- Announced FDA Acceptance of APHEXDA® (motixafortide) New Drug Application (NDA) in Stem Cell Mobilization with Prescription Drug User Fee Act (PDUFA) Target Action Date of
- Named Tami Rachmilewitz, M.D., as new Chief Medical Officer and Completed Formation of
- Entered into Clinical Trial Collaboration with
- Management to hold conference call today, March 22, at
"Over the last quarter and into this year, we continue to proceed with activities to advance the NDA review process of APHEXDA®, while in parallel progressing with pre-launch activities in anticipation of potential approval later this year," said
Recent Corporate Updates
- Appointed Tami Rachmilewitz, M.D. as Chief Medical Officer
- Finalized formation of the
U.S. commercial leadership team, which collectively has significant drug launch and sales experience, with particular expertise in stem cell mobilization and transplantation
Portfolio Execution
Motixafortide (selective inhibitor of CXCR4 chemokine receptor)
Multiple Myeloma
- Announced FDA acceptance of the APHEXDA® (motixafortide) NDA in stem cell mobilization for autologous transplantation in multiple myeloma patients. PDUFA target action date set for
September 9, 2023 - Presented a cost-effectiveness analysis of APHEXDA® (motixafortide) versus plerixafor in stem cell mobilization for autologous transplantation in patients with multiple myeloma at the
American Society of Hematology (ASH) 64th Annual Meeting, which was heldDecember 10-13, 2022 , inNew Orleans, Louisiana . The analysis demonstrated significant net cost savings with APHEXADA® (motixafortide)
Pancreatic Ductal Adenocarcinoma (PDAC)
- Continued to advance preparation activities for a Phase 2b randomized clinical trial with 200 patients assessing motixafortide in combination with a PD-1 inhibitor and standard-of-care chemotherapy as a first line metastatic PDAC (mPDAC) therapy with collaboration partner GenFleet. Anticipate clinical trial initiation in 2023
- Continued collaboration progress with
Columbia University investigator-initiated Phase 2 study assessing motixafortide in combination with the PD-1 inhibitor cemiplimab and standard-of-care chemotherapy in first line mPDAC patients. Anticipate initial patient data in 2023
Sickle Cell Disease & Gene Therapy
- Announced clinical trial collaboration with
Washington University School of Medicine inSt. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell mobilization for gene therapies in sickle cell disease. Anticipate clinical trial initiation in 2023. Clinical trial design was presented at theAmerican Society of Hematology (ASH) 64th Annual Meeting, which was heldDecember 10-13, 2022 , inNew Orleans, Louisiana
AGI-134 (synthetic alpha-Gal glycolipid)
Solid Tumor Immunotherapy
- Announced results from Phase 1/2a study of investigational anti-tumor vaccine AGI-134 in metastatic solid tumors. First-in-human, single-agent study met primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers. The Company is evaluating potential development program pathways in consultation with its scientific advisory board
Financial Results for Year Ended
- Research and development expenses for the year ended
December 31, 2022 , were$17 .6 million compared to$19.5 million for the year endedDecember 31, 2021 . The decrease resulted primarily from lower expenses related to NDA supporting activities related to motixafortide, as well as lower expenses associated with the completed motixafortide GENESIS clinical trial, offset by an increase in expenses associated with the AGI-134 study and an increase in payroll and related expenses - Sales and marketing expenses for the year ended
December 31, 2022 , were$6.5 million compared to$1.0 million the year endedDecember 31, 2021 . The increase resulted primarily from initiation of pre-commercialization activities related to motixafortide, as well as an increase in market research - General and administrative expenses for the year ended
December 31, 2022 , were$5.1 million compared to$4.3 million for the year endedDecember 31, 2021 . The increase resulted primarily from an increase in share-based compensation and small increases in a number of general and administrative expenses - Net loss for the year ended
December 31, 2022 , was$25.0 million , compared to$27.1 million for the year endedDecember 31, 2021 - As of
December 31, 2022 , the Company had cash, cash equivalents, and short-term bank deposits of$51.1 million and anticipates this will be sufficient to fund operations, as currently planned, into the first half of 2024
A copy of the Company's annual report on Form 20-F for the year ended
Conference Call and Webcast Information
BioLineRx will hold a conference call today, Wednesday, March 22 at 10:00 a.m. EDT.
To access the conference call, please dial +1-888-281-1167 from the
About
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a pre-commercial-stage biopharmaceutical company focused on oncology. The Company's lead development program, motixafortide, a novel selective inhibitor of the CXCR4 chemokine receptor, may support diverse therapeutic approaches in oncology and other diseases. APHEXDA® (motixafortide) was successfully evaluated in a Phase 3 study in stem cell mobilization for autologous transplantation for multiple myeloma patients, has reported positive results from a pre-planned pharmacoeconomic study in the U.S., and has had its NDA submission accepted by the FDA with an assigned PDUFA date of September 9, 2023. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of metastatic pancreatic cancer (mPDAC) in combination with the PD-1 inhibitor pembrolizumab and chemotherapy and is currently being studied in combination with the PD-1 inhibitor cemiplimab and chemotherapy as a first line mPDAC therapy. In addition, a randomized phase 2b study with 200 patients assessing motixafortide in combination with a PD-1 inhibitor and chemotherapy as a first line mPDAC therapy is expected to initiate in 2023.
Forward Looking Statement
Various statements in this release concerning
Contacts:
IR@biolinerx.com
moran@lifesciadvisors.com
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
|
|||
|
|||
2021 |
2022 |
||
in USD thousands |
|||
Assets |
|||
CURRENT ASSETS |
|||
Cash and cash equivalents |
12,990 |
10,587 |
|
Short-term bank deposits |
44,145 |
40,495 |
|
Prepaid expenses |
127 |
198 |
|
Other receivables |
142 |
721 |
|
Total current assets |
57,404 |
52,001 |
|
NON-CURRENT ASSETS |
|||
Property and equipment, net |
952 |
726 |
|
Right-of-use assets, net |
1,331 |
1,772 |
|
Intangible assets, net |
21,704 |
21,885 |
|
Total non-current assets |
23,987 |
24,383 |
|
Total assets |
81,391 |
76,384 |
|
Liabilities and equity |
|||
CURRENT LIABILITIES |
|||
Current maturities of long-term loans |
2,757 |
1,542 |
|
Accounts payable and accruals: |
|||
Trade |
5,567 |
6,966 |
|
Other |
1,227 |
1,744 |
|
Current maturities of lease liabilities |
168 |
427 |
|
Total current liabilities |
9,719 |
10,679 |
|
NON-CURRENT LIABILITIES |
|||
Warrants |
1,859 |
4,509 |
|
Long-term loans, net of current maturities |
- |
8,626 |
|
Lease liabilities |
1,726 |
1,729 |
|
Total non-current liabilities |
3,585 |
14,864 |
|
COMMITMENTS AND CONTINGENT LIABILITIES |
|||
Total liabilities |
13,304 |
25,543 |
|
EQUITY |
|||
Ordinary shares |
21,066 |
27,100 |
|
Share premium |
339,346 |
338,976 |
|
Warrants |
975 |
1,408 |
|
Capital reserve |
13,157 |
14,765 |
|
Other comprehensive loss |
(1,416) |
(1,416) |
|
Accumulated deficit |
(305,041) |
(329,992) |
|
Total equity |
68,087 |
50,841 |
|
Total liabilities and equity |
81,391 |
76,384 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
|
Year ended |
|||||
2020 |
2021 |
2022 |
||||
in USD thousands |
||||||
RESEARCH AND DEVELOPMENT EXPENSES |
(18,173) |
(19,466) |
(17,629) |
|||
SALES AND MARKETING EXPENSES |
(840) |
(1,003) |
(6,462) |
|||
GENERAL AND ADMINISTRATIVE EXPENSES |
(3,914) |
(4,308) |
(5,066) |
|||
OPERATING LOSS |
(22,927) |
(24,777) |
(29,157) |
|||
NON-OPERATING INCOME (EXPENSES), NET |
(5,701) |
(1,830) |
5,670 |
|||
FINANCIAL INCOME |
236 |
559 |
694 |
|||
FINANCIAL EXPENSES |
(1,629) |
(1,006) |
(2,158) |
|||
LOSS AND COMPREHENSIVE LOSS |
(30,021) |
(27,054) |
(24,951) |
|||
in USD |
||||||
LOSS PER ORDINARY SHARE – BASIC AND DILUTED |
(0.12) |
(0.04) |
(0.03) |
|||
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE |
252,844,394 |
662,933,695 |
773,956,973 |
|||
STATEMENTS OF CHANGES IN EQUITY
|
Ordinary shares |
Share premium |
Warrants |
Capital reserve |
Other comprehensive |
Accumulated deficit |
Total |
in USD thousands |
|||||||
BALANCE AT |
4,692 |
265,938 |
- |
12,132 |
(1,416) |
(247,966) |
33,380 |
CHANGES IN 2020: |
|||||||
Issuance of share capital and warrants, 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 expired |
- |
854 |
- |
(854) |
- |
- |
- |
Share-based compensation |
- |
- |
- |
1,272 |
- |
- |
1,272 |
Comprehensive loss for the year |
- |
- |
- |
- |
- |
(30,021) |
(30,021) |
BALANCE AT |
9,870 |
279,241 |
- |
12,322 |
(1,416) |
(277,987) |
22,030 |
CHANGES IN 2021: |
|||||||
Issuance of share capital and warrants, net |
8,956 |
40,476 |
975 |
- |
- |
- |
50,407 |
Warrants exercised |
2,235 |
18,967 |
- |
- |
- |
- |
21,202 |
Employee stock options exercised |
5 |
41 |
- |
(39) |
- |
- |
7 |
Employee stock options expired |
- |
621 |
- |
(621) |
- |
- |
- |
Share-based compensation |
- |
- |
- |
1,495 |
- |
- |
1,495 |
Comprehensive loss for the year |
- |
- |
- |
- |
(27,054) |
(27,054) |
|
BALANCE AT |
21,066 |
339,346 |
975 |
13,157 |
(1,416) |
(305,041) |
68,087 |
CHANGES IN 2022: |
|||||||
Issuance of share capital and warrants, net |
6,029 |
(1,007) |
433 |
- |
- |
- |
5,455 |
Employee stock options exercised |
5 |
14 |
- |
(14) |
- |
- |
5 |
Employee stock options expired |
- |
623 |
- |
(623) |
- |
- |
- |
Share-based compensation |
- |
- |
- |
2,245 |
- |
- |
2,245 |
Comprehensive loss for the year |
- |
- |
- |
- |
(24,951) |
(24,951) |
|
BALANCE AT |
27,100 |
338,976 |
1,408 |
14,765 |
(1,416) |
(329,992) |
50,841 |
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
Year ended |
||
2020 |
2021 |
2022 |
|
in USD thousands |
|||
CASH FLOWS - OPERATING ACTIVITIES |
|||
Loss |
(30,021) |
(27,054) |
(24,951) |
Adjustments required to reflect net cash used in operating activities (see appendix below) |
6,815 |
3,481 |
(1,289) |
Net cash used in operating activities |
(23,206) |
(23,573) |
(26,240) |
CASH FLOWS - INVESTING ACTIVITIES |
|||
Investments in short-term deposits |
(33,500) |
(78,000) |
(44,000) |
Maturities of short-term deposits |
50,168 |
39,873 |
48,322 |
Purchase of property and equipment |
- |
(97) |
(131) |
Purchase of intangible assets |
- |
- |
(185) |
Net cash provided by (used in) investing activities |
16,668 |
(38,224) |
4,006 |
CASH FLOWS - FINANCING ACTIVITIES |
|||
Issuance of share capital and warrants, net of issuance costs |
19,246 |
50,407 |
14,359 |
Exercise of warrants |
1,969 |
10,907 |
- |
Employee stock options exercised |
8 |
7 |
5 |
Proceeds from long-term loan, net of issuance costs |
- |
- |
9,126 |
Repayments of loans |
(3,133) |
(3,376) |
(2,832) |
Repayments of lease liabilities |
(224) |
(196) |
(220) |
Net cash provided by financing activities |
17,866 |
57,749 |
20,438 |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
11,328 |
(4,048) |
(1,796) |
CASH AND CASH EQUIVALENTS - BEGINNING OF YEAR |
5,297 |
16,831 |
12,990 |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS |
206 |
207 |
(607) |
CASH AND CASH EQUIVALENTS - END OF YEAR |
16,831 |
12,990 |
10,587 |
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
Year ended |
|||
2020 |
2021 |
2022 |
||
in USD thousands |
||||
APPENDIX |
||||
Adjustments required to reflect net cash used in operating activities: |
||||
Income and expenses not involving cash flows: |
||||
Depreciation and amortization |
934 |
703 |
654 |
|
Exchange differences on cash and cash equivalents |
(206) |
(207) |
607 |
|
Fair value adjustments of warrants |
5,142 |
1,936 |
(6,425) |
|
Share-based compensation |
1,272 |
1,495 |
2,245 |
|
Interest and exchange differences on short-term deposits |
(232) |
(262) |
(672) |
|
Interest accrued |
474 |
301 |
1,117 |
|
Warrant issuance costs |
594 |
- |
171 |
|
Exchange differences on lease liabilities |
125 |
55 |
(224) |
|
8,103 |
4,021 |
(2,527) |
||
Changes in operating asset and liability items: |
||||
Decrease (increase) in prepaid expenses and other receivables |
428 |
24 |
(650) |
|
Increase (decrease) in accounts payable and accruals |
(1,716) |
(564) |
1,888 |
|
(1,288) |
(540) |
1,238 |
||
6,815 |
3,481 |
(1,289) |
||
Supplemental information on interest received in cash |
381 |
138 |
342 |
Supplemental information on interest paid in cash |
994 |
682 |
593 |
Supplemental information on non-cash transactions: |
|||
Changes in right-of-use asset and lease liabilities |
13 |
183 |
706 |
Warrant issuance costs |
- |
- |
262 |
Purchase of property and equipment |
- |
- |
28 |
Fair value of exercised warrants (portion related to accumulated fair value adjustments) |
1,251 |
10,295 |
- |
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