Significant events and achievements during the third quarter 2020 and subsequent period:
- Reported positive results from a pre-planned interim analysis of GENESIS Phase 3 trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma patients. The Data Monitoring Committee (DMC) found statistically significant evidence favoring treatment with motixafortide in the primary endpoint, and subsequently issued a recommendation to cease patient enrollment immediately. In accordance with the DMC's recommendation, study enrollment was completed at 122 patients (instead of 177 as originally planned). SCM is the Company's most efficient path to registration;
- Announced initiation of Phase 2 investigator-initiated study of motixafortide in combination with LIBTAYO® and chemotherapy in first-line PDAC. The study is being run by
Columbia University ; - Announced initiation of investigator-initiated Phase 1b study, led by
Wolfson Medical Center in Holon,Israel , to evaluate motixafortide in patients hospitalized with acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections; - Renewed study enrollment in Part of Phase 1/2a trial for AGI-134, which had been temporarily suspended in the second quarter of 2020 due to clinical operating risks associated with the COVID-19 pandemic;
- Conducted interim analysis for Phase 2b BLAST study in consolidation AML; analysis did not demonstrate statistically significant effect in primary endpoint; DMC recommended not to continue the study.
"The past several months have been very exciting for
"With regard to the Phase 2b BLAST study in consolidation AML, based on the results of the interim analysis, the DMC recommended not to continue the study. Although we are disappointed by this outcome, particularly following the positive results that we previously observed in our Phase 1/2a study of motixafortide with cytarabine in relapsed/refractory AML, we continue to believe in the relevance of CXCR4 as a viable target in other AML treatment lines, such as rr/AML and induction treatment. We will decide on next steps in AML once we've had a chance to review and analyze the unblinded data, including detailed biomarker and subpopulation data, from this study. I would also like to express our gratitude to the
"Finally, in the coming weeks, we plan to announce full results, including progression free survival (PFS) and overall survival (OS) data, on all study patients from the triple combination arm of our Phase 2a COMBAT/KEYNOTE-202 study in second-line PDAC. We previously shared preliminary positive overall response rate and disease control rate data, on approximately half of the patients enrolled in this study arm, at last year's ESMO IO conference, and we remain optimistic that the combination of motixafortide and KEYTRUDA®, together with chemotherapy, will prove beneficial to survival as well.
"The significant and growing body of data that we are compiling on motixafortide, including the strikingly positive results of the interim analysis in the GENESIS phase 3 study reported last month, reassure us about the unique characteristics of motixafortide as the best-in-class CXCR4 antagonist, and confirm our belief that this promising compound can potentially serve as the backbone of combination therapies to treat a broad range of solid tumor and hematological cancers,"
Upcoming Expected Milestones
- Overall final results, including PFS and OS data, from the COMBAT/KEYNOTE-202 Phase 2a triple combination study in second-line PDAC by the end of 2020;
- Final results from the Phase 3 GENESIS trial in SCM in the first half of 2021;
- Preliminary results of the Phase 1b study in ARDS in the first half of 2021;
- Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021;
- Data from the
Columbia University -initiated study of motixafortide in combination with LIBTAYO® and chemotherapy in first-line PDAC in mid-2022;
Financial Results for the Quarter Ended
Research and development expenses for the three months ended
Sales and marketing expenses for three months ended
General and administrative expenses for the three months ended
The Company's operating loss for the three months ended
Non-operating income (expenses) for the three- and nine-month periods ended
Net financial expenses for the three months ended
The Company's net loss for the three months ended
The Company held
Net cash used in operating activities was
Net cash provided by investing activities was
Net cash provided by financing activities was
Conference Call and Webcast Information
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
(Tables follow)
About
The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform currently being evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation, and for which positive data in respect of the study's primary endpoint was recently announced from an interim analysis, resulting in early cessation of recruitment. Motixafortide is also being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a collaboration agreement with MSD.
For additional information on
Various statements in this release concerning
Contact:
+1-212-915-2564
tim@lifesciadvisors.com
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION (UNAUDITED) |
||
|
|
|
2019 |
2020 |
|
in USD thousands |
||
Assets |
||
CURRENT ASSETS |
||
Cash and cash equivalents |
5,297 |
6,552 |
Short-term bank deposits |
22,192 |
14,275 |
Prepaid expenses |
108 |
269 |
Other receivables |
613 |
327 |
Total current assets |
28,210 |
21,423 |
NON-CURRENT ASSETS |
||
Property and equipment, net |
1,816 |
1,462 |
Right-of-use assets, net |
1,650 |
1,423 |
Intangible assets, net |
21,891 |
21,731 |
Total non-current assets |
25,357 |
24,616 |
Total assets |
53,567 |
46,039 |
Liabilities and equity |
||
CURRENT LIABILITIES |
||
Current maturities of long-term loans |
2,692 |
2,969 |
Accounts payable and accruals: |
||
Trade |
7,794 |
5,933 |
Other |
1,280 |
1,374 |
Lease liabilities |
202 |
200 |
Total current liabilities |
11,968 |
10,476 |
NON-CURRENT LIABILITIES |
||
Warrants |
658 |
5,600 |
Long-term loans, net of current maturities |
5,799 |
3,554 |
Lease liabilities |
1,762 |
1,601 |
Total non-current liabilities |
8,219 |
10,755 |
COMMITMENTS AND CONTINGENT LIABILITIES |
||
Total liabilities |
20,187 |
21,231 |
EQUITY |
||
Ordinary shares |
4,692 |
8,281 |
Share premium |
265,938 |
271,107 |
Capital reserve |
12,132 |
12,835 |
Other comprehensive loss |
(1,416) |
(1,416) |
Accumulated deficit |
(247,966) |
(265,999) |
Total equity |
33,380 |
24,808 |
Total liabilities and equity |
53,567 |
46,039 |
|
|||||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS |
|||||
(UNAUDITED) |
|||||
Three months ended |
Nine months ended |
||||
2019 |
2020 |
2019 |
2020 |
||
in USD thousands |
in USD thousands |
||||
RESEARCH AND DEVELOPMENT EXPENSES |
(5,558) |
(3,484) |
(15,252) |
(13,546) |
|
SALES AND MARKETING EXPENSES |
(201) |
(309) |
(683) |
(666) |
|
GENERAL AND ADMINISTRATIVE EXPENSES |
(884) |
(856) |
(2,763) |
(2,843) |
|
OPERATING LOSS |
(6,643) |
(4,649) |
(18,698) |
(17,055) |
|
NON-OPERATING INCOME (EXPENSES), NET |
3,055 |
294 |
3,976 |
(80) |
|
FINANCIAL INCOME |
247 |
39 |
628 |
214 |
|
FINANCIAL EXPENSES |
(597) |
(302) |
(1,484) |
(1,112) |
|
NET LOSS AND COMPREHENSIVE LOSS |
(3,938) |
(4,618) |
(15,578) |
(18,033) |
|
in USD |
in USD |
||||
LOSS PER ORDINARY SHARE - BASIC AND DILUTED |
(0.03) |
(0.02) |
(0.11) |
(0.08) |
|
WEIGHTED AVERAGE NUMBER OF SHARES USED IN |
148,920,707 |
296,508,550 |
142,527,942 |
231,380,969 |
|
|
||||||
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY |
||||||
(UNAUDITED) |
||||||
Ordinary Shares |
Share premium |
Capital reserve |
Other |
Accumulated deficit |
Total |
|
in USD thousands |
||||||
BALANCE AT |
3,110 |
250,192 |
11,955 |
(1,416) |
(222,520) |
41,321 |
CHANGES FOR NINE MONTHS ENDED |
||||||
Issuance of share capital, net |
1,018 |
11,266 |
- |
- |
- |
12,284 |
Employee stock options exercised |
1 |
53 |
(53) |
- |
- |
1 |
Employee stock options forfeited and expired |
- |
919 |
(919) |
- |
- |
- |
Share-based compensation |
- |
- |
1,170 |
- |
- |
1,170 |
Comprehensive loss for the period |
- |
- |
- |
- |
(15,578) |
(15,578) |
BALANCE AT |
4,129 |
262,430 |
12,153 |
(1,416) |
(238,098) |
39,198 |
Ordinary Shares |
Share premium |
|||||
Capital reserve |
Other |
Accumulated deficit |
Total |
|||
in USD thousands |
||||||
BALANCE AT |
4,692 |
265,938 |
12,132 |
(1,416) |
(247,966) |
33,380 |
CHANGES FOR NINE MONTHS ENDED |
||||||
Issuance of share capital, net |
3,581 |
4,754 |
- |
- |
- |
8,335 |
Employee stock options exercised |
8 |
224 |
(224) |
- |
- |
8 |
Employee stock options forfeited and expired |
- |
191 |
(191) |
- |
- |
- |
Share-based compensation |
- |
- |
1,118 |
- |
- |
1,118 |
Comprehensive loss for the period |
- |
- |
- |
- |
(18,033) |
(18,033) |
BALANCE AT |
8,281 |
271,107 |
12,835 |
(1,416) |
(265,999) |
24,808 |
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)
Ordinary |
Share |
Capital |
Other |
Accumulated |
||
Shares |
premium |
reserve |
Loss |
deficit |
Total |
|
in USD thousands |
||||||
BALANCE AT |
4,001 |
261,522 |
11,835 |
(1,416) |
(234,160) |
41,782 |
CHANGES FOR THREE MONTHS ENDED |
||||||
Issuance of share capital, net |
128 |
829 |
- |
- |
- |
957 |
Employee stock options exercised |
- |
26 |
(26) |
- |
- |
- |
Employee stock options forfeited and expired |
- |
53 |
(53) |
- |
- |
- |
Share-based compensation |
- |
- |
397 |
- |
- |
397 |
Comprehensive loss for the period |
- |
- |
- |
- |
(3,938) |
(3,938) |
BALANCE AT |
4,129 |
262,430 |
12,153 |
(1,416) |
(238,098) |
39,198 |
Ordinary |
Share |
Capital |
Other |
Accumulated |
||
Shares |
premium |
Reserve |
Loss |
deficit |
Total |
|
in USD thousands |
||||||
BALANCE AT |
8,281 |
271,107 |
12,639 |
(1,416) |
(261,381) |
29,230 |
CHANGES FOR THREE MONTHS ENDED |
||||||
Issuance of share capital, net |
- |
- |
- |
- |
- |
- |
Employee stock options exercised |
- |
- |
- |
- |
- |
- |
Employee stock options forfeited and expired |
- |
- |
- |
- |
- |
- |
Share-based compensation |
- |
- |
196 |
- |
- |
196 |
Comprehensive loss for the period |
- |
- |
- |
- |
(4,618) |
(4,618) |
BALANCE AT |
8,281 |
271,107 |
12,835 |
(1,416) |
(265,999) |
24,808 |
|
||
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS |
||
(UNAUDITED) |
||
Nine months ended |
||
2019 |
2020 |
|
in USD thousands |
||
CASH FLOWS - OPERATING ACTIVITIES |
||
Comprehensive loss for the period |
(15,578) |
(18,033) |
Adjustments required to reflect net cash used in operating activities (see appendix below) |
(1,658) |
259 |
Net cash used in operating activities |
(17,236) |
(17,774) |
CASH FLOWS - INVESTING ACTIVITIES |
||
Investments in short-term deposits |
(34,517) |
(28,500) |
Maturities of short-term deposits |
36,637 |
36,626 |
Purchase of property and equipment |
(54) |
(1) |
Net cash provided by investing activities |
2,066 |
8,125 |
CASH FLOWS - FINANCING ACTIVITIES |
||
Issuance of share capital and warrants, net of issuance costs |
16,836 |
13,411 |
Employee stock options exercised |
1 |
8 |
Repayments of loans |
(70) |
(2,338) |
Repayments of lease liabilities |
(165) |
(162) |
Net cash provided by financing activities |
16,602 |
10,919 |
INCREASE IN CASH AND CASH EQUIVALENTS |
1,432 |
1,270 |
CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD |
3,404 |
5,297 |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS |
49 |
(15) |
CASH AND CASH EQUIVALENTS - END OF PERIOD |
4,885 |
6,552 |
|
||
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS |
||
(UNAUDITED) |
||
Nine months ended |
||
2019 |
2020 |
|
in USD thousands |
||
Adjustments required to reflect net cash used in operating activities: |
||
Income and expenses not involving cash flows: |
||
Depreciation and amortization |
667 |
737 |
Long-term prepaid expenses |
(3) |
- |
Exchange differences on cash and cash equivalents |
(49) |
15 |
Fair value adjustments of warrants |
(4,429) |
(727) |
Share-based compensation |
1,170 |
1,118 |
Warrant issuance costs |
417 |
593 |
Interest and exchange differences on short-term deposits |
(628) |
(209) |
Interest on loans |
512 |
370 |
Exchange differences on lease liability |
- |
4 |
(2,343) |
1,901 |
|
Changes in operating asset and liability items: |
||
Decrease in prepaid expenses and other receivables |
265 |
125 |
Increase (decrease) in accounts payable and accruals |
420 |
(1,767) |
685 |
(1,642) |
|
(1,658) |
259 |
|
Supplemental information on interest received in cash |
628 |
342 |
Supplemental information on interest paid in cash |
782 |
671 |
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