On May 11, 2022 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported its financial results for the first quarter ended March 31, 2022 and provides a corporate update (Press release, BioLineRx, MAY 11, 2022, View Source [SID1234614171]).
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Significant events and achievements during the first quarter 2022 and subsequent period:
Progressed the New Drug Application (NDA) for Motixafortide in stem cell mobilization, remaining on track to submit mid-year;
Advanced critical pre-launch activities while maintaining full optionality with respect to Motixafortide commercialization plans in the U.S., if approved;
Commissioned a comprehensive third-party market assessment of the US stem cell mobilization market, which identified a commercial opportunity of ~$360 million annually in the U.S. alone;
Announced significantly positive and commercially relevant results from a pharmacoeconomic cost effectiveness study comparing Motixafortide + G-CSF versus G-CSF alone and indirectly comparing Motixafortide + G-CSF versus plerixafor + G-CSF:
– Versus plerixafor + G-CSF, the study found that the addition of Motixafortide to G-CSF is associated with a net cost savings of ~$30,000 per patient (not including the cost of Motixafortide).
– Versus G-CSF alone, the study found that the addition of Motixafortide to G-CSF is associated with a net cost savings of ~$19,000 per patient (not including the cost of Motixafortide).
Completed recruitment of part 2 of ongoing Phase 1/2a trial of AGI-134 in solid tumors;
Ended the first quarter on solid financial footing, with cash and cash equivalents of $50.6 million, sufficient to fund operations, as currently planned, into the first half of 2024.
"During the first quarter and subsequent period, we continued to prepare our New Drug Application for Motixafortide in stem cell mobilization, and we remain on track for submission to the FDA mid-year, consistent with our prior guidance," stated Philip Serlin, Chief Executive Officer of BioLineRx. "In parallel, we are advancing a range of critical pre-launch activities, should Motixafortide be approved, while maintaining full optionality with respect to our commercialization plans, in light of the highly concentrated end market in the U.S., in which 80 transplant centers conduct the vast majority of stem cell transplant procedures.
"The third-party commercial market assessment that we recently commissioned estimates the size of the stem cell mobilization market to be $360 million annually in the U.S. alone and growing. In this respect, the overwhelmingly positive results from our GENESIS Phase 3 study, together with the very compelling cost savings identified through our pharmacoeconomic cost effectiveness studies, give us optimism that Motixafortide, if approved, can quickly become a core component of a new mobilization paradigm in multiple myeloma patients, and in potential other indications as well.
"With over $50 million in cash, we believe we are well financed to extract maximum value from Motixafortide in stem cell mobilization while at the same time advancing our other pipeline programs, allowing us to achieve notable corporate and clinical milestones into the first half of 2024," concluded Mr. Serlin.
Upcoming Expected Milestones:
Submission of NDA to FDA for Motixafortide as novel mobilization agent for multiple myeloma patients undergoing autologous stem cell transplantation in mid-2022;
Initial results from Part 2 of Phase 1/2a trial of AGI-134 in solid tumors in H2 2022;
Initiate Phase 2 study of AGI-134 in 2023;
Potential FDA approval of Motixafortide in 2023;
Potential US launch of Motixafortide in SCM in 2023.
Financial Results for the Quarter Ended March 31, 2022:
Research and development expenses for the quarter ended March 31, 2022 were $4.4 million, an increase of $0.1 million, or 3.7%, compared to $4.3 million for the quarter ended March 31, 2021. The increase resulted primarily from an increase in expenses associated with the AGI-134 study, offset by lower expenses associated with the completed Motixafortide GENESIS and COMBAT clinical trials.
Sales and marketing expenses for the quarter ended March 31, 2022 were $0.7 million, an increase of $0.5 million, or 313% compared to $0.2 million for the quarter ended March 31, 2021. The increase resulted primarily from an increase in market research and consultancy services, as well as initiation of pre-launch activities related to Motixafortide.
General and administrative expenses for the quarter ended March 31, 2022 were $1.0 million, similar to the comparable period in 2021.
The Company’s operating loss for the quarter ended March 31, 2022 amounted to $6.1 million, compared to an operating loss of $5.4 million for the quarter ended March 31, 2021.
Non-operating income amounted to $1.3 million for the quarter ended March 31, 2022, compared to non-operating expenses of $4.6 million for the quarter ended March 31, 2021. 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 $0.1 million for the quarter ended March 31, 2022, compared to net financial expenses of $0.2 million for the quarter ended March 31, 2021. 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, 2022 amounted to $4.9 million, compared with a net loss of $10.2 million for the quarter ended March 31, 2021.
The Company held $50.6 million in cash, cash equivalents and short-term bank deposits as of March 31, 2022, compared with $57.1 million as of December 31, 2021.
Net cash used in operating activities was $5.6 million for the quarter ended March 31, 2022, compared with net cash used in operating activities of $6.2 million for the quarter ended March 31, 2021. The $0.6 million decrease in net cash used in operating activities between the two periods was primarily the result of changes in operating asset and liability items in the two periods, i.e., a smaller increase in prepaid expenses and other receivables in 2022 versus 2021, as well as increase in accounts payable and accruals in 2022, versus a decrease in the 2021 period.
Net cash provided by investing activities was $5.0 million for the quarter ended March 31, 2022, compared to net cash used in investing activities of $36.3 million for the quarter ended March 31, 2021. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.
Net cash used in financing activities was $1.0 million for the quarter ended March 31, 2022, compared to net cash provided by financing activities of $41.9 million for the quarter ended March 31, 2021. The cash flows in 2022 primarily reflect repayments of the loan from Kreos Capital. The cash flows in 2021 primarily reflect the underwritten public offering of ADSs in January 2021, warrant exercises, and net proceeds from an ATM facility, offset by repayments of the loan from Kreos Capital.
Conference Call and Webcast Information
BioLineRx will hold a conference call today, Wednesday, May 11 at 10:00 a.m. EDT. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0644 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 13, 2022; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.