BioLineRx Ltd (BLRX)

[midastouch017]

BioLineRx Reports Third Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates

https://finance.yahoo.com/news/biolinerx-reports-third-quarter-2023-120000394.html

- Received FDA Approval of APHEXDA® (motixafortide) in Combination with Filgrastim (G-CSF) to Mobilize Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma -

- Closed Exclusive License Agreement for Motixafortide in Asia Region with Concurrent Strategic Equity Investment -

- Presented Encouraging Data at AACR from Pilot Phase of Randomized Phase 2 Combination Trial with Motixafortide in Patients with First Line PDAC -

- Began Enrollment of Phase 1 Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease -

- Management to host conference call today, November 20, at 10:00 a.m. EST -

TEL AVIV, Israel, Nov. 20, 2023 /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 third quarter ended September 30, 2023, and provided corporate and portfolio updates.

"FDA approval of APHEXDA® in September was a transformative event for the company, and our U.S. commercial team is now working with payers and providers to make this important innovation available to patients," said Philip Serlin, Chief Executive Officer of BioLineRx. "We were pleased that APHEXDA® was recently added to the NCCN guidelines, and we believe that as centers adjust their protocols to include and gain experience with APHEXDA®, transplant teams will gain a deep appreciation for the efficiencies that it can provide, and more importantly, the improved treatment journey patients experience as they navigate their essential transplant process.

"In addition, the company also closed its motixafortide licensing agreement covering the important Asia market. The agreement, which provided significant upfront funding, will first advance potential indications in the region for stem cell mobilization and pancreatic cancer, areas of high unmet need. We continue to evaluate additional commercial partnership opportunities in other markets.

"Lastly, exciting data were presented at AACR from the single-arm pilot phase of the randomized Phase 2 combination clinical trial with motixafortide in first-line pancreatic cancer by the study's lead investigator at Columbia University. The highly encouraging data triggered a change in the protocol, from a small, single-arm study to a much larger randomized study. This study, as well as the enrolling Phase 1 study evaluating motixafortide for stem cell mobilization in patients with sickle cell disease seeking gene therapy, highlight the potential versatility of motixafortide and the tremendous progress we are making to realize the full promise of this novel molecule for patients around the world," Mr. Serlin concluded.

Corporate Updates

Received U.S. Food and Drug Administration approval of APHEXDA® (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma

Closed exclusive license agreement to develop and commercialize motixafortide in Asia, alongside strategic equity investment:

License agreement included $15 million upfront payment, up to $50 million in potential development and regulatory milestones, up to $200 million in potential commercial milestones, and tiered double-digit royalties on sales

Straight common equity investment of $14.6 million in BioLineRx American Depository Shares (ADSs)

Gloria Biosciences expected to begin pivotal bridging study to support potential approval and commercialization of motixafortide in stem cell mobilization in China

Gloria Biosciences planning randomized Phase 2/3 first-line pancreatic cancer clinical trial evaluating motixafortide in combination with PD-1 inhibitor zimberelimab and standard of care combination chemotherapy

Clinical Portfolio Updates

Motixafortide (selective inhibitor of CXCR4 chemokine receptor)

Multiple Myeloma

Received inclusion of APHEXDA® in the National Comprehensive Cancer Network (NCCN) guidelines for Hematopoietic Cell Transplantation

Received acceptance of an abstract on combination premedication benefits in the Phase 3 GENESIS trial, further educating on the use of APHEXDA at transplant centers. The poster will be presented at the American Society of Hematology (ASH) 65th Annual Meeting on December 10, 2023, in San Diego, California

Initiated pivotal bridging study preparation activities with Gloria Biosciences to support potential approval and commercialization of motixafortide in stem cell mobilization in China

Pancreatic Ductal Adenocarcinoma

Presented data from the single-arm pilot phase of the investigator-initiated CheMo4METPANC Phase 2 combination clinical trial in first-line pancreatic cancer (PDAC) at the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer. Of 11 patients with metastatic pancreatic cancer enrolled, 7 patients (64%) experienced a partial response (PR), of which 5 (45%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. Three patients (27%) experienced stable disease, resulting in a disease control rate of 91%. Based on these encouraging results, the study was substantially revised to a multi-institution, randomized trial of 108 patients

Initiated preparation activities with Gloria Biosciences to support the development of a randomized Phase 2/3 clinical trial evaluating motixafortide in combination with the PD-1 inhibitor zimberelimab and standard of care combination chemotherapy in first-line pancreatic cancer

Sickle Cell Disease & Gene Therapy

Began enrollment in investigator-initiated Phase 1 pilot study led by Washington University School of Medicine in St. Louis evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell mobilization for gene therapies in sickle cell disease. Anticipate data in 2H of 2024

AGI-134 (synthetic alpha-Gal glycolipid)

Solid Tumor Immunotherapy

Evaluating next development pathways for AGI-134 program. The Phase 1/2a first-in-human, single-agent study, results of which were announced in Q4 2022, met the primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers

Third Quarter 2023 Financial Results

Research and development expenses for the three months ended September 30, 2023 were $2.7 million, a decrease of $1.6 million, or 37.6%, compared to $4.3 million for the three months ended September 30, 2022. The decrease resulted primarily from lower expenses associated with NDA supporting activities related to motixafortide as well as lower expenses associated with the completed AGI-134 clinical trial

Sales and marketing expenses for the three months ended September 30, 2023 were $8.1 million, an increase of $6.8 million, or 517.4% compared to $1.3 million for the three months ended September 30, 2022. The increase resulted primarily from the ramp-up of pre-commercialization activities related to motixafortide

General and administrative expenses for the three months ended September 30, 2023 were $1.5 million, an increase of $0.1 million, or 7.7% compared to $1.4 million for the three months ended September 30, 2022. The increase resulted from small increases in a number of individual G&A expenses

Non-operating expenses for the three months ended September 30, 2023 were $3.1 million, an increase of $3.5 million, compared to non-operating income of $0.4 million for the three months ended September 30, 2022. The increase relates primarily to the revaluation of outstanding warrants resulting from an increase in the company's share price during the 2023 period

Net loss for the three months ended September 30, 2023 was $16.0 million, compared to $6.8 million for the three months ended September 30, 2022. Net loss for the nine months ended September 30, 2023 amounted to $46.7 million, compared to $19.2 million for the nine months ended September 30, 2022. The increases in net loss for both the three- and nine-month periods in 2023 were primarily due to the significant non-operating expenses (which were also non-cash) related to revaluation of outstanding warrants, as well as the significant increases in sales and marketing expenses related to pre-commercialization and commercialization activities, which were partially offset by a decrease in research and development expenses

As of September 30, 2023, we held $26.0 million of cash, cash equivalents and short-term bank deposits. We anticipate that this amount, as well as the consideration from the exclusive license agreement and the securities purchase agreement of $29.6 million that was received in October 2023, will be sufficient to fund operations, as currently planned, into 2025

Conference Call and Webcast Information
To access the conference call, please dial [phone] from the U.S. or [phone] 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 22, 2023; please dial [phone] from the US or [phone] internationally.

[turning stone]

Looks like market makers are having fun this morniing. (99%) of the trades so far today are 100 shares or under, !00 share trades are usually signals amounst market makers.

[midastouch017]

1.7100+0.1700 (+11.0390%)
As of 01:26PM EST. Market open.
Nice

[midastouch017]

BioLineRx to Report Third Quarter 2023 Results on November 20, 2023

https://finance.yahoo.com/news/biolinerx-report-third-quarter-2023-120000735.html

- Management to Hold Conference Call at 10:00 a.m. EST -

TEL AVIV, Israel, Nov. 13, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced it will release its unaudited financial results for the quarter ended September 30, 2023 on Monday, November 20, 2023, before the U.S. markets open.

The Company will host a conference call at 10:00 a.m. EST featuring remarks by Philip Serlin, Chief Executive Officer.

To access the conference call, please dial [phone] from the U.S. or [phone] 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 22, 2023; please dial [phone] from the US or [phone] internationally.

[BarrellofHay]

Mozobil sales down 23% last quarter. Lots of generics. Can BLRX really compete in this environment even given that they have a better product? I thought Rolvedon could with Nualesta and boy was i wrong $ASRT

[bubbarayjr]

agree. Aphexda has been added to several Formularies of very large insurance plans. I think we'll hear just how good the roll out (very good imo) has been and may be an early sales projection.

[turning stone]

Looks like this little gem is finally beginning to shine. Hope the earnings report 11/9 will help to continue the upward momentum.

GOOD LUCK TO US LONGS

[murocman]

They have a few facts wrong in that article, namely that BLRX has no products on the market!

The lack of basic fact checking, research and due diligence in “Journalism” these days is the reason everything needs to be taken with a grain of salt an nothing should be trusted at face value.

Murocman

[midastouch017]

3 Tech Stocks That Wall Street Loves More Than Nvidia

https://investorplace.com/2023/11/3-tech-stocks-that-wall-street-loves-more-than-nvidia/

BioLine RX (BLRX)

BioLine RX (NASDAQ:BLRX) is a therapeutics company driven by drug development in various blood-related regions. With current collaborations with Columbia University and the Washington University School of Medicine, BioLine is in a great place to grow from the current valuation of $1.29, making a year-over-year growth of 52.38%.

The current stage of the biopharmaceutical industry is well off, with positive growth seen from the 2021 revenue of $328 billion. Further, by 2030, expect the sector to bring in $853 billion in revenue, marking a CAGR of 11.3% for that period. BioLine RX, based out of Israel, is one of the only Israeli companies competing in this industry, proving to be profitable for BLRX.

Revenue-wise for BioLine RX, the company is currently in a pre-commercial status with no current products on the market, but expect that to change in the near future after the FDA accepts their new discovery APHEXDA. Although the financial reports all show net negatives across the board, BioLine has managed to keep operating expenses at a low during the time of pre-commercial status, so expect profitability soon.

Overall, the largest strong point of BLRX has been the recent development in their commercial activity. In this September, BioLine RX received the news that APHEXDA, their flagship drug, has just been approved by the FDA to begin commercial testing and activity. This drug, a subcutaneous drug for stem cell transplantation in patients with myeloma, is a major victory in the industry overall due to it being the first stem-cell mobilization product to be approved in 10 years. Expect APHEXDA to carry BLRX to victory, and create profitability.

[midastouch017]

The license agreement provides for a $15 million upfront payment and an equity investment of $14.6 million, up to $50 million in potential development and regulatory milestones, up to $200 million in potential commercial milestones and tiered double-digit royalties on sales.

Great news!

[midastouch017]

BioLineRx entered Exclusive License Agreement to Motixafortide in Asia, advisored by M.S.Q. Ventures

https://finance.yahoo.com/news/biolinerx-entered-exclusive-license-agreement-130000593.html

NEW YORK, Oct. 31, 2023 /CNW/ -- M.S.Q. Ventures ("MSQ") is pleased to announce that its client, BioLineRx Ltd. ("BioLineRx") (NASDAQ/TASE: BLRX), has entered into an exclusive license agreement with Guangzhou Gloria Biosciences Co., Ltd. (GloriaBio) and an associated investor for the development of motixafortide across all indications in Asia.

MSQ Ventures is a New York-based cross-border advisory firm that bridges the healthcare industries globally by offering our deep knowledge, strong network, and local insights into the China market. From understanding key segments of the China healthcare market to identifying and vetting the high potential counterparties to negotiating deals aimed at maximizing value creation, our team focuses on results, prioritizes efficiency to guide our clients through the entire process. (PRNewsfoto/MSQ Ventures)
MSQ Ventures is a New York-based cross-border advisory firm that bridges the healthcare industries globally by offering our deep knowledge, strong network, and local insights into the China market. From understanding key segments of the China healthcare market to identifying and vetting the high potential counterparties to negotiating deals aimed at maximizing value creation, our team focuses on results, prioritizes efficiency to guide our clients through the entire process. (PRNewsfoto/MSQ Ventures)More
The license agreement provides for a $15 million upfront payment and an equity investment of $14.6 million, up to $50 million in potential development and regulatory milestones, up to $200 million in potential commercial milestones and tiered double-digit royalties on sales.

"Given GloriaBio's expertise and track record in the development and commercialization of cancer immunotherapies in China, we believe GloriaBio is well suited to further develop motixafortide in Asia. GloriaBio has demonstrated a clear commitment to the motixafortide programs in stem cell mobilization and pancreatic cancer in Asia, and this transaction provides us with additional capital to continue our launch plans in the U.S.," said Philip Serlin, Chief Executive Officer of BioLineRx Ltd. "We are very excited about the swift and successful conclusion of this monumental Asian market licensing agreement. The MSQ team showed remarkable agility and a deep understanding of mutual benefits to both parties right from our initial discussions. MSQ's disciplined deal management ensured a seamless process. Echo, with her visionary leadership, expertise, and impressive execution skills, played a key role in making this collaboration happen."

"We are pleased to enter into this strategic partnership with BioLineRx and are committed to the development and commercialization of motixafortide in Asia, which we believe will bring additional value to GloriaBio's portfolio via clear synergies with zimberelimab," said Jiman Zhu, Founder of GloriaBio. "The MSQ team's great efforts made a huge impact on the closing of this successful transaction in such a short time. The MSQ team provided valuable advice for both sides. We are impressed with the MSQ team's extensive knowledge of financial structures and drug development".

Echo Hindle-Yang, CEO of MSQ, reflecting on the transaction, "We're thrilled about the cross-border collaboration between BioLineRx, the pioneering company behind FDA-approved APHEXDA™ (motixafortide), and GloriaBio, the team behind the PD-1 inhibitor YuTuo® (zimberelimab). This partnership showcases their commitment to advancing global drug development and benefiting patients on a global scale. BioLineRx brings an innovative pipeline, successful FDA approval of APHEXDA™ for stem cell mobilization, strategic collaboration abilities, and a seasoned team to the table. On the other hand, GloriaBio, with their expertise in cancer immunotherapies, clinical development capabilities, and strong commercialization capabilities in Asia, is a formidable partner. The dedication of leaders like Mr. Serlin, Dr. Zhu, and their stellar teams played a pivotal role in swiftly achieving the success of this transformative deal. As part of this momentous partnership, we eagerly anticipate the positive developments ahead, promising an even brighter future for global patients."

About MSQ
M.S.Q. Ventures is a New York-based cross-border advisory firm that bridges the healthcare industries globally by offering our deep knowledge, strong network, and local insights.
[e-mail]

Cision
Cision
View original content to download multimedia:https://www.prnewswire.com/news-releases/biolinerx-entered-exclusive-license-agreement-to-motixafortide-in-asia-advisored-by-msq-ventures-301972192.html

SOURCE MSQ Ventures

Cision
Cision
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/October2023/31/c5866.html

[midastouch017]

BioLine RX (BLRX)

https://investorplace.com/2023/10/3-top-penny-stocks-to-make-you-a-millionaire-in-5-years/

BioLine RX (NASDAQ:BLRX) is an Israeli biotech firm with U.S. operations. The company has multiple FDA-approved treatments in its pipeline and more on the way potentially.

Bioline RX received FDA approval for APHEXDA for use in the collection of stem cells in the treatment of multiple myeloma. It is injected and allows most patients to reach a collection goal of more than 6 million hematopoietic stem cells. That improves stem cell transplantation, a standard treatment for multiple myeloma.

So, it is arguably the exact time to consider BLRX stock as it moves into the revenue production stages. The company is developing other drugs for commercialization in areas as diverse as sickle cell anemia and pancreatic cancer. Pancreatic cancer is a particularly lethal form of cancer that is often intractable because it is detected late in many cases. In short, BioLine RX offers immediate upside potential and longer-term upside due to the suite of drugs it continues to develop that address unmet needs.

[bubbarayjr]

Aphexda has been added to several Drug Formularies for large health insurance plans like the National Association of Letter Carriers Health Insurance and today it was added to Kaiser Permanente's Formulary Health Plan (the largest not for profit Health plan in the US).

[bubbarayjr]

in 🙂

[BarrellofHay]

I believe with the current naked short ruling we as shareholders can go after Sabby and any other naked short seller (perhaps wainwright?) especially if it led to predatory financing, which i am sure it did. i would be very interested in such a class action. I predict law firms are going to be all over this. much easier to sue giant investment firms flush with cash than biotechs struggling. whos in? get enough folks here and we can crush them and make an example

[jcon777]

added at 1.48

[midastouch017]

Have you checked the NBI index lately?
The XBI?
Look what happened in the past few months.
There is the answer to your question!

[turning stone]

Fmello

I have stopped guessing what PR'S will do for BLRX my concern is what they will do down the road when the company starts showing EARNINGS.

[Fmello]

It's weird that the news only caused a 2% pop to the stock.

[midastouch017]

The geat positive point in this PR is that
there was no backing from the agreement
as some thought due to the situation in
Israel.
A great sign of confidence.

[turning stone]

GREAT PR GO BLRX

[midastouch017]

BioLineRx Announces Closing of Exclusive License Agreement to Motixafortide in Asia and Concurrent Strategic Equity Investment

https://finance.yahoo.com/news/biolinerx-announces-closing-exclusive-license-110000024.html

- License agreement includes $15 million upfront, up to $50 million in potential development and regulatory milestones; up to ~$200 million in potential commercial milestones, and tiered double-digit royalties on sales -

- Gloria Biosciences expected to begin bridging study to support potential approval and commercialization of motixafortide in the territory in stem cell mobilization -

- Gloria Biosciences expected to initiate randomized Phase 2/3 first-line pancreatic cancer clinical trial, evaluating motixafortide in combination with PD-1 inhibitor *zimberelimab and standard of care combination chemotherapy -

TEL AVIV, Israel, Oct. 12, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced the closing of an exclusive license agreement with Guangzhou Gloria Biosciences Co., Ltd. (GloriaBio) and an associated investor for the development of motixafortide across all indications in Asia. Motixafortide is a novel, high-affinity CXCR4 inhibitor that received approval for its first indication in September 2023 by the U.S. Food and Drug Administration (FDA) for stem cell mobilization (SCM) in autologous stem cell transplantation (ASCT) in patients with multiple myeloma. Motixafortide is also being studied for other potential uses in oncologic and hematologic diseases.

The license agreement provides for a $15 million upfront payment (which was received at closing), up to $50 million in potential development and regulatory milestones in China and Japan, and up to $200 million in potential commercial milestones based on defined sales targets. BioLineRx is also eligible to receive tiered double-digit royalties on net sales.

In addition, the transaction included an equity investment of $14.6 million in BioLineRx through the purchase of newly issued American Depositary Shares (ADSs) at a price of $2.136 per ADS in a private placement. No warrants were issued in the transaction. Along with the investment, the purchaser received the right to appoint one representative to the BioLineRx Board of Directors.

Collaboration Details

Under the terms of the license agreement, GloriaBio will be responsible for development and commercialization of motixafortide in Asia initially in SCM. With the recent FDA approval of APHEXDA for this indication, GloriaBio plans to initiate a bridging study to support potential approval and commercialization of motixafortide in the licensed territories in SCM for ASCT in patients with multiple myeloma.

In addition, GloriaBio plans to initiate a Phase 2/3 first-line pancreatic cancer clinical trial evaluating motixafortide in combination with PD-1 inhibitor *zimberelimab and standard of care combination chemotherapy. BioLineRx has been developing motixafortide in combination with PD-1 inhibitors and standard of care combination chemotherapies in pancreatic cancer, and recently announced the initiation of a randomized Phase 2 clinical trial sponsored by Columbia University in first-line metastatic pancreatic cancer based on promising preliminary data from a single-arm pilot phase reported on September 29 at the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer.

"We are tremendously pleased by the swift closing of this significant licensing agreement for the Asian market, which brings substantial benefits to BioLineRx, and ultimately, to patients, including the advancement of our two leading development programs," said Philip Serlin, Chief Executive Officer of BioLineRx Ltd. "Given GloriaBio's expertise and track record in the development and commercialization of cancer immunotherapies in China, we believe GloriaBio is well suited to further develop motixafortide in Asia. The combined initial investment of nearly $30 million through the upfront payment and equity investment demonstrates a clear commitment to the motixafortide programs in stem cell mobilization and pancreatic cancer in Asia, and provides us with additional capital to continue our aggressive launch plans in the U.S."

"We are very pleased to enter into this strategic partnership with BioLineRx and are committed to the development and commercialization of motixafortide in Asia, which we believe will bring additional value to GloriaBio's portfolio via clear synergies with zimberelimab," said Jiman Zhu, Founder of GloriaBio. "There are very significant unmet patient needs in pancreatic cancer in Asia, especially in China. We are excited to see the encouraging clinical data of motixafortide in combination with PD-1 inhibitors and chemotherapy in pancreatic cancer and look forward to initiating a Phase 2/3 randomized trial in a first-line pancreatic cancer, as well as investigating additional indications for motixafortide in Asia."

MSQ Ventures served as advisor to BioLineRx on this transaction.

About Pancreatic Cancer in Asia
At nearly 240,000 reported cases in 2022, it is estimated that Asia had the largest number of pancreatic cancer cases globally (496,000 estimated cases worldwide). In China alone, the number of pancreatic cancer cases in 2020 reached approximately 125,000, with a 5-year survival rate of just 7.2%.

About Multiple Myeloma and Autologous Stem Cell Transplantation in Asia
Multiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow.
In 2022, it is estimated that Asia had over 51,000 reported cases of multiple myeloma (MM), the largest number of MM cases globally. New cases of MM reached over 20,000 in Greater China in 2018, and MM incidence is predicted to increase at an annual growth rate of 2.9%.

Autologous stem cell transplantation (ASCT) can be an important treatment paradigm for a number of blood cancers, including multiple myeloma. In China, ASCTs are included in medical insurance reimbursement, and in 2019, the total number of ASCTs in China reached more than 10,000 for the first time (for comparative purposes, as many as 14,000 ASCTs are performed each year in the U.S.).

*About Zimberelimab (YuTuo®)
Zimberelimab is a fully human anti-PD-1 monoclonal antibody. GloriaBio is developing and commercializing zimberelimab in Greater China, including mainland China, Hong Kong, Macao and Taiwan, where zimberelimab is approved for relapsed or refractory classical Hodgkin's lymphoma and recurrent or metastatic cervical cancer. Arcus Biosciences, and development partner Gilead Sciences, have the exclusive rights to develop and commercialize zimberelimab throughout the world except in Greater China and certain territories.

About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company's first approved product is APHEXDA™ (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.

Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.

About Gloria Biosciences
Gloria Biosciences is a commercial stage biopharma company focused on the development and commercialization of novel or highly differentiated immunotherapies and biologics for oncology. Toward the company's ultimate goal of improving accessibility, affordability, and availability for patients with innovation, Gloria Biosciences is striving to build a pipeline of more efficacious and patient-centered treatments to address unmet medical needs, driven by the company's efficient execution of clinical development, proven fast-to-market commercialization ability, world-class GMP-compliant manufacturing capability and global partnerships.

Forward Looking Statement

Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the potential benefits of APHEXDA, the timing and execution of the launch of APHEXDA and the plans and objectives of management for future operations and expectations and commercial potential of motixafortide, as well as its potential investigational uses. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, manage, and maintain corporate collaborations, as well as the ability of its collaborators to execute on their development and commercialization plans; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the commercial launch of APHEXDA; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; statements as to the impact of the political and security situation in Israel on BioLineRx's business; and the impact of the COVID-19 pandemic and the Russian invasion of Ukraine, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 22, 2023. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Contacts:

United States
John Lacey
BioLineRx
[e-mail]

Israel
Moran Meir
LifeSci Advisors, LLC
[e-mail]

China
Ying Huang
Gloria Biosciences
[e-mail]

Cision
Cision
View original content:https://www.prnewswire.com/news-releases/biolinerx-announces-closing-of-exclusive-license-agreement-to-motixafortide-in-asia-and-concurrent-strategic-equity-investment-301954789.html

SOURCE BioLineRx Ltd

[turning stone]

midastouch017

If there is any way I can help please let me know.

[bubbarayjr]

It looks like 5.5M shares traded at the TASE close when the price spiked.

[midastouch017]

Yes, on TASE, alas, no data, no PR, but it
certainly had an (delayed) effect in the Naz.
From minus 10% to plus 5% or so is quite
strange. Perhaps we will hear news tomorrow!
Very strange indeed

[Fmello]

Did that bump happen today?

[midastouch017]

BioLineRx Ltd. (BLRX.TA)
Tel Aviv - Tel Aviv Delayed Price. Currency in ILA (0.01 ILS)
Follow
Quote Lookup
44.00+7.30 (+19.89%)
At close: 05:30PM IDT
https://finance.yahoo.com/quote/BLRX.TA?p=BLRX.TA&.tsrc=fin-srch

Very strange indeed. BLRX/Naz should follow suit imo

[midastouch017]

Thank - you, still alive and kicking!
A very sad situation. Just terrible!

[turning stone]

midastouch017
Are you okay. Am following situation all day from here. Stay safe!!!!!!!!

[turning stone]

midastouch017

woke up to find PRZO doubled my money and I sold out. Will take 1/2 of my profit to buy more BLRX and then wait for Przo to pull back and then buy back in. The sun is shining this morning.

[midastouch017]

$BLRX is in 'good' company, eg $GMDA, $EVGN,
$PLX, $CGEN to name a few. It seems that the
bio sector in general is not doing too well to say
the least.
I have no educated explanation or reasoning.

[turning stone]

"midastouch017"
So what are your thoughts with this dropping like a lead balloon? I bought a few more thousand this morning in the $1.30s . There is no bad news so it seem the shorts are on the loose at this point. I am still very profitable and if they take it to a buck I will probably go for another 5000 and then sit on it till it goes through at least 3 quarterly reports. I wish every short had a family member suffering from this deadly problem and then just maybe they would leave this little company alone. YES I AM A NASTY PERSON WHEN SOMEONE OR GROUP MESSES WITH A COMPANY THAT IS TRYING TO SAVE MILLIONS OF PEOPLES LIVES and of course my money.

[bubbarayjr]

#AACRPan23 talk by Dr. Gulam Manji @columbiacancer on CheMoMETPANC 👉🏽 gemcitabine plus nab-paclitaxel + motixafortide (CXCR4 antagonist) + cemiplimib in advanced #PancreaticCancer. Responses observed in both primary & metastatic sites, with 64% partial responses & 27% stable… pic.twitter.com/IWQfGPQxEg

— Anirban Maitra (@Aiims1742) September 28, 2023

[bubbarayjr]

From Dr. Manji's presentation: pancreas and liver tumors shrinking

Proud to report the results of the pilot phase of our investigator-initiated clinical trial @AACR Pancreas.
I started the preclinical study in KPC mice in @KenOliveLab and then work continued in my lab. Randomized phase 2 to activate soon at 5 sites! pic.twitter.com/qpOfUKdXPF

— Gulam Abbas Manji (@DrGManji) September 29, 2023

[bubbarayjr]

From the PDAC abstract: Notice how the Biomarkers for Cancer begin to decline after the immune system starts to ramp up

Proud to be a part of this exciting Phase 1 trial of chemo/immuno therapy in #pdac @columbiacancer led by my former fellow/current colleague @DrGManji. Started with a preclinical trial in our lab, now moving to randomized phase 2. Presented @aacr pdac2023. #justkeepswimming pic.twitter.com/fXVv87ptYD

— KenOliveLab (@KenOliveLab) September 28, 2023

[turning stone]

Exhibit 1





FOR IMMEDIATE RELEASE

BioLineRx Announces Encouraging Data from Pilot Phase of Phase 2 Combination
Clinical Trial with Motixafortide in First-Line Pancreatic Cancer (PDAC)

- 6 of 11 Patients in the Pilot Phase Experienced a Partial Response, with 4 Confirmed;
One Patient Experienced Resolution of the Hepatic Metastatic Lesion -

- Data Presented at AACR Special Conference on Pancreatic Cancer -

- Multi-Center, Randomized Phase 2 Study Currently Enrolling -

TEL AVIV, Israel, September 28, 2023 – BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced encouraging data from the single-arm pilot phase of the investigator-initiated CheMo4METPANC Phase 2 combination clinical trial 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).

The data were published in an online abstract as part of the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer taking place in Boston, Massachusetts from September 27-30, 2023. An oral presentation of the data will take place later today, September 28, 2023.

The pilot phase of the Phase 2 study enrolled 11 patients with metastatic pancreatic cancer. As of May 2023, 6 patients (55%) experienced a partial response (PR) of which 4 (36%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. Three patients (27%) experienced stable disease, resulting in a disease control rate of 82%. These findings compare favorably to historic partial response and disease control rates of 23% and 48%, respectively, reported with the current standard of care, the chemotherapy combination gemcitabine and nab-paclitaxel.

“These initial data from the pilot phase of this ongoing Phase 2 study give us hope that motixafortide could potentially serve as the backbone of a new treatment regimen for PDAC, which is among the most difficult cancers to treat,” said Philip Serlin, Chief Executive Officer of BioLineRx Ltd. “We are deeply committed to this important collaboration with Columbia University investigators and eagerly look forward to the data from the randomized phase of the trial.”


Based on these pilot data, earlier this year, the CheMo4METPANC Phase 2 trial was amended to become a randomized study, with planned enrollment increasing from 30 to 102 patients. The trial, sponsored by Columbia University, is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies. A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2-6 in Chicago, Illinois (see abstract).

Pancreatic ductal adenocarcinoma (PDAC) is the most common type of pancreatic cancer and is expected to be the second leading cause of cancer-related death in the U.S. by 2023. Because it is typically diagnosed at later stages, greater than 80 percent of pancreatic cancer is inoperable. Most pancreatic cancer is incurable and unfortunately newer immunotherapy approaches, while beneficial against other solid tumor types, have had limited efficacy in pancreatic cancer due to immunosuppressive pathways.

An earlier single-arm, Phase 2a clinical trial (COMBAT/KEYNOTE-202) and pre-clinical studies evaluating motixafortide in combination with PD-1 immunotherapies and chemotherapies in PDAC have been promising, suggesting the ability of motixafortide to support an immune response.
__________________________________

Presentation at AACR Special Conference in Cancer Research: Pancreatic Cancer
Westin Copley Place, Boston Massachusetts

Plenary Session Details

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 A. Manji, MD, PhD, Columbia University Irving Medical Center/New York Presbyterian, New York, N.Y.

Session:
Plenary Session 3: Clinical Updates

Date:
Thursday, September 28, 2023

Time:
2:30-4:40 pm EDT


About CheMo4METPANC Phase 2 Clinical Trial
The multi-center CheMo4METPANC Phase 2 clinical trial is a randomized, investigator-initiated clinical trial in first line metastatic pancreatic cancer. Sponsored by Columbia University, 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 102 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 2023, an estimated 64,000 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. 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%.1 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.

About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company’s first approved product is APHEXDA™ (motixafortide) with an indication in the U.S. for stem cell mobilization for?autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.

Learn more about who we are, what we do, and how we do it at?www.biolinerx.com, or on?Twitter?and?LinkedIn.?

Forward Looking Statement
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management’s expectations, beliefs and intentions regarding, among other things, the potential benefits of APHEXDA, the timing and execution of the launch of APHEXDA and the plans and objectives of management for future operations and expectations and commercial potential of motixafortide, as well as its potential investigational uses. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the commercial launch of APHEXDA; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; statements as to the impact of the political and security situation in Israel on BioLineRx's business; and the impact of the COVID-19 pandemic and the Russian invasion of Ukraine, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 22, 2023. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Contacts:

United States
John Lacey
BioLineRx

[turning stone]

Something is wrong here. Hope we don't have another GMDA. The PR this morning was at best very mundane. The announcement should have had lights and bells and whistles around it. The people getting the word out are terrible as they are not good at flaring the word The company needs to understand we kept them alive when things were not so positive. Get off your asses and get the word out. There is no one more positive on this company. but don't screw it up

[midastouch017]

BioLineRx Announces Encouraging Data from Pilot Phase of Phase 2 Combination Clinical Trial with Motixafortide in First-Line Pancreatic Cancer (PDAC)

https://finance.yahoo.com/news/biolinerx-announces-encouraging-data-pilot-110000312.html

- 6 of 11 Patients in the Pilot Phase Experienced a Partial Response, with 4 Confirmed; One Patient Experienced Resolution of the Hepatic Metastatic Lesion -

- Data Presented at AACR Special Conference on Pancreatic Cancer -

- Multi-Center, Randomized Phase 2 Study Currently Enrolling -

TEL AVIV, Israel, Sept. 28, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced encouraging data from the single-arm pilot phase of the investigator-initiated CheMo4METPANC Phase 2 combination clinical trial 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).

The data were published in an online abstract as part of the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer taking place in Boston, Massachusetts from September 27-30, 2023. An oral presentation of the data will take place later today, September 28, 2023.

The pilot phase of the Phase 2 study enrolled 11 patients with metastatic pancreatic cancer. As of May 2023, 6 patients (55%) experienced a partial response (PR) of which 4 (36%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. Three patients (27%) experienced stable disease, resulting in a disease control rate of 82%. These findings compare favorably to historic partial response and disease control rates of 23% and 48%, respectively, reported with the current standard of care, the chemotherapy combination gemcitabine and nab-paclitaxel.

"These initial data from the pilot phase of this ongoing Phase 2 study give us hope that motixafortide could potentially serve as the backbone of a new treatment regimen for PDAC, which is among the most difficult cancers to treat," said Philip Serlin, Chief Executive Officer of BioLineRx Ltd. "We are deeply committed to this important collaboration with Columbia University investigators and eagerly look forward to the data from the randomized phase of the trial."

Based on these pilot data, earlier this year, the CheMo4METPANC Phase 2 trial was amended to become a randomized study, with planned enrollment increasing from 30 to 102 patients. The trial, sponsored by Columbia University, is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies. A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2-6 in Chicago, Illinois (see abstract).

Pancreatic ductal adenocarcinoma (PDAC) is the most common type of pancreatic cancer and is expected to be the second leading cause of cancer-related death in the U.S. by 2023. Because it is typically diagnosed at later stages, greater than 80 percent of pancreatic cancer is inoperable. Most pancreatic cancer is incurable and unfortunately newer immunotherapy approaches, while beneficial against other solid tumor types, have had limited efficacy in pancreatic cancer due to immunosuppressive pathways.

An earlier single-arm, Phase 2a clinical trial (COMBAT/KEYNOTE-202) and pre-clinical studies evaluating motixafortide in combination with PD-1 immunotherapies and chemotherapies in PDAC have been promising, suggesting the ability of motixafortide to support an immune response.

Presentation at AACR Special Conference in Cancer Research: Pancreatic Cancer

Westin Copley Place, Boston Massachusetts

Plenary Session Details

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 A. Manji, MD, PhD, Columbia University Irving Medical Center/New York Presbyterian, New York, N.Y.

Session: Plenary Session 3: Clinical Updates

Date: Thursday, September 28, 2023

Time: 2:30-4:40 pm EDT

About CheMo4METPANC Phase 2 Clinical Trial

The multi-center CheMo4METPANC Phase 2 clinical trial is a randomized, investigator-initiated clinical trial in first line metastatic pancreatic cancer. Sponsored by Columbia University, 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 102 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 2023, an estimated 64,000 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. 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%. 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.

About BioLineRx

BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company's first approved product is APHEXDA™ (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.

Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.

Forward Looking Statement

Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding

management's expectations, beliefs and intentions regarding, among other things, the potential benefits of APHEXDA, the timing and execution of the launch of APHEXDA and the plans and objectives of management for future operations and expectations and commercial potential of motixafortide, as well as its potential investigational uses. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the commercial launch of APHEXDA; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; statements as to the impact of the political and security situation in Israel on BioLineRx's business; and the impact of the COVID-19 pandemic and the Russian invasion of Ukraine, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 22, 2023. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Contacts:

United States
John Lacey
BioLineRx
[e-mail]

Israel
Moran Meir
LifeSci Advisors, LLC
[e-mail]

ASCO Cancer.Net. Cancer.Net Editorial Board Approval March 2023.



Cision
Cision
View original content:https://www.prnewswire.com/news-releases/biolinerx-announces-encouraging-data-from-pilot-phase-of-phase-2-combination-clinical-trial-with-motixafortide-in-first-line-pancreatic-cancer-pdac-301941126.html

SOURCE BioLineRx Ltd


Business Wire
First Patient Receives Gam

[Fmello]

Conclusions:

Preliminary results from this pilot study of MCGN in mPDAC were promising, with a durable PR rate of 55% and disease control rate (DCR) of 82%, compared to historic PRs and DCRs of 23% and 48% reported with gemcitabine and nab-paclitaxel (GN), respectively. Based on these results, the study was amended to transition to a randomized phase 2 trial testing MCGN compared to GN (N=112). The primary endpoint is progression free survival (PFS).

[turning stone]

What is wrong with GMDA ???? Glad I cashed in a while back (still at a profit) and bought more BLRX.

[midastouch017]

It will not be a smooth ride

Indeed so!

[midastouch017]

Teaser is my middle name!

[turning stone]

adamp is a short don't waste your time with him just block him out. He rolls out when things look good for us longs and his shorts FLAME UP.

[midastouch017]

this thing is a stinker. I could care less how things went with this stock years ago.
For anyone holding this now, this one is a liability.

Are you still holding to your above opinion?

[turning stone]

Great finish to a great day. Hopefully this will carry through to the end of the month where new momentum will care us even further. It looks like shorts are in trouble. I called my two brokerage houses that hold shares of BLRX for me and told them under no circumstances are they to use my shares in any way until I tell them to and told them I will not sell under $150/share or I tell them otherwise.

[midastouch017]

BioLineRx Announces Acceptance of Oral Presentation on Pilot Phase Data from Phase 2 Combination Clinical Trial with Motixafortide in First-Line PDAC at AACR Special Conference on Pancreatic Cancer

https://finance.yahoo.com/news/biolinerx-announces-acceptance-oral-presentation-110000805.html

Abstracts to be Published on American Association of Cancer Research (AACR)
Virtual Meeting Platform at 5:30 pm EDT on Wednesday, September 27, 2023

Oral Presentation on Thursday, September 28, 2023, in Boston, Massachusetts

TEL AVIV, Israel, Sept. 19, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that pilot phase data from an investigator-initiated, open-label, multicenter Phase 2 clinical trial with motixafortide in first-line pancreatic ductal adenocarcinoma (PDAC) will be presented at the American Association for Cancer Research (AACR) Special Conference on Pancreatic Cancer taking place in Boston, Massachusetts, September 27-30, 2023. The Phase 2 clinical trial is designed to evaluate the company's CXCR4 inhibitor motixafortide in combination with 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).

Sponsored by Columbia University, the single-arm pilot phase of the Phase 2 trial focused on the safety of the drug combination. Additionally, based on the original protocol, if =3 of the planned 10 patients within the pilot phase experienced a partial response (PR) by RECIST criteria within 16 weeks, the combination would be considered promising and an expansion cohort of an additional 30 patients would be initiated for enrollment. Earlier this year, following a review of the pilot phase data, the trial was amended to become a randomized study, with planned enrollment increasing from 30 to 102 patients. A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2-6 in Chicago, Illinois (see abstract).

Presentation at AACR Special Conference in Cancer Research: Pancreatic Cancer

Westin Copley Place, Boston Massachusetts

Plenary Session Details

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 A. Manji, MD, PhD, Columbia University Irving Medical Center/New York Presbyterian, New York, N.Y.

Session: Plenary Session 3: Clinical Updates

Date: Thursday, September 28, 2023

Time: 2:30-4:40 pm EDT

About Pancreatic Cancer

Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In the United States in 2023, an estimated 64,000 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. 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 people who are initially diagnosed with metastatic cancer, the 5-year relative survival rate is 3%. 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.

About BioLineRx

BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company's first approved product is APHEXDA™ (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with commercial operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.

Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.

[jcon777]

BLRX might help 3/4 of pancreatic cancer patients

This article is from December of 2019. "Seventy-seven percent of patients were able to achieve disease control rate," said Philip Serlin, chief executive officer of BioLineRx.
https://www.jpost.com/HEALTH-SCIENCE/New-Israeli-pancreatic-cancer-treatment-could-extend-most-patients-lives-611085

[jcon777]

added early this morning at 1.93

[midastouch017]

Bottom-Line Summary
BLRX has a drug approved, full stop. This is a big landmark for any company, and their drug definitely has a role to play in multiple myeloma. Exactly how big a role remains a question, since there's generic plerixafor competition now (even if plerixafor is marginally worse than motixafortide), and fewer patients need immediate autologous transplants. This stock is worth a close watch, since if they can bounce off this approval into decent sales relatively quickly, then the current market cap of $120 million is basically a joke.

[midastouch017]

Assessing BioLineRx As A Buy After Drug Approval

Sep. 18, 2023 1:28 AM ETBioLineRx Ltd. (BLRX)

Summary

BioLineRx has received approval for their stem cell mobilizing compound, motixafortide, for certain forms of blood cancer.
The compound has shown impressive results in mobilizing stem cells in patients, with a high success rate in optimal stem cell collection.
However, there are concerns about competition from generic versions of a similar drug and the decreasing need for immediate autologous transplants in patients with multiple myeloma.

Topline Summary
BioLineRx (NASDAQ:BLRX) is a biotech company focused mainly on developing a stem cell mobilizing compound to help patients with certain forms of blood cancer. Their exciting news is that they've received a first approval for their compound, but there is reason for caution moving forward, given that their setting of choice continues to be questioned in the literature. There's also generic competition, although BLRX has attempted to get in front of this with a post-hoc analysis suggesting better benefits with their drug. Long story short: this stock is sitting at a bargain price if they're able to capitalize decently on their recent approval.

Pipeline Overview
Motixafortide

The main compound being developed by BLRX is motixafortide, an inhibitor of CXCR4. This target has numerous potential benefits for patients with cancer and blood diseases, but the most advanced in BLRX's pipeline is as a stimulator of blood stem cell production and mobilization.

Why? Transplant of blood stem cells, either from the patients themselves (autologous) or from a donor (allogeneic), has been a core piece of managing blood cancers like leukemia and lymphoma for decades. In patients with multiple myeloma, autologous stem cell transplantation was for a long time one of the best options for patients.

That is, it's one of the best options if you're able to get the body to move stem cells into the blood so you can collect them. And a large number of patients are unable to present enough of these stem cells in the blood with standard procedures. Addition of the CXCR4 inhibitor plerixafor and the growth factor G-CSF (filgrastim) has improved this rate of mobilization, but many patients continue to struggle with getting the optimal number of stem cells, which can negatively impact how well they do post-transplant.

Motixafortide is a more potent CXCR4 inhibitor that was assessed in the phase 3 GENESIS trial, part 2 of which compared motixafortide plus filgrastim versus placebo plus filgrastim. This study showed impressive mobilization of stem cells with motixafortide, with 96.3% of patients achieving optimal stem cell collection by day 3, compared with 36.5% in the placebo group. Moreover, optimal collection was achieved after just one round of apheresis in 88.8% of patients with motixafortide.

Outcomes post-transplant, like engraftment of cells and graft durability, were similar between the two arms, suggesting that motixafortide did not negatively alter the stem cells that were collected. Almost 2 years since that presentation, motixafortide was approved on September 11, 2023, in combination with filgrastim to help mobilize hematopoietic stem cells in patients with multiple myeloma.

At ASH 2022, the company presented an indirect comparison of motixafortide versus plerixafor that suggested motixafortide could achieve optimal stem cell mobilization in fewer rounds of treatment, with concomitant potential benefit in terms of cost overall.

BLRX is continuing to develop motixafortide in different applications, mainly in sickle cell disease, but few developments have been announced in this direction.

More recently, the company announced that an investigator-initiated, randomized, phase 2 trial to investigate motixafortide plus cemiplimab plus gemcitabine/nab-paclitaxel in patients with advanced pancreatic cancer, hoping to build on results they observed in the COMBAT study in the second-line setting.

Financial Overview
As of their Q2 2023 filing, BLRX held $10.1 million in cash and equivalents, with another $22.7 million in short-term bank deposits. This was set against a $9.9 million operating loss, most of which went to expansion of their sales capabilities in anticipation of their approval. There was an unusual $7.7 million in non-operating income loss, as well, related to the revaluation of outstanding warrants, so the net loss reached $18.5 million for the quarter, compared with $7.4 million in the same fiscal quarter 2022.

Assuming this net loss was anomalous, BLRX has approximately 3 quarters of cash and current assets on hand to fund operations from the end of Q2. That gives them approximately 7 months to get a launch off the ground.

Strengths and Risks
A drug approval is the holy grail for developmental biotechs, and now BLRX gets to begin the transition into a commercial entity. That is indisputable, and now the company is going to be able to gain traction.

The only question, then, is how much traction? There are 2 red flags that come to mind for motixafortide. First, the GENESIS trial did not include plerixafor as a comparator, and their attempts to compare the cost/benefit of the 2 agents in a post-hoc analysis underscores how important a question it is to answer whether the new drug is as good or better than the old.

You cannot do this convincingly by these kinds of analyses. So it will remain a question whether a clinician should use plerixafor or motixafortide. A future head-to-head study could definitively answer the question, which would be a boon because the cost-effectiveness of plerixafor has also been called into question.

Now that plerixafor has multiple generic versions launched, BLRX may have an uphill battle.

The other potential red flag is that novel therapies have continuously undermined the role of upfront stem cell transplant for patients with multiple myeloma. Most recently, the DETERMINATION trial demonstrated that stem cell transplant offered no overall survival benefit after RVD therapy compared with RVD alone.

Long story short: newer, better therapies are delaying and preventing the need for a costly stem cell transplant in more patients than ever, which could tighten the pool of patients that could potentially benefit from motixafortide. Of course, it is approved to mobilize stem cells for storage in case of a future transplant, and a lot of patients may opt for that strategy.

But it's uncertainty, meaning that motixafortide is very much not a slam dunk as a commercial product. We'll have to watch carefully how BLRX handles the rollout.

That said, all of these risks cannot trump that motixafortide has impressive phase 3 data and drug approval. Some analysts on Seeking Alpha have proposed that BLRX is a strong buyout candidate, but that is very much speculative. Cash is another issue BLRX will need to solve in the near term. Hopefully, they can launch motixafortide sales before they need to do an equity raise.

Bottom-Line Summary
BLRX has a drug approved, full stop. This is a big landmark for any company, and their drug definitely has a role to play in multiple myeloma. Exactly how big a role remains a question, since there's generic plerixafor competition now (even if plerixafor is marginally worse than motixafortide), and fewer patients need immediate autologous transplants. This stock is worth a close watch, since if they can bounce off this approval into decent sales relatively quickly, then the current market cap of $120 million is basically a joke.