and development in the areas of oncology and rare diseases -
- Executed license agreement with Ayrmid Pharma Ltd. for APHEXDA® (motixafortide) with $10 million upfront payment, up to $87 million in commercial milestones, and high double-digit royalties on net sales -
- Completed financings raising combined gross proceeds of $19 million and reduced operating expense run rate by 70%, extending the Company's cash runway through H2 2026 -
- Management to host conference call today, March 31st, at 8:30 am EDT -
TEL AVIV, Israel, March 31, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its audited financial results for the year ended December 31, 2024, and provided a corporate update.
"It has been just over four months since we implemented a major strategy shift, highlighted by the transformational exclusive licensing agreement that we entered into with Ayrmid Ltd., granting it the rights to commercialize APHEXDA® (motixafortide) in all non-solid-tumor indications and all territories other than Asia," said Philip Serlin, Chief Executive Officer of BioLineRx. "Since then, we implemented cost efficiencies across the Company, including the shutdown of our U.S. commercial operations, that have resulted in an approximate 70% reduction in our operating expense base, which, together with recent financings, have put us on a firm footing with a cash runway through the second half of 2026."
"As we return to our roots as a lean drug development company, with a highly validated development platform focused on oncology and rare diseases, we believe these actions help ensure that we remain nimble and capable of seizing the opportunities in front of us. Our strategy moving forward is to in-license additional assets over the next year that we can advance through clinical proof-of-concept, funded in part by milestones and royalties from our out-licensing transactions. To that end, I am pleased to report that we are evaluating numerous promising candidates. This process is methodical and steady to ensure that our due diligence is thorough as we look for new chemical entities. Based on our deep and validated experience in drug development, I believe we are well positioned to create sustained value for our shareholders. I am excited about what the future holds for our Company this year and beyond," Mr. Serlin concluded.
Corporate Updates
Executed license agreement with Ayrmid Pharma Ltd. to develop and commercialize APHEXDA® (motixafortide) in all indications except solid tumors, and across all territories except Asia
- License agreement included a $10 million upfront payment, up to $87 million in potential commercial milestones, and royalties on net sales ranging from 18% to 23%
Announced receipt of a Notice of Allowance from the U.S. Patent & Trademark Office (USPTO) for a patent, titled "Composition of BL-8040," which strengthens BioLineRx's robust intellectual property (IP) estate and extends its patent protection on motixafortide (BL-8040) in the U.S. through December 2041
Financial Updates
Completed two financings in past few months which raised combined gross proceeds of $19 million
Reduced operating expense run rate by approximately 70% beginning January 1, 2025 through the APHEXDA program transfer to Ayrmid and the resulting shutdown of the Company's U.S. commercial operations in Q424, as well as additional headcount and other operating expense reductions
Significantly reduced outstanding debt and restructured the remainder on favorable terms to the Company
APHEXDA 2024 Performance Update
Aphexda achieved 10 percent market share of total CXCR4 inhibitor usage in the U.S., which compares APHEXDA to branded MOZOBIL and generic plerixafor in all indications
BioLineRx generated more than $6 million in net product sales year-to-date through the November 2024 completion of the Ayrmid out-licensing transaction
Clinical Updates
Motixafortide
Pancreatic Ductal Adenocarcinoma (mPDAC)
Additional trial sites activated for the CheMo4METPANC Phase 2b clinical trial being led by Columbia University. Full enrollment in the randomized trial targeting 108 patients is anticipated in 2027, with a prespecified interim futility analysis planned when 40% of PFS events are observed
Sickle Cell Disease (SCD) & Gene Therapy
First patient dosed in the multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with Sickle Cell Disease (SCD). The trial is sponsored by St. Jude Children's Research Hospital.
Oral presentation delivered at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition detailing initial results from a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in SCD. Sponsored by investigators at Washington University in St. Louis, the findings from this proof-of-concept study suggest motixafortide alone, and in combination with natalizumab, could support the collection of the large number of stem cells required by gene therapies for sickle cell disease within a single apheresis cycle.
Financial Results for the Year Ended December 31, 2024
Revenues for the year ended December 31, 2024 were $28.9 million, an increase of $24.1 million, or 502.1%, compared to $4.8 million for the year ended December 31, 2023. The revenues in 2024 primarily reflect a portion of the up-front payment received, and a milestone payment achieved, under the Gloria license, which collectively amounted to $15.0 million, as well as the up-front payment received under the Ayrmid license and $6.0 million of net revenues from product sales of APHEXDA in the U.S. The revenues in 2023 (all of which were recorded in the fourth quarter of 2023) primarily reflect a portion of the up-front payment received under the Gloria license of $4.6 million, as well as $0.2 million of revenues from product sales of APHEXDA in the U.S.
Cost of revenues for the year ended December 31, 2024 were $9.3 million, an increase of $5.6, or 151.4%, compared to $3.7 million for the year ended December 31, 2023. The cost of revenues in 2024 primarily reflects amortization of intangible assets, Biokine's share of the up-front payment received under the Ayrmid license, sub-license fees accrued on a milestone payment recorded under the Gloria license, as well as royalties on net product sales of APHEXDA in the U.S. and cost of goods sold on product sales. The cost of revenues in 2023 primarily reflects Biokine's share of the up-front payment received under the Gloria license and of the net sales.
Research and development expenses for the year ended December 31, 2024 were $9.2 million, a decrease of $3.3 million, or 26.4%, compared to $12.5 million for the year ended December 31, 2023. The decrease resulted primarily from lower expenses related to motixafortide NDA supporting activities, termination of the development of AGI-134 and a decrease in payroll and share-based compensation.
Sales and marketing expenses for the year ended December 31, 2024 were $23.6 million, a decrease of $1.7 million, or 6.7%, compared to $25.3 million for the year ended December 31, 2023. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid license.
General and administrative expenses for the year ended December 31, 2024 were $6.3 million, similar to the year ended December 31, 2023.
Net non-operating income amounted to $18.4 million for the year ended December 31, 2024, compared to net non-operating expenses of $10.8 million for the year ended December 31, 2023. Non-operating income for the year ended December 31, 2024 primarily relates to non-cash, fair-value adjustments of warrant liabilities on the Company's balance sheet, as a result of changes in the Company's share price, offset by warrant offering expenses. Non-operating expenses for the year ended December 31, 2023 primarily relate to non-cash, fair-value adjustments of warrant liabilities on the Company's balance sheet.
Net financial expenses amounted to $7.3 million for the year ended December 31, 2024, compared to net financial expenses of $0.1 million for the year ended December 31, 2023. Net financial expenses for both periods primarily relate to interest paid on loans, which increased in 2024 due to a one-time $4.0 million charge to interest expense in connection with the November 2024 amendment to the loan agreement with BlackRock, partially offset by investment income earned on bank deposits.
Net loss for the year ended December 31, 2024 was $9.2 million, compared to $60.6 million for the year ended December 31, 2023.
As of December 31, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $19.6 million (approximately $29.0 million on a pro-forma basis, following the financing completed at the beginning of January 2025).
A copy of the Company's annual report on Form 20-F for the year ended December 31, 2024 has been filed with the U.S. Securities and Exchange Commission at https://www.sec.gov/ and posted on the Company's investor relations website at https://ir.biolinerx.com.The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request at IR@BioLineRx.com.
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until April 2, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
midastouch017
1年前
BioLineRx Issues Letter to Shareholders
- Company outlines strategic long-term vision and financial outlook -
TEL AVIV, Israel -- January 21, 2025 – BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today issued the following letter to shareholders.
To my fellow shareholders,
It has been approximately two months since we announced a major strategy shift with the signing of an exclusive license agreement with Ayrmid Ltd. to commercialize APHEXDA® (motixafortide), the next-generation stem cell mobilization agent that we successfully shepherded from early clinical development through FDA approval and commercial launch in September 2023. Following such a transformational transaction, I wanted to provide more granularity regarding our vision for our company moving forward, as we remain as committed as ever to maximizing value for our shareholders.
To fully understand where we plan to go, it is important to recap the salient terms of the license agreement with Ayrmid Ltd. (Ayrmid), as well as the previously announced license agreement that we entered into with Guangzhou Gloria Biosciences Co., Ltd. (GloriaBio). Both agreements provided significant non-dilutive upfront capital, while allowing us to retain upside potential from royalties on future sales of APHEXDA, as well as from potential future commercial and development milestones in the respective territories. We expect these collaborations to provide a growing stream of cash flows into our company over time while we work to rebuild our pipeline with new assets.
Ayrmid
The license agreement with Ayrmid, which we announced in November 2024, gives Ayrmid the right to develop and commercialize APHEXDA (motixafortide) across all indications, excluding solid tumor indications, and in all territories other than Asia. In exchange for the license, we received a $10 million upfront payment, and are eligible to receive up to an additional $87 million in potential commercial milestones, plus royalties ranging from 18% to 23% on net sales of APHEXDA. In addition, certain funds managed by Highbridge Capital Management LLC, Ayrmid’s principal shareholder, executed a $9 million equity investment in the Company.
GloriaBio
The license agreement with GloriaBio, which we first announced in August 2023, gives GloriaBio the right to develop and commercialize motixafortide across all indications in the Asia region, beginning with stem cell mobilization (SCM), followed by pancreatic ductal adenocarcinoma (PDAC). In exchange, we received a $15 million upfront payment, and are eligible to receive up to ~$50 million in potential development and regulatory milestones in China and Japan, as well as up to ~$200 million in potential commercial milestones based on defined sales targets. We are also eligible to receive tiered double-digit royalties on net sales. In addition, a $14.6 million equity investment in the Company was executed here as well.
BioLineRx 2.0
As it pertains to BioLineRx, or what I now like to call “BioLineRx 2.0,” we have returned to our roots as a lean drug development company, leveraging the many years of experience and the track record of success that our team brings, as evidenced by our successful development of motixafortide, which we advanced from early-stage clinical development through a successful Phase 3 trial, and culminating with FDA approval in September 2023.
We have retained the rights to develop motixafortide across all solid tumor indications, in all territories other than Asia, including in pancreatic ductal adenocarcinoma (PDAC), for which an investigator-initiated Phase 2b trial, sponsored by Columbia University, and supported equally by BioLineRx and Regeneron, is ongoing at a relatively minimal cost to BioLineRx. A second Phase 2b trial in PDAC is being planned by GloriaBio, at no cost to us. We expect these pipeline programs to continue to advance without any significant expense to our Company, while providing the potential for a meaningful future upside.
At the same time, a key component of our strategy moving forward is to in-license additional assets in oncology and/or rare diseases over the next two years that we can advance through clinical development. We have substantial experience in scouting and assessing assets in transactions with back-ended, success-based consideration, which can be acquired or licensed for a modest upfront payment, and with relatively modest and affordable clinical development programs. We are actively working on this initiative and are being presented with many promising opportunities that meet these criteria. Visibility on our progress with this initiative, like most companies, will be minimal until we have a tangible agreement to announce.
Our longer-term vision is to develop innovative assets with significant potential value whose development costs have been offset by the royalties and milestones from our existing motixafortide partnerships. We aim to continue pursuing new partnerships on these programs to create additional value for our shareholders.
Strengthened Balance Sheet and Streamlined Cost Structure Provide Runway through H2 2026
Proceeds from the Ayrmid and GloriaBio transactions, together with the opportunistic $10 million equity financing that we completed in early January and our significantly reduced cost structure (our currently planned operating burn rate going forward is ~$12 million per year) are expected to provide us with a current cash runway to execute upon our goals through the second half of 2026. This includes the relatively minor costs associated with continuing to support the PDAC trials, while also engaging in our planned pipeline expansion activities. Furthermore, it does not take into account any potential revenue upside generated from sales royalties or commercial milestones under our out-licensing agreements that I just described.
ADS Ratio Change Maintains Nasdaq Listing Compliance
Finally, to regain compliance with Nasdaq’s minimum bid price requirement, we announced just a few days ago our intent to change the ratio of our American Depositary Shares to ordinary shares, from 15 ordinary shares per ADS to 600 ordinary shares per ADS. This is equivalent to a 1-for-40 reverse stock split, and will go into effect on January 30, 2025.
As we continue to execute on our long-term strategy, including the potential in-licensing of new assets, maintaining our Nasdaq exchange listing is a critical objective. By implementing this change, we hope to regain compliance with all of Nasdaq’s applicable requirements, allowing us to continue to enjoy all the benefits that such a listing confers.
In closing, we are entering 2025 with a renewed focus on innovative drug development within our core competency areas, a strengthened balance sheet with $29.5 million of cash, a very lean cost structure, and a cash runway based on our current operating plan through the second half of 2026. With these strategic actions completed, I believe we are well positioned to create enduring value for our shareholders while introducing novel therapeutics for patients suffering from cancer or rare diseases.
I am excited about what the future holds for BioLineRx, both for this year and beyond, and I look forward to keeping you apprised of our continued progress, beginning with our fourth quarter 2024 results release in March.
Thank you for your continued support.
Sincerely,
Phil Serlin
Philip Serlin
Chief Executive Officer
midastouch017
2年前
BioLineRx Reports Third Quarter 2024 Financial Results and Provides Update on Transformation to Drive Shareholder Value
- Executed license agreement with Ayrmid Ltd. for APHEXDA® (motixafortide) for $10 million upfront, up to $87 million in commercial milestones, and 18-23% tiered royalties on sales -
- Received $9 million equity investment from certain funds managed by Highbridge Capital Management, LLC -
- Entered into agreement to reduce and restructure long-term debt by ~$16.5 million -
- Annual operational expenses expected to decline by over 70% following out-license of APHEXDA® (motixafortide) commercial program to Ayrmid -
- Company to continue to support motixafortide PDAC program while evaluating additional assets for development in rare diseases and oncology -
- Management to host conference call today, November 25, at 8:30 am EDT -
TEL AVIV, Israel, Nov. 25, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the third quarter ended September 30, 2024, and provided updates on strategic actions designed to drive shareholder value.
"The license agreement for APHEXDA that we announced last week was made possible by the tremendous work of our commercial team, who through their hard work proved the significant value that APHEXDA can bring to transplant centers and patients," said Philip Serlin, Chief Executive Officer of BioLineRx. "Our launch progress attracted Ayrmid, who will now, through Gamida Cell, continue to build on the strong commercial foundation that has been laid. We would like to thank our employees for their outstanding contributions to APHEXDA growth and expect this innovative product to reach even more patients with the additional resources from Ayrmid.
"Looking forward, our streamlined and nimble company has a new financial foundation supported by sales royalties and potential milestone payments, which will allow our experienced team to develop important new therapies in rare disease and oncology that address areas with high unmet need. We will also focus on advancing our motixafortide PDAC program through existing collaborations that require de-minimis investment. Through this strategy, we anticipate delivering near- and long-term value for our shareholders," Mr. Serlin concluded.
Corporate Updates
Executed license agreement with Ayrmid Ltd. to develop and commercialize APHEXDA® (motixafortide) in all indications except solid tumors, and across all territories except Asia
License agreement included a $10 million upfront payment, up to $87 million in potential commercial milestones, and royalties on net sales ranging from 18% to 23%
BioLineRx will supply motixafortide on a cost-plus basis, for both commercial and development supply
Certain members of the BioLineRx U.S.-based commercial organization will be transitioned to Ayrmid Pharma Ltd.
Received $9 million equity investment from certain funds managed by Highbridge Capital Management, LLC, to support BioLineRx's pipeline expansion
Operating expense run-rate expected to decrease by more than 70% beginning January 1, 2025 through APHEXDA commercial program transfer and additional headcount reductions
Company intends to evaluate additional asset opportunities in 2025, with a focus on early-stage clinical programs in oncology or rare diseases that address major areas of unmet need
Financial Updates
Executed repayment and restructuring agreement with BlackRock EMEA Venture and Growth Lending to repay $16.5 million of approximately $29 million in total debt due; remaining balance will be paid over the next three years at the existing fixed annual interest rate of 9.5 percent
As of September 30, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $29.2 million
Following the out-license to Ayrmid, the equity investment from Highbridge and the debt repayment to Blackrock, the Company's cash, cash equivalents and short-term bank deposits are expected to be approximately $20 million, which management believes will be sufficient to fund operations into 2026, as currently planned
APHEXDA Launch Updates
Aphexda achieved 10 percent market share milestone of total CXCR4 inhibitor usage in the U.S., which compares APHEXDA to branded MOZOBIL and generic plerixafor in all indications
Institutions ordering APHEXDA increased by 40 percent in the third quarter
Clinical Portfolio Updates
Motixafortide
Pancreatic Ductal Adenocarcinoma (mPDAC)
Continued enrollment in the CheMo4METPANC Phase 2b clinical trial collaboration with Columbia University. In addition to Columbia, patient enrollment has begun at Brown University, and three additional sites are anticipated to begin enrollment over the next two quarters. Full enrollment in the randomized trial targeting 108 patients is anticipated in 2027, with a prespecified interim futility analysis planned when 40% of PFS events are observed
Multiple Myeloma
Collaboration partner Gloria Biosciences' stem cell mobilization bridging study IND was filed and approved by the Center for Drug Evaluation of the National Medical Products Administration in China. Anticipate initiation of pivotal clinical trial in 1H 2025
Gloria Biosciences has received regulatory approval to commercialize APHEXDA in the Boao Region of China and Macao, areas in Asia that do not require a bridging study
Sickle Cell Disease (SCD) & Gene Therapy
Announced oral presentation at ASH 2024 on initial results from a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD). Sponsored by investigators at Washington University in St. Louis, the findings from this proof-of-concept study suggest motixafortide alone, and in combination with natalizumab, could support the collection of the large number of stem cells required by gene therapies for sickle cell disease within a single apheresis cycle. The presentation will occur at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition taking place December 7-10, 2024, in San Diego, California
Third Quarter 2024 Financial Results
Total revenue for the three months ended September 30, 2024 was $4.9 million. The Company did not record any revenue during the third quarter of 2023. Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.2 million, as well as $1.7 million of net revenue from product sales of APHEXDA in the U.S.
Cost of revenue for the three months ended September 30, 2024 was $0.8 million. The Company did not record any cost of revenue during the third quarter of 2023. Cost of revenue for the quarter primarily reflects the amortization of intangible assets, royalties on net product sales of APHEXDA in the U.S., and cost of goods sold on product sales
Research and development expenses for the three months ended September 30, 2024 were $2.6 million, compared to $2.7 million for the same period in 2023. The decrease resulted primarily from lower expenses related to the termination of the development of AGI-134 and a decrease in payroll and share-based compensation
Sales and marketing expenses for the three months ended September 30, 2024 were $5.5 million, compared to $8.1 million for the same period in 2023. The decrease resulted primarily from lower expenses of commercialization activities related to motixafortide. The higher expenses in the corresponding period of 2023 reflect the ramp-up of pre-commercialization activities related to motixafortide
General and administrative expenses for the three months ended September 30, 2024 were $1.4 million, compared to $1.5 million for the same period in 2023. The decrease resulted primarily from small decreases in a number of G&A expenses
Net loss for the three months ended September 30, 2024 was $5.8 million, compared to net loss of $16.0 million for the same period in 2023. The net loss for the 2024 period included $0.8 million in non-operating income, compared to non-operating expenses of $3.1 million for the same period in 2023, both primarily related to non-cash revaluation of warrants
As of September 30, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $29.2 million.
Third Quarter Results Conference Call and Webcast
BioLineRx will report its third quarter 2024 results on November 25, 2024. To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until November 27, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
midastouch017
2年前
BioLineRx and Ayrmid Ltd. Enter into Exclusive License Agreement to Commercialize APHEXDA® (motixafortide) through Gamida Cell Ltd.
https://finance.yahoo.com/news/biolinerx-ayrmid-ltd-enter-exclusive-113000874.html
– BioLineRx to receive $10 million upfront payment from Ayrmid Ltd. (parent company of Gamida Cell) plus up to $87 million in commercial milestones, as well as royalties on net sales ranging from 18% to 23% –
– BioLineRx retains rights to develop and commercialize motixafortide in solid tumors, including PDAC –
– BioLineRx received $9 million equity investment from certain funds managed by Highbridge Capital Management, LLC to support company's pipeline and expansion –
– Transactions enable significant reduction in BioLineRx's operational expenses and debt, and allow the company to focus on development activities in areas of high unmet need in oncology and rare diseases –
– BioLineRx will provide further corporate updates on its Q3 results conference call, which is scheduled for November 25 at 8:30 am ET –
TEL AVIV, Israel, Nov. 21, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Ayrmid Ltd. ("Ayrmid"), the parent company of Gamida Cell Ltd., today announced that on November 20, 2024, the companies entered into a license agreement for motixafortide (commercially sold in the U.S. as APHEXDA®), BioLineRx's FDA-approved stem cell mobilization agent indicated in combination with filgrastim (G-CSF) for collection and subsequent autologous transplantation in patients with multiple myeloma.
Under the terms of the agreement, BioLineRx granted Ayrmid an exclusive license to develop and commercialize APHEXDA (motixafortide) across all indications, excluding solid tumor indications, and in all territories other than Asia. BioLineRx previously granted an exclusive license agreement to Gloria Biosciences for APHEXDA (motixafortide) in the Asia region.
In exchange for the license, BioLineRx will receive a $10 million upfront payment and is also eligible to receive up to an additional $87 million of potential commercial milestones, plus royalties ranging from 18% to 23% on net sales of APHEXDA.
Ayrmid will add APHEXDA to its commercial portfolio, which also includes Gamida Cell's OMISIRGE®, the first and only FDA-approved, nicotinamide (NAM)-modified cell therapy for patients with hematologic malignancies in need of a stem cell transplant. As part of this transaction, Ayrmid expects to transition certain members of BioLineRx's U.S.-based commercial organization, who will support both stem cell transplant drugs.
Through this transaction, BioLineRx will significantly reduce its long-term debt and operational expenses, which will be reviewed in detail during the company's upcoming Q3 results conference call and webcast.
BioLineRx also entered into a share purchase agreement for a $9 million equity investment from certain funds managed by Highbridge Capital Management, LLC. This investment and the combined future potential commercial milestones from licensing agreements with Ayrmid and Gloria Biosciences, as well as royalties on net sales, are expected to provide a strong foundation for BioLineRx to advance its pipeline and identify potential additional assets for development. The equity investment is expected to close today, November 21, 2024, subject to the satisfaction of customary closing conditions.
BioLineRx will continue the development of motixafortide for pancreatic ductal adenocarcinoma (PDAC) through meaningful collaborations, including an active Phase 2b PDAC study led by Columbia University, and supported equally by BioLineRx and Regeneron, as well as a planned Phase 2b PDAC study in China led by Gloria Biosciences.
"Since APHEXDA's launch last year, patients and transplant centers continue to see the tremendous benefits it can provide, and I could not be prouder of our commercial organization that has proven its value," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Our agreement with Ayrmid, and their vision of creating a strong commercial transplant portfolio, makes them the ideal partner to realize APHEXDA's full commercial potential. BioLineRx will now leverage its proven expertise in drug development, with a continued focus on oncology and rare diseases. This new path forward aligns with our core strengths and allows us the opportunity to create enduring value for all stakeholders."
Dr. Joe Wiley, Chief Executive Officer of Ayrmid Ltd, added, "APHEXDA represents a significant advancement in improving the lives of multiple myeloma patients as they progress along the stem cell transplant journey. APHEXDA complements our existing portfolio by supporting OMISIRGE's growth, doubling our transplant portfolio, and enhancing the capabilities Gamida Cell has already established in cell therapy. Our growing momentum positions us well for continued expansion in the U.S. and beyond, marking a key step in our journey as we continue to build on our success, strengthen our commitment to the transplant community, and execute our long-term strategy."
The equity investment offering is being made by BioLineRx pursuant to its shelf registration statement on Form F-3 (File No. 333-276323) previously filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on January 5, 2024, and only by means of a prospectus and prospectus supplement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's web site at www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
MTS Health Partners, L.P. served as the exclusive financial advisor to BioLineRx Ltd. in connection with the transaction.
Moelis & Company LLC served as the exclusive financial advisor to Ayrmid Ltd. in connection with the transaction.
BioLineRx Third Quarter Results Conference Call and Webcast
BioLineRx will report its third quarter 2024 results on November 25, 2024. To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until November 27, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
About Ayrmid Ltd. and Gamida Cell Ltd
Ayrmid Ltd. is the parent company of Gamida Cell Ltd. Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company's proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include OMISIRGE® (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy. Gamida Cell operates as a wholly owned subsidiary of Ayrmid Limited, a UK entity. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.
About Highbridge Capital Management
Founded in 1992, Highbridge Capital Management, LLC ("Highbridge") is a global alternative investment firm offering differentiated credit and volatility focused solutions across a range of liquidity and investment profiles, including hedge funds, drawdown vehicles, and co-investments. The firm seeks to generate attractive risk-adjusted returns for sophisticated investors, which include financial institutions, public and corporate pension funds, sovereign wealth funds, endowments and family offices. Highbridge is headquartered in New York, with a research presence in London. In 2004 Highbridge established a strategic partnership with J.P. Morgan. Highbridge has over $4 billion in assets under management, as of April 1, 2024, and holds meaningful investments across the global healthcare and life sciences spectrum.
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