On August 25, 2021 CTI BioPharma Corp. (Nasdaq: CTIC) (CTI) and DRI Healthcare Trust (TSX: DHT.UN) (TSX: DHT.U) (DRI) reported transactions totaling up to $135 million in funding for CTI, with $50 million in secured debt to be funded at closing and $60 million to purchase a tiered royalty on sales of pacrinitib upon product approval of pacrinitib by the U.S. Food and Drug Administration (FDA) (Press release, CTI BioPharma, AUG 25, 2021, View Source [SID1234586876]). The proceeds of the transactions will be used by CTI to fund the commercialization of pacritinib for the treatment of myelofibrosis patients with severe thrombocytopenia. CTI has a New Drug Application (NDA) under priority review by FDA with a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2021, and is preparing for a potential commercial launch by end of year.
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CTI BioPharma and DRI Healthcare Trust Announce up to $135 Million Debt and Royalty Transaction
"CTI is in a strong position to deliver a meaningful new treatment option for patients with myelofibrosis with thrombocytopenia who are in urgent need of new therapies. If we achieve our sales goals in the first two years of launch, we anticipate that this transaction will put us on a clear path to profitability," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "We thank DRI for their support of CTI and for their partnership during the launch and commercialization of pacritinib."
"We are excited to announce DRI’s partnership with CTI," said Behzad Khosrowshahi, Chief Executive Officer of DRI Healthcare Trust. "Pacritinib is a great addition to our portfolio as a new therapy that addresses a high unmet medical need for patients with myelofibrosis with severe thrombocytopenia."
"This transaction highlights our ability to offer flexible deal structures that provide DRI with excellent assets and strong cash flow, while providing for the objectives of our partners such as CTI," continued Mr. Khosrowshahi.
About the Transaction
DRI Healthcare will provide a $50 million credit facility at closing. The credit facility bears interest at LIBOR + 8.25% (with a LIBOR floor of 1.75%) and is interest-only for the loan term of 5 years, with the outstanding principal due at maturity. The company will be subject to one financial covenant, which is maintaining minimum liquidity of at least $10 million during the term of the loan.
DRI Healthcare will also provide CTI with $60 million upon receiving accelerated approval of pactritinib, and will receive royalties on annual pacrinitib net sales in the United States of 9.6% for the first $125 million of annual U.S. net sales, 4.5% between $125 million and $175 million of annual U.S. net sales, 0.5 % between $175 million and $400 million of annual U.S. net sales, with no entitlement above $400 million of annual U.S. net sales. CTI will be entitled up to an additional $25 million on achievement of certain sales milestones.
Cowen acted as financial advisor to CTI on this transaction.
About Myelofibrosis and Severe Thrombocytopenia
Myelofibrosis is bone marrow cancer that results in formation of fibrous scar tissue and can lead to severe thrombocytopenia and anemia, weakness, fatigue and enlarged spleen and liver. Patients with severe thrombocytopenia are estimated to make up more than one-third of patients treated for myelofibrosis, or approximately 17,000 people in the United States and Europe. Severe thrombocytopenia, defined as blood platelet counts of less than 50,000 per microliter, has been shown to result in overall survival rates of just 15 months. Thrombocytopenia in patients with myelofibrosis is associated with the underlying disease but has also been shown to correlate with treatment with ruxolitinib, which can lead to dose reductions, and as a result, may potentially reduce clinical benefit. Survival in patients who have discontinued ruxolitinib therapy is further compromised, with an average overall survival of seven to 14 months. Myelofibrosis patients with severe thrombocytopenia have limited treatment options, creating a significant area of unmet medical need.
About Pacritinib
Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, IRAK1, and CSF1R, but not JAK1. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia, and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and chronic lymphocytic leukemia (CLL), due to its inhibition of c-fms, IRAK1, JAK2 and FLT.