Trillium Therapeutics Reports Third Quarter 2018 Financial and Operating Results
November 14 2018 - 7:00AM
Trillium Therapeutics Inc. (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, 2018.
2018 Third Quarter
Highlights:
- Presented an update at the European
Organisation for Research and Treatment of Cancer, Cutaneous
Lymphoma Task Force (EORTC CLTF) meeting on the safety and efficacy
of the ongoing multicenter, open-label phase 1 intratumoral trial
of TTI-621 in 23 patients with relapsed/refractory mycosis
fungoides/Sézary syndrome, 20 of whom only received induction
therapy consisting of 1-6 injections over 2 weeks. Local delivery
of TTI-621 was well tolerated, with no treatment-related > Grade
3 adverse events or dose-limiting toxicity observed. Reductions in
CAILS scores, which measure local lesion responses, were observed
in 89% of patients, with 44% exhibiting reductions of 50% or
greater. These responses occurred rapidly within the 2-week
induction period. Similar CAILS scores changes were seen in
adjacent non-injected lesions, suggesting locoregional effects that
were not confined to the site of injection. Evidence of a systemic
effect was observed in 1 of 2 patients receiving continuation
monotherapy beyond the 2-week induction therapy. In addition, data
suggest a combination effect with pegylated IFN-alpha-2a.
- Presented an update at the
Discovery on Target conference on the safety and efficacy of the
ongoing multicenter, open-label phase 1a/b intravenous trial of
TTI-621 in patients with relapsed/refractory hematologic
malignancies. 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 3 or higher
treatment-emergent adverse event, occurring in 20% of patients.
Platelet reductions, however, were shown to be transient and
pre-dose 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% ORR, n=21), peripheral T-cell lymphoma, or PTCL (25%
ORR, n=12), and diffuse large B-cell lymphoma, or DLBCL (25% ORR,
n=8), and in DLBCL patients when combined with rituximab (25% ORR,
n=24). This clinical activity was observed in patients receiving
relatively low doses of drug (0.2 mg/kg for monotherapy or 0.1
mg/kg in combination with rituximab). Dose intensification beyond
0.2 mg/kg is currently ongoing, and doses of 0.5 mg/kg have been
well tolerated for up to 27 weeks.
“The growing body of data from the TTI-621
intratumoral trial in patients with CTCL continues to look
encouraging, and we believe that there are several potential paths
forward in this indication, and possibly in other accessible
tumors,” said Dr. Niclas Stiernholm, president and CEO of Trillium
Therapeutics. “Additionally, data from over 160 patients in our
intravenous trial indicate that systemically delivered TTI-621 has
single-agent and combination activity at relatively low doses, and
ongoing efforts to dose intensify appear encouraging. We believe
that flexibility is the best way to address this new IO pathway,
and having two development candidates in the clinic, and options of
intravenous and intratumoral delivery, as monotherapy or in
combination, gives Trillium the most comprehensive approach to
targeting CD47.”
Third Quarter 2018 Financial
Results:
As of September 30, 2018, Trillium had cash and
cash equivalents and marketable securities, and working capital, of
$52.1 million and $41.8 million, respectively, compared to $81.8
million and $68.9 million, respectively, at December 31, 2017. The
decrease in cash and cash equivalents and marketable securities was
due mainly to cash used in operations of $30.8 million, net of an
unrealized foreign exchange gain of $1.3 million. The decrease in
working capital was due mainly to cash used in operations,
increases to amounts receivable and prepaid expenses, and a
decrease to accounts payable and accrued liabilities due to
clinical trial payments.
Net loss for the nine months ended September 30,
2018 of $33.9 million was lower than the loss of $34.4 million for
the nine months ended September 30, 2017. The net loss was lower
mainly due to a net foreign currency gain of $1.5 million for the
nine months ended September 30, 2018, compared to a net foreign
currency loss of $4.9 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
license agreement.
Selected Consolidated Financial
Information:
Consolidated statements of loss and
comprehensive loss |
Amounts in
thousands of Canadian dollars except per share amounts |
Nine
months endedSeptember 30, 2018 |
|
Nine
months endedSeptember 30, 2017 |
Research and development expenses |
$32,815 |
|
$27,324 |
General and administrative expenses |
3,376 |
|
2,607 |
Net
finance costs (income) |
(2,265 |
) |
4,499 |
Income tax expense |
7 |
|
- |
Net
loss and comprehensive loss for the period |
33,933 |
|
34,430 |
Basic
and diluted loss per common share |
2.49 |
|
3.77 |
Consolidated statements of financial
position |
Amounts in
thousands of Canadian dollars |
As
atSeptember 30, 2018 |
As
atDecember 31, 2017 |
Cash
and marketable securities |
$52,095 |
$81,791 |
Total
assets |
63,059 |
94,403 |
Total
equity |
49,295 |
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.
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 development plan
(including our proposed clinical trial program). With respect to
the forward-looking statements contained in this press release,
Trillium has made numerous assumptions regarding, among other
things: 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,
2017 filed with Canadian securities authorities and available at
www.sedar.com and on Form 40-F with the U.S. Securities Exchange
Commission and available at www.sec.gov, 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.
Contact:James ParsonsChief
Financial OfficerTrillium Therapeutics Inc. 416-595-0627
x232james@trilliumtherapeutics.com www.trilliumtherapeutics.com
Investor Relations:Jason Wong
Blueprint Life Science Group for Trillium Therapeutics 415-375-3340
x4jwong@bplifescience.com
Media Relations:Jessica Tieszen
Canale Communications for Trillium Therapeutics
619-849-5385jessica@canalecomm.com
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