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, including an update on
its CD47 clinical programs, for the year ended December 31, 2020.
All financial amounts in this news release are in United States
dollars, unless otherwise stated.
“2020 was a critical year in Trillium’s
evolution, as we completed a wide-ranging transformation program
spanning all aspects of our activities, including strategy,
governance, leadership, advisory infrastructure, corporate
development, funding, investor base, intellectual property and
operations,” said Jan Skvarka, Trillium’s President and CEO. “At
the same time, we substantially advanced dose escalation studies of
TTI-622 and TTI-621, which clearly demonstrated class-leading
monotherapy activity. Our mission critical goal for 2021 is to
rapidly move to proof of concept studies in a range of hematologic
malignancy and solid tumor indications. We are incredibly excited
about our prospects going forward based upon the unique monotherapy
activity of our molecules, which provides a strong foundation for
moving to combination studies.”
2020 Transformation Program
In 2020, we completed a wide-ranging
transformation program under a new leadership, with the following
highlights:
- Strategy: Reset corporate strategy
by discontinuing a lead intra-tumoral cutaneous T-cell lymphoma
(CTCL) program, and shifting focus toward large hematological
malignancy and solid tumor indications via intravenous
administration.
- Clinical development: Substantially
advanced TTI-622 and TTI-621 dose escalation studies, while
demonstrating unique, highly differentiating monotherapy activity;
positioned both programs for moving to phase 2 development in
2021.
- Corporate development: Received $25
million equity investment from Pfizer, with Dr. Jeff Settleman,
Pfizer Oncology Chief Scientific Officer, joining Trillium’s
Scientific Advisory Board (SAB).
- Governance: Appointed three new
directors, including Mr. Paul Walker (partner at NEA), Dr. Mike
Kamarck (CTO at Vir Biotechnology, formerly with Merck, Wyeth and
Bayer), and Mr. Paolo Pucci (former CEO of ArQule), as well as Dr.
Ali Behbahani (NEA partner) as a Board observer.
- Leadership: Appointed new Chief
Medical Officer, Ingmar Bruns, MD, PhD, a highly experienced and
accomplished hematologist-oncologist and drug developer who
previously held leadership roles at Pieris Pharmaceuticals and
Bayer.
- Advisory infrastructure: Formed a
highly qualified SAB consisting of Karen Ferrante, MD; Gordon
Freeman, PhD; Tom Reynolds, MD, PhD; Steven Rosen, MD; and Jeff
Settleman, PhD.
- Intellectual property: Solidified
leading CD47 SIRPaFc patent estate by receiving a US patent
for TTI-622 as a composition of matter, and (to our Licensor)
a US patent for the method of using SIRPaFc fusion
protein for treating CD47+ cancer including hematologic and
solid tumors.
- Finance & reporting: Converted
functional and reporting currency from CAD to USD, transitioned
from foreign private issuer to domestic filer under SEC rules, and
converted reporting from IFRS to US GAAP.
- Fundraising: Raised more than $300
million through two public fundraising rounds, an equity investment
from Pfizer, and the exercise of warrants.
- Investor base: Strengthened
shareholder base, now consisting primarily of leading specialist
life sciences investors.
TTI-622 (SIRPα-IgG4 Fc)
- Substantially advanced TTI-622
single agent dose escalation study in relapsed or refractory
lymphoma through dose levels from 4 to 18 mg/kg (currently
ongoing).
- Per the last data update at ASH
2020 (data cutoff as of November 3, 2020), we reported the
following TTI-622 profile:
- No major safety concerns and no maximum tolerated dose (MTD)
reached through 12 mg/kg dose level;
- 35% ORR, with six responses (including one complete response)
in 17 response evaluable patients, at dose levels of 0.8-12 mg/kg
(one patient assessed in 12 mg/kg cohort as of the data cutoff);
and
- Dose dependent increases in receptor occupancy and TTI-622
serum exposure.
TTI-621 (SIRPα-IgG1 Fc)
- Progressed TTI-621 single agent
dose escalation study in advanced relapsed or refractory
hematologic malignancies through dose levels from 1.0 to 2.0 mg/kg
(currently ongoing), though COVID-19 negatively affected the speed
of patient enrollment.
- As of our last data update at ASH
2020 (data cutoff as of November 3, 2020), we reported the
following TTI-621 profile:
- No DLTs reached through dose level 1.4 mg/kg; transient
thrombocytopenia observed, though not clinically relevant; and
- Monotherapy activity observed in T-cell and B-cell lymphomas,
including 17% ORR in CTCL (N=53), 18% ORR in PTCL (N=22%), and 29%
ORR in DLBCL (N=9) across dose levels ranging up to 0.5 mg/kg in
PTCL and DLBC, and up to 1.4 mg/kg in CTCL.
R&D Day
On April 28, 2021, we plan to hold an R&D
Day, at which we will:
- Provide a data update for TTI-622
and TTI-621, including data for the 18 mg/kg and 2 mg/kg dose
cohorts, respectively;
- Announce key strategic priorities
in terms of target indications and drug combinations across
hematologic malignancies and solid tumors;
- Outline clinical development plan
and clinical studies to be initiated in 2021.
Annual 2020 Financial
Results:
Trillium began reporting its results in
accordance with U.S. GAAP effective for the fiscal year ended
December 31, 2020. This transition is a result of the Company no
longer being classified as a foreign private issuer as defined
under the rules of the SEC. As a domestic filer, the Company now
prepares consolidated financial statements in accordance with U.S.
GAAP, reports with the SEC on domestic forms, and complies with SEC
rules and regulations applicable to domestic issuers.
As of December 31, 2020, Trillium had cash and
cash equivalents and marketable securities of $291.2 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 year ended December 31, 2020 of
$59.3 million was higher than the loss of $38.1 million for the
year ended December 31, 2019. The net loss was higher due mainly to
a non-cash loss of $22.1 million on the revaluation of the deferred
share unit liability (reclassified from a liability to equity
effective June 30, 2020 on adoption of the new omnibus incentive
plan), non-cash stock-based compensation expenses relating to the
revaluation of the Company’s stock option liabilities of $12.5
million, and higher manufacturing costs. This was partially offset
by lower clinical trial and salary expenses.
Selected Consolidated Financial
Information:
Consolidated Statements of Operations |
Amounts in thousands of US dollarsexcept per share amounts |
Year endedDecember 31, 2020 |
Year endedDecember 31, 2019 |
Revenue |
$148 |
$124 |
Research and development
expenses |
25,348 |
26,688 |
General and administrative
expenses |
36,255 |
5,724 |
Other income (expense),
net |
2,211 |
(5,766) |
Income tax expense |
102 |
28 |
Net loss |
(59,346) |
(38,082) |
Net loss per share, basic and
diluted |
(0.70) |
(1.15) |
Consolidated Balance Sheets |
Amounts in thousands of US dollars |
As ofDecember 31, 2020 |
As ofDecember 31, 2019 |
Cash and cash equivalents, and
marketable securities |
$291,165 |
$22,666 |
Total assets |
300,822 |
26,393 |
Total stockholders’ equity
(deficit) |
278,847 |
(1,333) |
Exemption for Filing of Restated Interim
Financial Reports
Pursuant to subsection 4.3(4) of National
Instrument 51-102 (“NI 51-102”), in connection with filing its
annual financial statements in accordance with U.S. GAAP, Trillium
is also required to file restated interim financial reports for the
interim periods in 2020 under U.S. GAAP (the “Restated Interim
Financial Reports”).
Trillium was granted an exemption by the Ontario
Securities Commission providing Trillium with an additional 45 days
from the deadline otherwise applicable under NI 51-102. As such,
Trillium will be filing its Restated Interim Financial Reports and
related MD&As prepared in accordance with U.S. GAAP on or
before May 3, 2021. Trillium confirms that its management and other
insiders are subject to its Employee and Insider Trading Policy
which contains an insider trading black-out policy that reflects
the principles in Section 9 of National Policy 11-207.
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 the Private Securities Litigation
Reform Act of 1995 and applicable United States federal
securities laws and forward-looking information within the meaning
of Canadian securities laws (collectively, "forward-looking
statements"). The use of words such as "may," "will," "could",
"should," "expects," "intends," "plans," "anticipates," "believes,"
"estimates," "predicts," "projects," "seeks," "endeavor,"
"potential," "continue" or the negative of such words or other
similar expressions can be used to identify forward-looking
statements. Forward-looking statements in this press release
include, but are not limited to, express or implied statements
regarding our expectation of hosting an R&D Day in April, the
therapeutic potential and monotherapy activity of our programs, and
our clinical development plans and our expectations with respect to
the timing of clinical development milestones, including with
respect to initiating Phase 2 studies in hematological and solid
tumor malignancies in 2021. 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 Report
on Form 10-K for the year ended December 31, 2020, 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.
Company Contact:James
ParsonsChief Financial OfficerTrillium Therapeutics Inc.
416-595-0627
x232james@trilliumtherapeutics.comwww.trilliumtherapeutics.com
Media Relations:Mike Beyer Sam
Brown Inc.312-961-2502mikebeyer@sambrown.com
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