0001062993-20-001306.txt : 20200310 0001062993-20-001306.hdr.sgml : 20200310 20200310070948 ACCESSION NUMBER: 0001062993-20-001306 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20200310 FILED AS OF DATE: 20200310 DATE AS OF CHANGE: 20200310 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: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36596 FILM NUMBER: 20699904 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 CURRENT REPORT 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, 2020

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 [X]      Form 40-F [   ]

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 10, 2020
  By:     /s/ James Parsons                                       
  Name: James Parsons
  Title: Chief Financial Officer

2


EXHIBIT INDEX

Exhibit Description
  
99.1   Press Release dated March 10, 2020
99.2   Certificate of Annual Filings - Chief Executive Officer
99.3   Certificate 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 FINANCIAL AND OPERATING RESULTS

CAMBRIDGE, MA, March 10, 2020 - 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 transformation program, for the year ended December 31, 2019.

2019 Transformation Program

2019 was a critical year in Trillium's evolution toward a more clinical development-focused CD47 immuno-oncology company. Key developments, as part of a wide-ranging transformation program, were:

  • Transitioned leadership to a new CEO, Jan Skvarka, who joined in September. Mr. Skvarka is an experienced healthcare executive, who was previously CEO of a PureTech Health portfolio company (Tal Medical), and leading Partner in the Healthcare practice at Bain & Company. He holds an MBA from Harvard Business School.
  • Established office in Cambridge, MA, which will allow the company to tap the local talent pool. The CEO office and clinical development are now based in Cambridge.
  • Restructured the company's footprint by reducing staff by 40% to create a more efficient organization with stronger clinical development focus, as well as extend the cash runway.
  • Substantially revised the company strategy, namely:
    • Refocused on intravenous TTI-621 & TTI-622 programs and large hematologic malignancy indications, specifically acute myeloid lymphoma & myelodysplastic syndromes (AML/MDS), peripheral T-cell lymphoma (PTCL), diffuse large B-cell lymphoma (DLBCL) and multiple myeloma;
    • Deprioritized a lead intratumoral TTI-621 program with intended focus on early-stage cutaneous T-cell lymphoma (CTCL).

  • Zeroed in on execution of TTI-621 & TTI-622 dose escalation studies, which were declared mission critical path in the near term.

Subsequently, on January 7, 2020, the company announced a data update that confirmed TTI-621 monotherapy activity at initial low dose escalation levels (up to 0.5 mg/kg) across several hematologic malignancies. As such, TTI-621 is the only CD47 blocker that has shown meaningful single agent activity. Further dose optimization is in progress, and TTI-621 is now enrolling patients at a 1.4 mg/kg dose level, or 7 times the initially selected dose at which monotherapy activity was observed.

Following the (i) transformation program, (ii) changes in strategic direction, and (iii) encouraging data update, the company raised $117 million in January 2020, in a substantially oversubscribed public offering. Among key investors were experienced healthcare funds, such as Boxer Capital, Logos Capital, New Enterprise Associates, Venrock Healthcare Capital Partners and Vivo Capital. Paul Walker joined the Board of Directors, and Ali Behbahani became Board Observer; both are General Partners at NEA.

Cash Position and Guidance

As of February 28, the company had approximately $130 million in cash and cash equivalents.

Over the next three years (2020-22), the company plans to accomplish the following goals:

  • Complete TTI-621 and TTI-622 dose escalation studies, expected in 2020 (potentially in 2021, depending on the dose selected);
  • Conduct 3-4 new hematologic malignancy studies in AML/MDS, PTCL, DLBCL and/or multiple myeloma; and
  • Initiate and complete a solid tumor exploratory effort with TTI-621 in several key indications.

In 2020, the company will provide the following updates:

  • TTI-622 study update at the 2020 ASCO annual meeting;
  • TTI-621 study update mid-year and at the 2020 ASH annual meeting;
  • TTI-621 and TTI-622 study updates once maximum tolerated doses or recommended phase 2 doses are identified.

Annual 2019 Financial Results:

As of December 31, 2019, Trillium had cash and cash equivalents and marketable securities, and working capital of $22.7 million and $9.8 million, respectively, compared to $33.4 million and $25.1 million, respectively at December 31, 2018. The decrease in cash and cash equivalents and marketable securities, and the decrease in working capital were due mainly to cash used in operations, partially offset by the cash received from the February 2019 public offering. The decrease in working capital was due mainly to cash used in operations and an increase to accounts payable and accrued liabilities due to timing of clinical trial related payments.


Net loss for the year ended December 31, 2019 of $41.6 million was higher than the loss of $32.9 million for the year ended December 31, 2018. The net loss was higher due mainly to a warrant liability revaluation loss of $5.7 million, the write down of Fluorinov intangible assets of $3.0 million, higher manufacturing costs, and a net foreign currency loss of $0.8 million in the current year compared to a net foreign currency gain of $2.7 million in the prior year. The higher loss was partially offset by lower clinical trial expenses.

In January 2020, the Company completed an underwritten public offering for gross proceeds of $117 million comprising 41,279,090 common shares and 1,250,000 Series II Non-Voting Convertible First Preferred Shares, each issued at $2.75 per share.

Selected Consolidated Financial Information:

 
  Consolidated statements of loss and comprehensive loss
 
 


Amounts in thousands of US dollars except per share amounts
   
Year ended
December 31, 2019
     
Year ended
December 31, 2018
 
Research and development expenses $ 27,171   $ 33,585  
General and administrative expenses   5,439     2,786  
Net finance costs (income)   6,156     (3,512 )
Income tax expense   28     7  
Net loss and comprehensive loss for the period   41,622     32,866  
Basic and diluted loss per common share   1.65     2.35  

 
  Consolidated statements of financial position
 
 




Amounts in thousands of US dollars
   
As at
December 31, 2019
     
As at
December 31, 2018
 
Cash and marketable securities $ 22,666   $ 33,389  
Total assets   25,407     40,780  
Total equity (deficiency)   (168 )   30,591  

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.

The Company's pipeline also includes a preclinical STING (stimulator of interferon genes) agonist program. As previously announced, the program is earmarked for out-licensing.


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 belief that TTI-621 is the only CD47 blocker that has shown meaningful single agent activity, our estimated cash balance and our guidance for the years 2020 through 2022. 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, 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.

Company Contact:

James Parsons

Chief Financial Officer

Trillium Therapeutics Inc.

416-595-0627 x232

james@trilliumtherapeutics.com

www.trilliumtherapeutics.com 

Media Relations:

Mike Beyer
Sam Brown Inc.

312-961-2502

mikebeyer@sambrown.com

 


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, Jan Skvarka, 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, 2019.

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, 2019 and ended on December 31, 2019 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 10, 2020


(signed) "Jan Skvarka"

Jan Skvarka

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, 2019.

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, 2019 and ended on December 31, 2019 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 10, 2020


(signed) "James Parsons"

James Parsons

Chief Financial Officer


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