0001062993-18-001131.txt : 20180309 0001062993-18-001131.hdr.sgml : 20180309 20180309070239 ACCESSION NUMBER: 0001062993-18-001131 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20180309 FILED AS OF DATE: 20180309 DATE AS OF CHANGE: 20180309 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Trillium Therapeutics Inc. CENTRAL INDEX KEY: 0001616212 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: A6 FISCAL YEAR END: 1214 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36596 FILM NUMBER: 18678448 BUSINESS ADDRESS: STREET 1: 2488 DUNWIN DRIVE CITY: MISSISSAUGA STATE: A6 ZIP: L5L 1J9 BUSINESS PHONE: (416) 595-0627 MAIL ADDRESS: STREET 1: 2488 DUNWIN DRIVE CITY: MISSISSAUGA STATE: A6 ZIP: L5L 1J9 6-K 1 form6k.htm FORM 6-K Trillium Therapeutics Inc. - Form 6-K - Filed by newsfilecorp.com

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

___________________

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934

For the month of March, 2018

Commission File Number: 001-36596

___________________

TRILLIUM THERAPEUTICS INC.
(Translation of registrant's name into English)

2488 Dunwin Drive
Mississauga, Ontario L5L 1J9
Canada
(Address of principal executive offices)
___________________

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F [   ]      Form 40-F [X]

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1) [   ]

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7) [   ]


DOCUMENTS FILED AS PART OF THIS FORM 6-K

See the Exhibit Index hereto.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

  Trillium Therapeutics Inc.
   
   
Date: March 9, 2018
  By:     /s/ James Parsons                                       
  Name: James Parsons
  Title: Chief Financial Officer

2


EXHIBIT INDEX

Exhibit Description
 
99.1 News Release dated March 9, 2018
   
99.2 Certification of Annual Filings - Chief Executive Officer
   
99.3 Certification of Annual Filings - Chief Financial Officer


EX-99.1 2 exhibit99-1.htm EXHIBIT 99.1 Trillium Therapeutics Inc.: Exhibit 99.1 - Filed by newsfilecorp.com

FOR IMMEDIATE RELEASE NASDAQ: TRIL
TSX: TRIL

TRILLIUM THERAPEUTICS REPORTS ANNUAL 2017 FINANCIAL AND OPERATING RESULTS

Presented evidence of clinical activity and good tolerability from both TTI- 621 trials at ASH
Received FDA clearance to proceed with second clinical CD47 program, TTI- 622
  Cash and marketable securities of $81.8 million at December 31

TORONTO, March 9, 2018 – 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 year ended December 31, 2017.

“In 2017 we achieved a marked increase in patient enrollment in both our intravenous and intratumoral trials with TTI-621, which has allowed us to gain further insight into the safety and activity of this novel innate immune checkpoint inhibitor,” said Dr. Niclas Stiernholm, President and CEO of Trillium Therapeutics. “We were especially gratified to see single-agent activity, as it may provide us with a relatively direct route to more advanced trials, while still having opportunities to pursue combination therapies in the future. In 2018 we plan to transition from signal-seeking mode to focusing on the most promising indications. We will also be introducing our second clinical CD47 program, TTI-622, leveraging the knowledge gained with TTI-621.”

2017 Highlights:

Presented data at the 2017 American Society of Hematology (ASH) Annual Meeting showing locoregional tumor regression in 9/10 cutaneous T cell lymphoma patients receiving intratumoral TTI-621 monotherapy, often after a single injection.

   

Presented data at the 2017 ASH Annual Meeting demonstrating that heavily pre- treated patients with relapsed/refractory diffuse large B cell lymphoma can achieve objective responses and/or prolonged progression-free intervals, following intravenous administration of TTI-621 either as monotherapy or in combination with rituximab.




ASH data indicate that TTI-621 is well tolerated by both routes of administration; notably, the transient thrombocytopenia observed after intravenous dosing was shown to be attenuated after the first dose.

   

Received a “Study May Proceed” letter from the FDA to enable a Phase 1a/b clinical trial of TTI-622 (SIRPa-IgG4 Fc) in cancer patients. This study will consist of a 3+3 intrapatient dose-escalation phase followed by an expansion phase with combination therapy cohorts.

Annual 2017 Financial Results

As of December 31, 2017, Trillium had cash and cash equivalents and marketable securities, and working capital of $81.8 million and $68.9 million, respectively, compared to $50.5 million and $45.5 million, respectively at December 31, 2016. The increase in cash and cash equivalents and marketable securities, and working capital was due mainly to the June and December 2017 financings raising net proceeds of $62.5 million partially offset by cash used in operations of approximately $27.0 million and an unrealized foreign exchange loss of $3.7 million.

Net loss for the year ended December 31, 2017 of $45.1 million was higher than the loss of $31.7 million for the year ended December 31, 2016. The net loss was higher due mainly to higher research and development expenses of $7.3 million in 2017 from two active TTI-621 phase I trials and manufacturing expenses for TTI-622, the recognition of a deferred tax recovery in the year ended December 31, 2016 related to the acquisition of Fluorinov of $3.7 million, and a higher net foreign currency loss of $2.7 million in 2017.

Selected Consolidated Financial Information:


Consolidated statements of loss and comprehensive loss



    Year ended     Year ended  
Amounts in thousands of Canadian   December 31, 2017     December 31, 2016  
dollars except per share amounts            
Research and development expenses $ 37,135   $ 29,789  
General and administrative expenses   3,861     3,933  
Net finance costs   4,088     1,692  
Income tax expense (recovery)   -     (3,681 )
Net loss and comprehensive loss for the period 45,088 31,733
Basic and diluted loss per common share 4.61 4.06

-2-




Consolidated statements of financial position



    As at     As at  
Amounts in thousands of Canadian
dollars
December 31, 2017 December 31, 2016
Cash and marketable securities $ 81,791   $ 50,473  
Total assets   94,403     66,623  
Total equity   78,577     58,119  

About Trillium Therapeutics

Trillium Therapeutics Inc. is a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer. The company’s lead program, TTI-621, is a SIRPaFc fusion protein that consists of the CD47-binding domain of human SIRPa linked to the Fc region of a human immunoglobulin (IgG1). It is designed to act as a soluble decoy receptor, preventing CD47 from delivering its inhibitory (“do not eat”) signal. Neutralization of the inhibitory CD47 signal enables the activation of macrophage anti-tumor effects by pro-phagocytic (“eat”) signals. A Phase 1 clinical trial (NCT02663518) evaluating intravenous dosing of SIRPaFc in patients with advanced cancer is ongoing, and a second Phase 1 trial evaluating direct intratumoral injections is underway in solid tumors and mycosis fungoides (NCT02890368). TTI-622, an IgG4 SIRPaFc protein which is primarily being developed for combination therapy, is expected to begin clinical testing in 2018. Trillium also has a proprietary medicinal chemistry platform, using unique fluorine chemistry, which permits the creation of new chemical entities from validated drugs and drug candidates with improved pharmacological properties. Stemming from this platform, the company’s most advanced preclinical program is an orally-available epidermal growth factor receptor antagonist with increased uptake and retention in the brain. In addition, a number of compounds directed at undisclosed immuno-oncology targets are currently in the discovery phase.

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, Trillium's expected timing of upcoming clinical events. 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. Known risk factors include, among others: positive preliminary results from early-stage clinical trials may not be indicative of the final results from the trial or be indicative of favorable outcomes in later-stage clinical trials and data are subject to audit for inclusion in the final clinical trial database; clinical data may not demonstrate adequate efficacy and safety to result in regulatory approval to market any of our product candidates in any jurisdiction; given the early stage of Trillium’s product development, there can be no assurance that its research and development programs will result in regulatory approval or commercially viable products and that Trillium can adequately demonstrate TTI-621’s individual contribution in a combination therapy; clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; Trillium may not receive the necessary regulatory approvals for the clinical development of Trillium's products; economic and market conditions may worsen; and market shifts may require a change in strategic focus.

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A more complete discussion of the risks and uncertainties facing Trillium appears in Trillium's Annual Information Form for the year ended December 31, 2017 filed with the 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.

Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.

Contact:
James Parsons
Chief Financial Officer
Trillium Therapeutics Inc.
416-595-0627 x232
james@trilliumtherapeutics.com
www.trilliumtherapeutics.com

Mark Corbae
Canale Communications for Trillium Therapeutics
619-849-5375
mark@canalecomm.com

-4-


EX-99.2 3 exhibit99-2.htm EXHIBIT 99.2 Trillium Therapeutics Inc.: Exhibit 99.2 - Filed by newsfilecorp.com

FORM 52-109F1
CERTIFICATION OF ANNUAL FILINGS
FULL CERTIFICATE

I, Niclas Stiernholm, Chief Executive Officer of Trillium Therapeutics Inc., certify the following:

1. Review: I have reviewed the AIF, if any, annual financial statements and annual MD&A, including, for greater certainty, all documents and information that are incorporated by reference in the AIF (together, the “annual filings”) of Trillium Therapeutics Inc. (the “issuer”) for the financial year ended December 31, 2017.

2. No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the annual filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, for the period covered by the annual filings.

3. Fair presentation: Based on my knowledge, having exercised reasonable diligence, the annual financial statements together with the other financial information included in the annual filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the annual filings.

4. Responsibility: The issuer’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings, for the issuer.

5. Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officer and I have, as at the financial year end

  a.

designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that


  i.

material information relating to the issuer is made known to us by others, particularly during the period in which the annual filings are being prepared; and

     
  ii.

information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and


  b.

designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP.

5.1 Control framework: The control framework the issuer’s other certifying officer and I used to design the issuer’s ICFR is the Internal Control – Integrated Framework (COSO 2013 Framework) published by The Committee of Sponsoring Organizations of the Treadway Commission.

5.2

N/A

   
5.3

N/A



6. Evaluation: The issuer’s other certifying officer and I have

  a.

evaluated, or caused to be evaluated under our supervision, the effectiveness of the issuer’s DC&P at the financial year end and the issuer has disclosed in its annual MD&A our conclusions about the effectiveness of DC&P at the financial year end based on that evaluation; and

     
  b.

evaluated, or caused to be evaluated under our supervision, the effectiveness of the issuer’s ICFR at the financial year end and the issuer has disclosed in its annual MD&A


  i.

our conclusions about the effectiveness of ICFR at the financial year end based on that evaluation; and

     
  ii.

N/A

7. Reporting changes in ICFR: The issuer has disclosed in its annual MD&A any change in the issuer’s ICFR that occurred during the period beginning on October 1, 2017 and ended on December 31, 2017 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.

8. Reporting to the issuer’s auditors and board of directors or audit committee: The issuer’s other certifying officer and I have disclosed, based on our most recent evaluation of ICFR, to the issuer’s auditors, and the board of directors or the audit committee of the board of directors any fraud that involves management or other employees who have a significant role in the issuer’s ICFR.

Date: March 9, 2018

(signed) “Niclas Stiernholm”
Niclas Stiernholm
Chief Executive Officer


EX-99.3 4 exhibit99-3.htm EXHIBIT 99.3 Trillium Therapeutics Inc.: Exhibit 99.3 - Filed by newsfilecorp.com

FORM 52-109F1
CERTIFICATION OF ANNUAL FILINGS
FULL CERTIFICATE

I, James Parsons, Chief Financial Officer of Trillium Therapeutics Inc., certify the following:

1. Review: I have reviewed the AIF, if any, annual financial statements and annual MD&A, including, for greater certainty, all documents and information that are incorporated by reference in the AIF (together, the “annual filings”) of Trillium Therapeutics Inc. (the “issuer”) for the financial year ended December 31, 2017.

2. No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the annual filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, for the period covered by the annual filings.

3. Fair presentation: Based on my knowledge, having exercised reasonable diligence, the annual financial statements together with the other financial information included in the annual filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the annual filings.

4. Responsibility: The issuer’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings, for the issuer.

5. Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officer and I have, as at the financial year end

  a.

designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that


  i.

material information relating to the issuer is made known to us by others, particularly during the period in which the annual filings are being prepared; and

     
  ii.

information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and


  b.

designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP.

5.1 Control framework: The control framework the issuer’s other certifying officer and I used to design the issuer’s ICFR is the Internal Control – Integrated Framework (COSO 2013 Framework) published by The Committee of Sponsoring Organizations of the Treadway Commission.

5.2

N/A

   
5.3

N/A



6. Evaluation: The issuer’s other certifying officer and I have

  a.

evaluated, or caused to be evaluated under our supervision, the effectiveness of the issuer’s DC&P at the financial year end and the issuer has disclosed in its annual MD&A our conclusions about the effectiveness of DC&P at the financial year end based on that evaluation; and

     
  b.

evaluated, or caused to be evaluated under our supervision, the effectiveness of the issuer’s ICFR at the financial year end and the issuer has disclosed in its annual MD&A


  i.

our conclusions about the effectiveness of ICFR at the financial year end based on that evaluation; and

     
  ii.

N/A

7. Reporting changes in ICFR: The issuer has disclosed in its annual MD&A any change in the issuer’s ICFR that occurred during the period beginning on October 1, 2017 and ended on December 31, 2017 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.

8. Reporting to the issuer’s auditors and board of directors or audit committee: The issuer’s other certifying officer and I have disclosed, based on our most recent evaluation of ICFR, to the issuer’s auditors, and the board of directors or the audit committee of the board of directors any fraud that involves management or other employees who have a significant role in the issuer’s ICFR.

Date: March 9, 2018

(signed) “James Parsons”
James Parsons
Chief Financial Officer


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