On September 15, 2022 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, reported that the Company has entered into a $40 million non-dilutive secured debt financing agreement with Kreos Capital, a leading provider of innovative and flexible debt solutions to equity-backed, pan-European and Israeli high-growth companies in the technology and healthcare sectors (Press release, BioLineRx, SEP 15, 2022, View Source [SID1234619570]).

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Per the terms of the agreement, the first tranche of $10 million was made available to BioLineRx upon execution of the definitive agreement, subject to customary conditions to closing. The remaining $30 million will be made available in two additional tranches subject to the achievement of pre-specified milestones. The tranches are available for drawdown at BioLineRx’s discretion at various time points through October 1, 2024.

Each tranche carries a pre-defined interest-only payment period, followed by a loan principal amortization period of up to 36 months subsequent to the interest-only period. The interest-only periods are subject to possible extension based on certain pre-defined milestones. Borrowings under the financing will bear interest at a fixed rate of 9.5% per annum (~11.0%, including associated cash fees). In addition, Kreos will be entitled to mid-to-high single-digit royalties on Motixafortide sales, up to a pre-defined cap. No warrants were issued by BioLineRx in connection with this financing.

BioLineRx intends to use the available funds from this agreement, together with cash on-hand, to support an aggressive commercial launch for Motixafortide in autologous stem cell mobilization for multiple myeloma patients, if approved, while it continues to evaluate U.S. commercialization strategies. BioLineRx recently submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking marketing approval for this underserved hematology/oncology indication.

"We are very pleased to have the support of Kreos Capital, a well-known and highly regarded healthcare investor, as we prepare to transition to a commercial stage company next year," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Kreos has been a very supportive partner in the past, having assisted with critical debt financing in 2018 as we further increased our stake in, and commitment to, the development of Motixafortide. Having successfully satisfied that obligation, we are fortunate to again be working with a team that is already very familiar with our Company and our lead program."

"Access to this non-dilutive funding, at terms that we believe are favorable to the Company, allows us to prepare for a robust launch of Motixafortide, if approved, while we continue to evaluate different U.S. commercialization alternatives. This will help ensure that multiple myeloma patients across the U.S. have broad access to this new and highly effective mobilization agent as quickly as possible," Mr. Serlin concluded.

"At Kreos, we have established a track record of investing in therapeutics companies that drive true innovation, and we believe Motixafortide, if approved, has the potential to quickly become the standard of care in stem cell mobilization for the benefit of providers, patients and payers," stated Chris Church, Principal at Kreos. "We look forward to working closely with BioLineRx as it works toward achieving its regulatory and post-launch commercial goals."

As of June 30, 2022, BioLineRx reported cash and cash equivalents of $43.2 million.