|
BioLineRx Ltd.
|
|
|
|
|
|
|
|
By:
|
/s/ Philip A. Serlin
|
|
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Philip A. Serlin
|
|
|
|
Chief Executive Officer
|
|
• |
Accessed $20 million in non-dilutive debt financing from previously announced agreement with BlackRock EMEA Venture and Growth Lending (previously Kreos Capital) and completed a $6 million registered direct equity offering. Funds will be
used to support ongoing commercialization of APHEXDA in the U.S. and to advance lifecycle expansion activities
|
• |
Strengthened motixafortide intellectual property estate with notice of allowance for U.S. patent covering method of manufacturing motixafortide suitable for large scale production; the patent supplements existing protections offered by
Orphan Drug Designation in the U.S. and Europe for the treatment of pancreatic cancer, as well as Orphan Drug market exclusivity for autologous stem cell mobilization in multiple myeloma patients in the U.S. following last year’s FDA approval
of APHEXDA
|
• |
Among top 80 transplant centers, secured formulary placement to date at institutions representing ~26% of stem cell transplant procedures performed – on track to reach stated goal of ~35% by end of Q2 and ~60% by year-end 2024
|
• |
Granted “pass through” status from the Centers for Medicare and Medicaid Services (CMS), ensuring that reimbursement for APHEXDA for Medicare and certain commercial payers will be separate from payment bundling methodologies when
administered in the hospital outpatient setting
|
• |
Presented posters at both the American Society for Apheresis 2024 Annual Meeting on April 17, 2024, and the International Society for Pharmacoeconomics and Outcomes Research on April 6, 2024. The
posters reviewed apheresis center efficiency between CXCR4 antagonists, including APHEXDA, in patients with multiple myeloma, as well as economic model data on APHEXDA for HSC mobilization in patients
with multiple myeloma
|
• |
Collaboration partner Gloria Biosciences’ stem cell mobilization bridging study IND filed and approved by the Center for Drug Evaluation of the National Medical Products Administration in China. Anticipate initiation of pivotal clinical
trial in 2H 2024
|
• |
Announced new data in an abstract accepted at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on the pilot phase of the ongoing CheMo4METPANC Phase 2 clinical trial collaboration with Columbia University, including new analysis of paired pre- and on-treatment biopsy samples. The presentation will be held on June 1, 2024 in Chicago, IL
|
• |
Announced first patient dosed in the randomized CheMo4METPANC Phase 2 clinical trial, an expansion of the pilot phase single-arm study, evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard-of-care
chemotherapy as first-line treatment in 108 patients with metastatic pancreatic cancer
|
• |
Advanced plans with collaboration partner Gloria Biosciences on a Phase 2b randomized clinical trial in China assessing motixafortide in combination with the PD-1 inhibitor zimberelimab and standard-of-care chemotherapy as first-line
treatment in patients with metastatic pancreatic cancer. Anticipate clinical trial initiation in 2025
|
• |
Continued to enroll patients into a clinical trial in collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene
therapies in sickle cell disease. Anticipate initial data in 2H 2024
|
• |
Total revenue for the first three months ended March 31, 2024 was $6.9 million. The Company did not record any revenue during the first quarter of 2023. Revenue for the quarter reflect a portion of the upfront payment from the Gloria
Biosciences license agreement and a milestone payment achieved under the same license agreement, which collectively amounted to $5.9 million, as well as $0.9 million of net revenue from product sales of APHEXDA in the U.S.
|
• |
Cost of revenue for the first three months ended March 31, 2024 was $1.5 million. The Company did not record any cost of revenue during the first quarter of 2023. The cost of revenue for the quarter primarily reflects sub-license fees on a
milestone payment received under the Gloria Biosciences license agreement and royalties on net product sales of APHEXDA in the U.S., as well as amortization of intangible assets and cost of goods sold on product sales
|
• |
Research and development expenses for the first three months ended March 31, 2024 were $2.5 million, compared to $3.7 million for the same period in 2023. The decrease resulted primarily from lower expenses related to motixafortide New
Drug Application (NDA) supporting activities, as well as termination of the development of AGI-134
|
• |
Sales and marketing expenses for the first three months ended March 31, 2024 were $6.3 million, compared to $3.9 million for the same period in 2023. The increase resulted primarily from the ramp-up of commercialization activities related
to motixafortide, including headcount costs associated with fully hired field team
|
• |
General and administrative expenses for the first three months ended March 31, 2024 were $1.4 million, compared to $1.3 million for the same period in 2023. The increase resulted primarily from a small increase in share-based compensation
|
• |
Non-operating income for the first three months ended March 31, 2024 was $4.5 million, compared to non-operating expenses of $2.9 million for the same period in 2023. Non-operating expenses and income primarily relate to the non-cash
revaluation of outstanding warrants resulting from changes in the Company’s share price during the respective periods
|
• |
Net loss for the first three months ended March 31, 2024 was $0.7 million, compared to $12.2 million for the same period in 2023. The net loss for the 2024 period included $4.5 million in non-cash income, compared to non-operating expenses
of $2.9 million for the same period in 2023, both specifically related to the revaluation of warrants
|
• |
As of March 31, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $28.2 million. This amount does not include $6.0 million in gross proceeds received from a registered direct offering and a $20.0 million
drawdown of the second tranche from the existing loan agreement with BlackRock, which were both completed in April 2024. The Company anticipates that this amount will be sufficient to fund operations, as currently planned, into 2025
|
December 31,
|
March 31,
|
|||||||
2023
|
2024
|
|||||||
in USD thousands
|
||||||||
Assets
|
||||||||
CURRENT ASSETS
|
||||||||
Cash and cash equivalents
|
4,255
|
5,990
|
||||||
Short-term bank deposits
|
38,739
|
22,183
|
||||||
Trade receivables
|
358
|
2,832
|
||||||
Prepaid expenses
|
1,048
|
1,290
|
||||||
Other receivables
|
830
|
507
|
||||||
Inventory
|
1,953
|
2,889
|
||||||
Total current assets
|
47,183
|
35,691
|
||||||
NON-CURRENT ASSETS
|
||||||||
Property and equipment, net
|
473
|
411
|
||||||
Right-of-use assets, net
|
1,415
|
1,308
|
||||||
Intangible assets, net
|
14,854
|
14,190
|
||||||
Total non-current assets
|
16,742
|
15,909
|
||||||
Total assets
|
63,925
|
51,600
|
||||||
Liabilities and equity
|
||||||||
CURRENT LIABILITIES
|
||||||||
Current maturities of long-term loan
|
3,145
|
3,680
|
||||||
Contract liabilities
|
12,957
|
9,027
|
||||||
Accounts payable and accruals:
|
||||||||
Trade
|
10,869
|
8,256
|
||||||
Other
|
3,353
|
2,455
|
||||||
Current maturities of lease liabilities
|
528
|
467
|
||||||
Warrants
|
11,932
|
7,488
|
||||||
Total current liabilities
|
42,784
|
31,373
|
||||||
NON-CURRENT LIABILITIES
|
||||||||
Long-term loan, net of current maturities
|
6,628
|
5,938
|
||||||
Lease liabilities
|
1,290
|
1,229
|
||||||
Total non-current liabilities
|
7,918
|
7,167
|
||||||
COMMITMENTS AND CONTINGENT LIABILITIES
|
||||||||
Total liabilities
|
50,702
|
38,540
|
||||||
EQUITY
|
||||||||
Ordinary shares
|
31,355
|
31,355
|
||||||
Share premium
|
355,482
|
355,482
|
||||||
Warrants
|
1,408
|
1,408
|
||||||
Capital reserve
|
17,000
|
17,533
|
||||||
Other comprehensive loss
|
(1,416
|
)
|
(1,416
|
)
|
||||
Accumulated deficit
|
(390,606
|
)
|
(391,302
|
)
|
||||
Total equity
|
13,223
|
13,060
|
||||||
Total liabilities and equity
|
63,925
|
51,600
|
Three months ended March 31,
|
||||||||
2023
|
2024
|
|||||||
in USD thousands
|
||||||||
REVENUES
|
-
|
6,855
|
||||||
COST OF REVENUES
|
-
|
(1,455
|
)
|
|||||
GROSS PROFIT
|
-
|
5,400
|
||||||
RESEARCH AND DEVELOPMENT EXPENSES
|
(3,684
|
)
|
(2,494
|
)
|
||||
SALES AND MARKETING EXPENSES
|
(3,874
|
)
|
(6,342
|
)
|
||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
(1,298
|
)
|
(1,386
|
)
|
||||
OPERATING LOSS
|
(8,856
|
)
|
(4,822
|
)
|
||||
NON-OPERATING INCOME (EXPENSES), NET
|
(2,916
|
)
|
4,490
|
|||||
FINANCIAL INCOME
|
537
|
565
|
||||||
FINANCIAL EXPENSES
|
(927
|
)
|
(929
|
)
|
||||
NET LOSS AND COMPREHENSIVE LOSS
|
(12,162
|
)
|
(696
|
)
|
||||
in USD
|
||||||||
LOSS PER ORDINARY SHARE - BASIC AND DILUTED
|
(0.01
|
)
|
(0.00
|
)
|
||||
WEIGHTED AVERAGE NUMBER OF SHARES USED IN
CALCULATION OF LOSS PER ORDINARY SHARE |
922,958,942
|
1,086,589,165
|
Ordinary shares
|
Share premium
|
Warrants
|
Capital reserve
|
Other comprehensive loss
|
Accumulated deficit
|
Total
|
||||||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2023
|
27,100
|
338,976
|
1,408
|
14,765
|
(1,416
|
)
|
(329,992
|
)
|
50,841
|
|||||||||||||||||||
CHANGES FOR THREE MONTHS ENDED MARCH 31, 2023:
|
||||||||||||||||||||||||||||
Employee stock options expired
|
-
|
66
|
-
|
(66
|
)
|
-
|
-
|
-
|
||||||||||||||||||||
Share-based compensation
|
-
|
-
|
-
|
435
|
-
|
-
|
435
|
|||||||||||||||||||||
Comprehensive loss for the period
|
-
|
-
|
-
|
-
|
-
|
(12,162
|
)
|
(12,162
|
)
|
|||||||||||||||||||
BALANCE AT MARCH 31, 2023
|
27,100
|
339,042
|
1,408
|
15,134
|
(1,416
|
)
|
(342,154
|
)
|
39,114
|
Ordinary shares
|
Share premium
|
Warrants
|
Capital reserve
|
Other comprehensive loss
|
Accumulated deficit
|
Total
|
||||||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2024
|
31,355
|
355,482
|
1,408
|
17,000
|
(1,416
|
)
|
(390,606
|
)
|
13,223
|
|||||||||||||||||||
CHANGES FOR THREE MONTHS ENDED MARCH 31, 2024:
|
||||||||||||||||||||||||||||
Share-based compensation
|
-
|
-
|
-
|
533
|
-
|
-
|
533
|
|||||||||||||||||||||
Comprehensive loss for the period
|
-
|
-
|
-
|
-
|
-
|
(696
|
)
|
(696
|
)
|
|||||||||||||||||||
BALANCE AT MARCH 31, 2024
|
31,355
|
355,482
|
1,408
|
17,533
|
(1,416
|
)
|
(391,302
|
)
|
13,060
|
Three months ended
March 31,
|
||||||||
2023
|
2024
|
|||||||
in USD thousands
|
||||||||
CASH FLOWS - OPERATING ACTIVITIES
|
||||||||
Comprehensive loss for the period
|
(12,162
|
)
|
(696
|
)
|
||||
Adjustments required to reflect net cash used in operating activities
(see appendix below)
|
4,146
|
(13,413
|
)
|
|||||
Net cash used in operating activities
|
(8,016
|
)
|
(14,109
|
)
|
||||
CASH FLOWS - INVESTING ACTIVITIES
|
||||||||
Investments in short-term deposits
|
(5,500
|
)
|
-
|
|||||
Maturities of short-term deposits
|
12,271
|
16,719
|
||||||
Purchase of property and equipment
|
(32
|
)
|
(32
|
)
|
||||
Purchase of intangible assets
|
(97
|
)
|
-
|
|||||
Net cash provided by investing activities
|
6,642
|
16,687
|
||||||
CASH FLOWS - FINANCING ACTIVITIES
|
||||||||
Repayments of loan
|
-
|
(765
|
)
|
|||||
Repayments of lease liabilities
|
(49
|
)
|
(129
|
)
|
||||
Net cash used in financing activities
|
(49
|
)
|
(894
|
)
|
||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
(1,423
|
)
|
1,684
|
|||||
CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD
|
10,587
|
4,255
|
||||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
(98
|
)
|
51
|
|||||
CASH AND CASH EQUIVALENTS - END OF PERIOD
|
9,066
|
5,990
|
Three months ended
March 31,
|
||||||||
2023
|
2024
|
|||||||
in USD thousands
|
||||||||
Adjustments required to reflect net cash used in operating activities:
|
||||||||
Income and expenses not involving cash flows:
|
||||||||
Depreciation and amortization
|
259
|
897
|
||||||
Exchange differences on cash and cash equivalents
|
98
|
(51
|
)
|
|||||
Fair value adjustments of warrants
|
3,040
|
(4,444
|
)
|
|||||
Share-based compensation
|
435
|
533
|
||||||
Interest on short-term deposits
|
(497
|
)
|
(163
|
)
|
||||
Interest on loan
|
630
|
610
|
||||||
Exchange differences on lease liabilities
|
(92
|
)
|
(25
|
)
|
||||
3,873
|
(2,643
|
)
|
||||||
Changes in operating asset and liability items:
|
||||||||
Increase in trade receivables
|
-
|
(2,474
|
)
|
|||||
Increase in inventory
|
-
|
(936
|
)
|
|||||
Decrease (increase) in prepaid expenses and other receivables
|
(121
|
)
|
81
|
|||||
Increase (decrease) in accounts payable and accruals
|
394
|
(3,511
|
)
|
|||||
Decrease in contract liabilities
|
-
|
(3,930
|
)
|
|||||
273
|
(10,770
|
)
|
||||||
4,146
|
(13,413
|
)
|
||||||
Supplemental information on interest received in cash
|
276
|
357
|
||||||
Supplemental information on interest paid in cash
|
311
|
255
|
||||||
Changes in right-of-use asset and lease liabilities
|
66
|
32
|
Page
|
|
2
|
|
3 | |
4 | |
5-6
|
|
7-14
|
December 31,
|
March 31,
|
|||||||
2023
|
2024
|
|||||||
in USD thousands
|
||||||||
Assets
|
||||||||
CURRENT ASSETS
|
||||||||
Cash and cash equivalents
|
4,255
|
5,990
|
||||||
Short-term bank deposits
|
38,739
|
22,183
|
||||||
Trade receivables
|
358
|
2,832
|
||||||
Prepaid expenses
|
1,048
|
1,290
|
||||||
Other receivables
|
830
|
507
|
||||||
Inventory
|
1,953
|
2,889
|
||||||
Total current assets
|
47,183
|
35,691
|
||||||
NON-CURRENT ASSETS
|
||||||||
Property and equipment, net
|
473
|
411
|
||||||
Right-of-use assets, net
|
1,415
|
1,308
|
||||||
Intangible assets, net
|
14,854
|
14,190
|
||||||
Total non-current assets
|
16,742
|
15,909
|
||||||
Total assets
|
63,925
|
51,600
|
||||||
Liabilities and equity
|
||||||||
CURRENT LIABILITIES
|
||||||||
Current maturities of long-term loan
|
3,145
|
3,680
|
||||||
Contract liabilities
|
12,957
|
9,027
|
||||||
Accounts payable and accruals:
|
||||||||
Trade
|
10,869
|
8,256
|
||||||
Other
|
3,353
|
2,455
|
||||||
Current maturities of lease liabilities
|
528
|
467
|
||||||
Warrants
|
11,932
|
7,488
|
||||||
Total current liabilities
|
42,784
|
31,373
|
||||||
NON-CURRENT LIABILITIES
|
||||||||
Long-term loan, net of current maturities
|
6,628
|
5,938
|
||||||
Lease liabilities
|
1,290
|
1,229
|
||||||
Total non-current liabilities
|
7,918
|
7,167
|
||||||
COMMITMENTS AND CONTINGENT LIABILITIES
|
||||||||
Total liabilities
|
50,702
|
38,540
|
||||||
EQUITY
|
||||||||
Ordinary shares
|
31,355
|
31,355
|
||||||
Share premium
|
355,482
|
355,482
|
||||||
Warrants
|
1,408
|
1,408
|
||||||
Capital reserve
|
17,000
|
17,533
|
||||||
Other comprehensive loss
|
(1,416
|
)
|
(1,416
|
)
|
||||
Accumulated deficit
|
(390,606
|
)
|
(391,302
|
)
|
||||
Total equity
|
13,223
|
13,060
|
||||||
Total liabilities and equity
|
63,925
|
51,600
|
Three months ended March 31,
|
||||||||
2023
|
2024
|
|||||||
in USD thousands
|
||||||||
REVENUES
|
-
|
6,855
|
||||||
COST OF REVENUES
|
-
|
(1,455
|
)
|
|||||
GROSS PROFIT
|
-
|
5,400
|
||||||
RESEARCH AND DEVELOPMENT EXPENSES
|
(3,684
|
)
|
(2,494
|
)
|
||||
SALES AND MARKETING EXPENSES
|
(3,874
|
)
|
(6,342
|
)
|
||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
(1,298
|
)
|
(1,386
|
)
|
||||
OPERATING LOSS
|
(8,856
|
)
|
(4,822
|
)
|
||||
NON-OPERATING INCOME (EXPENSES), NET
|
(2,916
|
)
|
4,490
|
|||||
FINANCIAL INCOME
|
537
|
565
|
||||||
FINANCIAL EXPENSES
|
(927
|
)
|
(929
|
)
|
||||
NET LOSS AND COMPREHENSIVE LOSS
|
(12,162
|
)
|
(696
|
)
|
in USD
|
||||||||
LOSS PER ORDINARY SHARE - BASIC AND DILUTED
|
(0.01
|
)
|
(0.00
|
)
|
||||
WEIGHTED AVERAGE NUMBER OF SHARES USED IN
CALCULATION OF LOSS PER ORDINARY SHARE |
922,958,942
|
1,086,589,165
|
Ordinary shares
|
Share premium
|
Warrants
|
Capital reserve
|
Other comprehensive loss
|
Accumulated deficit
|
Total
|
||||||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2023
|
27,100
|
338,976
|
1,408
|
14,765
|
(1,416
|
)
|
(329,992
|
)
|
50,841
|
|||||||||||||||||||
CHANGES FOR THREE MONTHS ENDED MARCH 31, 2023:
|
||||||||||||||||||||||||||||
Employee stock options expired
|
-
|
66
|
-
|
(66
|
)
|
-
|
-
|
-
|
||||||||||||||||||||
Share-based compensation
|
-
|
-
|
-
|
435
|
-
|
-
|
435
|
|||||||||||||||||||||
Comprehensive loss for the period
|
-
|
-
|
-
|
-
|
-
|
(12,162
|
)
|
(12,162
|
)
|
|||||||||||||||||||
BALANCE AT MARCH 31, 2023
|
27,100
|
339,042
|
1,408
|
15,134
|
(1,416
|
)
|
(342,154
|
)
|
39,114
|
Ordinary shares
|
Share premium
|
Warrants
|
Capital reserve
|
Other comprehensive loss
|
Accumulated deficit
|
Total
|
||||||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2024
|
31,355
|
355,482
|
1,408
|
17,000
|
(1,416
|
)
|
(390,606
|
)
|
13,223
|
|||||||||||||||||||
CHANGES FOR THREE MONTHS ENDED MARCH 31, 2024:
|
||||||||||||||||||||||||||||
Share-based compensation
|
-
|
-
|
-
|
533
|
-
|
-
|
533
|
|||||||||||||||||||||
Comprehensive loss for the period
|
-
|
-
|
-
|
-
|
-
|
(696
|
)
|
(696
|
)
|
|||||||||||||||||||
BALANCE AT MARCH 31, 2024
|
31,355
|
355,482
|
1,408
|
17,533
|
(1,416
|
)
|
(391,302
|
)
|
13,060
|
Three months ended
March 31,
|
||||||||
2023
|
2024
|
|||||||
in USD thousands
|
||||||||
CASH FLOWS - OPERATING ACTIVITIES
|
||||||||
Comprehensive loss for the period
|
(12,162
|
)
|
(696
|
)
|
||||
Adjustments required to reflect net cash used in operating activities
(see appendix below)
|
4,146
|
(13,413
|
)
|
|||||
Net cash used in operating activities
|
(8,016
|
)
|
(14,109
|
)
|
||||
CASH FLOWS - INVESTING ACTIVITIES
|
||||||||
Investments in short-term deposits
|
(5,500
|
)
|
-
|
|||||
Maturities of short-term deposits
|
12,271
|
16,719
|
||||||
Purchase of property and equipment
|
(32
|
)
|
(32
|
)
|
||||
Purchase of intangible assets
|
(97
|
)
|
-
|
|||||
Net cash provided by investing activities
|
6,642
|
16,687
|
||||||
CASH FLOWS - FINANCING ACTIVITIES
|
||||||||
Repayments of loan
|
-
|
(765
|
)
|
|||||
Repayments of lease liabilities
|
(49
|
)
|
(129
|
)
|
||||
Net cash used in financing activities
|
(49
|
)
|
(894
|
)
|
||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
(1,423
|
)
|
1,684
|
|||||
CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD
|
10,587
|
4,255
|
||||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
(98
|
)
|
51
|
|||||
CASH AND CASH EQUIVALENTS - END OF PERIOD
|
9,066
|
5,990
|
Three months ended
March 31,
|
||||||||
2023
|
2024
|
|||||||
in USD thousands
|
||||||||
Adjustments required to reflect net cash used in operating activities:
|
||||||||
Income and expenses not involving cash flows:
|
||||||||
Depreciation and amortization
|
259
|
897
|
||||||
Exchange differences on cash and cash equivalents
|
98
|
(51
|
)
|
|||||
Fair value adjustments of warrants
|
3,040
|
(4,444
|
)
|
|||||
Share-based compensation
|
435
|
533
|
||||||
Interest on short-term deposits
|
(497
|
)
|
(163
|
)
|
||||
Interest on loan
|
630
|
610
|
||||||
Exchange differences on lease liabilities
|
(92
|
)
|
(25
|
)
|
||||
3,873
|
(2,643
|
)
|
||||||
Changes in operating asset and liability items:
|
||||||||
Increase in trade receivables
|
-
|
(2,474
|
)
|
|||||
Increase in inventory
|
-
|
(936
|
)
|
|||||
Decrease (increase) in prepaid expenses and other receivables
|
(121
|
)
|
81
|
|||||
Increase (decrease) in accounts payable and accruals
|
394
|
(3,511
|
)
|
|||||
Decrease in contract liabilities
|
-
|
(3,930
|
)
|
|||||
273
|
(10,770
|
)
|
||||||
4,146
|
(13,413
|
)
|
||||||
Supplemental information on interest received in cash
|
276
|
357
|
||||||
Supplemental information on interest paid in cash
|
311
|
255
|
||||||
Changes in right-of-use asset and lease liabilities
|
66
|
32
|
a. |
General
|
b. |
Israel-Hamas war
|
c. |
Going concern
|
d. |
Approval of financial statements
|
a. |
General
|
b. |
New international financial reporting standards, amendments to standards and new interpretations
|
Number of ordinary shares
|
||||||||
December 31,
|
March 31,
|
|||||||
2023
|
2024
|
|||||||
Authorized share capital
|
2,500,000,000
|
2,500,000,000
|
||||||
Issued and paid-up share capital
|
1,086,589,165
|
1,086,589,165
|
In USD and NIS
|
||||||||
December 31,
|
March 31,
|
|||||||
2023
|
2024
|
|||||||
Authorized share capital (in NIS)
|
250,000,000
|
250,000,000
|
||||||
Issued and paid-up share capital (in NIS)
|
108,658,916
|
108,658,916
|
||||||
Issued and paid-up share capital (in USD)
|
31,355,056
|
31,355,056
|
a. |
Revenue for the SCM license was recognized in the fourth quarter of 2023, upon transfer of control over the license to the licensee, in the amount of approximately $2.0 million.
|
b. |
Revenue from providing the SCM support services is recognized using the input method, which is based on costs incurred and labor hours expended, expected to result in straight-line revenue recognition over six months, totaling
approximately $0.1 million.
|
c. |
Revenue from the PDAC performance obligation is recognized over time, with the percentage of completion determined based on support hours incurred, and expected to be recognized through the end of 2024, in the total amount of $15.5
million.
|
a. |
Revenues
|
Three months ended
March 31,
|
||||||||
2023
|
2024
|
|||||||
in USD thousands
|
||||||||
License revenues (see Note 7)
|
-
|
5,931
|
||||||
Product sales, net
|
-
|
924
|
||||||
-
|
6,855
|
b. |
Cost of revenues
|
Three months ended
March 31,
|
||||||||
2023
|
2024
|
|||||||
in USD thousands
|
||||||||
Cost related to license revenues
|
-
|
741
|
||||||
Amortization of intangible asset in respect of license revenues
|
-
|
646
|
||||||
Cost of product sales
|
-
|
68
|
||||||
-
|
1,455
|
a. |
Equity financing
|
b. |
Drawdown of second tranche on long-term loan
|
|
•
|
the clinical development, commercialization and market acceptance of our therapeutic candidates, including the degree and pace
of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients;
|
|
•
|
the initiation, timing, progress and results of our preclinical studies, clinical trials and other therapeutic candidate
development efforts;
|
|
•
|
our ability to advance our therapeutic candidates into clinical trials or to successfully complete our preclinical studies or
clinical trials;
|
|
•
|
whether the clinical trial results for APHEXDA will be predictive of real-world results;
|
|
•
|
our receipt of regulatory approvals for our therapeutic candidates, and the timing of other regulatory filings and approvals;
|
|
|
|
|
•
|
whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from
third-party payors;
|
|
|
|
|
•
|
our ability to establish, manage, and maintain corporate collaborations, as well as the ability of our collaborators to execute
on their development and commercialization plans;
|
|
•
|
our ability to integrate new therapeutic candidates and new personnel, as well as new collaborations;
|
|
•
|
the interpretation of the properties and characteristics of our therapeutic candidates and of the results obtained with our
therapeutic candidates in preclinical studies or clinical trials;
|
|
•
|
the implementation of our business model and strategic plans for our business and therapeutic candidates;
|
|
•
|
the scope of protection that we are able to establish and maintain for intellectual property rights covering our therapeutic
candidates and our ability to operate our business without infringing the intellectual property rights of others;
|
|
•
|
estimates of our expenses, future revenues, capital requirements and our need for and ability to access sufficient additional
financing, including any unexpected costs or delays in the ongoing commercialization of APHEXDA;
|
|
•
|
risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere;
|
|
•
|
competitive companies, technologies and our industry; and
|
|
•
|
statements as to the impact of the political and security situation in Israel on our business, including the impact of Israel’s
war with Hamas and other militant groups, which may exacerbate the magnitude of the factors discussed above.
|
Project
|
Status
|
Expected Near Term Milestones
|
||
motixafortide
|
1.
|
FDA approval received on September 8, 2023 for stem-cell mobilization in multiple myeloma patients.
|
1.
|
Commercialization ongoing
|
2.
|
Reported data from single-arm pilot phase of the investigator-initiated Phase 2 combination trial in first-line PDAC. Of 11
patients with metastatic pancreatic cancer enrolled, 7 patients (64%) experienced partial response (PR), of which 6 (55%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. 3 patients (27%)
experienced stable disease, resulting in a disease control rate of 91%. Based on these encouraging results, study was substantially revised to a multi-institution, randomized Phase 2b trial of 108 patients
|
2.
|
First patient dosed in February 2024 and currently enrolling*
|
|
3.
|
Phase 1b study in patients with ARDS secondary to COVID-19 and other respiratory viral infections
|
3.
|
Data from the study is anticipated in 2024*
|
|
4.
|
Phase 1 study for gene therapies in SCD (with Washington
University School of Medicine in St. Louis)
|
4.
|
First patient dosed in December 2023 and data from the study is expected in the second half of 2024*
|
|
5.
|
IND approved in China for initiation of pivotal bridging study in SCM under license agreement with Gloria
|
5.
|
Initiation of the study is expected in second half of 2024
|
|
6.
|
Phase 2b randomized study in first-line PDAC in China under license agreement with Gloria
|
6.
|
IND submission and protocol finalization expected in 2024 and study initiation in 2025
|
* |
These studies are investigator-initiated studies; therefore, the timelines are ultimately controlled by the independent investigators and are subject to change.
|
|
•
|
the number of sites included in the clinical trials;
|
|
•
|
the length of time required to enroll suitable patients;
|
|
|
|
|
•
|
the number of patients that participate, and are eligible to participate, in the clinical trials;
|
|
•
|
the duration of patient follow-up;
|
|
|
|
|
•
|
whether the patients require hospitalization or can be treated on an outpatient basis;
|
|
•
|
the development stage of the therapeutic candidate; and
|
|
•
|
the efficacy and safety profile of the therapeutic candidate.
|
Three months ended
March 31,
|
||||||||||||
2023
|
2024
|
Increase
(decrease)
|
||||||||||
(in thousands of U.S. dollars)
|
||||||||||||
License revenues
|
-
|
5,931
|
5,931
|
|||||||||
Product sales, net
|
-
|
924
|
924
|
|||||||||
Total revenues
|
-
|
6,855
|
6,855
|
Three months ended March 31,
|
||||||||||||
2023
|
2024
|
Increase
(decrease)
|
||||||||||
(in thousands of U.S. dollars)
|
||||||||||||
Cost related to license revenues
|
-
|
741
|
741
|
|||||||||
Amortization of intangible asset in respect of license revenues
|
-
|
646
|
646
|
|||||||||
Cost of product sales
|
-
|
68
|
68
|
|||||||||
Total cost of revenues
|
-
|
1,455
|
1,455
|
Three months ended March 31,
|
||||||||||||
2023
|
2024
|
Increase (decrease)
|
||||||||||
(in thousands of U.S. dollars)
|
||||||||||||
Research and development expenses
|
3,684
|
2,494
|
(1,190
|
)
|
Three months ended March 31,
|
||||||||||||
2023
|
2024
|
Increase (decrease)
|
||||||||||
(in thousands of U.S. dollars)
|
||||||||||||
Sales and marketing expenses
|
3,874
|
6,342
|
2,468
|
Three months ended March 31,
|
||||||||||||
2023
|
2024
|
Increase (decrease)
|
||||||||||
(in thousands of U.S. dollars)
|
||||||||||||
General and administrative expenses
|
1,298
|
1,386
|
88
|
Three months ended March 31,
|
||||||||||||
2023
|
2024
|
Increase (decrease)
|
||||||||||
(in thousands of U.S. dollars)
|
||||||||||||
Non-operating income (expenses), net
|
(2,916
|
)
|
4,490
|
7,406
|
Three months ended March 31,
|
||||||||||||
2023
|
2024
|
Increase (decrease)
|
||||||||||
(in thousands of U.S. dollars)
|
||||||||||||
Financial income
|
537
|
565
|
28
|
|||||||||
Financial expenses
|
(927
|
)
|
(929
|
)
|
(2
|
)
|
||||||
Net financial income (expenses)
|
(390
|
)
|
(364
|
)
|
(26
|
)
|
|
•
|
the progress and costs of our preclinical studies, clinical trials and other research and development activities;
|
|
•
|
the scope, prioritization and number of our clinical trials and other research and development programs;
|
|
•
|
the amount of revenues we receive, if any, under our collaboration or licensing arrangements;
|
|
|
|
|
•
|
the costs of the development and expansion of our operational infrastructure;
|
|
•
|
the costs and timing of obtaining regulatory approval of our therapeutic candidates;
|
|
•
|
our success in effecting out-licensing arrangements with third parties;
|
|
•
|
the ability of our collaborators and licensees to achieve development milestones, marketing approval and other events or
developments under our collaboration and out-licensing agreements;
|
|
•
|
the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;
|
|
•
|
the costs and timing of securing manufacturing arrangements for clinical or commercial production;
|
|
•
|
the costs of establishing sales and marketing capabilities or contracting with third parties to provide these capabilities for
us;
|
|
•
|
the costs of acquiring or undertaking development and commercialization efforts for any future therapeutic candidates;
|
|
•
|
the magnitude of our general and administrative expenses;
|
|
•
|
interest and principal payments on the loan from BlackRock;
|
|
•
|
any cost that we may incur under current and future licensing arrangements relating to our therapeutic candidates;
|
|
•
|
market conditions;
|
|
•
|
payments to the IIA; and
|
|
•
|
the impact of any resurgence of the COVID-19 pandemic and the military campaigns by Israel against Hamas and other terrorist
organizations (including the declaration of war by Israel against Hamas), which may exacerbate the magnitude of the factors discussed above.
|
Three months ended
March 31,
|
||||||||
2023
|
2024
|
|||||||
(in U.S. dollars)
|
||||||||
Loss per ADS – basic and diluted
|
(0.19
|
)
|
(0.01
|
)
|
||||
Los per ordinary share – basic and diluted
|
(0.013
|
)
|
(0.001
|
)
|
December 31, 2023
|
March 31,
2024
|
|||||||
(in number of ADSs)
|
||||||||
Authorized share capital
|
166,666,667
|
166,666,667
|
||||||
Issued and paid-up capital
|
61,530,596
|
72,439,278
|