Dr. Michael Kamarck reports
TRILLIUM THERAPEUTICS REPORTS THIRD QUARTER 2020 FINANCIAL AND OPERATING RESULTS
Trillium Therapeutics Inc. has provided financial and operating results for the nine months ended Sept. 30, 2020.
"Third quarter was a productive quarter for Trillium," said Jan Skvarka, the company's president and chief executive officer. "We reported encouraging clinical data updates for both TTI-622 and TTI-621, announced a $25-million equity investment from Pfizer, raised $150-million in a follow-on offering, and added Dr. Michael Kamarck to the board of directors. After the close of the third quarter, we announced formation of a scientific advisory board, appointment of Dr. Ingmar Bruns as our new chief medical officer and addition of Mr. Paolo Pucci to the board of directors. With close to $300-million in cash, we are well capitalized to embark on a phase 2 program in heme and solid tumour malignancies in 2021."
TTI-622 study update provided in the third quarter of 2020
In the Phase 1a/1b study in patients with advanced relapsed or refractory lymphoma or multiple myeloma (NCT03530683), the company reported that a total of six objective responses (33 per cent; one complete response, five partial responses) have been observed among 18 response evaluable patients treated at dose levels of 0.8, 2.0, 4.0 and 8.0 milligrams per kilogram. Responses had occurred across all dose levels in this range, with three of six (50 per cent) patients achieving responses in the 8.0 mg/kg cohort (response assessment for one additional patient at eight mg/kg dose not available as of the cut-off date).
The safety assessment of the eight mg/kg dosing cohort was successfully completed with one Grade 4 thrombocytopenia dose-limiting toxicity (DLT) reported among the six evaluable patients and no additional Grade 3 or higher thrombocytopenia events observed.
Clinical responses had been observed across multiple lymphoma indications, including diffuse large B-cell lymphoma, cutaneous T-cell lymphoma with large cell transformation, peripheral T-cell lymphoma and follicular lymphoma.
All responses were observed at the first assessment at eight weeks.
The study began enrolling patients at the 12 mg/kg dose level.
TTI-621 study update provided in the third quarter of 2020
In the phase 1 study in patients with advanced relapsed or refractory hematologic malignancies (NCT02663518), preliminary data from part 4 indicated the weekly infusions of TTI-621 up to 1.4 mg/kg were well tolerated without dose-limiting thrombocytopenia. Platelet decreases generally occurred on dosing days, recovered in two to four days, and had not worsened with increasing dose levels. Infusion-related reactions (IRRs) typically occurred during initial infusions and often resolved without recurrence. One Grade 3 IRR DLT was observed at 1.0 mg/kg.
Anti-tumour activity in the one mg/kg cohort included one partial response and one skin complete response (overall assessment stable disease) in six evaluable patients; two patients were bridged to allogeneic transplantation. Preliminary data suggested dose-dependent improvements in modified severity weighted assessment tool (mSWAT) scores in the 0.5 to 1.0 mg/kg cohorts (1.4 mg/kg cohort data not yet available).
The study began enrolling patients at the 2.0 mg/kg dose level.
In September, 2020, the company issued 2,297,794 common shares at a price of $10.88 per share to Pfizer Inc. in a registered direct offering. The gross proceeds from this offering were $25.0-million, before deducting offering expenses of $100,000.
In September, 2020, the company also completed an underwritten public offering of 11.5 million common shares, at a public offering price of $13 per share. The number of shares sold include 1.5 million common shares pursuant to the full exercise by the underwriters of their option to purchase additional common shares. The gross proceeds from this offering were $149.5-million, before deducting underwriting discounts and commissions, and offering expenses of $9.1-million.
In September, 2020, Dr. Kamarck joined the board of directors. Dr. Kamarck is chief technology officer for Vir Biotechnology Inc. and has significant experience and expertise with the development and manufacturing of biologic products.
In addition, Mr. Pucci joined the board of directors on Nov. 12, 2020, and brings significant expertise in oncology drug development and commercialization. He most recently served as chief executive officer of ArQule until it was acquired by Merck for $2.7-billion in January, 2020.
Third quarter 2020 financial results
As of Sept. 30, 2020, Trillium had cash and cash equivalents and marketable securities of $292.4-million, compared with $22.7-million at Dec. 31, 2019. The increase in cash and cash equivalents and marketable securities was due mainly to proceeds from financings completed in January, 2020, and September, 2020.
Net loss for the nine months ended Sept. 30, 2020, of $173.0-million was higher than the loss of $22.4-million for the nine months ended Sept. 30, 2019. The net loss was higher due mainly to a net warrant liability revaluation loss of $132.7-million, a loss of $22.1-million on the revaluation of the deferred share unit (DSU) liability (reclassified from a liability to equity effective June 30, 2020, on adoption of the new omnibus incentive plan) and higher manufacturing costs. This was partially offset by lower clinical trial expenses, salary expenses, intangible assets amortization and share-based compensation. Trillium's outstanding warrants are a non-cash liability, and revaluation losses on the company's warrant liability balance are of a non-cash nature.
CONSOLIDATED STATEMENTS OF LOSS
(amounts in thousands of U.S. dollars except per share amounts)
Nine months ended Nine months ended
Sept. 30, 2020 Sept. 30, 2019
Revenue $115 $124
Research and development expenses 15,186 21,779
General and administrative expenses 26,506 2,485
Impairment of intangible assets - 2,952
Net finance costs (income) 131,367 (4,695)
Income tax expense 60 24
Net loss for the period 173,004 22,421
Basic and diluted loss per common share 2.19 0.93
About Trillium Therapeutics Inc.
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 me signal that cancer cells frequently use to evade the immune system.
We seek Safe Harbor.
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