BioLineRx Reports Third Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates
- Received FDA Approval of APHEXDA® (motixafortide) in Combination with Filgrastim (G-CSF) to Mobilize Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma -
- Closed Exclusive License Agreement for Motixafortide in
- Presented Encouraging Data at AACR from Pilot Phase of Randomized Phase 2 Combination Trial with Motixafortide in Patients with First Line PDAC -
- Began Enrollment of Phase 1 Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease -
- Management to host conference call today,
"FDA approval of APHEXDA® in September was a transformative event for the company, and our
"In addition, the company also closed its motixafortide licensing agreement covering the important
"Lastly, exciting data were presented at AACR from the single-arm pilot phase of the randomized Phase 2 combination clinical trial with motixafortide in first-line pancreatic cancer by the study's lead investigator at
Corporate Updates
Received U.S. Food and Drug Administration approval of APHEXDA® (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma- Closed exclusive license agreement to develop and commercialize motixafortide in
Asia , alongside strategic equity investment:- License agreement included
$15 million upfront payment, up to$50 million in potential development and regulatory milestones, up to$200 million in potential commercial milestones, and tiered double-digit royalties on sales - Straight common equity investment of
$14.6 million in BioLineRx American Depository Shares (ADSs) - Gloria Biosciences expected to begin pivotal bridging study to support potential approval and commercialization of motixafortide in stem cell mobilization in
China - Gloria Biosciences planning randomized Phase 2/3 first-line pancreatic cancer clinical trial evaluating motixafortide in combination with PD-1 inhibitor zimberelimab and standard of care combination chemotherapy
- License agreement included
Clinical Portfolio Updates
Motixafortide (selective inhibitor of CXCR4 chemokine receptor)
Multiple Myeloma
- Received inclusion of APHEXDA® in the National Comprehensive Cancer Network (NCCN) guidelines for Hematopoietic Cell Transplantation
- Received acceptance of an abstract on combination premedication benefits in the Phase 3 GENESIS trial, further educating on the use of APHEXDA at transplant centers. The poster will be presented at the
American Society of Hematology (ASH) 65th Annual Meeting onDecember 10, 2023 , inSan Diego, California - Initiated pivotal bridging study preparation activities with Gloria Biosciences to support potential approval and commercialization of motixafortide in stem cell mobilization in
China
Pancreatic Ductal Adenocarcinoma
- Presented data from the single-arm pilot phase of the investigator-initiated CheMo4METPANC Phase 2 combination clinical trial in first-line pancreatic cancer (PDAC) at the
American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer . Of 11 patients with metastatic pancreatic cancer enrolled, 7 patients (64%) experienced a partial response (PR), of which 5 (45%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. Three patients (27%) experienced stable disease, resulting in a disease control rate of 91%. Based on these encouraging results, the study was substantially revised to a multi-institution, randomized trial of 108 patients - Initiated preparation activities with Gloria Biosciences to support the development of a randomized Phase 2/3 clinical trial evaluating motixafortide in combination with the PD-1 inhibitor zimberelimab and standard of care combination chemotherapy in first-line pancreatic cancer
Sickle Cell Disease & Gene Therapy
- Began enrollment in investigator-initiated Phase 1 pilot study led by
Washington University School of Medicine inSt. Louis evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell mobilization for gene therapies in sickle cell disease. Anticipate data in 2H of 2024
AGI-134 (synthetic alpha-Gal glycolipid)
Solid Tumor Immunotherapy
- Evaluating next development pathways for AGI-134 program. The Phase 1/2a first-in-human, single-agent study, results of which were announced in Q4 2022, met the primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers
Third Quarter 2023 Financial Results
- Research and development expenses for the three months ended
September 30, 2023 were$2.7 million , a decrease of$1.6 million , or 37.6%, compared to$4.3 million for the three months endedSeptember 30, 2022 . The decrease resulted primarily from lower expenses associated with NDA supporting activities related to motixafortide as well as lower expenses associated with the completed AGI-134 clinical trial - Sales and marketing expenses for the three months ended
September 30, 2023 were$8.1 million , an increase of$6.8 million , or 517.4% compared to$1.3 million for the three months endedSeptember 30, 2022 . The increase resulted primarily from the ramp-up of pre-commercialization activities related to motixafortide - General and administrative expenses for the three months ended
September 30, 2023 were$1.5 million , an increase of$0.1 million , or 7.7% compared to$1.4 million for the three months endedSeptember 30, 2022 . The increase resulted from small increases in a number of individual G&A expenses - Non-operating expenses for the three months ended
September 30, 2023 were$3.1 million , an increase of$3.5 million , compared to non-operating income of$0.4 million for the three months endedSeptember 30, 2022 . The increase relates primarily to the revaluation of outstanding warrants resulting from an increase in the company's share price during the 2023 period - Net loss for the three months ended
September 30, 2023 was$16.0 million , compared to$6.8 million for the three months endedSeptember 30, 2022 . Net loss for the nine months endedSeptember 30, 2023 amounted to$46.7 million , compared to$19.2 million for the nine months endedSeptember 30, 2022 . The increases in net loss for both the three- and nine-month periods in 2023 were primarily due to the significant non-operating expenses (which were also non-cash) related to revaluation of outstanding warrants, as well as the significant increases in sales and marketing expenses related to pre-commercialization and commercialization activities, which were partially offset by a decrease in research and development expenses - As of
September 30, 2023 , we held$26.0 million of cash, cash equivalents and short-term bank deposits. We anticipate that this amount, as well as the consideration from the exclusive license agreement and the securities purchase agreement of$29.6 million that was received inOctober 2023 , will be sufficient to fund operations, as currently planned, into 2025
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the
About
Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.
Forward Looking Statement
Various statements in this release concerning
Contacts:
IR@biolinerx.com
moran@lifesciadvisors.com
|
||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION |
||
(UNAUDITED) |
||
|
|
|
2022 |
2023 |
|
in USD thousands |
||
Assets |
||
CURRENT ASSETS |
||
Cash and cash equivalents |
10,587 |
7,727 |
Short-term bank deposits |
40,495 |
18,241 |
Inventory |
- |
1,352 |
Prepaid expenses |
198 |
1,170 |
Other receivables |
721 |
315 |
Total current assets |
52,001 |
28,805 |
NON-CURRENT ASSETS |
||
Property and equipment, net |
726 |
561 |
Right-of-use assets, net |
1,772 |
1,462 |
Intangible assets, net |
21,885 |
22,027 |
Total non-current assets |
24,383 |
24,050 |
Total assets |
76,384 |
52,855 |
Liabilities and equity |
||
CURRENT LIABILITIES |
||
Current maturities of long-term loan |
1,542 |
3,078 |
Accounts payable and accruals: |
||
Trade |
6,966 |
8,438 |
Other |
1,744 |
2,683 |
Current maturities of lease liabilities |
427 |
526 |
Total current liabilities |
10,679 |
14,725 |
NON-CURRENT LIABILITIES |
||
Warrants |
4,509 |
15,287 |
Long-term loan, net of current maturities |
8,626 |
8,458 |
Lease liabilities |
1,729 |
1,251 |
Total non-current liabilities |
14,864 |
24,996 |
Total liabilities |
25,543 |
39,721 |
EQUITY |
||
Ordinary shares |
27,100 |
28,332 |
Share premium |
338,976 |
345,462 |
Warrants |
1,408 |
1,408 |
Capital reserve |
14,765 |
16,070 |
Other comprehensive loss |
(1,416) |
(1,416) |
Accumulated deficit |
(329,992) |
(376,722) |
Total equity |
50,841 |
13,134 |
Total liabilities and equity |
76,384 |
52,855 |
|
||||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS |
||||
(UNAUDITED) |
||||
Three months ended |
Nine months ended |
|||
2022 |
2023 |
2022 |
2023 |
|
in USD thousands |
in USD thousands |
|||
RESEARCH AND DEVELOPMENT EXPENSES |
(4,369) |
(2,727) |
(14,199) |
(9,417) |
SALES AND MARKETING EXPENSES |
(1,317) |
(8,131) |
(3,112) |
(17,609) |
GENERAL AND ADMINISTRATIVE EXPENSES |
(1,392) |
(1,499) |
(3,448) |
(4,102) |
OPERATING LOSS |
(7,078) |
(12,357) |
(20,759) |
(31,128) |
NON-OPERATING INCOME (EXPENSES), NET |
389 |
(3,141) |
2,115 |
(13,790) |
FINANCIAL INCOME |
109 |
312 |
256 |
1,289 |
FINANCIAL EXPENSES |
(267) |
(837) |
(832) |
(3,101) |
NET LOSS AND COMPREHENSIVE LOSS |
(6,847) |
(16,023) |
(19,220) |
(46,730) |
in USD |
in USD |
|||
LOSS PER ORDINARY SHARE - BASIC AND DILUTED |
(0.01) |
(0.02) |
(0.03) |
(0.05) |
WEIGHTED AVERAGE NUMBER OF SHARES USED IN |
740,767,492 |
929,058,619 |
723,805,390 |
925,014,511 |
|
|||||||
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY |
|||||||
(UNAUDITED) |
|||||||
Ordinary |
Share |
Capital |
Other comprehensive |
Accumulated |
|||
shares |
premium |
Warrants |
reserve |
loss |
deficit |
Total |
|
in USD thousands |
|||||||
BALANCE AT |
21,066 |
339,346 |
975 |
13,157 |
(1,416) |
(305,041) |
68,087 |
CHANGES FOR NINE MONTHS ENDED |
|||||||
Issuance of share capital and warrants, net |
6,030 |
(1,008) |
433 |
- |
- |
- |
5,455 |
Employee stock options exercised |
2 |
12 |
- |
(12) |
- |
- |
2 |
Employee stock options expired |
- |
491 |
- |
(491) |
- |
- |
- |
Share-based compensation |
- |
- |
- |
1,200 |
- |
- |
1,200 |
Comprehensive loss for the period |
- |
- |
- |
- |
- |
(19,220) |
(19,220) |
BALANCE AT |
27,098 |
338,841 |
1,408 |
13,854 |
(1,416) |
(324,261) |
55,524 |
Ordinary |
Share |
Capital |
Other comprehensive |
Accumulated |
|||
shares |
premium |
Warrants |
reserve |
loss |
deficit |
Total |
|
in USD thousands |
|||||||
BALANCE AT |
27,100 |
338,976 |
1,408 |
14,765 |
(1,416) |
(329,992) |
50,841 |
CHANGES FOR NINE MONTHS ENDED |
|||||||
Issuance of share capital, net |
361 |
1,535 |
- |
- |
- |
- |
1,896 |
Warrants exercised |
865 |
4,855 |
- |
- |
- |
- |
5,720 |
Employee stock options exercised |
6 |
18 |
- |
(9) |
- |
- |
15 |
Employee stock options expired |
- |
78 |
- |
(78) |
- |
- |
- |
Share-based compensation |
- |
- |
- |
1,392 |
- |
- |
1,392 |
Comprehensive loss for the period |
- |
- |
- |
- |
- |
(46,730) |
(46,730) |
BALANCE AT |
28,332 |
345,462 |
1,408 |
16,070 |
(1,416) |
(376,722) |
13,134 |
|
||
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS |
||
(UNAUDITED) |
||
Nine months ended |
||
2022 |
2023 |
|
in USD thousands |
||
CASH FLOWS - OPERATING ACTIVITIES |
||
Net loss for the period |
(19,220) |
(46,730) |
Adjustments required to reflect net cash used in operating activities |
(1,337) |
19,131 |
Net cash used in operating activities |
(20,557) |
(27,599) |
CASH FLOWS – INVESTING ACTIVITIES |
||
Investments in short-term deposits |
(36,000) |
(13,882) |
Maturities of short-term deposits |
36,232 |
36,000 |
Purchase of property and equipment |
(74) |
(100) |
Purchase of intangible assets |
(14) |
(179) |
Net cash provided by investing activities |
144 |
21,839 |
CASH FLOWS – FINANCING ACTIVITIES |
||
Issuance of share capital and warrants, net of issuance costs |
14,359 |
1,896 |
Exercise of warrants |
- |
2,530 |
Employee stock options exercised |
2 |
15 |
Proceeds of long-term loan, net of issuance costs |
9,682 |
- |
Repayments of loan |
(2,832) |
(802) |
Repayments of lease liabilities |
(126) |
(323) |
Net cash provided by financing activities |
21,085 |
3,316 |
INCREASE (DECREASE) IN CASH AND CASH |
672 |
(2,444) |
CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD |
12,990 |
10,587 |
EXCHANGE DIFFERENCES ON CASH AND CASH |
(557) |
(416) |
CASH AND CASH EQUIVALENTS - END OF PERIOD |
13,105 |
7,727 |
|
||
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS |
||
(UNAUDITED) |
||
Nine months ended |
||
2022 |
2023 |
|
in USD thousands |
||
Adjustments required to reflect net cash used in operating activities: |
||
Income and expenses not involving cash flows: |
||
Depreciation and amortization |
467 |
678 |
Exchange differences on cash and cash equivalents |
557 |
416 |
Fair value adjustments of warrants |
(2,778) |
13,968 |
Share-based compensation |
1,200 |
1,392 |
Warrant issuance costs |
171 |
- |
Interest and exchange differences on short-term deposits |
(244) |
136 |
Interest on loan |
104 |
2,170 |
Exchange differences on lease liability |
(233) |
(122) |
Long-term loan issuance cost |
(566) |
- |
(1,312) |
18,638 |
|
Changes in operating asset and liability items: |
||
Increase in inventory |
- |
(1,352) |
Increase in prepaid expenses and other receivables |
(411) |
(566) |
Increase in accounts payable and accruals |
386 |
2,411 |
(25) |
493 |
|
(1,337) |
19,131 |
|
Supplemental information on interest received in cash |
244 |
1,268 |
Supplemental information on interest paid in cash |
307 |
833 |
Supplemental information on warrant issuance costs paid in cash |
591 |
- |
Supplemental information on non-cash transactions: |
||
Changes in right-of-use asset |
123 |
66 |
Warrant issuance costs |
262 |
- |
Exercise of warrants (portion related to accumulated |
- |
3,190 |
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