BLRX BioLineRx Ltd.

2.81
-0.04  -1%
Previous Close 2.85
Open 2.84
52 Week Low 1.4
52 Week High 6.34
Market Cap $127,899,895
Shares 45,515,977
Float 45,515,977
Enterprise Value $126,295,342
Volume 985,428
Av. Daily Volume 6,324,378
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Upcoming Catalysts

Drug Stage Catalyst Date
Motixafortide
Acute respiratory distress syndrome (ARDS) secondary to COVID-19
Phase 1b
Phase 1b
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AGI-134
Solid tumors
Phase 1/2
Phase 1/2
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Motixafortide and Libtayo
First-line pancreatic ductal adenocarcinoma
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
BL-8040 GENESIS
Stem-cell mobilization for autologous transplantation
Phase 3
Phase 3
Phase 3 top-line data met all primary and secondary endpoints - May 4, 2021.
BL-8040 in combination with KEYTRUDA - COMBAT trial
Pancreatic cancer
Phase 2
Phase 2
Phase 2 data released December 16, 2020. ORR 21%; PFS 4 months; OS 6.5 months.
Motixafortide (BL-8040) - BLAST
Consolidation treatment for AML cancer patients
Phase 2b
Phase 2b
Phase 2b trial did not meet primary endpoint - November 23, 2020.
BL-8040 in combination with KEYTRUDA
Pancreatic cancer
Phase 2a
Phase 2a
Phase 2a data presented at ESMO December 13, 2019.

Latest News

  1. BioLineRx Announces Positive Top-Line Results from GENESIS Phase 3 Trial of Motixafortide in Stem-Cell Mobilization for Autologous Bone Marrow Transplantation in Multiple Myeloma Patients

    TEL AVIV, Israel, May 4, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced positive top-line results from the Company's GENESIS Phase 3 trial evaluating its lead clinical candidate, Motixafortide, in combination with granulocyte colony stimulating factor (G-CSF, the standard of care in this indication), for hematopoietic stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients.

    An analysis of data on all 122 enrolled patients (the intent to treat, or ITT, population) found highly statistically significant evidence across all primary and secondary endpoints favoring Motixafortide in addition to G-CSF, as compared…

    TEL AVIV, Israel, May 4, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced positive top-line results from the Company's GENESIS Phase 3 trial evaluating its lead clinical candidate, Motixafortide, in combination with granulocyte colony stimulating factor (G-CSF, the standard of care in this indication), for hematopoietic stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients.

    An analysis of data on all 122 enrolled patients (the intent to treat, or ITT, population) found highly statistically significant evidence across all primary and secondary endpoints favoring Motixafortide in addition to G-CSF, as compared to placebo plus G-CSF. In addition, the combination was found to be safe and well tolerated.

    The primary endpoint of the study demonstrated a 4.9-fold increase (70.0% vs 14.3%; difference 54.6%; 95% CI 39.7-69.5%; p<0.0001) in the proportion of patients in the treatment arm, as compared to the control arm mobilizing ≥ 6 million CD34+ cells/kg in up to two apheresis sessions, and after only one administration of Motixafortide. This translates to an odds-ratio of 12.9.

    The study also achieved its main secondary endpoint, demonstrating a 14.1-fold increase (67.5% vs 4.8%; difference 61.7%; 95% CI 49.5-73.8%; p<0.0001) in the proportion of patients in the treatment arm, as compared to the control arm, who mobilized ≥ 6 million CD34+ cells/kg in just one apheresis session. This translates to an odds-ratio of 56.0.

    Other important data from the study include median number of CD34+ cells collected on the first day of apheresis (8.5 million in the treatment arm vs 1.5 million in the control arm) – a 5.6-fold increase. The addition of Motixafortide to G-CSF also allowed 88.3% of patients to undergo transplantation after only one apheresis session, compared to 10.8% in the G-CSF arm – an 8.2-fold increase. Engraftment endpoints, including the number of days needed for engraftment, success of engraftment and the durability of engraftment 100 days post-transplant, further support the study's success.

    "The results of the GENESIS study are extremely impressive, and all the more so when considering that almost 90% of the patients in the treatment arm proceeded to transplantation after only one apheresis session," stated John DiPersio, MD, Washington University School of Medicine, and lead investigator of the study. "This is a great achievement in alleviating the burden for the patients and reducing hospital resources. I believe these results make the combination of Motixafortide and G-CSF a very attractive candidate for use in all patients with multiple myeloma undergoing autologous stem-cell transplantation."

    "These strikingly positive data significantly exceeded our expectations, and are truly transformational for our company," stated Philip Serlin, Chief Executive Officer of BioLineRx. "The statistical significance across all primary and secondary endpoints was consistent across twelve different sensitivity analyses. These results support our goal of becoming the standard of care for autologous bone-marrow transplantation, providing a strong clinical and pharmaco-economic advantage for its use, on top of G-CSF, in all transplant procedures.  

    "We are working aggressively to gain regulatory approval for Motixafortide in this transplant setting for multiple myeloma patients – with plans to make an NDA submission in the first half of next year – and we are also pressing forward to unlock the full potential of this therapy in this and other stem-cell mobilization indications. I would like to express our sincere thanks to the patients and investigators who participated in the study and enabled its great success," Mr. Serlin concluded.

    Conference Call and Webcast Information

    BioLineRx will hold a conference call today, Tuesday, May 4, 2021 at 10:00 a.m. EDT. To access the conference call, please dial +1-866-860-9642 from the US or +972-3-918-0644 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx'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.

    A replay of the conference call will be available for a limited time approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until May 6, 2021; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

    About the GENESIS Trial

    The GENESIS trial (NCT03246529) was initiated in December 2017. GENESIS was a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of Motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of hematopoietic stem-cells for autologous transplantation in multiple myeloma patients. The primary objective of the study was to demonstrate that only one dose of Motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize ≥ 6 million CD34+ cells in up to two apheresis sessions. Additional objectives included time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters. Local laboratories and a central laboratory were used to determine CD34+ cell yields. For regulatory purposes, efficacy endpoints were calculated using the percentage of CD34+ cells determined by the central laboratory. The local laboratory values were used for all clinical decisions, including the number of apheresis days and the decision to proceed to transplantation.

    About BioLineRx

    BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem-cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to Motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    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 "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties 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; 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; 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 additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; risks related to the COVID-19 pandemic; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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 February 23, 2021. 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.

    Contact:

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    or

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945

    Cision View original content:http://www.prnewswire.com/news-releases/biolinerx-announces-positive-top-line-results-from-genesis-phase-3-trial-of-motixafortide-in-stem-cell-mobilization-for-autologous-bone-marrow-transplantation-in-multiple-myeloma-patients-301282969.html

    SOURCE BioLineRx Ltd.

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  2. BioLineRx Announces Presentation at 2021 American Association for Cancer Research (AACR) Annual Meeting

    TEL AVIV, Israel, April 15, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical Company focused on oncology, today announced that the Company has presented a poster at the AACR Annual Meeting, which is being held April 10-15 on a virtual basis."

    The poster, entitled: "A Multi-Center Phase 2a Trial of the CXCR4 inhibitor Motixafortide (BL-8040) in Combination with Pembrolizumab and Chemotherapy, in Patients with Metastatic Pancreatic Adenocarcinoma, the COMBAT Study," includes new analyses from the Company's Phase 2a COMBAT/KEYNOTE-202 triple combination study of motixafortide in metastatic pancreatic cancer, further detailing the clinical effect of the combination in patients with and without…

    TEL AVIV, Israel, April 15, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical Company focused on oncology, today announced that the Company has presented a poster at the AACR Annual Meeting, which is being held April 10-15 on a virtual basis."

    The poster, entitled: "A Multi-Center Phase 2a Trial of the CXCR4 inhibitor Motixafortide (BL-8040) in Combination with Pembrolizumab and Chemotherapy, in Patients with Metastatic Pancreatic Adenocarcinoma, the COMBAT Study," includes new analyses from the Company's Phase 2a COMBAT/KEYNOTE-202 triple combination study of motixafortide in metastatic pancreatic cancer, further detailing the clinical effect of the combination in patients with and without liver metastases.

    The COMBAT/KEYNOTE-202 study evaluated BioLineRx's lead clinical candidate, motixafortide, in combination with KEYTRUDA® and chemotherapy in patients with advanced pancreatic ductal adenocarcinoma, or PDAC. Top-line results from the study were announced in December 2020.

    "Liver metastases are a critical factor driving poor prognoses for patients with metastatic PDAC," stated Dr. Abi Vainstein, Chief Medical Officer of BioLineRx. "We are very pleased to present this additional analysis, which further strengthens the results reported from the COMBAT/KEYNOTE-202 trial in December 2020, since not only were substantially all patients initially diagnosed with stage 4 disease, but the vast majority (~80%) of the patients had liver metastases, emphasizing the extremely difficult patient population in this study. These data should be further confirmed in a randomized trial, and we continue to work diligently to define next steps for the program with potential collaboration partners."

    Summary data:

    Endpoint

    Evaluable Patients (N=38)

    Liver Metastases

    (N=30)

    No Liver Metastases

    (N=8)

    mOS (months)

    (95% CI)

    6.5

    (4.5-9.6)

    5.9

    (4.4-9.6)

    8.4

    (3.5-10.8)

    mPFS (months)

    (95% CI)

    4.0

    (1.5-5.6)

    1.9

    (1.5-5.7)

    5.4

    (1.5-8.0)

    ORR

    (95% CI)

    21.1%

    (8.1%-34.0%)

    16.7%

    (3.3%-30.0%)

    37.5%

    (4.0%-71.0%)

    DCR

    (95% CI)

    63.2%

    (47.8%-78.5%)

    56.7%

    (38.9%-74.4%)

    87.5%

    (64.6%-100.0%)

    "We believe these incremental data provide strong support for continued development of motixafortide as the backbone of a new regimen for the treatment of PDAC and will likely prove beneficial as we advance discussions with potential collaboration partners," stated Philip Serlin, Chief Executive Officer of BioLineRx. "At the same time, we are very much looking forward to final data from our Phase 3 GENESIS study in stem cell mobilization in the next few weeks, which we hope will give us a clear pathway to potential registration and highlight the versatility of motixafortide across both hematological and solid tumor cancer types."   

    A copy of the poster is now available on the Company's website, www.biolinerx.com.

    About BioLineRx

    BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem-cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    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 "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties 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; 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; 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 additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; risks related to the COVID-19 pandemic; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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 February 23, 2021. 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.

    Contact:

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    or

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945

     

    Cision View original content:http://www.prnewswire.com/news-releases/biolinerx-announces-presentation-at-2021-american-association-for-cancer-research-aacr-annual-meeting-301269730.html

    SOURCE BioLineRx Ltd.

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  3. BioLineRx Reports Year-End 2020 Financial Results and Provides Corporate Update

    TEL AVIV, Israel, Feb. 23, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the year ended December 31, 2020 and provides a corporate update.

    Significant events and achievements during the fourth quarter 2020 and subsequent period:

    • Announced positive results from an interim analysis of its GENESIS Phase 3 trial of motixafortide in stem-cell mobilization (SCM). The interim analysis found statistically significant evidence for the primary endpoint favoring treatment with motixafortide. Based on a recommendation from the independent Data Monitoring Committee (DMC), enrollment was ceased early at 122 patients (instead of 177…

    TEL AVIV, Israel, Feb. 23, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the year ended December 31, 2020 and provides a corporate update.

    Significant events and achievements during the fourth quarter 2020 and subsequent period:

    • Announced positive results from an interim analysis of its GENESIS Phase 3 trial of motixafortide in stem-cell mobilization (SCM). The interim analysis found statistically significant evidence for the primary endpoint favoring treatment with motixafortide. Based on a recommendation from the independent Data Monitoring Committee (DMC), enrollment was ceased early at 122 patients (instead of 177 originally planned), and top-line data, including full primary and secondary efficacy endpoints, is anticipated in early second quarter of 2021. In parallel, the Company is proceeding with all activities in support of an NDA submission in this indication anticipated in the first half of 2022, including a pre-NDA meeting with the FDA planned for the second half of 2021.

     

    • Reported positive final results from the triple combination arm of the Company's COMBAT/KEYNOTE-202 study evaluating motixafortide in combination with KEYTRUDA® (pembrolizumab) and chemotherapy in patients with second-line stage IV pancreatic ductal adenocarcinoma (PDAC). The results of the study showed substantial improvement as compared to historical results across all study endpoints. The Company is currently planning next development steps for this program, including discussions with potential collaboration partners and development of a protocol for a randomized controlled study.

     

    • Announced initiation of a Phase 2 investigator-initiated clinical trial evaluating motixafortide in combination with LIBTAYO® and chemotherapy in first-line metastatic PDAC. The study is led by Columbia University.

     

    • Announced initiation of a Phase 1b investigator-initiated clinical trial evaluating motixafortide in patients suffering from acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections.

     

    • Completed underwritten public offering with gross proceeds of $34.5 million.

     

    "The fourth quarter 2020 was perhaps our most significant so far, having achieved positive data milestones in two programs with significant unmet medical needs – stem-cell mobilization and PDAC," stated Philip Serlin, Chief Executive Officer of BioLineRx. "The Phase 3 SCM interim data that we reported in October were overwhelmingly positive, and based on the DMC's recommendation, we ceased enrollment at 122 out of the originally planned 177 patients. We now look forward to presenting full top-line results from the study, including data related to 100 days of post-transplantation follow-up, by early second quarter of this year. SCM remains our most expeditious path to registration, and we therefore view these data as potentially transformational for our company. In parallel, we are moving forward very aggressively with all activities in support of an NDA submission, which we expect in the first half of next year.

    "We are equally excited about the final results from our Phase 2a COMBAT/KEYNOTE-202 PDAC study that we announced in December last year. The data demonstrated that the triple combination of motixafortide, KEYTRUDA and chemotherapy outperformed historical data across all endpoints, including median overall survival, median progression free survival, confirmed and overall response rates and disease control rate. In a cancer population as difficult to treat as second-line metastatic PDAC, and even more specifically those patients initially diagnosed with unresectable stage IV disease, we view these results as highly encouraging and are planning our next development steps forward in this program, likely in collaboration with a biopharmaceutical partner.

    "Finally, subsequent to the end of the year, we strengthened our balance sheet through a financing that resulted in gross proceeds of $34.5 million. These funds will allow us to continue to execute on our strategy for motixafortide in both SCM and PDAC, while in parallel advancing our second clinical candidate, the anti-cancer immunotherapy AGI-134, through clinical development. In summary, we exited 2020 on a very positive note, with two data sets that demonstrate both the effectiveness and versatility of motixafortide across multiple indications, and we plan to build upon these successes this year," concluded Mr. Serlin.

    Upcoming Significant Expected Milestones

    • Top-line results from the Phase 3 GENESIS trial in SCM in early Q2 2021.

     

    • Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021.

     

    • Pre-NDA meeting with the FDA for SCM in the second half of 2021

     

    • NDA submission for SCM in the first half of 2022

    Financial Results for the Year Ended December 31, 2020

    Research and development expenses for the year ended December 31, 2020 were $18.2 million, a decrease of $5.2 million, or 22.5%, compared to $23.4 million for the year ended December 31, 2019. The decrease resulted primarily from termination of the BATTLE clinical study for motixafortide in 2019, from lower expenses associated with the motixafortide  COMBAT clinical trial and from lower expenses associated with the AGI-134 study, as well as a decrease in share-based compensation and payroll due to a company-wide salary reduction related to the COVID-19 pandemic.

    Sales and marketing expenses for the year ended December 31, 2020 were $0.8 million, similar to sales and marketing expenses for the year ended December 31, 2019.

    General and administrative expenses for the year ended December 31, 2020 were $3.9 million, an increase of $0.1 million, or 2.6% compared to $3.8 million for the year ended December 31, 2019. The increase resulted primarily from an increase in D&O insurance expenses and share-based compensation, offset by small decreases in a number of G&A expenses.

    The Company's operating loss for the year ended December 31, 2020 amounted to $22.9 million, compared to an operating loss of $28.1 million for the year ended December 31, 2019.

    Non-operating expenses amounted to $5.7 million for the year ended December 31, 2020, compared to non-operating income of $4.2 million for the year ended December 31, 2019. Non-operating expenses for the year ended December 31, 2020 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet, warrant offering expenses and ATM issuance expenses. Non-operating income for the year ended December 31, 2019 primarily relates to fair-value adjustments of warrant liabilities on the Company's balance sheet, offset by warrant offering expenses.

    Net financial expenses amounted to $1.4 million for the year ended December 31, 2020, compared to net financial expenses of $1.5 million for the year ended December 31, 2019. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.

    The Company's net loss for the year ended December 31, 2020 amounted to $30.0 million, compared with a net loss of $25.5 million for the year ended December 31, 2019.

    The Company held $22.6 million in cash, cash equivalents and short-term bank deposits as of December 31, 2020. Subsequent to year end, the Company raised gross proceeds of $34.5 million in an underwritten public offering, and received another $9.8 million in gross proceeds from the exercise of outstanding warrants.

    Net cash used in operating activities for the year ended December 31, 2020 was $23.2 million, compared to $22.7 million for the year ended December 31, 2019. The $0.5 million increase in 2020 was primarily the result of a decrease in accounts payable and accruals.

    Net cash provided by investing activities for the year ended December 31, 2020 was $16.7 million, compared to $5.3 million for the year ended December 31, 2019. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.

    Net cash provided by financing activities for the year ended December 31, 2020 was $17.9 million, compared to $19.2 million for the year ended December 31, 2019. The cash flows in 2020 primarily reflect the registered direct offerings of the Company's ADSs in May and June 2020, as well as net proceeds from the ATM program, offset by repayments of the loan from Kreos Capital. The cash flows in 2019 primarily reflect the underwritten public offering of the Company's ADSs in February 2019, as well as net proceeds from the ATM program.

    Conference Call and Webcast Information

    BioLineRx will hold a conference call today, Thursday, February 23, 2021 at 10:00 a.m. EST. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0610  internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx'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.

    A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until February 25, 2021; please dial +1-888-782-4291 from the US or +972-3-925-5904 internationally.

    (Tables follow)

    About BioLineRx

    BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem-cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    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 "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties 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; 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; 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 additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; risks related to the COVID-19 pandemic; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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 February 23, 2021. 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.

    Contact:

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    or

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945



     

     

    BioLineRx Ltd.

    CONSOLIDATED STATEMENTS OF FINANCIAL POSITION







    December 31,



    2019

    2020



    in USD thousands

    Assets





    CURRENT ASSETS





    Cash and cash equivalents

    5,297

    16,831

    Short-term bank deposits

    22,192

    5,756

    Prepaid expenses

    108

    152

    Other receivables

    613

    141

              Total current assets

    28,210

    22,880







    NON-CURRENT ASSETS





    Property and equipment, net

    1,816

    1,341

    Right-of-use assets, net

    1,650

    1,355

    Intangible assets, net

    21,891

    21,714

              Total non-current assets

    25,357

    24,410

              Total assets

    53,567

    47,290







    Liabilities and equity





    CURRENT LIABILITIES





    Current maturities of long-term loans

    2,692

    3,092

    Accounts payable and accruals:





         Trade

    7,794

    5,918

         Other

    1,280

    1,440

    Lease liabilities

    202

    191

              Total current liabilities

    11,968

    10,641







    NON-CURRENT LIABILITIES





    Warrants

    658

    10,218

    Long-term loans, net of current maturities

    5,799

    2,740

    Lease liabilities

    1,762

    1,661

              Total non-current liabilities

    8,219

    14,619







    COMMITMENTS AND CONTINGENT LIABILITIES





              Total liabilities

    20,187

    25,260







    EQUITY





    Ordinary shares

    4,692

    9,870

    Share premium

    265,938

    279,241

    Capital reserve

    12,132

    12,322

    Other comprehensive loss

    (1,416)

    (1,416)

    Accumulated deficit

    (247,966)

    (277,987)

              Total equity

    33,380

    22,030

              Total liabilities and equity

    53,567

    47,290

     



     



    BioLineRx Ltd.



    CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS





    Year ended December 31,





    2018

    2019

    2020





    in USD thousands











    RESEARCH AND DEVELOPMENT EXPENSES

    (19,808)

    (23,438)

    (18,173)

    SALES AND MARKETING EXPENSES

    (1,362)

    (857)

    (840)

    GENERAL AND ADMINISTRATIVE EXPENSES

    (4,435)

    (3,816)

    (3,914)

    OPERATING LOSS

    (25,605)

    (28,111)

    (22,927)

    NON-OPERATING INCOME (EXPENSES), NET

    2,397

    4,165

    (5,701)

    FINANCIAL INCOME

    719

    777

    236

    FINANCIAL EXPENSES

    (473)

    (2,277)

    (1,629)

    NET LOSS AND COMPREHENSIVE LOSS

    (22,962)

    (25,446)

    (30,021)











    in USD



    LOSS PER ORDINARY SHARE – BASIC AND DILUTED

    (0.21)

    (0.17)

    (0.12)











    WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE

    108,595,702

    146,407,055

    252,844,394

























     

     

    BioLineRx Ltd.



    STATEMENTS OF CHANGES IN EQUITY





     

    Ordinary shares

     

    Share premium

     

    Capital reserve

    Other comprehensive

     loss

     

    Accumulated deficit

     

     

    Total



    in USD thousands

    BALANCE AT JANUARY 1, 2018

    2,836

    240,682

    10,337

    (1,416)

    (199,558)

    52,881

    CHANGES IN 2018:













      Issuance of share capital, net

    263

    8,567

    -

    -

    -

    8,830

      Employee stock options exercised

    11

    415

    (380)

    -

    -

    46

      Employee stock options forfeited and expired

    -

    528

    (528)

    -

    -

    -

      Share-based compensation   

    -

    -

    2,526

    -

    -

    2,526

      Comprehensive loss for the year

    -

    -

    -

    -

    (22,962)

    (22,962)

    BALANCE AT DECEMBER 31, 2018

    3,110

    250,192

    11,955

    (1,416)

    (222,520)

    41,321

    CHANGES IN 2019:













      Issuance of share capital, net

    1,580

    14,165

    -

    -

    -

    15,745

      Employee stock options exercised

    2

    83

    (84)

    -

    -

    1

      Employee stock options forfeited and expired

    -

    1,498

    (1,498)

    -

    -

    -

      Share-based compensation   

    -

    -

    1,759

    -

    -

    1,759

      Comprehensive loss for the year

    -

    -

    -

    -

    (25,446)

    (25,446)

    BALANCE AT DECEMBER 31, 2019

    4,692

    265,938

    12,132

    (1,416)

    (247,966)

    33,380

    CHANGES IN 2020:













      Issuance of share capital, net

    4,777

    9,395

    -

    -

    -

    14,172

      Warrants exercised

    393

    2,826

    -

    -

    -

    3,219

      Employee stock options exercised

    8

    228

    (228)

    -

    -

    8

      Employee stock options forfeited and expired

    -

    854

    (854)

    -

    -

    -

      Share-based compensation   

    -

    -

    1,272

    -

    -

    1,272

      Comprehensive loss for the year

    -

    -

    -

    -

    (30,021)

    (30,021)

    BALANCE AT DECEMBER 31, 2020

    9,870

    279,241

    12,322

    (1,416)

    (277,987)

    22,030

     



     

    BioLineRx Ltd.



    CONSOLIDATED CASH FLOW STATEMENTS





    Year ended December 31,



    2018

    2019

    2020



    in USD thousands

    CASH FLOWS - OPERATING ACTIVITIES







         Net loss

    (22,962)

    (25,446)

    (30,021)

         Adjustments required to reflect net cash used in operating activities (see appendix below)

    (1,230)

    2,780

    6,815

    Net cash used in operating activities

    (24,192)

    (22,666)

    (23,206)









    CASH FLOWS - INVESTING ACTIVITIES







         Realization of long-term investment

    1,500

    -

    -

         Investments in short-term deposits

    (26,500)

    (43,545)

    (33,500)

         Maturities of short-term deposits

    44,771

    48,875

    50,168

         Purchase of property and equipment

    (173)

    (67)

    -

         Purchase of intangible assets

    (10,043)

    (6)

    -

    Net cash provided by investing activities

    9,555

    5,257

    16,668









    CASH FLOWS - FINANCING ACTIVITIES







         Issuance of share capital and warrants, net of issuance cost

    3,830

    20,297

    21,215

         Employee stock options exercised

    46

    1

    8

         Proceeds of long-term loan and warrants, net of issuance costs

    9,632

    -

    -

         Repayment of loans

    (411)

    (889)

    (3,133)

         Repayments of lease liabilities

    -

    (215)

    (224)

    Net cash provided by financing activities

    13,097

    19,194

    17,866









    INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

    (1,540)

    1,785

    11,328

    CASH AND CASH EQUIVALENTS - BEGINNING

       OF YEAR

    5,110

    3,404

    5,297

    EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS

    (166)

    108

    206

    CASH AND CASH EQUIVALENTS - END OF YEAR

    3,404

    5,297

    16,831









     

     

    BioLineRx Ltd.



    CONSOLIDATED CASH FLOW STATEMENTS





    Year ended December 31,



    2018

    2019

    2020



    in USD thousands

    APPENDIX















    Adjustments required to reflect net cash used in operating activities:







    Income and expenses not involving cash flows:







    Depreciation and amortization

    545

    940

    934

    Long-term prepaid expenses

    5

    56

    -

    Exchange differences on cash and cash equivalents

    166

    (108)

    (206)

    Fair value adjustments of warrants

    (1,743)

    (4,634)

    5,142

    Share-based compensation

    2,526

    1,759

    1,272

    Interest and exchange differences on short-term deposits

    (645)

    (775)

    (232)

    Interest on loans

    123

    647

    474

    Gain on realization of long-term investment

    (500)

    -

    -

    Warrant issuance costs

    -

    417

    594

    Exchange differences on lease liability 

    -

    154

    125



    477

    (1,544)

    8,103









    Changes in operating asset and liability items:







    Decrease (increase) in prepaid expenses and other receivables

    (934)

    1,106

    428

    Increase (decrease) in accounts payable and accruals

    (773)

    3,218

    (1,716)



    (1,707)

    4,324

    (1,288)











    (1,230)

    2,780

    6,815

























    Supplemental information on interest received in cash

    834

    868

    381









    Supplemental information on interest paid in cash

    165

    1,198

    994









    Supplemental information on non-cash transactions

    5,000

    147

    1,251

























     

    Cision View original content:http://www.prnewswire.com/news-releases/biolinerx-reports-year-end-2020-financial-results-and-provides-corporate-update-301233309.html

    SOURCE BioLineRx Ltd.

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  4. BioLineRx to Report Annual 2020 Results on February 23, 2021

    TEL AVIV, Israel, Feb. 17, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, announced today it will release its audited financial results for the year ended December 31, 2020 on Tuesday, February 23, 2021, before the US markets open.

    The Company will host a conference call on Tuesday, February 23, 2021 at 10:00 a.m. EST featuring remarks by Philip Serlin, Chief Executive Officer, and other members of the management team. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the…

    TEL AVIV, Israel, Feb. 17, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, announced today it will release its audited financial results for the year ended December 31, 2020 on Tuesday, February 23, 2021, before the US markets open.

    The Company will host a conference call on Tuesday, February 23, 2021 at 10:00 a.m. EST featuring remarks by Philip Serlin, Chief Executive Officer, and other members of the management team. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx'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.

    To dial into the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0610 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until February 25, 2021; please dial +1-888-782-4291 from the US or +972-3-925-5904 internationally.

    About BioLineRx

    BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    Contacts:

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945

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    SOURCE BioLineRx Ltd.

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  5. BioLineRx Announces Closing of $34.5 Million Bought Deal Offering and Full Exercise of the Option of the Underwriter

    TEL AVIV, Israel, Jan. 22, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced the closing of its previously announced underwritten offering of 14,375,000 American Depositary Shares (ADSs) of the Company, inclusive of the full exercise by Wainwright of its option to purchase 1,875,000 additional ADSs, at a price to the public of $2.40 per ADS, less underwriting discounts and commissions. Each ADS represents fifteen ordinary shares, par value NIS 0.10 per share, of the Company.

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

    The gross proceeds to BioLineRx, before deducting underwriting discounts and commissions…

    TEL AVIV, Israel, Jan. 22, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced the closing of its previously announced underwritten offering of 14,375,000 American Depositary Shares (ADSs) of the Company, inclusive of the full exercise by Wainwright of its option to purchase 1,875,000 additional ADSs, at a price to the public of $2.40 per ADS, less underwriting discounts and commissions. Each ADS represents fifteen ordinary shares, par value NIS 0.10 per share, of the Company.

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

    The gross proceeds to BioLineRx, before deducting underwriting discounts and commissions and offering expenses, are approximately $34.5 million. The Company intends to use the net proceeds from this offering for general corporate purposes, which may include but are not limited to working capital and funding clinical trials.

    The securities described above were offered by BioLineRx pursuant to a "shelf" registration statement on Form F-3 (File No. 333-251857) previously filed with the Securities and Exchange Commission (the "SEC") on December 31, 2020 and declared effective by the SEC on January 11, 2021. The offering of the securities was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities offered have been filed with the SEC and are available on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About BioLineRx

    BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    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 "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events, such as statements relating to the bought deal offering, including as to the intended use of proceeds. These forward-looking statements involve known and unknown risks and uncertainties 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; 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; 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 additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; risks related to the coronavirus outbreak; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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 12, 2020. 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.

    Company contact:

     

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

     

     

    or

     

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945

     



     

    Cision View original content:http://www.prnewswire.com/news-releases/biolinerx-announces-closing-of-34-5-million-bought-deal-offering-and-full-exercise-of-the-option-of-the-underwriter-301213408.html

    SOURCE BioLineRx Ltd

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