BioLineRx Ltd (BLRX)

[midastouch017]

BioLineRx Reports Year-End 2021 Financial Results and Provides Corporate Update

https://finance.yahoo.com/news/biolinerx-reports-end-2021-financial-110000323.html

- Commercial assessment commissioned indicating US stem-cell mobilization opportunity of ~$360m

- Successful pre-NDA meeting with FDA; NDA submission anticipated in mid-2022

- Announced highly positive results from additional pharmacoeconomic study indirectly comparing Motixafortide plus G-CSF versus plerixafor plus G-CSF

- Cash and cash equivalents at December 31, 2021 of $57.1 million

- Management to hold conference call today, March 16, at 10:00 am EDT

TEL AVIV, Israel, March 16, 2022 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the fourth quarter and year ended December 31, 2021 and provides a corporate update.

Significant events and achievements during the fourth quarter 2021 and subsequent period:

Commissioned a comprehensive third-party market assessment of the US stem cell mobilization market, which identified a commercial opportunity in the US of ~$360 million;

Completed a successful pre-NDA meeting with the FDA, at which the FDA agreed that the Company's proposed regulatory data package is sufficient to support an NDA submission in stem cell mobilization. To that end, the Company intends to submit its NDA in this indication in mid-2022;

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. Both analyses demonstrated substantial cost savings from using Motixafortide and further strengthened the case for use of Motixafortide as a primary mobilization agent for all multiple myeloma patients undergoing autologous stem cell transplantation (ASCT);

Delivered one oral and three poster presentations at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition, which was held December 11-14, 2021. The oral presentation highlighted the successful GENESIS Phase 3 pivotal trial;

Announced formation of Immuno-Oncology Scientific Advisory Board comprised of recognized leaders in the fields of cancer immunology, intra-tumoral injections and clinical development. The SAB will provide guidance on the Company's ongoing AGI-134 anti-cancer vaccine program and other potential immuno-oncology initiatives;

Completed recruitment of part 2 of ongoing Phase 1/2a trial of AGI-134 in solid tumors;

Ended the fourth quarter on solid financial footing, with cash and cash equivalents of $57.1 million.

"The opportunity for Motixafortide in stem-cell mobilization is significant," stated Philip Serlin, Chief Executive Officer of BioLineRx. "We recently commissioned a comprehensive third-party market assessment which identified a $360 million addressable annual opportunity in the US. We continue to maintain optionality among a number of commercialization alternatives, as we believe the very concentrated end market, where approximately 80 transplant centers in the US conduct the vast majority of stem cell transplant procedures, would require a limited commercialization footprint. In the meantime, in order to ensure that Motixafortide is well positioned for a timely and robust US launch that will maximize the value of the asset, we have initiated a number of pre-commercialization launch activities.

At the same time, we are very pleased with the additional results of our pharmacoeconomic study, which demonstrate a significant cost benefit for Motixafotide plus G-CSF as compared to plerixafor plus G-CSF, one of the main current treatment options. These results, together with the overwhelmingly positive results from our GENESIS Phase 3 study, give us tremendous optimism for the potential of Motixafortide to become the new standard of care mobilization agent for multiple myeloma patients – the first true advancement in stem cell mobilization since the approval of plerixafor in 2008.

Following our very productive pre-NDA meeting with FDA that we completed in December, we are diligently working to submit the NDA and position the product for commercialization. We anticipate the NDA submission will occur in mid-2022."

"With over $57 million in cash, we believe we are well financed to extract maximum value from Motixafortide in SCM while at the same time advancing our other pipeline programs," 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;

Announce initial results for 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 Year Ended December 31, 2021:

Research and development expenses for the year ended December 31, 2021 were $19.5 million, an increase of $1.3 million, or 7.1%, compared to $18.2 million for the year ended December 31, 2020. The increase resulted primarily from an increase in expenses associated with the AGI-134 phase 1/2a study, as well as an increase in payroll and related-expenses due to a company-wide salary reduction related to the COVID-19 pandemic in the comparable 2020 period, offset by lower expenses associated with the completed Motixafortide GENESIS and COMBAT clinical trials.

Sales and marketing expenses for the year ended December 31, 2021 were $1.0 million, an increase of $0.2 million, or 19.4% compared to $0.8 million for the year ended December 31, 2020. The increase resulted primarily from an increase in consultancy services related to Motixafortide.

General and administrative expenses for the year ended December 31, 2021 were $4.3 million, an increase of $0.4, or 10.0% compared to $3.9 million for the year ended December 31, 2020. The increase resulted primarily from an increase in directors' and officers' insurance expenses.

The Company's operating loss for the year ended December 31, 2021 amounted to $24.8 million, compared to an operating loss of $22.9 million for the year ended December 31, 2020.

Non-operating expenses amounted to $1.8 million for the year ended December 31, 2021, compared to non-operating expenses of $5.7 million for the year ended December 31, 2020. Non-operating expenses for both periods primarily relate to fair-value adjustments of warrant liabilities and issuance expenses related to the ATM.

Net financial expenses amounted to $0.4 million for the year ended December 31, 2021, compared to net ?nancial expenses of $1.4 million for the year ended December 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 year ended December 31, 2021 amounted to $27.1 million, compared with a net loss of $30.0 million for the year ended December 31, 2020.

The Company held $57.1 million in cash, cash equivalents and short-term bank deposits as of December 31, 2021.

Net cash used in operating activities for the year ended December 31, 2021 was $23.6 million, compared to $23.2 million for the year ended December 31, 2020. The $0.4 million increase in 2021 was primarily the result of an increase in research and development expenses.

Net cash used in investing activities for the year ended December 31, 2021 was $38.2 million, compared to net cash provided by investing activities of $16.7 million for the year ended December 31, 2020. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits during the respective periods.

Net cash provided by financing activities for the year ended December 31, 2021 was $57.7 million, compared to $17.9 million for the year ended December 31, 2020. The cash flows in 2021 primarily reflect the underwritten public offering of the Company's ADSs in January 2021, warrant exercises, and net proceeds from the ATM facility, offset by repayments of the loan from Kreos Capital. The cash flows in 2020 primarily reflect the registered direct offerings of ADSs in May and June 2020, as well as net proceeds from the ATM facility, offset by repayments of the loan from Kreos Capital.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, Wednesday, March 16 at 10:00 a.m. EDT. To access the conference call, please dial [phone] from the US or [phone] 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 March 18, 2022; please dial [phone] from the US or [phone] internationally.