• Elaborating on agreement terms and tranches scheduleHAIFA, Israel, April 30, 2020 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI) (the “Company”), a leading regenerative medicine company developing a platform of novel biological therapeutic products, today provided a summary of an Investor & Analyst Call (the “Call”) conducted on April 30, 2020, in conjunction with the European Investment Bank (“EIB”) and kENUP Foundation. The purpose of the Call was to discuss the €50 million venture loan financing (the “Financing”) to Pluristem by the EIB and followed a signing ceremony of the Financing contract on Innovation Cell Therapies (EGFF) between the parties.Speakers on the Call included Pluristem’s CEO and President, Yaky Yanay, and the Company’s, CFO, Chen Franco-Yehuda; the kENUP Foundation’s Chairman Holm Keller; and the EIB’s Investment Officer, Anna Stodolkiewicz. During the Call, the speakers presented details regarding the EIB’s Financing to Pluristem in support of the Company’s research and development in the European Union to further advance its regenerative cell therapy platform, and to assist in moving its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19. The presentation was followed by a question and answer session with financial and industry analysts.Pluristem CFO, Chen Franco-Yehuda, summarized the EIB’s Financing to Pluristem and provided an update on the Company’s financial highlights.A total of up to €50 million is made available from the EIB to Pluristem through three tranches over a period of 36 months. The Financing will not exceed 50% of the total cost of the applicable project. Each tranche will be disbursed following the achievement of certain clinical, regulatory and scaleup milestones. The first tranche is €20 million, followed by a second tranche of €18 million, and a third tranche of €12 million.Each tranche will be treated independently from the others, with the following repayment dates: a) the first tranche of €20 million will be repaid 5 years following its disbursement with a 4% deferred annual interest, paid at maturity of the tranche; b) the second tranche of €18 million will be repaid 5 years following its disbursement with a 3% deferred annual interest, paid at maturity of the tranche, and 1% annual cash interest; and c) the third tranche of €12 million will be repaid in 2 annual installments starting on the 4th anniversary from its disbursement with 2% deferred annual interest, paid at maturity of the tranche, and 1% annual cash interest.Royalties will be paid on Pluristem’s consolidated revenues if generated between fiscal years 2024-2030, pro-rated to the amount disbursed from the EIB Financing, as follows:
a) 2.3% of consolidated annual revenues applying on the portion of less than $350 million;
b) 1.2% of consolidated annual revenues applying on the portion between $350 million and $500 million;
c) 0.2% of consolidated annual revenues exceeding $500 million. Pluristem can buy back the royalty commitment for a payment that will not exceed €50 million.Pluristem has cash and deposits of approximately $44 million as of April 30, 2020 as compared to approximately $17 million on December 31, 2019. Since January 1, 2020, funding has been obtained through an At-the-Market (ATM) facility, warrant exercises and grants from the European Horizon 2020 program. Pluristem’s currently available resources, including the EIB Financing, assuming all milestones are reached and applicable payments are made, are expected to total approximately $100 million and are expected to fund Pluristem’s operations through the coming 3 years.Pluristem CEO and President, Yaky Yanay, provided an update on the Company’s clinical programs. An Investigational New Drug (IND) application has been filed with the U.S. Food and Drug Administration (“FDA”) and a Clinical Trial Authorization (CTA) application has been submitted in Europe, starting with Germany and Italy. Pluristem intends to commence Phase II studies of PLX cell therapy in the treatment of complications arising from COVID-19 as soon as it receives clearance from regulators in the U.S. and Europe. Anticipating responses in the next few weeks, Pluristem aims to complete enrollment and treatment in a few months, by utilizing its logistical and technological competitive advantages to support effective enrollment. In parallel, the Company will conduct an Expanded Access Program in the U.S. and Europe. The EIB Financing, once received, will allow the Company to expedite the process.The critical limb ischemia (CLI) Phase III study is advancing with more than 80% patients enrolled; enrollment has slowed in April2020. Pluristem is now finalizing discussions with the FDA and European Medicines Agency (EMA) regarding the interim data readout, confirming understandings on endpoint, timing, and procedures for cleaning data during COVID-19 limitations. Expected announcement of the interim readout top line results to be delayed to the beginning of the fourth quarter of calendar year 2020. The Company is and will continue to closely follow the guidelines that will enable access to the clinical sites to clean the data prior to data lock.The Company will provide guidelines for expected end of enrollment of the entire study once having better clarity of the impact of COVID-19 on the enrollment rate.The Phase III study on muscle regeneration following hip fracture is more than 60% enrolled; enrollment has slowed in April 2020. Pluristem has been working hard to secure Short Physical Performance Battery (SPPB) data capture, working with the sites on home monitoring.The Company will provide guidelines for expected end of enrollment of the entire study once having better clarity of the impact of COVID-19 on the enrollment rate.“By leveraging our logistical and technological competitive advantages, we believe we can rapidly and effectively enroll and treat COVID-19 patients in the U.S. and Europe. We believe that the EIB’s Financing allows us to expedite this process and we are immensely grateful for their support. While we plan to treat COVID-19 patients through a clinical trial framework, we plan to have parallel expanded access and compassionate use programs in the U.S., Europe, and Israel, through which we can continue to deliver our potentially life-saving PLX therapy to patients in need,” concluded Mr. Yanay.Holm Keller, Chairman of kENUP Foundation, commented regarding Pluristem’s activity, “Pluristem is an exceptionally innovative company advancing regenerative medicine solutions with cell manufacturing technologies that can truly make cell therapy available in mass quantities and efficiently. It is for this reason that kENUP was compelled to bring Pluristem and the EIB together in partnership to accelerate the commercialization of regenerative medicine.”Anna Stodolkiewicz, Investment Officer of the EIB, said: “Through our financing, we aim to support Pluristem in addressing life threatening medical problems. Be it COVID-19, critical limb ischemia or the recovery following hip fracture – all of them disproportionally affect an aging population. We especially appreciate that Pluristem seeks to accelerate regenerative, non-invasive treatments that ease the burden on patients and Europe’s healthcare systems alike. In addition, Pluristem will create highly skilled jobs and economic opportunities in the EU.”About the European Investment Bank
The European Investment Bank (EIB) is the long-term lending institution of the European Union, owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals.
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