About Us | ScientistBLRX BioLineRx Ltd.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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AGI-134
Solid tumors
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Phase 1/2
Phase 1/2
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Motixafortide (BL-8040) - (GENESIS)
Stem-cell mobilization for autologous transplantation
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NDA Filing
NDA Filing
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Motixafortide (BL-8040) and LIBTAYO (cemiplimab)
First-line pancreatic ductal adenocarcinoma
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Phase 2
Phase 2
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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Motixafortide (BL-8040)
Acute respiratory distress syndrome (ARDS) secondary to COVID-19
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Phase 1b
Phase 1b
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Phase 1b initiation announced November 18, 2020.
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Motixafortide (BL-8040) and KEYTRUDA (pembrolizumab)
Pancreatic cancer
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Phase 2a
Phase 2a
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Phase 2a data presented at ESMO December 13, 2019.
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Motixafortide (BL-8040) and KEYTRUDA (pembrolizumab) - COMBAT trial
Pancreatic cancer
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Phase 2
Phase 2
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Phase 2 data released December 16, 2020. ORR 21%; PFS 4 months; OS 6.5 months.
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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.
|
Latest News
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TEL AVIV, Israel, May 26, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended March 31, 2021 and provides a corporate update.
Significant events and achievements during the first quarter 2021 and subsequent period:
- Announced positive topline results from GENESIS Phase 3 trial of Motixafortide in stem-cell mobilization (SCM). The data demonstrate that the study successfully met all primary and secondary endpoints with an exceptionally high level of statistical significance (p<0.0001).
- 88.3% of patients receiving Motixafortide + G-CSF underwent transplantation after only ONE administration of Motixafortide and in only ONE apheresis session, compared to 10.8% for G-CSF alone; potentially supports Motixafortide on top of G-CSF as new standard-of-care mobilization agent in autologous bone-marrow transplantation.
- The Company is proceeding with 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 this year.
- Presented data at the 2021 American Association for Cancer Research (AACR) Annual Meeting analyzing results by liver metastasis status from the Company's Phase 2a COMBAT/KEYNOTE-202 triple combination study testing Motixafortide in metastatic pancreatic cancer. The analysis further strengthened the results reported from the study 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.
- Strengthened balance sheet with underwritten public offering resulting in gross proceeds of $34.5 million.
"Subsequent to the end of the first quarter, we were extremely excited to announce positive topline results from our GENESIS Phase 3 trial of Motixafortide in stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients," stated Philip Serlin, Chief Executive Officer of BioLineRx. "The results demonstrated, with a high degree of statistical significance, a meaningful clinical benefit from adding Motixafortide to the current standard of care, G-CSF, for the mobilization of the targeted number of stem cells required for transplantation. While this was not a head-to-head study, our results compare very favorably to the registrational study of plerixafor.
"Importantly, almost 90% of patients in the treatment cohort underwent transplantation after only one administration of Motixafortide and in only one apheresis session, compared to 10.8% for G-CSF alone. We believe this positions Motixafortide to become the new standard of care in this indication, with a clear clinical benefit of 'one dose, one apheresis, 90% mobilization success rate.' We are working diligently to submit a New Drug Application to the FDA in the first half of next year. If approved, this would be transformative for BioLineRx, and a huge milestone in the Company's history.
"Regarding our PDAC program, the compelling liver metastases data that we recently presented at AACR further strengthen an already robust case for continued development in this very challenging indication. We continue to engage in discussions with potential partners regarding future development.
"To support these and other initiatives, including continued advancement of our second clinical candidate, the anti-cancer vaccine AGI-134, we raised $34.5 million in January that we believe will finance the Company through multiple potentially value-creating milestones," concluded Mr. Serlin.
Upcoming Significant Expected Milestones:
- 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 Quarter Ended March 31, 2021
Research and development expenses for the quarter ended March 31, 2021 were $4.3 million, a decrease of $1.1 million, or 21.1%, compared to $5.4 million for the quarter ended March 31, 2020. The decrease resulted primarily from lower expenses associated with the Motixafortide COMBAT clinical trial, as well as lower expenses associated with the AGI-134 study.
Sales and marketing expenses for the quarter ended March 31, 2021 were $0.2 million, similar to sales and marketing expenses for the quarter ended March 31, 2020.
General and administrative expenses for the quarter ended March 31, 2021 were $1.0 million, a decrease of $0.2 million, or 18.2% compared to $1.2 million for the quarter ended March 31, 2020. The decrease resulted primarily from a decrease in share-based compensation.
The Company's operating loss for the quarter ended March 31, 2021 amounted to $5.5 million, compared to an operating loss of $6.8 million for the quarter ended March 31, 2020.
Non-operating expenses amounted to $4.6 million for the quarter ended March 31, 2021, compared to non-operating income of $0.5 million for the quarter ended March 31, 2020. Non-operating income (expenses) for both periods primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet.
Net financial expenses amounted to $0.2 million for the quarter ended March 31, 2021, compared to net financial expenses of $0.3 million for the quarter ended March 31, 2020. 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 quarter ended March 31, 2021 amounted to $10.2 million, compared with a net loss of $6.6 million for the quarter ended March 31, 2020.
The Company held $58.1 million in cash, cash equivalents and short-term bank deposits as of March 31, 2021.
Net cash used in operating activities was $6.2 million for the quarter ended March 31, 2021, compared with net cash used in operating activities of $6.7 million for the quarter ended March 31, 2020. The $0.5 million decrease in net cash used in operating activities between the two periods was primarily the result of a decrease in research and development expenses.
Net cash used in investing activities was $36.3 million for the quarter ended March 31, 2021, compared to net cash provided by investing activities of $6.2 million for the quarter ended March 31, 2020. 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 was $41.9 million for the quarter ended March 31, 2021, compared to net cash provided by financing activities of $0.4 million for the quarter ended March 31, 2020. The cash flows in 2021 primarily reflect the underwritten public offering of the Company's ADSs in January 2021, warrant exercises and net proceeds from an ATM facility, offset by repayments of a loan from Kreos Capital. The cash flows in 2020 primarily reflect the net proceeds from an ATM facility, offset by repayments of a loan from Kreos Capital.
Conference Call and Webcast Information
BioLineRx will hold a conference call today, Wednesday, May 26, 2021 at 10:00 a.m. EDT. 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 May 28, 2021; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
(Tables follow)
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 also 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
[email protected]or
Moran Meir
LifeSci Advisors, LLC
+972-54-476-4945
[email protected]BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)December 31,
March 31,
2020
2021
in USD thousands
Assets
CURRENT ASSETS
Cash and cash equivalents
16,831
16,047
Short-term bank deposits
5,756
42,036
Prepaid expenses
152
1,079
Other receivables
141
190
Total current assets
22,880
59,352
NON-CURRENT ASSETS
Property and equipment, net
1,341
1,243
Right-of-use assets, net
1,355
1,297
Intangible assets, net
21,714
21,707
Total non-current assets
24,410
24,247
Total assets
47,290
83,599
Liabilities and equity
CURRENT LIABILITIES
Current maturities of long-term loans
3,092
3,220
Accounts payable and accruals:
Trade
5,918
5,756
Other
1,440
1,100
Lease liabilities
191
140
Total current liabilities
10,641
10,216
NON-CURRENT LIABILITIES
Warrants
10,218
5,247
Long-term loans, net of current maturities
2,740
1,891
Lease liabilities
1,661
1,598
Total non-current liabilities
14,619
8,736
COMMITMENTS AND CONTINGENT LIABILITIES
Total liabilities
25,260
18,952
EQUITY
Ordinary shares
9,870
18,731
Share premium
279,241
321,920
Warrants
-
975
Capital reserve
12,322
12,616
Other comprehensive loss
(1,416)
(1,416)
Accumulated deficit
(277,987)
(288,179)
Total equity
22,030
64,647
Total liabilities and equity
47,290
83,599
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)Three months ended March 31,
2020
2021
in USD thousands
RESEARCH AND DEVELOPMENT EXPENSES
(5,422)
(4,278)
SALES AND MARKETING EXPENSES
(175)
(154)
GENERAL AND ADMINISTRATIVE EXPENSES
(1,243)
(1,017)
OPERATING LOSS
(6,840)
(5,449)
NON-OPERATING INCOME (EXPENSES), NET
469
(4,561)
FINANCIAL INCOME
140
117
FINANCIAL EXPENSES
(414)
(299)
NET LOSS AND COMPREHENSIVE LOSS
(6,645)
(10,192)
LOSS PER ORDINARY SHARE - BASIC AND DILUTED
(0.04)
(0.02)
WEIGHTED AVERAGE NUMBER OF SHARES USED IN
CALCULATION OF LOSS PER ORDINARY SHARE
176,454,423
559,537,952
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)Ordinary shares
Share premium
Warrants
Capital Reserve
Other
comprehensive lossAccumulated deficit
Total
in USD thousands
BALANCE AT JANUARY 1, 2020
4,692
265,938
-
12,132
(1,416)
(247,966)
33,380
CHANGES FOR THREE MONTHS ENDED MARCH 31, 2020:
Issuance of share capital, net
208
895
-
-
-
-
1,103
Employee stock options exercised
7
204
-
(204)
-
-
7
Employee stock options forfeited and expired
-
103
-
(103)
-
-
-
Share-based compensation
-
-
-
663
-
-
663
Comprehensive loss for the period
-
-
-
-
-
(6,645)
(6,645)
BALANCE AT MARCH 31, 2020
4,907
267,140
-
12,488
(1,416)
(254,611)
28,508
Ordinary shares
Share premium
Warrants
Capital Reserve
Other
comprehensive lossAccumulated deficit
Total
in USD thousands
BALANCE AT JANUARY 1, 2021
9,870
279,241
-
12,322
(1,416)
(277,987)
22,030
CHANGES FOR THREE MONTHS ENDED MARCH 31, 2021:
Issuance of share capital and warrants, net
6,805
24,979
975
-
-
-
32,759
Warrants exercised
2,051
17,523
-
-
-
-
19,574
Employee stock options exercised
5
38
-
(38)
-
-
5
Employee stock options forfeited and expired
-
139
-
(139)
-
-
-
Share-based compensation
-
-
-
471
-
-
471
Comprehensive loss for the period
-
-
-
-
-
(10,192)
(10,192)
BALANCE AT MARCH 31, 2021
18,731
321,920
975
12,616
(1,416)
(288,179)
64,647
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)Three months ended
March 31,
2020
2021
in USD thousands
CASH FLOWS - OPERATING ACTIVITIES
Comprehensive loss for the period
(6,645)
(10,192)
Adjustments required to reflect net cash used in operating activities
(see appendix below)
(93)
3,963
Net cash used in operating activities
(6,738)
(6,229)
CASH FLOWS - INVESTING ACTIVITIES
Investments in short-term deposits
(6,000)
(42,000)
Maturities of short-term deposits
12,191
5,758
Purchase of property and equipment
-
(19)
Net cash provided by (used in) investing activities
6,191
(36,261)
CASH FLOWS - FINANCING ACTIVITIES
Issuance of share capital and warrants, net of issuance costs
1,103
42,765
Employee stock options exercised
7
5
Repayments of loans
(682)
(814)
Repayments of lease liabilities
(41)
(49)
Net cash provided by financing activities
387
41,907
DECREASE IN CASH AND CASH EQUIVALENTS
(160)
(583)
CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD
5,297
16,831
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
(65)
(201)
CASH AND CASH EQUIVALENTS - END OF PERIOD
5,072
16,047
BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)Three months ended
March 31,
2020
2021
in USD thousands
Adjustments required to reflect net cash used in operating activities:
Income and expenses not involving cash flows:
Depreciation and amortization
321
182
Exchange differences on cash and cash equivalents
65
201
Fair value adjustments of warrants
(476)
4,597
Share-based compensation
663
471
Interest and exchange differences on short-term deposits
(108)
(38)
Interest on loans
44
93
Exchange differences on lease liability
(82)
(65)
427
5,441
Changes in operating asset and liability items:
Increase in prepaid expenses and other receivables
(238)
(976)
Decrease in accounts payable and accruals
(282)
(502)
(520)
(1,478)
(93)
3,963
Supplemental information on interest received in cash
184
22
Supplemental information on interest paid in cash
275
200
Supplemental information on non-cash portion oftransaction related to exercised warrants
-
9,568
View original content:http://www.prnewswire.com/news-releases/biolinerx-reports-first-quarter-2021-financial-results-and-provides-corporate-update-301299676.htmlSOURCE BioLineRx Ltd.
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TEL AVIV, Israel, May 20, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, announced today it will release its unaudited financial results for the quarter ended March 31, 2021 on Wednesday, May 26, 2021, before the US markets open.
The Company will host a conference call on Wednesday, May 26, 2021 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. 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 U.S. 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 May 28, 2021; please dial +1-888-295-2634 from the U.S. 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.
Contact:
Tim McCarthy
LifeSci Advisors, LLC
+1-212-915-2564
[email protected]Moran Meir
LifeSci Advisors, LLC
+972-54-476-4945
[email protected]
View original content:http://www.prnewswire.com/news-releases/biolinerx-to-report-first-quarter-2021-results-on-may-26-2021-301295733.htmlSOURCE BioLineRx Ltd.
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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
[email protected]or
Moran Meir
LifeSci Advisors, LLC
+972-54-476-4945
[email protected]SOURCE BioLineRx Ltd.
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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
[email protected]or
Moran Meir
LifeSci Advisors, LLC
+972-54-476-4945
[email protected]
View original content:http://www.prnewswire.com/news-releases/biolinerx-announces-presentation-at-2021-american-association-for-cancer-research-aacr-annual-meeting-301269730.htmlSOURCE BioLineRx Ltd.
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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
[email protected]or
Moran Meir
LifeSci Advisors, LLC
+972-54-476-4945
[email protected]BioLineRx Ltd.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITIONDecember 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 LOSSYear 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 EQUITYOrdinary shares
Share premium
Capital reserve
Other comprehensive
lossAccumulated 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 STATEMENTSYear 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 STATEMENTSYear 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
View original content:http://www.prnewswire.com/news-releases/biolinerx-reports-year-end-2020-financial-results-and-provides-corporate-update-301233309.htmlSOURCE BioLineRx Ltd.
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