BioLineRx Ltd. (NASDAQ:BLRX) almost doubled motixafortide product sales sequentially in 2Q:24. The second quarter’s $1.8 million in sales coincided with formulary placement of 37% of targeted centers. Product gross margin was 95%, rising slightly over 1Q:24. The company expects to reach formulary status of 60% of the top 80 transplant centers by year end 2024.
Other achievements of note include BioLine’s clinical trial agreement with St. Jude’s to evaluate motixafortide in a second gene therapy study for sickle cell disease. Gloria Biosciences’ IND application for stem cell mobilization was cleared in China with a pivotal trial slated for 2H:24. Design for Gloria’s Phase IIb in pancreatic cancer was completed with trial initiation expected in 2025 and Columbia’s pancreatic trial continues to enroll patients with full enrollment expected in 2027.
2Q:24 Operational and Financial Results
BioLineRx’ second quarter in 2024 achieved sales of $5.4 million and net income of $484,000 or $0.00 per share. After removing non-operating income, net loss was ($7.3) million or ($0.01) per share. The results were announced in a press release on August 15, 2024 followed by a conference call with management and the filing of Form 6-K providing additional information.
Below we summarize financial results for the three-month period ended June 30, 2024, compared to the same prior year period:
➢ Revenues were $5.4 million representing a portion of the upfront and milestone payment from Gloria Biosciences ($3.6 million) and Aphexda product revenues of ($1.8 million) versus $0;
➢ Cost of revenues was $0.9 million which largely represents a pass through to license-holder Biokine as a royalty on motixafortide revenues. Amortization of intangible assets is also included in cost of revenues. Product gross margin relating to Aphexda sales was 95.4%;
➢ Research and development expenses totaled $2.2 million, down 26% from $3.0 million, on account of lower expenses related to the new drug application (NDA) supporting activities related to Aphexda, lower expenses associated with the termination of the AGI-134 program and a decrease in share-based compensation;
➢ Sales and marketing expenses were $6.4 million, up 14% from $5.6 million as a result of commercialization activities related to Aphexda including the addition of new sales personnel and a fully hired field team;
➢ General and administrative (G&A) expenses were $1.6 million, up 25% from $1.3 million due to a rise in legal and other expenses;
➢ Non-operating income was $7.8 million reflecting changes in fair-value adjustments of warrant liabilities on the balance sheet as the company’s share price fell;
➢ Net financial expenses amounted to ($1.6) million which was impacted by interest paid on loans offset by interest received from bank deposits;
➢ Net income was $484,000 compared with ($18.5) million, or $0.00 and ($0.02) per share respectively. After removing non-operating income of $7.8 million related to the warrant liabilities, net loss was ($7.3) million or ($0.01) per share.
Cash, equivalents and short-term bank deposits as of June 30, 2024 totaled $40.1 million, down from the year end 2023 balance of $43.0 million. 1H:24 cash burn was ($25.5) million and cash from financing was $23.0 million. Financing cash contributions came from issuance of share capital and warrants as well as net proceeds from the loan agreement with BlackRock. BioLineRx expects to have sufficient resources to meet capital requirements into 2025.
Motixafortide Trials
Since December of 2023, BioLineRx partners have started dosing patients in multiple trials for motixafortide in gene therapy and PDAC. Both partners are associated with US-based universities, but the end indications are quite different. The first trial is sponsored by the Washington University School of Medicine and is evaluating motixafortide and natalizumab to mobilize CD34+ HSCs for gene therapy in sickle cell disease. The second trial is sponsored by Columbia University and is examining motixafortide treatment in combination with a checkpoint inhibitor and first line chemotherapies in PDAC. A new study was announced in May with St. Jude Children’s Hospital which will evaluate motixafortide in stem cell mobilization for gene therapy in sickle cell disease.
Washington University School of Medicine Sickle Cell Disease In late December, BioLineRx partner Washington University School of Medicine (WashU) in Saint Louis, Missouri dosed its first patient. WashU is conducting a proof-of-concept study to identify a more efficient CD34+ HSC mobilization regimen for patients with sickle cell disease (SCD). The study, registered under the NCT05618301 identifier, initially planned to enroll five patients diagnosed with SCD to assess the safety and tolerability of motixafortide alone and with natalizumab to produce HSCs for use in gene therapy. This was later increased to ten patients who will be followed for eight weeks for adverse event monitoring. The trial seeks to evaluate the safety of stem cell mobilization in sickle cell patients; however, it will not be followed by gene therapy treatment which may take place at a later time under another investigational new drug (IND) application. Data from the trial is expected in 2H:24.
Columbia University Pancreatic Adenocarcinoma The investigator-initiated trial is a multi-center, randomized Phase IIb study evaluating motixafortide with cemiplimab, gemcitabine and nab-paclitaxel for effectiveness in treating pancreatic ductal adenocarcinoma. It combines the might of Regeneron and BioLineRx along with Columbia University in this combination drug trial. On February 28th, BioLineRx announced that the first patient had been enrolled in the CheMo4METPANC Phase II combination study. While checkpoint inhibitors have been effective in a number of cancers such as melanoma, this has not been the case for PDAC prompting investigators to examine the use of combination therapies to improve prognosis. Early pilot data was supportive of this proof-of-concept study where 64% of patients experienced a partial response and 27% experienced stable disease. Listed under NCT04543071 in the clinical trials database, the study first enrolled 11 participants to measure response rate and safety. Study objectives were met with the first group, and it is now expanding into a randomized Phase IIb study enrolling 108 participants in two arms. Early pilot phase data were presented at the Immuno-oncology 360° Summit on February 29, 2024. Data was later presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting held on June 1. New analyses of paired pre- and on-treatment biopsy samples demonstrated a statistically significant increase in CD8+ T-cell density in tumors from all 11 patients treated with the combination therapy approach with a p-value of 0.007. Enrollment in the randomized trial targeting 108 patients is ongoing with full enrollment anticipated in 2027.
St. Jude Children’s Research Hospital On May 30th, 2024 BioLine announced that it had entered into an agreement with St. Jude Children's Research Hospital to expand clinical research of motixafortide into stem cell mobilization for sickle cell disease (SCD). The investigator-initiated study will enroll SCD patients at three clinical sites. Enrollment in the trial is expected in September with results to be shared in 2025.
The trial is designated SCDSTEMM (Sickle Cell Disease Stem Cell Mobilization and Apheresis Using Motixafortide). It will be an open-label, multi-center Phase I clinical trial evaluating the safety, tolerability and feasibility of single-agent motixafortide for the mobilization and collection of CD34+ HSCs in 12 adult patients with SCD. The trial's primary objective is to assess the safety and tolerability of motixafortide in SCD patients, as determined by the incidence of adverse events. Secondary objectives include understanding CD34+ kinetics after motixafortide administration in patients with SCD and determining the number of CD34+ HSCs collected via leukapheresis. The study is designed in two parts with equal enrollment in each arm. The first, Part A, will evaluate single dose motixafortide mobilization followed by one apheresis session. The second, Part B, will evaluate daily motixafortide administration over a two-day mobilization and apheresis regimen. Additional goals include phenotype and cell function characterization as well as assessment of the gene modifying potential and senescence of CD34+ cells.
Milestones
➢ IND filing for bridging study for Aphexda in China – February 2024
➢ Motixafortide PDAC trial first patient dosed – February 2024
➢ Gloria Biosciences’ bridging study data report – 2025
➢ St. Jude sickle cell initial data – 2025
➢ Data from St. Jude Phase I sickle cell study - 2026
➢ Full enrollment for Columbia University PDAC - 2027
Summary
Aphexda has continued to penetrate target institutions reaching 37% of the top 80 transplant centers during the second quarter. Management has maintained its year-end target of 60% penetration. BioLineRx doubled Aphexda revenues sequentially and is on track to recognize almost $16 million in performance related revenues from Gloria this year. The Asian partner’s stem cell mobilization bridging study has been cleared in China and it plans to begin enrolling in 2H:24. Efforts with the pancreatic programs continue to advance with Gloria planning a Phase IIb trial in China in combination the PD-1 inhibitor zimberelimab and chemotherapy. In the United States, Columbia University has dosed its first patient in the Phase II pancreatic trial, which is expected to enroll 108 patients. The principal investigator for the Columbia study, Dr Manji, presented details of the program at ASCO in early June. Gene therapy is also generating attention with the Washington University sickle cell disease trial enrolling patients and St. Jude Children’s Hospital sponsoring another sickle cell trial which should enroll its first patient in September. BioLineRx is making steady progress in its Aphexda product launch and with partner programs generating an array of opportunities for shareholders.
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