On May 11, 2022, BioLineRx Ltd. (NASDAQ:BLRX) reported 1Q:22 operational and financial results in a press release concurrent with the filing of Form 6-K. A conference call and webcast were hosted later that morning. Key highlights for 2022 include continued progression of the new drug application (NDA) for Motixafortide in stem cell mobilization (SCM) anticipated to be submitted mid-2022, results from a study estimating the US stem cell mobilization market value at $360 million and completion of recruitment of the second part of the ongoing Phase I/IIa AGI-134 trial in solid tumors.
Achievements for the first quarter ending March 31, 2022 and to-date include:
➢ Pre-NDA meeting with FDA held for BL-8040 – January 2022
➢ Phase I/IIa AGI-134 enrollment completed – January 2022
➢ Additional positive results from pharmacoeconomic study – March 2022
Upcoming milestones include:
➢ AGI-134 Phase I/IIa initial results – 2H:22
➢ Presentation of GENESIS data at medical meetings & conferences – 2022
➢ BL-8040 NDA submission for stem cell mobilization (SCM) – mid-2022
➢ Phase II study of AGI-134 – 2023
➢ Potential FDA approval of Motixafortide – 2023
➢ US launch of Motixafortide in SCM – 2023
Below we summarize financial results for the year ended March 31, 2022, compared to the same ending March 31, 2021:
➢ Research and development expenses totaled $4.4 million, increasing 3.7% from $4.3 million, resulting primarily from an increase in expenses associated with the AGI-134 Phase I/IIa study partially offset by lower expenses related to the completed Motixafortide GENESIS and COMBAT clinical trials;
➢ Sales and marketing expenses were $0.7 million, up 313% from $0.2 million on greater research and consultancy services and initiation of pre-launch activities related to Motixafortide;
➢ General and administrative expenses were $1.0 million, even with prior period levels;
➢ Net financial expenses amounted to ($0.1) million compared to ($0.2) million, on reduced financial expenses and a $1.3 million gain related to fair value adjustments of warrant liabilities;
➢ Net loss was ($4.9) million compared with ($10.2) million, or ($0.01) and ($0.02) per share respectively.
Cash, equivalents and short term bank deposits as of March 31, 2022 totaled $50.6 million. BioLineRx has only current maturities of long-term loans amounting to $2.8 million. Cash burn during 1Q:22 amounted to ($5.6) million. Financing cash flows of ($0.9) million relate to repayments of a loan from Kreos Capital and lease liabilities.
Following last year’s pharmacoeconomic study which found from $19,000 to $30,000 in savings by using Motixafortide, an additional study was commissioned by BioLineRx to estimate market size for SCM. It was conducted by ZS Associates and found that the value of the U.S. stem cell mobilization market was estimated at $360 million and is in growth mode. Management estimates that global markets for SCM exceed $500 million in annual revenues.
Management has shared initial thoughts regarding commercialization plans for motixafortide. Pre-commercialization activities have started and include preparations related to medical affairs, commercial packaging and design, market access activities and brand name selection. The company is open to either internal or external commercialization and has identified about 80 transplant centers2 in the US that represent over 80% of stem cell transplant volume. A sales force of about 15-20 sales personnel would likely be appropriate for this number of touch points.
Pre-NDA meeting with FDA held for BL-8040
On January 18, 2022, BioLineRx announced that it had a successful pre-NDA meeting with the FDA. Last year, top-line results for GENESIS were reported in May, following last-patient last-follow-up. GENESIS was launched in December 2017, and was a randomized, placebo-controlled, multi-center, Phase III registrational trial for the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma (MM). The trial began with an open-label, lead-in period for dose confirmation targeting 10-30 patients to evaluate safety and efficacy of Motixafortide with G-CSF. Positive results from the initial lead-in period with 11 patients prompted the Data Monitoring Committee to give the go-ahead to advance the full study, which targeted inclusion of 177 patients across more than 25 centers. In August 2020, an interim analysis for the full study, based on approximately 65% of the intended study sample size, was developed as patient dropout had been significantly lower than expected. Interim results were positive and were announced in October 2020. Equipped with statistically significant results, the DMC recommended a halt to patient enrollment. Topline results were made available in May 2021. On January 18, 2022, BioLineRx announced that it had a successful pre-NDA meeting with the FDA. The purpose of the meeting was to reach an agreement with the FDA regarding the content of motixafortide’s NDA and to confirm that GENESIS provided sufficient clinical data. The FDA agreed that the proposed submission was sufficient. BioLineRx anticipates the NDA submission will occur in mid-2022.
Enrollment completed, Phase I/IIa (Part 2) AGI-134
On January 24, 2022, BioLineRx announced that enrollment for its Phase I/IIa was completed for AGI-134. AGI-134 is BioLineRx’ intratumoral cancer vaccine candidate. This first-in-man study (NCT03593226) is designed to assess the safety and biological activity of AGI-134 in unresectable metastatic solid tumors. The Phase 1/2a study is a multicenter, open-label affair, which recruited 38 patients in the UK, Spain and Israel in two parts. Part 1 was completed in five subjects, and determined the recommended dose for part 2. Part 2 is a dose expansion study at the recommended dose in 33 patients, designed to evaluate the safety and tolerability of AGI-134, and to validate AGI-134’s mechanism of action using a wide array of biomarkers. Results from the trial are expected to be announced in 2H:22.
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1. BioLineRx April 2022 Corporate Presentation
2. BioLineRX management stated that there were about 212 stem cell transplant centers in the United States, of which 79% comprise more than 80% of all procedures.
3. BioLineRx April 2022 Corporate Presentation