BioLineRx Ltd. (NASDAQ:BLRX) produced a 390% sequential sales increase in its first full quarter of sales in 1Q:24. While it was off of a small base, the quarter’s $924,000 in sales coincided with quarter end formulary placement of around 20%. As of the 1Q:24 report date at the end of May, BioLine had achieved formulary placement of about 26% which is expected to rise to 35% by the end of the second quarter. Product gross margin was firmly above 90%, essentially even with last quarter’s level. The company expects to achieve formulary status at 60% of the top 80 transplant centers by year end 2024.
BioLine’s partnerships are advancing with Gloria Biosciences’ investigational new drug (IND) application for hematopoietic stem cell (HSC) mobilization cleared by the Center for Drug Evaluation of the National Medical Products Administration in China. The pancreatic trial in collaboration with Columbia University dosed its first patient and a new sickle cell gene therapy trial was announced with St. Jude Children’s Research Hospital. Other achievements for 2024 include the close of additional debt and equity financing and participation in several scientific conferences.
Early success with PDAC has prompted Gloria to expand its work here. The partner will develop a Phase IIb randomized first line PDAC trial in China combining motixafortide with Gloria’s PD-1 inhibitor zimberelimab along with standard of care chemotherapy. This second trial is expected to begin in 2025.
1Q:24 Operational and Financial Results
BioLineRx’ first quarter in 2024 achieved sales of $6.9 million and net loss of ($696,000) or ($0.00) per share. The results were announced on May 28, 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 March 31, 2024, compared to the same prior year period:
➢ Revenues were $6.9 million representing a portion of the upfront and milestone payment from Gloria Biosciences ($5.9 million) and Aphexda product revenues of $924,000 versus $0;
➢ Cost of revenues was $1.5 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 92.6%;
➢ Research and development expenses totaled $2.5 million, down 32% from $3.7 million, on account of lower expenses related to the new drug application (NDA) supporting activities related to Aphexda and lower expenses associated with the termination of the AGI-134 program;
➢ Sales and marketing expenses were $6.3 million, up 64% from $3.9 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 $1.4 million, up 7% from $1.3 million due to a rise in payroll and related expenses due to an increase in share-based compensation;
➢ Non-operating income was $4.5 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 ($0.4) million which was impacted by interest paid on loans offset by interest received from bank deposits;
➢ Net loss was ($696,000) compared with ($12.2) million, or ($0.00) and ($0.01) per share respectively.
Cash, equivalents and short-term bank deposits as of March 31, 2024 totaled $28.2 million, down from the year end 2023 balance of $43.0 million. 1Q:24 cash burn was ($14.1) million and cash used in financing was ($0.9) million related to repayments of loan and lease liabilities. Some of the contributors to the difference in net loss and cash burn include subtraction of the fair value adjustment [($4.4) million], increase in trade receivables [($2.5) million], decrease in accounts payable [($3.5) million] and decrease in contract liabilities [($3.9) million]. Following the end of the quarter, BioLine raised net proceeds of $5.4 million from a registered direct offering and drew down $20 million in its loan agreement with BlackRock. BioLineRx expects to have sufficient resources to meet capital requirements into 2025.
2Q:24 Capital Raises
BioLineRx raised gross proceeds of $26 million in two transactions following the end of the first quarter including a $6 million registered direct offering and access of the second tranche of a $20 million in debt financing with BlackRock, previously Kreos Capital.
On April 1st, BioLineRx announced a $6 million registered direct offering through the issuance and sale of 7.5 million American Depository Shares (ADS) at $0.80 per share. The transaction included a warrant for each share with an exercise price of $0.80 which carries a five-year life. Net proceeds will be used to support commercialization of Aphexda and for general corporate purposes. JonesTrading Institutional Services served as the exclusive placement agent.
The following week, the company raised additional proceeds related to its September 2022 debt financing agreement with BlackRock EMEA Venture and Growth Lending (previously Kreos Capital). Details of the $20 million transaction were provided in a April 10th press release. This was the second tranche of a $40 million arrangement for which $10 million was accessed upon signing. The remaining tranche of $10 million may be accessed through October 1st, 2024. Borrowings under the financing bear interest at a fixed rate of 9.5% per annum or ~11.0%, including associated cash fees. In addition, funds and accounts managed by BlackRock are entitled to mid-to-high single-digit royalties on Aphexda sales, up to a pre-defined cap. No warrants were issued by BioLineRx in connection with the financing.
Other Motixafortide Trials
Since December of 2023, BioLineRx partners have started dosing patients in two 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 post earnings report with St. Jude Children’s Hospital.
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, plans 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. Patients will be followed for eight weeks for adverse event monitoring. This purpose of this trial is to evaluate the safety of stem cell mobilization in sickle cell patients and will not be followed by gene therapy treatment which may take place at a later time under another investigational new drug (IND) application.
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.
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 the next few months and may be informed by the other gene therapy sickle cell trial at Washington University, which is expected to provide results in 2H:24.
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.
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