On March 9, 2016 Trillium Therapeutics Inc. (NASDAQ:TRIL; TSX: TR) a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial results for the year ended December 31, 2015 and provides a corporate update (Press release, Trillium Therapeutics, MAR 9, 2016, View Source [SID:1234509480]).
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"2015 was a pivotal year for Trillium with the successful advancement of TTI-621, our checkpoint inhibitor targeting CD47, into human clinical trials in patients with advanced hematologic malignancies and we look forward to providing an update on this trial by the end of this year," commented Trillium’s Chief Executive Officer, Dr. Niclas Stiernholm. "Another important event that took place in 2015 was the release of our in vitro data demonstrating markedly low binding of TTI-621 to human red blood cells, which may be an important differentiation factor from other agents targeting CD47, such as monoclonal antibodies."
2015 Highlights:
Filed our investigational new drug application with the FDA and initiated our multi-center, open-label Phase 1a/1b trial, evaluating TTI-621 as a single-agent in patients with relapsed or refractory hematologic malignancies. During the dose escalation phase set to enroll up to 36 subjects, we intend to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics in order to determine the optimal dose for subsequent enrollment in the expansion phase. In the second part of the trial, we intend to explore the safety and preliminary antitumor activity of TTI-621 at the optimal dose identified in the escalation phase in 12–15 subjects per hematologic malignancy type, which includes indolent B-cell lymphoma, aggressive B-cell lymphoma, T-cell lymphoma, Hodgkin lymphoma, chronic lymphocytic leukemia, multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome.
Subsequent to the end of the year, Trillium acquired privately-held Fluorinov Pharma Inc. to gain an in-house proprietary fluorine-based chemistry platform and several preclinical oncology programs.
Presented data from an expanded pool of human donors that conclusively demonstrated that TTI-621, which targets the CD47 "do not eat" signal, exhibits only minimal binding to human red blood cells (RBCs) despite their high expression of CD47. These data are in direct contrast to anti-CD47 monoclonal antibodies, which bind strongly to RBCs. Consequently, compared to antibodies TTI-621 may be less likely to induce anemia in patients, may result in improved pharmacological properties due to the avoidance of the antigen "sink" effect caused by RBCs, and may avoid interference with laboratory blood typing tests.
Presented data at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) demonstrating that TTI-621 triggers macrophage-mediated phagocytosis of a broad range of human B cell tumors and was effective at controlling the growth of aggressive B cell lymphoma xenografts in mice.
Strengthened our research and drug development teams, including the appointment of Eric L. Sievers, MD, who joined us as Chief Medical Officer from Seattle Genetics.
Completed an underwritten public offering of US$55 million in April providing funds enabling the clinical advancement and expansion of our TTI-621 program. Participating investors included several premier US healthcare funds.
2015 Financial Results:
Our cash increased to $86,770,542 at December 31, 2015 compared to $26,165,056 at December 31, 2014 due mainly to funds received in the April 2015 public offering, warrant exercises and foreign exchange gains, partially offset by cash used in operations.
Net loss for the year ended December 31, 2015 of $14,733,699 exceeded the loss of $12,881,820 for the comparable prior year due mainly to higher costs for our SIRPaFc development program including increased personnel costs.
For the year ended December 31, 2015, research and development costs increased over the comparable prior year as we completed IND-enabling toxicology studies, incurred manufacturing costs to supply our clinical trial, completed the IND submission and initiated the Phase I trial in 2015. Personnel costs were also higher in 2015 as we added staff to manage our expanded research and development activities.
General and administrative expenses for the year ended December 31, 2015 were higher than the comparable prior year due mainly to higher insurance expenses, Fluorinov acquisition costs, and personnel-related costs, partially offset by lower stock exchange filing fees.
Finance income for the year ended December 31, 2015 was higher than the comparable prior year due mainly to a net foreign currency gain of $6,106,703 due mainly to holding U.S. dollar denominated cash with a strengthening U.S. dollar.
Selected Consolidated Financial Information:
Consolidated Statements of Loss and Comprehensive Loss
Amounts in Canadian dollars Year ended December 31, 2015 Year ended December 31, 2014
Research and development expenses 18,050,091 10,595,808
General and administrative expenses 3,184,347 2,577,460
Net finance income (6,510,241) (291,448)
Net loss and comprehensive loss for the year 14,733,699 12,881,820
Basic and diluted loss per common share (2.22) (3.06)
Consolidated Statements of Financial Position
Amounts in Canadian dollars As at December 31, 2015 As at December 31, 2014
Cash 86,770,542 26,165,056
Total assets 90,039,468 28,186,032
Total equity 85,803,868 24,304,294