midastouch017
2月前
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
4月前
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
4月前
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.
midastouch017
4月前
BioLineRx Announces Oral Presentation on Data from Phase 1 Clinical Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease at ASH 2024
https://finance.yahoo.com/news/biolinerx-announces-oral-presentation-data-140000877.html
- Findings 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 -
- Data from proof-of-concept study shows that motixafortide was safe and well tolerated -
- Oral presentation at ASH 2024 on Saturday, December 7, 2024 in San Diego, California -
TEL AVIV, Israel and WALTHAM, Mass., Nov. 5, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that an abstract including the 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) was accepted for oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition taking place December 7-10, 2024 in San Diego, California. The proof-of-concept study, conducted in collaboration with Washington University School of Medicine in St. Louis, is exploring alternative HSC mobilization strategies that could significantly improve the treatment journey of patients with sickle cell disease seeking gene therapy.
"Currently available gene therapies for sickle cell disease rely on the collection of significant quantities of CD34+ hematopoietic stem cells, posing challenges for many patients," said Zachary Crees, MD, principal investigator for the trial, Division of Oncology, Washington University School of Medicine. "The findings in this trial suggest that patients with sickle cell disease given motixafortide alone, or in combination with natalizumab, could mobilize and potentially collect the number of stem cells required for approved gene therapies in a single apheresis cycle. These are encouraging findings that we look forward to presenting in greater detail at ASH 2024."
"We are encouraged by the initial findings in this Phase 1 study showing that motixafortide is safe and well-tolerated and may hold potential to improve the overall treatment process and access to gene therapy for more people with SCD," said Philip Serlin, Chief Executive Officer of BioLineRx. "We look forward to continued collaboration with Washington University on this important research and our ongoing work to develop motixafortide for the potential benefit of patients with sickle cell disease."
The Phase 1 safety and feasibility study is evaluating motixafortide (CXCR4 inhibitor) as monotherapy and in combination with natalizumab (VLA-4 inhibitor) as novel regimens to mobilize CD34+ hematopoietic stem cells for gene therapies in SCD. As reported in the abstract, five patients completed mobilization and apheresis with motixafortide alone, and four of five with motixafortide in combination with natalizumab.
Motixafortide alone, and in combination with natalizumab, were safe and well-tolerated in the trial. Common adverse events (AEs) were transient and included Grade 1-2 injection site (pruritis, tingling/pain) and systemic reactions (pruritis, hives). No Grade 4 AEs or vaso-occlusive events occurred.
Motixafortide alone, and in combination with natalizumab, resulted in robust CD34+ HSC mobilization to peripheral blood (PB). Motixafortide alone mobilized a median of 198 CD34+ cells/µl (range 77-690) to PB with median 3.49x10 CD34+ cells/kg as part of a single blood volume collection, projecting the collection of 13.9x106 HSCs in a normal, single-day four blood volume apheresis collection session. Motixafortide in combination with natalizumab mobilized a median of 231 CD34+ cells/µl (range 117-408), with median 4.64x10 CD34+ cells/kg collected as part of a single blood volume collection, projecting the collection of 18.6x106 CD34+ HSCs in a single day four blood volume apheresis collection session.
The two approved gene therapies for sickle cell disease in the U.S. require 16.5 million, and 22 million, total CD34+ HSCs, respectively.i,ii Unfortunately, granulocyte colony-stimulating factor (G-CSF), the most commonly used drug to support the collection of stem cells, is contraindicated in patients with SCD. The use of the mobilization agent plerixafor is the current standard of care for collecting HSCs for SCD gene therapies; however, plerixafor alone requires multiple mobilization attempts and often yields suboptimal HSC numbers. For some, gene therapy may be prohibitive due to the failure to obtain adequate numbers of HSCs.
In the trial, patients who underwent prior mobilization with plerixafor, experienced 2.8- fold greater HSC mobilization with motixafortide alone, and 3.2-fold greater HSC mobilization with motixafortide in combination with natalizumab compared to plerixafor.
Oral Presentation at ASH 2024
San Diego Convention Center, San Diego, California
Oral Presentation Details
Session Name: 711. Cell Collection and Manufacturing of HSPCs, CAR-T Cells, and Other Cellular Therapy Products: Innovations in Mobilization, Collection, and Manufacturing for Cellular Therapies
Title: Motixafortide (CXCR4 Inhibition) Alone and in Combination with Natalizumab (VLA-4 Inhibition) As a Novel Regimen to Mobilize Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease: A First-in-Human, Proof-of-Principle Safety and Feasibility Study
Presenter: Zachary D. Crees, MD, Division of Oncology, Washington University School of Medicine, Saint Louis, MO
Abstract ID#: 193210
Date: Saturday, December 7, 2024
Time: 12:00 PM
Location: San Diego Convention Center, Room 25
About the Clinical Trial of Motixafortide in Sickle Cell Disease (SCD)
The trial (ClinicalTrials.gov Identifier: NCT05618301) is a safety and feasibility study to evaluate motixafortide (CXCR4 inhibitor) as monotherapy and in combination with natalizumab (VLA-4 inhibitor) as novel regimens to mobilize CD34+ hematopoietic stem cells for gene therapies in SCD. The study enrolled five adults with a diagnosis of SCD who are receiving automated red blood cell exchanges via apheresis. The trial's primary objective is to assess the safety and tolerability of motixafortide alone and the combination of motixafortide + natalizumab in SCD patients, defined by dose-limiting toxicities. Secondary objectives include determining the number of CD34+ hematopoietic stem and progenitor cells (HSPCs) mobilized via apheresis; and determining the kinetics of CD34+ HSPC mobilization to peripheral blood in response to motixafortide alone and motixafortide + natalizumab in SCD patients.
About Sickle Cell Disease
Sickle cell disease (SCD) is one of the most common genetic diseases globally, affecting millions of people throughout the world and disproportionately impacting persons of color. Sickle cell disease arises from mutations in the hemoglobin gene, ultimately leading to the production of abnormally shaped (sickle) red blood cells that tend to stick within blood vessels causing their occlusion. The clinical manifestations of SCD include anemia and blood vessel occlusion which can lead to both acute and chronic pain, as well as tissue ischemia across multiple organ systems (e.g., stroke, heart attack, respiratory failure), ultimately compromising end organ function. The cumulative impact of these complications significantly impacts morbidity and mortality for patients with SCD.
midastouch017
6月前
BioLineRx Launches 'Mobilization Matters': A Digital Resource for People with Multiple Myeloma Preparing for Stem Cell Collection
https://finance.yahoo.com/news/biolinerx-launches-mobilization-matters-digital-170100432.html
Patient survey currently underway in partnership with the HealthTree Foundation; data expected in Q1 2025
TEL AVIV, Israel and WALTHAM, Mass., Sept. 17, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced the launch of Mobilization Matters, a digital resource for people with multiple myeloma who are preparing for stem cell collection for an autologous stem cell transplant. Launched on Apheresis Awareness Day, this platform offers patient stories, educational resources, and more to support those undergoing this critical phase of treatment.
In conjunction with this launch, BioLineRx is partnering with the HealthTree Foundation to conduct the Mobilization Matters Stem Cell Collection Survey. This initiative aims to gather insights from patients about their experiences with stem cell collection and apheresis as part of their multiple myeloma journey. The findings will help illuminate patient experiences, enhance understanding, and improve care and support strategies. Survey results are expected in Q1 2025.
"We are deeply committed to supporting multiple myeloma patients and their care partner through their stem cell collection process," said Holly May, MBA, President of BioLineRx USA. "Our goal is to enrich education and foster dialogue, empowering patients with knowledge. Mobilization Matters is designed to achieve this by amplifying patient voices and providing comprehensive resources."
In addition to patient stories and survey information, Mobilization Matters features a discussion guide to facilitate conversations between patients and their healthcare teams before apheresis. For more information, visit www.mobilizationmatters.com.
AbouAt the Mobilization Matters Survey
The Mobilization Matters Stem Cell Collection Survey is being conducted by the HealthTree Foundation on behalf of BioLineRx among adults with multiple myeloma (ages 18+) who have attempted stem cell collection for a planned transplant. Developed in collaboration with experts from leading institutions and patient advisors, the survey aims to provide valuable insights into the emotional, physical, and daily life challenges patients face during the stem cell collection process. Results will be shared on mobilizationmatters.com, once available.
"This survey will provide important insights into the patient experience with stem cell collection, offering a deeper understanding of the potential challenges involved," said Beth B. Giblin, PharmD, Head of US Medical Affairs, BioLineRx. "Our aim is to use the findings to build on the existing literature and inform data-driven approaches to patient care and support."
"We need to better understand the patient's journey during the stem cell collection process," said Jenny Ahlstrom, Founder & CEO of the HealthTree Foundation. "We are excited to use these data to advance education and drive patient-centered care. This collaboration supports our mission to empower multiple myeloma patients with knowledge, enhance their care experiences, and contribute meaningfully to research."
This survey marks the first patient experience study by the HealthTree Foundation on this critical topic. The research is being conducted through the HealthTree Cure Hub, a patient-data platform and community with over 14,000 registered myeloma patients, where participants can opt into surveys and studies to accelerate research and shape the future of healthcare.
About Stem Cell Mobilization for Multiple Myeloma
Autologous stem cell transplantation (ASCT) is the preferred first-line treatment for multiple myeloma – the second most common blood cancer – and is integral to the prospect of improving survival and helping to restore the immune system.i,ii
Prior to ASCT, patients undergo apheresis, a procedure to collect stem cells for transplant. Stem cells are made deep in the bone marrow and need to be mobilized from the bone marrow to the bloodstream for collection during apheresis.iii,iv
ASCT success depends on adequate mobilization and collection of stem cells.iii While more multiple myeloma patients are candidates for ASCT than ever before, stem cell mobilization and collection is a growing challenge. This is due to factors such as increasing proportion of older patients receiving ASCTvi and the use of standard 3- and 4-drug induction therapy, which can further impair mobilization with fewer cells mobilized and additional days of apheresis required.vii, viii
About the HealthTree Foundation
HealthTree is a global nonprofit using innovation to save lives. They provide lifetime personalized support and education, meaningful patient-to-patient connections and a powerful patient data portal. HealthTree's cutting-edge technology empowers patients to better manage their health and engages them as critical contributors to lifesaving research. The trust of their patient community allows HealthTree to provide continually updated, real-world patient data to researchers who seek to advance clinical care and find cures for blood cancers. Visit healthtree.org today.
midastouch017
7月前
BioLineRx Ltd. (BLRX) Q2 2024 Earnings Call Transcript
Aug. 15, 2024 3:03 PM ETBioLineRx Ltd. (BLRX) Stock
Q2: 2024-08-15 Earnings Summary
EPS of $0.00 beats by $0.14 | Revenue of $5.39M beats by $2.45M
BioLineRx Ltd. (NASDAQ:BLRX) Q2 2024 Earnings Conference Call August 15, 2024 8:30 AM ET
Company Participants
John Lacey - Head of IR and Corporate Communications
Phil Serlin - CEO
Holly May - President of BioLineRx USA
Mali Zeevi - CFO
Ella Sorani - Chief Development Officer
Conference Call Participants
John Vandermosten - Zacks
Operator
Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter 2024 Financial Results Conference Call. [Operator Instructions]. Following management's formal presentation, instructions will be given for the question-and-answer session.
I would now like to hand the call over to John Lacey, Head of Investor Relations, and Corporate Communications. John, please go ahead.
John Lacey
Thank you, operator. Welcome, everyone. Thank you for joining us on our second quarter 2024 results conference call. Earlier today, we issued a press release, a copy of which is available in the Investor Relations section of our website. It was also filed as a 6-K.
I'd like to remind you that certain statements we make during the call will be forward-looking. Because such statements deal with future events, and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks, and uncertainties, please review our annual report on Form 20-F and our quarterly reports on Form 6-K that are filed with the U.S. Securities and Exchange Commission. On the call today, we will have Phil Serlin, Chief Executive Officer of BioLineRx; Holly May, President of BioLineRx USA; and Mali Zeevi, our Chief Financial Officer. In addition, Ella Sorani, our Chief Development Officer, will be joining the call for Q&A.
At this time, it is now my pleasure to turn the call over to Phil.
Phil Serlin
Thank you, John, and good morning, everyone, and thank you for joining us on today's call.
Following our strong second quarter 2024 performance and the encouraging progress of APHEXDA to launch to date. I wanted to highlight that today's BioLineRx is a fully integrated leader in stem cell mobilization with promising label expand opportunities. This is a stark change from last year, and we are well positioned to deliver value to all of our stakeholders. I will begin with a brief update on the important progress that we are making on our APHEXDA launch then turn the call over to Holly who'll go into our commercialization and life cycle management progress in more detail.
Mali will review our financial results, and then I will give a brief summary of our upcoming milestones. We will then open up all for your questions. Let me begin with an effect to commercialization update. Last quarter, we set an important goal. We said that among our targeted top 80 transplant centers, by the end of the second quarter, we would secure formulary placement at institutions managing 35% of stem cell transplant procedures.
And I'm happy to say that we surpassed this goal by June 30 with formulary placement at institutions managing 37% of transplant procedures. We continue to make steady progress on this most important launch metric and remain on track to achieve our year-end target of 60%.
Additionally, last quarter, we achieved formulary status at two of the largest transplant centers in the U.S., and we also doubled the number of centers ordering product. We are pleased with this continued positive momentum in only the second full quarter of our commercialization program. Each week, we learn about patients who have failed to collect enough stem cells on other mobilization agents putting their path to transplant at risk.
These patients were then given APHEXDA and they achieved their stem cell mobilization goals, many in a single apheresis session. Transplant centers are seeing the tremendous efficacy that APHEXDA can provide in this new era for multiple myeloma patients, where patients more often are older and increasingly received quad induction therapy which can increase mobilization risk.
In July, the FDA granted approval of an important quad therapy approach for transplant eligible, newly diagnosed multiple myeloma patients, including daratumumab and lenalidomide which can negatively impact stem cell yields. The approval was based on the tremendous efficacy results seen in the PERSEUS trial, which compared the quad therapy to the leading triple therapy. The quad therapy lowered the risk of disease progression or death by 60%.
Physicians have been treating patients with quad therapies prior to this approval. However, we believe that the data from this trial and the subsequent FDA approval will accelerate the process of quad therapy becoming the new standard of care, which, while beneficial to patients has the potential to further increase the need for APHEXDA. Our team is excited to be introducing a new standard of care for the mobilization of stem cells for multiple myeloma in this new era of care for patients.
At this point, I'd like to turn the call over to Holly May, President of BioLineRx U.S., to discuss our commercialization efforts and some of our life cycle management initiatives. Holly, please go ahead.
Holly May
Thank you, Phil.
Last quarter, I discussed APHEXDA benefits on center efficiency and economics, and in conversations with transplant center key decision-makers, including physicians, pharmacists and apheresis unit Managing Directors. These two factors continue to be a significant determinant in transplant center formulary adoption.
We launched effect into a mobilization agent market that included generic plerixafor which had just entered generic status a few months before our approval. At the same time, transplant centers were realizing the impact that new induction therapy approaches have on stem cell collection yields.
These factors quite naturally created many questions for centers, centers that have, for many years, had long-standing protocols. It is within this changing landscape that institutions have also come to understand effective innovative benefits for patients and are actively studying how our product can benefit their center and members of our field force are supporting them in this effort with our efficiency modeling tools.
Additionally, we are publishing important health economic data and continues to work on additional research. Our health economic presentations in April at the American Society for Apheresis Annual Meeting and at the International Society for Pharmacoeconomics and Outcomes Research demonstrated the economic advantages for centers using G-CSF plus APHEXDA over G-CSF alone or G-CSF plus plerixafor. Given the efficacy, efficiency and economic benefits that APHEXDA provides, we believe that key decision-makers will continue to move toward our best-in-class mobilizer.
Let me transition now to our life cycle management efforts. Our vision is to maximize the potential of APHEXDA in its current indication and to expand into key areas with high unmet need. There is significant interest by independent investigators to evaluate APHEXDA across a number of areas associated with myeloma, including mobilization studies in patients treated with quad therapies or for post-CAR T cytopenia management.
We are also actively speaking with physician researchers across a number of additional disease states that have high unmet need in the area of stem cell mobilization. One critical area that continues to make progress is evaluating APHEXDA's stem cell mobilization potential in patients with sickle cell disease undergoing gene therapy.
This type of gene therapy is an area where I have significant experience based on my prior roles. The two currently approved gene therapies for sickle cell disease require significant quantities of stem cells to produce the therapies. And in speaking with leaders in the field using a mobilization agent that could speed the collection process would be a great advantage for patients. Our two ongoing sickle cell disease Phase 1 investigator-initiated studies with Washington University in St. Louis and St.
Jude's Children's Research Hospital in Memphis, were designed by significant key opinion leaders in this research area. We anticipate early data from the Washington collaboration in the second half of this year and the first patient dosed in the St. Jude study in September. Overall, in the next 12 months, we anticipate several independent investigators to initiate studies that will provide BioLine with critical data and insights to aid our ongoing life cycle management efforts.
Now let me turn the call over to Mali to provide a financial update.
Mali Zeevi
Thank you, Holly.
As is our practice, I will only go over the most significant items in our financial statements. Revenues, cost of revenues research and development expenses, sales and marketing expenses, net profit and cash. I invite you to review the filings we made this morning, which contain our financials and press release.
Total revenue for the three months ended June 30, 2024, was $5.4 million. We did not record any revenue during the second quarter of 2023. Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.6 million as well as $1.8 million of net revenue from product sales of APHEXDA in the U.S. Cost of revenue for the three months ended June 30, 2024, was $0.9 million. We did not record any cost of revenue during the second 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 June 30, 2024, were $2.2 million compared to $3 million for the same period in 2023.
The decrease resulted primarily from lower expenses related to motixafortide activities the termination of the development of AGI-134 and the decrease in share-based compensation. Sales and marketing expenses for the three months ended June 30, 2024, were $6.4 million compared to $5.6 million for the same period in 2023.
The increase resulted primarily from the ramp-up in head count costs associated with fully hired field team. Net income for the three months ended June 30, 2024, was $0.5 million compared to a net loss of $18.5 million for the same period in 2023. The net income for the 2024 period included $7.8 million in nonoperating income compared to nonoperating expenses of $7.7 million for the same period in 2023, both mainly related to the noncash revaluation of warrants.
As of June 30, 2024, the company had cash, cash equivalents and short-term bank deposits of $40.1 million. The company anticipates that this amount will be sufficient to fund operations as currently planned into 2025.
And with that, I'll turn the call over to Phil.
Phil Serlin
Thank you, Mali.
In closing, as is our custom, I would like to take a few moments to summarize our upcoming milestones. We anticipate first patient dosed in the St. Jude sickle cell disease gene therapy Phase 1 trial in September. The Phase 1 clinical trial is an open-label multicenter study evaluating the safety, tolerability and feasibility of single-agent motixafortide for the mobilization and collection of CD34+ hematopoietic stem cells in 12 patients, aged 18 and older with sickle cell disease.
We anticipate the initiation of the bridging study by collaboration partner, Gloria Biosciences to support approval of APHEXDA in stem cell mobilization for multiple myeloma in China in the second half of this year. Also in the second half of this year, as Holly mentioned, we anticipate a presentation on early data from the wash use sickle cell disease gene therapy Phase 1 trial, evaluating motixafortide as a monotherapy and in combination with natalizumab for stem cell mobilization.
Additionally, working with Gloria Bio, we completed the study design of the Phase 2b combination study evaluating motixafortide in first-line pancreatic cancer. We anticipate that Gloria will submit the study designed for regulatory review in 2024 with the study initiating in 2025.
Finally, we continue recruitment in the CheMo4METPANC IIb randomized clinical trial in first-line metastatic pancreatic cancer sponsored by Columbia University and in partnership with Regeneron. We anticipate that this trial, which had very encouraging pilot phase data published at ASCO this quarter will be fully enrolled by 2027.
With that, we have now concluded the formal part of our presentation. Operator, we will now open the call up for questions.
Question-and-Answer Session
Operator
[Operator Instructions] The first question is from John Vandermosten of Zacks. Please go ahead.
John Vandermosten
Great. Thank you. So the summer is usually known to have kind of negative seasonal effects for both, I guess, therapy use and with hospital staff, especially in academic settings. And I'm wondering if you could comment on how you expect seasonally the effort to go with sales of APHEXDA. Do you anticipate a strong pickup activity in September? And was this summer, I guess it's not over yet, but I guess was this summer as you had expected?
Phil Serlin
Yes. So John, good morning, and thanks for the question and joining the call. So I'll turn it over to Holly in a moment. But our results are through June 30. So we're talking now about the second quarter, which is really the spring. I would like to, again, mention that we doubled our sales in Q2 from Q1. And so I'm not sure the results at this point really reflect any kind of slowdown -- seasonal slowdown in the summer. We're looking -- things are looking very, very good at the moment. I'll let Holly expand on that, if she'd like.
Holly May
Yes. Thanks, Phil, and good morning John. So we have actually analyzed some of the seasonality on a month-to-month basis. because this is indicated for multiple myeloma, and it's very dependent on patients needing to get timely transplants. We don't necessarily see those same kind of seasonality effects with a product like APHEXDA as you may with others. That's a very general answer, but that is not something that we are terribly concerned about and have huge downturns built into any kind of forecasting for that reason. Does that answer your question?
John Vandermosten
Yes, it does. And how would you characterize the reorder rate? It seems like based on kind of a top-down view that it's fairly good. Would you characterize it that way as well?
Phil Serlin
Holly, you want to take that?
Holly May
Yes, I would love to. So yes, so once -- I think we've spoken about this before. Once a product is on formulary, that's the biggest hurdle to begin utilization -- adoption and utilization and an uptake in sales. And so our field teams are continuing to do both things to onboard institutions that have approved us for formulary through their P&T. So that is a significant part of future growth as well as then working on institutions where we already have formulary acceptance and continuing to do selling efforts in those hospitals to increase the quantities where we are on formulary.
So the team very early on, the field teams very early on were singularly focused on assuring the readiness of P&T committees to put us on formulary. That work continues, but now we are also looking at selling efforts in those institutions that have us on formulary to increase there. So we see revenues from both sources, new accounts and existing accounts as we move throughout the year.
John Vandermosten
Okay. And final question on sickle cell and gene therapy. I guess I was surprised to see two studies in the same gene therapy indication. And I guess that's because -- maybe you can tell me why that is. And then are there any other gene therapy indications that would also be kind of the next place to go for using motixafortide to collect the proper number of cells?
Phil Serlin
Yes. So let me ask Ella, maybe you can talk about the differences between the two studies a little bit.
Ella Sorani
Yes. I'm sorry, but -- the design of the St. Jude study is not -- I don't think that we have disclosed it yet. The design -- there is a difference between the two studies in terms of ...
Phil Serlin
Yes. I guess you're right. Yes, perhaps you can't disclose that yet. I mean are there different -- they're -- I'm wondering if -- I just don't remember whether we've disclosed that. You're sure we haven't disclosed it? Yes. So John, I'm sorry about that.
There are differences in the studies based on whether there are single administrations or multiple administrations and the size of the studies -- but I don't think, like as Ellen said, I don't think that we've spoken about the design yet. There are publication and embargoes and those kind of things that we can't really discuss it at this point. I apologize.
John Vandermosten
Okay. And well -- and then I guess are there any other kind of gene therapy indications that would be equally addressed from sponsors to use motixafortide to collect enough cells? Because I assume that's why the sickle cell was chosen compared to others, they just need more cells.
Phil Serlin
Yes. Well, it's more complicated than that. I mean, I'll turn it over to Holly, but I'll just say one of the reasons why mobilization is so difficult in sickle cell patients is because the underlying mobilization agent G-CSF is contraindicated in sickle cell patients. And therefore, they can only get what you'd call in air quotes, a booster, plerixafor or like APHEXDA. So they can't get the underlying G-CSF, which is given to patients like multiple myeloma before they're given booster agent, so to speak.
So that's one of the main reasons why this is an area that is extreme that has a clear unmet medical need in mobilization. But Holly, if you'd like to expand on that, please feel free.
Holly May
Yes, I'm happy to talk about that a little bit. So there are different types of gene therapy, some like AV therapy that do not require hematopoietic stem cells and others, like the sickle cell approved therapies right now by Bluebird and Vertex that do require stem cells in order to complete the gene therapy.
And so certainly, sickle cell based on the things that Phil just said is the ideal place to begin using a product like APHEXDA for the mobilization of stem cells to complete that type of gene therapy. But we do see that there could be other types of gene therapies that do require CD34 stem cells, which could very easily benefit from APHEXDA in the future. But currently, we are focused on generating the data in sickle cell because of the high unmet.
John Vandermosten
Understood. Thank you, Holly.
Holly May
Yes. Thanks John.
Operator
[Operator Instructions] The next question is from John Vandermosten of Zacks. Please go ahead.
John Vandermosten
Great. Thanks for allowing me a follow-up. Have there been any inquiries from investigators for use that APHEXDA outside of multiple myeloma, expanding more into some other leukemias?
Phil Serlin
As Holly mentioned, and I think I'll let her expand on it a little bit. We have a number of requests from investigators to perform investigate initiated studies in potentially different indications, et cetera? Holly, do you maybe want to expand on that a little bit?
Holly May
Yes. I guess I'm looking for some guidance here as sort of what I can and can't say. Some we are in the process of these ISSs. We are in the process of signing for what I would call kind of indication enhancing data and other investigators are very interested in other areas of study and investigation where mobilization of stem cells is required.
So I think the easiest way to say this is we have a very active IFS program that we have launched here since that we have initiated since launch, and we continue to review all of those proposals, but there does seem to be a lot of interest in motixafortide to be studied in areas to improve on things like multiple myeloma and then in other indications as well.
John Vandermosten
Okay, great. Thank you.
Holly May
Thanks John.
Operator
There are no further questions at this time. Before I ask Mr. Phil Serlin to go ahead with his closing statement, I would like to remind participants that a replay of this call is scheduled to begin two hours after the conference. In the U.S., please call 1 (888) 295-2634. In Israel, please call 03-925-5904. Internationally, please call 972-3-955-904.
Mr. Serlin, would you like to make your concluding statement?
Phil Serlin
Yes, I would. Thank you, operator. In closing, we are progressing through 2024 with significant momentum both with the ongoing commercial ramp-up of APHEXDA as well as the advancement of our development programs in sickle cell disease and pancreatic cancer. I'm excited to what we are poised to accomplish over the remainder of the year and next.
Thank you all very much for your continued interest in BioLineRx. We look forward to providing our next comprehensive quarterly update in November. Be safe, and have a good day.
Operator
This concludes BioLineRx second quarter 2024 conference call. Thank you for your participation. You may now go ahead and disconnect.
midastouch017
7月前
BioLineRx Reports Second Quarter 2024 Financial Results and Recent Corporate and Portfolio Updates
https://finance.yahoo.com/news/biolinerx-reports-second-quarter-2024-110000860.html
- Secured APHEXDA® formulary placement among top 80 transplant centers representing ~37% of stem cell transplant procedures performed, surpassing stated goal for quarter; on-track to reach goal of ~60% by end of Q4 -
- Doubled the number of centers ordering APHEXDA during the second quarter -
- Entered into clinical trial agreement with St. Jude Children's Research Hospital to evaluate motixafortide for hematopoietic stem cell mobilization for gene therapies in sickle cell disease -
- Management to host conference call today, August 15, at 8:30 am EDT -
TEL AVIV, Israel, Aug. 15, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the second quarter ended June 30, 2024, and provided recent corporate and portfolio updates.
"We continue to demonstrate positive commercial launch momentum with APHEXDA, our best-in-class stem cell mobilization agent," said Philip Serlin, Chief Executive Officer of BioLineRx. "Importantly, among our targeted top 80 transplant centers, we've secured formulary placement to date at institutions representing ~37% of stem cell transplant procedures performed, surpassing our stated goal. Additionally, we doubled the number of transplant centers ordering APHEXDA during the second quarter, which is a strong leading indicator and, we believe, reflects centers' growing recognition of the value that APHEXDA offers relative to other mobilization agents. Our goal is to achieve formulary placement at institutions representing approximately 60% of procedures by the end of year, which will support continued revenue growth and ease burdens on patients, caregivers, and transplant centers.
"Our vision is to maximize the potential of APHEXDA by expanding into key areas with high unmet need. To that end, we announced our second clinical trial collaboration, with St. Jude Children's Research Hospital, evaluating APHEXDA for stem cell mobilization in patients with sickle cell disease (SCD) seeking gene therapy. This new collaboration complements the ongoing SCD stem cell mobilization Phase 1 trial at Washington University in St. Louis (Wash U.). APHEXDA has the potential to support the collection of the immense amount of stem cells needed for these complex gene therapies in a more predictable and condensed timeline for patients. The companies launching these new gene therapies for SCD report continued expansion of authorized treatment centers and increased numbers of patients initiating cell collection. We look forward to seeing early data from the Wash U. Phase 1 trial later this year."
APHEXDA Launch Updates
Among top 80 transplant centers, secured formulary placement to date at institutions representing ~37% of stem cell transplant procedures performed, exceeding the company's stated goal for the quarter; on track to achieve ~60% by year-end 2024
Saw double the number of centers ordering APHEXDA during the second quarter as compared to the first quarter, which contributed to quarter-over-quarter net revenue growth of 100%
Clinical Portfolio Updates
Motixafortide
Multiple Myeloma
Presented a poster at the American Society for Apheresis (ASFA) 2024 Annual Meeting on April 17, 2024, demonstrating that transplant centers (averaging, for example, 20 transplants per month), when switching to G-CSF plus APHEXDA, could increase capacity by 52.0 patient days per month versus G-CSF alone, or by 12.3 patient days per month versus G-CSF in combination with plerixafor
Presented a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) on April 6, 2024, showing that even with APHEXDA's higher drug acquisition cost compared to other mobilization regimens, specifically G-CSF alone or G-CSF plus generic plerixafor, the combination of G-CSF plus APHEXDA may confer a similar or better overall financial impact while providing centers and patients with an improved mobilization experience
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 2H 2024
Sickle Cell Disease (SCD) & Gene Therapy
Entered into clinical trial agreement with St. Jude Children's Research Hospital to evaluate motixafortide for hematopoietic stem cell mobilization for gene therapies in sickle cell disease. The Phase 1 clinical trial is an open-label, multi-center study evaluating the safety, tolerability, and feasibility of single-agent motixafortide for the mobilization and collection of CD34+ HSCs in 12 patients (aged 18 and older) with SCD. Anticipate first patient dosed in September 2024 and initial data in 2025
Reported continuing enrollment of patients into 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, in collaboration with Washington University School of Medicine in St. Louis, has been expanded from five to 10 patients. Anticipate initial data in 2H 2024
Pancreatic Ductal Adenocarcinoma (mPDAC)
Presented positive biopsy data from the completed pilot phase of the ongoing CheMo4METPANC Phase 2b clinical trial collaboration with Columbia University at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting held on June 1, 2024 in Chicago, IL. New analyses of paired pre- and on-treatment biopsy samples demonstrated a statistically significant increase in CD8+ T-cell density in tumors from all 11 patients treated with the combination therapy approach (P=0.007). Enrollment in the randomized trial targeting 108 patients continues with full enrollment anticipated in 2027
Completed design of Phase 2b randomized clinical trial in China with collaboration partner Gloria Biosciences intended to assess motixafortide in combination with the PD-1 inhibitor zimberelimab and standard-of-care chemotherapy as first-line treatment in patients with metastatic pancreatic cancer. Anticipate clinical trial initiation in 2025
Second Quarter 2024 Financial Results
Total revenue for the three months ended June 30, 2024 was $5.4 million. The Company did not record any revenue during the second quarter of 2023. Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.6 million, as well as $1.8 million of net revenue from product sales of APHEXDA in the U.S.
Cost of revenue for the three months ended June 30, 2024 was $0.9 million. The Company did not record any cost of revenue during the second 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 June 30, 2024 were $2.2 million, compared to $3.0 million for the same period in 2023. The decrease resulted primarily from lower expenses related to motixafortide New Drug Application (NDA) supporting activities, termination of the development of AGI-134 and a decrease in share-based compensation
Sales and marketing expenses for the three months ended June 30, 2024 were $6.4 million, compared to $5.6 million for the same period in 2023. The increase resulted primarily from the ramp-up in headcount costs associated with a fully hired field team
General and administrative expenses for the three months ended June 30, 2024 were $1.6 million, compared to $1.3 million for the same period in 2023. The increase resulted primarily from an increase in legal and certain other expenses
Net income for the three months ended June 30, 2024 was $0.5 million, compared to net loss of $18.5 million for the same period in 2023. The net income for the 2024 period included $7.8 million in non-operating income, compared to non-operating expenses of $7.7 million for the same period in 2023, both primarily related to the non-cash revaluation of warrants
As of June 30, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $40.1 million. The Company anticipates that this amount will be sufficient to fund operations, as currently planned, into 2025
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 19, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
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