0001279569-11-001087.txt : 20110923 0001279569-11-001087.hdr.sgml : 20110923 20110923173041 ACCESSION NUMBER: 0001279569-11-001087 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20110923 FILED AS OF DATE: 20110923 DATE AS OF CHANGE: 20110923 FILER: COMPANY DATA: COMPANY CONFORMED NAME: YM BIOSCIENCES INC CENTRAL INDEX KEY: 0001178347 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32186 FILM NUMBER: 111105936 BUSINESS ADDRESS: STREET 1: 5045 ORBITOR DRIVE STREET 2: BUILDING 11 SUITE 400 CITY: MISSISSAUGA STATE: A6 ZIP: 00000 6-K 1 ym6k.htm FORM 6-K ym6k.htm
 


 
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 September 2011
 
Commission File Number: 1-32186

 
YM BIOSCIENCES INC. 
(Translation of registrant's name into English)
 
Suite 400, Building 11
5045 Orbiter Drive
Mississauga, Ontario
Canada L4W 4Y4
(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 o
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)  o
 
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)  o
 


 
 
 
 

 
DOCUMENTS FILED

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.
 
 
YM BIOSCIENCES INC.
   
   
  By: /s/ Leonard Vernon  
   
Leonard Vernon
Vice President, Finance and Administration
 
Date: September 23, 2011
 
 
 

 
 

 
EXHIBIT INDEX
 
Exhibit
 
Description
     
99.1  
Letter to Shareholders
99.2   CEO Certificate
99.3    CFO Certificate 

EX-99.1 2 ex991.htm LETTER TO SHAREHOLDERS ex991.htm
Exhibit 99.1
 
Dear Shareholders,

Fiscal 2011 was a transformative year for YM BioSciences. Twelve months ago we were just starting to see encouraging results from some of the first myelofibrosis patients treated with CYT387 in our Phase I/II trial. Since then, CYT387 has continued to produce compelling positive data, with interim results reported at both the ASH 2010 and ASCO 2011 conferences from the first 60 patients enrolled in the trial. Reflecting the growing potential for CYT387, we elevated it to become YM’s lead product and recently raised in aggregate an additional $60 million in capital during the year.

We have now completed enrolment of our Phase I/II trial, which had been expanded to include 166 patients across six centers. This trial will report updated data in December 2011 and guide the design of our Phase III program, anticipated to begin in mid-2012. In addition, we announced that given the favorable safety profile of CYT387 observed to date, we will initiate a complementary 60 patient Phase II BID clinical trial in calendar Q3, 2011 to augment data from the Phase I/II trial. Our team is also in the process of determining which additional clinical indications that it will evaluate CYT387’s effectiveness in and exploring opportunities to further develop and/or commercialize CYT387 with potential partners.

During Fiscal 2011, CIMYM advised it would focus its involvement with nimotuzumab to supporting the development and commercialization activities of its licensees. Daiichi Sankyo Co., Ltd. has advised that it had recently evaluated nimotuzumab in a gastric cancer Phase II trial, and also completed recruitment for a Phase II trial in first-line NSCLC with data expected to be reported at a scientific conference in the calendar third quarter of 2011. Oncoscience AG (OSAG) has advised that final efficacy data from its adult glioma trial may be released in the second half of calendar 2011, once a biomarker correlation study has been completed. OSAG also advised that it continues to recruit patients into a Phase IIb/III trial in pancreatic cancer. These programs are more advanced than CIMYM’s two Phase II trials of nimotuzumab in patients with brain metastasis from non-small cell lung cancer (NSCLC) and for the palliative treatment of NSCLC which were closed due to slow rates of patient accrual. The results from these two trials will contribute to the overall body of clinical data for nimotuzumab, as will results from the Phase II, second-line, single-arm study in children with progressive DIPG, which have been submitted for publication.

During the fiscal year, we closed enrollment for the Phase I/II trial of CYT997 given intravenously in combination with platinum chemotherapy in glioma patients. The preliminary data from this intravenous trial are expected in calendar H1 2012 and will inform the further advancement of the oral version of this drug, which will involve further preclinical testing and manufacturing development. In an effort to expand our pipeline, we also have active pre-clinical programs ongoing with several drug candidates and are evaluating opportunities to acquire new products.

While we all live in times of economic uncertainty, YM is well funded to advance its portfolio, with net cash reserves of approximately $75 million as at June 30, 2011. We have planned for an active year that focuses on generating robust and meaningful data for our product portfolio, and we look forward to updating you on our progress as we move forward. Thank you for your support.


Sincerely,

Signature


Dr. Nick Glover
President and CEO
YM BioSciences Inc.
Date: September 23, 2011

EX-99.2 3 ex992.htm CEO CERTIFICATE ex992.htm
Exhibit 99.2
 
FORM 52-109F1
 
CERTIFICATION OF ANNUAL FILINGS
 
FULL CERTIFICATE
 
 
I, Dr. Nicholas Glover, President and Chief Executive Officer, 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 YM BioSciences Inc. (the "issuer") for the financial year ended June 30, 2011.
 
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, results of operations 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(s) 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(s) 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(s) and I used to design the issuer's ICFR is COSO.
 
5.2 N/A
 
5.3 N/A
 
6. Evaluation: The issuer's other certifying officer(s) 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) for each material weakness relating to operation existing at the financial year end
 
(A) a description of the material weakness;
 
(B) the impact of the material weakness on the issuer's financial reporting and its ICFR; and
 
(C) the issuer's current plans, if any, or any actions already undertaken, for remediating the material weakness.
 
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 April 1, 2011 and ended on June 30, 2011 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(s) 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: September 23, 2011
 
Signature


/s/ Dr. Nicholas Glover                                     
Dr. Nicholas Glover
President & Chief Executive Officer


EX-99.3 4 ex993.htm CFO CERTIFICATE ex993.htm
Exhibit 99.3
FORM 52-109F1
 
CERTIFICATION OF ANNUAL FILINGS
 
FULL CERTIFICATE
 
I, Len Vernon, VP, Finance and Administration, 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 YM BioSciences Inc. (the "issuer") for the financial year ended June 30, 2011.
 
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, results of operations 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(s) 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(s) 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(s) and I used to design the issuer's ICFR is COSO.
 
5.2 N/A
 
5.3 N/A
 
6. Evaluation: The issuer's other certifying officer(s) 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) for each material weakness relating to operation existing at the financial year end
 
(A) a description of the material weakness;
 
(B) the impact of the material weakness on the issuer's financial reporting and its ICFR; and
 
(C) the issuer's current plans, if any, or any actions already undertaken, for remediating the material weakness.
 
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 April 1, 2011 and ended on June 30, 2011 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(s) 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: September 23, 2011
 
Signature

/s/ Len Vernon                                     
Len Vernon
VP, Finance and Administration

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