Trillium Therapeutics Reports Third Quarter 2020 Financial and Operating Results
November 16 2020 - 7:00AM
Trillium Therapeutics Inc. (“Trillium” or the “Company”)
(NASDAQ/TSX: TRIL), a clinical stage immuno-oncology
company developing innovative therapies for the treatment of
cancer, today reported financial and operating results for the nine
months ended September 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 tumor
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%; 1 complete response, 5 partial responses)
have been observed among 18 response evaluable patients treated at
dose levels of 0.8, 2.0, 4.0 and 8.0 mg/kg. Responses had occurred
across all dose levels in this range, with three of six (50%)
patients achieving responses in the 8.0 mg/kg cohort (response
assessment for one additional patient at 8 mg/kg dose not available
as of the cutoff date).
- The safety assessment of the 8
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 8 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 2-4 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.
- Antitumor activity in the 1 mg/kg
cohort included 1 partial response and 1 skin complete response
(overall assessment stable disease) in 6 evaluable patients; 2
patients were bridged to allogeneic transplantation. Preliminary
data suggested dose-dependent improvements in modified severity
weighted assessment tool (mSWAT) scores in the 0.5 to1.0 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.
Financings: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 $0.1 million.
In September 2020, the Company also completed an
underwritten public offering of 11,500,000 common shares, at a
public offering price of $13.00 per share. The number of shares
sold include 1,500,000 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.
Governance changes:In September
2020, Dr. Michael 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, Paolo Pucci joined the Board of Directors on
November 12, 2020 and brings significant expertise in oncology drug
development and commercialization. He most recently served as CEO
of ArQule until it was acquired by Merck for $2.7 billion in
January 2020.
Third Quarter 2020 Financial
Results:As of September 30, 2020, Trillium had cash and
cash equivalents and marketable securities of $292.4 million,
compared to $22.7 million at December 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 September 30,
2020 of $173.0 million was higher than the loss of $22.4 million
for the nine months ended September 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.
Selected Consolidated Financial
Information:
Consolidated statements of loss |
Amounts in thousands of US dollarsexcept per share amounts |
Nine months endedSeptember 30,
2020 |
Nine months endedSeptember 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 |
|
Consolidated statements of financial position |
Amounts
in thousands of US dollars |
As atSeptember 30, 2020 |
As atDecember 31, 2019 |
|
Cash and marketable securities |
$292,409 |
$22,666 |
|
Total assets |
|
297,798 |
|
25,407 |
|
Total equity (deficiency) |
|
184,289 |
|
(168) |
|
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 “don’t eat me”
signal that cancer cells frequently use to evade the immune
system.
For more information visit:
www.trilliumtherapeutics.com
Caution Regarding Forward-Looking
Information
This press release contains forward-looking
statements within the meaning of applicable United States
securities laws and forward-looking information within the meaning
of Canadian securities laws (collectively, "forward-looking
statements"). Forward-looking statements in this press release
include statements about, without limitation, our expectation of
initiating a Phase 2 program in heme and solid tumor malignancies
in 2021 and enrollment in our TTI-622 and TTI-621 studies. With
respect to the forward-looking statements contained in this press
release, Trillium has made numerous assumptions regarding, among
other things: the impact of the Covid-19 pandemic on its
operations, the effectiveness and timeliness of preclinical and
clinical trials; and the completeness, accuracy and usefulness of
the data. While Trillium considers these assumptions to be
reasonable, these assumptions are inherently subject to significant
scientific, business, economic, competitive, market and social
uncertainties and contingencies. Additionally, there are known and
unknown risk factors that could cause Trillium's actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements contained in this press release. A
discussion of risks and uncertainties facing Trillium appears in
Trillium's Annual Information Form for the year ended December 31,
2019 filed with Canadian securities authorities and on Form 40-F
with the U.S. Securities Exchange Commission, each as updated by
Trillium's continuous disclosure filings, which are available at
www.sedar.com and at www.sec.gov. All forward-looking
statements herein are qualified in their entirety by this
cautionary statement, and Trillium disclaims any obligation to
revise or update any such forward-looking statements or to publicly
announce the result of any revisions to any of the forward-looking
statements contained herein to reflect future results, events or
developments, except as required by law.
Investor Relations:James
ParsonsChief Financial OfficerTrillium Therapeutics Inc.
416-595-0627 x232james@trilliumtherapeutics.com
www.trilliumtherapeutics.com
Media Relations:Mike Beyer Sam
Brown Inc. 312-961-2502mikebeyer@sambrown.com
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