Dr. Niclas Stiernholm reports
TRILLIUM THERAPEUTICS REPORTS ANNUAL FINANCIAL AND OPERATING RESULTS
Trillium Therapeutics Inc. has released financial and operating results for the year ended Dec. 31, 2018.
Provided an update on the safety and anti-tumour activity observed in the phase 1 study of local TTI-621 administration in highly pretreated patients with relapsed or refractory mycosis fungoides or Sezary syndrome at the American Society of Hematology 60th annual meeting. Intratumoral TTI-621 was well tolerated in 27 treated patients, with no grade three or higher toxicity observed; a rapid reduction in composite assessment of index lesion severity (CAILS) scores, which measure local lesion responses, was observed in 91 per cent (20/22) of patients with available scores across all disease stages, with 41 per cent (9/22) exhibiting a 50 per cent or greater decrease in CAILS scores; similar CAILS-based changes were seen in adjacent non-injected lesions, suggesting local regional effects that were not confined to the site of injection; continuation monotherapy beyond the initial two-week induction period led to further reductions in CAILS scores in three out of four evaluable patients, and evidence of systemic effects was observed in one patient; in addition, emerging translational data demonstrate that local TTI-621 administration leads to a rapid influx of macrophages and "CD8+" T-cells;
Provided an update of the safety and efficacy of the phase 1a/b intravenous trial of TTI-621 in patients with relapsed/refractory hematologic malignancies at the 16th Annual Discovery on Target conference; based on an expanded data set of 163 patients, weekly infusions of TTI-621 were shown to be well tolerated; thrombocytopenia was the most frequent grade three or higher treatment-emergent adverse event, occurring in 20 per cent of patients. Platelet reductions, however, were shown to be transient, and predose platelet levels remained steady during the course of the study; notably, the reversible thrombocytopenia did not lead to an increased risk of bleeding and had no impact on drug delivery, nor was there a significant impact of TTI-621 on hemoglobin levels; monotherapy efficacy was observed in patients with mycosis fungoides (19 per cent ORR, n equals 21), peripheral T-cell lymphoma or PTCL (25 per cent ORR, n equals 12), and diffuse large B-cell lymphoma, or DLBCL (25 per cent ORR, n equals 8), and in DLBCL patients when combined with rituximab (25 per cent ORR, n equals 24); this clinical activity was observed in patients receiving relatively low doses of drug (0.2 milligram per kilogram for monotherapy or 0.1 milligram per kilogram in combination with rituximab); dose intensification beyond 0.2 milligram per kilogram is currently continuing, and doses of 0.5 milligram per kilogram have been well tolerated for up to 27 weeks;
Initiated a multicentre, open-label, phase 1a/1b study of TTI-622 (SRIPaFc-IgG4) in patients with advanced relapsed or refractory lymphoma or multiple myeloma; in the phase 1a dose-escalation part, patients are enrolled in sequential dose cohorts to receive TTI-622 once weekly to characterize safety, tolerability and pharmacokinetics and to determine the maximum tolerated dose; in the phase 1b part, patients will be treated with TTI-622 in combination with rituximab, a proteasome inhibitor-containing regimen, or a PD-1 inhibitor;
Received an orphan drug designation to TTI-621 for the treatment of cutaneous T-cell lymphoma from the U.S. Food and Drug Administration office of orphan product development.
"In 2018, we presented clear evidence of single-agent activity in B- and T-cell lymphoma. We believe that TTI-621 is the most potent CD47-blocking agent in the clinic due to its IgG1 Fc region, which can deliver an activating signal to the immune system," said Dr. Niclas Stiernholm, president and chief executive officer of Trillium Therapeutics. "What is especially noteworthy is the ability of TTI-621 to stimulate a rapid anti-tumour response when administered intratumorally to patients with cutaneous T-cell lymphoma. We are also encouraged by the activity we have seen after intravenous delivery of relatively low doses, and look forward to characterizing the responses as we continue to dose intensify. We believe that this represents the most compelling evidence of monotherapy activity compared to all other CD47-blocking agents in the clinic, and we continue to execute a focused development plan in T-cell lymphoma."
Annual 2018 financial results
As of Dec. 31, 2018, Trillium had cash and cash equivalents and marketable securities, and working capital of $45.4-million and $34.2-million, respectively, compared with $81.8-million and $68.9-million, respectively, at Dec. 31, 2017. The decrease in cash and cash equivalents and marketable securities was due mainly to cash used in operations of $39.3-million, net of an unrealized foreign exchange gain of $3.1-million. The decrease in working capital was due mainly to cash used in operations and a decrease to accounts payable and accrued liabilities due to timing of clinical-trial-related payments.
Net loss for the year ended Dec. 31, 2018, of $42.5-million was lower than the loss of $45.1-million for the year ended Dec. 31, 2017. The net loss was lower mainly due to a net foreign currency gain of $3.5-million for the year ended Dec. 31, 2018, compared with a net foreign currency loss of $4.7-million in the prior-year period, and lower manufacturing costs, partially offset by higher clinical trial expenses and the expense relating to the amendment of the SIRPaFc licence agreement.
Selected consolidated financial information
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(amounts in thousands of dollars except per-share amounts)
Year ended Year ended
Dec. 31, 2018 Dec. 31, 2017
Research and development expenses $43,426 $37,135
General and administrative expenses 3,582 3,861
Net finance costs (income) (4,530) 4,088
Income tax expense 8 4
Net loss and comprehensive loss for the period 42,486 45,088
Basic and diluted loss per common share 3.06 4.61
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(amounts in thousands of dollars)
As at Dec. 31, 2018 As at Dec. 31, 2017
Cash and marketable securities $45,409 $81,791
Total assets 55,459 94,403
Total equity 41,601 78,577
About Trillium Therapeutics
Trillium is an immuno-oncology company developing innovative therapies for the treatment of cancer. The company's two clinical programs, TTI-621 and TTI-622, target CD47, a do-not-eat signal that cancer cells frequently use to evade the immune system. Trillium also has a proprietary fluorine-based medicinal chemistry platform that is being used to develop novel compounds directed at undisclosed immuno-oncology targets.
We seek Safe Harbor.
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