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BLRX: September NDA

·8 min read

By John Vandermosten, CFA

NASDAQ:BLRX

READ THE FULL BLRX RESEARCH REPORT

Second Quarter 2022 Operational and Financial Results

On August 16, 2022, BioLineRx Ltd. (NASDAQ:BLRX) reported 2Q: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 since the previous update in May guidance toward a September submission of the new drug application (NDA) for Motixafortide in stem cell mobilization (SCM), the addition of a Chief Commercial Officer who has already begun pre-launch activities and entry into a motixafortide collaboration agreement with GenFleet Therapeutics.

Upcoming milestones include:

➢ BL-8040 NDA submission for stem cell mobilization (SCM) – September 2022

➢ AGI-134 Phase I/IIa initial results - 2H:22

➢ Presentation of GENESIS data at medical meetings & conferences – 2022/2023

➢ Phase II combination study of motixafortide with GenFleet - 2023

➢ Potential FDA approval of motixafortide - 2023

➢ US launch of motixafortide in SCM – 2023

➢ Potential initiation of randomized Phase 2 study of AGI-134 – 2023

Below we summarize financial results for the period ended June 30, 2022, compared to the same ending June 30, 2021:

➢ Research and development expenses totaled $5.4 million, increasing 5% from $5.1 million, resulting primarily from a rise in expenses associated with the AGI-134 study, offset by lower costs associated with the completed GENESIS trial, as well a decrease in motixafortide-related NDA support activities;

➢ Sales and marketing expenses were $1.2 million, up 250% from $0.3 million on account of initiation of pre-commercialization activities related to motixafortide, as well as an increase in market research;

➢ General and administrative expenses were $1.0 million, even with prior period levels;

➢ Non-operating income was $0.5 million related to revaluation of warrant liabilities;

➢ Net financial expenses amounted to ($0.3) million compared to ($0.1) million, on greater net financial expenses;

➢ Net loss was ($7.4) million compared with ($6.8) million, or ($0.01) and ($0.01) per share respectively.

Cash, equivalents and short-term bank deposits as of June 30, 2022 totaled $43.1 million. BioLineRx has only current maturities of long-term loans amounting to $1.0 million. Cash burn during 2Q:22 amounted to ($6.3) million. Financing cash flows of ($0.7) million relate to repayments of a loan from Kreos Capital and lease liabilities partially offset by issuance of share capital and warrants.

Collaboration with GenFleet Therapeutics

In June, BioLineRx signed an agreement with Shanghai, China-based GenFleet Therapeutics to design and manage a randomized Phase IIb triple combination trial of motixafortide in first line pancreatic ductal adenocarcinoma. While GenFleet will be running the trial, BioLineRx will maintain global rights to motixafortide in all indications.

GenFleet’s interest in the triple combination trial was stimulated by the results from the Phase IIa COMBAT/KEYNOTE-202 study included in the following exhibit. The 200-subject trial will evaluate motixafortide along with a checkpoint inhibitor and chemotherapy compared with standard of care. BioLineRx’ contribution to the venture will the drug. Oversight of the trial will be conducted by a joint development committee and if the triple combination is successful, and approved, GenFleet will receive low to mid-single digit tiered percentage royalties on future motixafortide sales.

Positive results from pharmacoeconomic study

As an adjunct to the Phase III trial, a pharmacoeconomic study was initiated to evaluate the potential cost savings from using motixafortide. The aim of the study, performed by IQVIA’s Global Health Economics and Outcomes Research team, was to demonstrate the cost benefit derived from a reduction in doses of G-CSF and apheresis sessions required, a reduction in rescue therapies required, higher rates of transplantation, and quality-of-life benefits in motixafortide-treated patients. The pharmacoeconomic study measured health resource utilization (HRU) during BioLineRX’ GENESIS trial. Included in the HRU data collected were the following:

➢ Motixafortide and G-CSF doses;

➢ Apheresis sessions performed, in primary mobilization;

➢ Percentage of patients needing rescue mobilization due to poor primary mobilization, including apheresis sessions needed; and

➢ G-CSF and plerixafor doses required and hospitalization costs related to conditioning and transplantation, including length of stay.

Quality-adjusted-life-years (QALYs) gained were also added to the model. Motixafortide plus G-CSF was associated with a statistically significant HRU decrease during the autologous stem cell transplantation process compared to standard-of-care G-CSF alone.

Data from the study was shared in an October 2021 release that highlighted a significant benefit for the use of motixafortide. The cost benefits for using motixafortide in combination with G-CSF in multiple myeloma patients were estimated at ~$17,000 (later updated to ~$19,000 in the FY:21 annual results to reflect inflation), excluding the cost of motixafortide, when compared to the cost of G-CSF alone. The benefits arise from the ability of motixafortide to increase the success of apheresis sessions, to HRU during the autologous stem cell transplantation process and produce QALY benefits. There are also additional safety and time benefits as well due to the fewer number of administrations and apheresis sessions needed.

On March 3, 2022, BioLineRx provided additional analysis from a follow-on pharmacoeconomic study based on data from BioLineRx’ Phase III GENESIS trial. This study evaluated cost effectiveness of motixafortide in combination with G-CSF compared with plerixafor with G-CSF in multiple myeloma patients undergoing autologous stem cell transplant. The supplemental analysis was performed by the same team at IQVIA which had generated the original findings reported in October 2021. Plerixafor data was sourced from literature as if it were an arm of the GENESIS trial (Bucher method), and these results were implemented in the cost-effectiveness model. Compared with plerixafor with G-CSF, motixafortide with G-CSF demonstrated a statistically significant decrease in HRU, improvement in QALY benefits, and net cost savings of ~$30,000 not including the cost of motixafortide, further supporting motixafortide and G-CSF as new standard of care in mobilization for autologous transplant.

An additional study was commissioned by BioLineRx and conducted by ZS Associates which identified the value of the U.S. stem cell mobilization market at $360 million and growing. Management estimates that global markets for SCM exceed $500 million in annual revenues.

Commercialization

Management has shared initial thoughts regarding commercialization plans for motixafortide. Pre-commercialization activities have started and include preparations related to engaging key vendors, commercial packaging and design, pricing and market access activities and brand name selection. The new hire with these responsibilities, Holly May, was hired in June as Chief Commercial Officer (CCO). Some of her other responsibilities will include medical affairs, which includes institutional profiling, medical materials outreach to key stakeholders, and engaging commercial packaging, serialization and third-party logistics planners. The company is open to either internal or external commercialization and has identified about 80 transplant centers3 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 if BioLineRx elects to pursue commercialization on its own.

Pre-NDA meeting with FDA held for BL-8040

On January 18, 2022, BioLineRx announced that it conducted 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 September 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. If results are favorable, BioLineRx will initiate a randomized Phase II study in 2023.

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1. BioLineRx August 2022 Corporate Presentation

2. BioLineRx August 2022 Corporate Presentation

3. 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.

4. BioLineRx August 2022 Corporate Presentation