– Phase 3 GENESIS study in stem-cell mobilization (SCM) demonstrated highly statistically significant positive results across all primary and secondary endpoints –
– ~90% of patients in treatment arm underwent transplantation following only one dose of Motixafortide and only one apheresis session; potentially positions Motixafortide + G-CSF to become new standard of care in this indication –
– Company proceeding with activities in support of NDA submission targeted for H1 2022 –
– Management to hold conference call today, May 26, at 10:00 am EST –
PR Newswire
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 20
2
1 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)
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BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
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BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)
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BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
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BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
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View original content:
http://www.prnewswire.com/news-releases/biolinerx-reports-first-quarter-2021-financial-results-and-provides-corporate-update-301299676.html
SOURCE BioLineRx Ltd.
