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 July 2007
Commission File Number 000-31062
Oncolytics Biotech Inc.
(Translation of registrant’s name into
English)
Suite 210, 1167 Kensington Crescent NW
Calgary, Alberta, Canada T2N 1X7
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
| Form 20-F o | Form 40-F þ |
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
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
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
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
| Yes o | No þ |
If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82 -
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.
| Oncolytics
Biotech Inc. (Registrant) |
||||
| Date: July 27, 2007 | By: | /s/ Doug Ball
Doug Ball Chief Financial Officer |
||
Second Quarter Report
July 30, 2007
Oncolytics Biotech Inc.
TSX: ONC
NASDAQ: ONCY
TSX: ONC
NASDAQ: ONCY
Second Quarter Report
For the quarter ended June 30, 2007
For the quarter ended June 30, 2007
Letter to Shareholders
Oncolytics made significant headway in the second quarter of 2007 in expanding the scope and pace
of development of the clinical program for REOLYSIN®. Among the highlights this
quarter, we announced positive clinical data from our U.S. Phase I systemic administration trial,
started patient enrolment in three new trials in the U.S. and the U.K., strengthened our U.S. and
Canadian patent portfolios and announced the successful completion of initial scale-up of our
manufacturing process for REOLYSIN®.
With the start of enrolment in these new trials, Oncolytics is treating patients in two monotherapy
clinical trials in the U.S. and five radiation or chemotherapy combination trials in the U.K. In
addition, the U.S. National Cancer Institute submitted a protocol to the U.S. Food and Drug
Administration in May to conduct a Phase II trial for patients with metastatic melanoma using
systemic administration of REOLYSIN®.
In April, we announced the initiation of a U.S. Phase II trial to evaluate the intravenous
administration of REOLYSIN® in patients with various sarcomas that had metastasized to
the lung. The trial is an open-label, single agent study whose primary objective is to measure
tumour responses, duration of response and to describe any evidence of antitumour activity of
intravenous, multiple dose REOLYSIN® in bone and soft tissue sarcomas metastatic to the
lung. There are few treatment options for patients with this type of cancer. This is a
multi-centre trial that follows the successful completion of Phase I intravenous trials with
REOLYSIN® in the U.K. and in the U.S. Up to 52 sarcoma patients will participate in the
trial, which started enrolling patients at the end of June.
Positive results from our U.S. Phase I systemic administration trial were announced in early June.
The results indicate that REOLYSIN® can be delivered systemically to patients with
advanced and metastatic cancers and cause anti-tumour activity. A total of 18 patients were
treated in the escalating dosage trial to a maximum daily dose of 3x1010
TCID50 in a one-hour infusion. Of the 18 patients treated, eight demonstrated stable
disease or better, including a patient with progressive breast cancer who experienced a 34%
shrinkage in tumour volume – a partial response. The trial was originally designed to demonstrate
the safety of a single, one-hour infusion of REOLYSIN®. During the treatment of the
fourth cohort of patients, Oncolytics applied for and was granted approval to allow subsequent
patients to receive repeat monthly treatments of REOLYSIN®. Of the patients eligible
for retreatment, three patients received a range of two to seven one-hour, monthly infusions of
REOLYSIN®. Toxicities possibly related to REOLYSIN® treatment in this trial
were generally mild (grade 1 or 2) and included chills, fever and fatigue.
During the quarter, the Company also started enrolment in two combination REOLYSIN® and
chemotherapy trials in the U.K. In May, we started enrolment in our
combination REOLYSIN® and paclitaxel/carboplatin in patients with advanced cancers
including head and neck, melanoma, lung and ovarian. In June, we started enrolment in our
combination REOLYSIN® and gemcitabine trial in patients with advanced cancers including
pancreatic, lung and ovarian. In July, enrolment commenced in a combination REOLYSIN®
and docetaxel trial in patients with advanced cancers including bladder, prostate, lung and upper
gastro-intestinal. Our preclinical studies have shown that the activity of these agents is
dramatically enhanced by the addition of REOLYSIN®. For example, a poster presented by
one of our research collaborators at the American Association for Cancer Research annual meeting in
Los Angeles in April showed that the treatment of human colon cancer cell lines with the
combination of REOLYSIN® and gemcitabine resulted in both in vitro and in vivo synergy.
Tumours treated with the combination were significantly smaller (by area and weight) than tumours
in control groups or tumours treated with either agent alone.
Advancements have also been made in our manufacturing process for REOLYSIN®. In April,
we announced that the combination of process improvements and advancements in the media formulation
used in the primary production of REOLYSIN® had resulted in increased total yields.
Our intellectual property portfolio continues to expand in concert with our clinical trial program.
During the quarter, Oncolytics was granted two U.S. patents; one relating to combination therapy
with REOLYSIN® and radiation, and the other relating to the production and purification
of viruses, including reovirus. Oncolytics also secured a Canadian patent covering combination
therapy with REOLYSIN® and chemotherapy. Our intellectual property portfolio now
includes 21 U.S. patents, 3 European patents and 6 Canadian patents, as well as issued patents in a
number of other jurisdictions.
On behalf of Oncolytics, I would like to thank you for your continued support as we move into this
important stage of development.
Brad Thompson, PhD
President and CEO
July 26, 2007
President and CEO
July 26, 2007
July 26, 2007
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
CONDITION AND RESULTS OF OPERATIONS
This discussion and analysis should be read in conjunction with the unaudited financial
statements of Oncolytics Biotech Inc. as at and for the three and six months ended June 30, 2007
and 2006, and should also be read in conjunction with the audited financial statements and
Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”)
contained in our annual report for the year ended December 31, 2006. The financial statements have
been prepared in accordance with Canadian generally accepted accounting principles (“GAAP”).
FORWARD-LOOKING STATEMENTS
The following discussion contains forward-looking statements, within the meaning of Section
21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including our
belief as to the potential of REOLYSIN® as a cancer therapeutic and our expectations as
to the success of our research and development and manufacturing programs in 2007 and beyond,
future financial position, business strategy and plans for future operations, and statements that
are not historical facts, involve known and unknown risks and uncertainties, which could cause our
actual results to differ materially from those in the forward-looking statements. Such risks and
uncertainties include, among others, the need for and availability of funds and resources to pursue
research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the
success and timely completion of clinical studies and trials, our ability to successfully
commercialize REOLYSIN®, uncertainties related to the research, development and
manufacturing of pharmaceuticals, uncertainties related to competition, changes in technology, the
regulatory process and general changes to the economic environment. Investors should consult our
quarterly and annual filings with the Canadian and U.S. securities commissions for additional
information on risks and uncertainties relating to the forward-looking statements. Forward-looking
statements are based on assumptions, projections, estimates and expectations of management at the
time such forward-looking statements are made, and such assumptions, projections, estimates and/or
expectations could change or prove to be incorrect or inaccurate. Investors are cautioned against
placing undue reliance on forward-looking statements. We do not undertake to update these
forward-looking statements.
OVERVIEW
Oncolytics Biotech Inc. is a Development Stage Company
Since our inception in April of 1998, Oncolytics Biotech Inc. has been a development stage company
and we have focused our research and development efforts on the development of
REOLYSIN®, our potential cancer therapeutic. We have not been profitable since our
inception and expect to continue to incur substantial losses as we continue research and
development efforts. We do not expect to generate significant revenues until, if and when, our
cancer product becomes commercially viable.
General Risk Factors
Prospects for biotechnology companies in the research and development stage should generally be
regarded as speculative. It is not possible to predict, based upon studies in animals, or early
studies in humans, whether a new therapeutic will ultimately prove to be safe and effective in
humans, or whether necessary and sufficient data can be developed through the clinical trial
process to support a successful product application and approval.
If a product is approved for sale, product manufacturing at a commercial scale and significant
sales to end users at a commercially reasonable price may not be successful. There can be no
assurance that we will generate adequate funds to continue development, or will ever achieve
significant revenues or profitable
operations. Many factors (e.g. competition, patent protection, appropriate regulatory approvals)
can influence the revenue and product profitability potential.
In developing a pharmaceutical product, we rely upon our employees, contractors, consultants and
collaborators and other third party relationships, including our ability to obtain appropriate
product liability insurance. There can be no assurance that these reliances and relationships will
continue as required.
In addition to developmental and operational considerations, market prices for securities of
biotechnology companies generally are volatile, and may or may not move in a manner consistent with
the progress being made by Oncolytics.
See also “RISK Factors Affecting Future Performance” in our 2006 MD&A.
REOLYSIN ® Development Update for the Second Quarter of 2007
We continue to develop our lead product REOLYSIN® as a potential cancer therapy. Our goal
each year is to advance REOLYSIN® through the various steps and stages of development
required for potential pharmaceutical products. In order to achieve this goal, we actively manage
the development of our clinical trial program, our pre-clinical and collaborative programs, our
manufacturing process and supply, and our intellectual property.
Clinical Trial Program
In the second quarter of 2007, we announced positive clinical data from our U.S. Phase I
REOLYSIN® systemic administration clinical trial. As well, we expanded our clinical
trial program to include eight clinical trials of which seven are being conducted by us and one is
being sponsored by the U.S. National Cancer Institute (“NCI”).
Clinical Trial Results
In the second quarter of 2007, we announced positive results from our U.S. Phase I clinical trial
examining the systemic administration of REOLYSIN® in patients with advanced cancers.
The results indicated that REOLYSIN® can be delivered systemically to patients with
advanced and metastatic cancers and cause anti-tumour activity.
A total of 18 patients were treated in the escalating dosage trial to a maximum daily dose of
3x1010 TCID50 in a one-hour infusion. Of the 18 patients treated, eight
demonstrated stable disease or better, as measured by RECIST (“Response Evaluation Criteria in
Solid Tumours”) including a patient with progressive breast cancer who experienced a 34% shrinkage
in tumour volume.
The trial was originally designed to demonstrate the safety of a single, one-hour infusion of
REOLYSIN®. During the treatment of the 4th cohort of patients, we applied for and were
granted approval to allow subsequent patients to receive repeat monthly treatments of
REOLYSIN®. Of the patients eligible for retreatment, three patients received a range of
two to seven one-hour infusions of REOLYSIN®. Toxicities possibly related to
REOLYSIN® treatment in this trial were generally mild (grade 1 or 2) and included
chills, fever and fatigue.
The primary objective of this trial was to determine the Maximum Tolerated Dose (“MTD”),
Dose-Limiting Toxicity (“DLT”), and safety profile of REOLYSIN® when administered
systemically to patients. A secondary objective was to examine any evidence of anti-tumour
activity. Eligible patients included those who had been diagnosed with advanced or metastatic solid
tumours that are refractory (“have not responded”) to standard therapy or for which no curative
standard therapy exists.
Clinical Trials – Actively Enrolling
During the
second quarter of 2007, we continued to enroll patients in our Phase II and Phase Ib
combination REOLYSIN®/radiation clinical trials in the U.K. and in our Phase I/II
recurrent malignant glioma clinical trial in the U.S. As well, we commenced enrollment in the
following studies:
U.S. Phase II Sarcoma Clinical Trial
During the second quarter of 2007, we received approval to commence and initiated patient
enrollment in our U.S. Phase II trial to evaluate the intravenous administration of REOLYSIN® in
patients with various sarcomas that have metastasized to the lung. Patients are being enrolled at
the Montefiore Medical Center/Albert Einstein College of Medicine in the Bronx, New York, the
University of Michigan Comprehensive Cancer Center in Ann Arbor, and the Cancer Therapy and
Research Center, Institute for Drug Development in San Antonio, Texas.
This trial is a Phase II, open-label, single agent study whose primary objective is to measure
tumour responses and duration of response, and to describe any evidence of antitumour activity of
intravenous, multiple dose REOLYSIN® in patients with bone and soft tissue sarcomas
metastatic to the lung. REOLYSIN® will be given intravenously to patients at a dose of
3x1010 TCID50 for five consecutive days. Patients may receive additional
five-day cycles of therapy every four weeks for a maximum of eight cycles.
Up to 52 patients will be enrolled in the study. Eligible patients must have a bone or soft tissue
sarcoma metastatic to the lung deemed by their physician to be unresponsive to or untreatable by
standard therapies.
U.K. Combination REOLYSIN® Paclitaxel and Carboplatin Clinical Trial
In the second quarter of 2007, we commenced patient enrolment in our U.K. clinical trial to
evaluate the anti-tumour effects of systemic administration of REOLYSIN® in combination
with paclitaxel and carboplatin in patients with advanced cancers including head and neck,
melanoma, lung and ovarian.
This trial has two components. The first is an open-label, dose-escalating, non-randomized study of
REOLYSIN® given intravenously with paclitaxel and carboplatin every three weeks.
Standard dosages of paclitaxel and carboplatin will be delivered with escalating dosages of
REOLYSIN® intravenously. A maximum of three cohorts will be enrolled in the
REOLYSIN® dose escalation portion. The second component of the trial will immediately
follow and will include the enrolment of a further 12 patients at the maximum dosage of
REOLYSIN® in combination with a standard dosage of paclitaxel and carboplatin.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours
such as head and neck, melanoma, lung and ovarian cancers that are refractory to standard therapy
or for which no curative standard therapy exists. The primary objective of the trial is to
determine the MTD, DLT, recommended dose and dosing schedule and safety profile of
REOLYSIN® when administered in combination with paclitaxel and carboplatin. Secondary
objectives include the evaluation of immune response to the drug combination, the body’s response
to the drug combination compared to chemotherapy alone and any evidence of anti-tumour activity.
U.K.
Combination REOLYSIN® Gemcitabine Clinical Trial
In the second quarter of 2007, we commenced patient enrolment in our U.K. clinical trial to
evaluate the anti-tumour effects of systemic administration of REOLYSIN® in combination
with gemcitabine (Gemzar®) in patients with advanced cancers including pancreatic, lung
and ovarian. The combination of reovirus and gemcitabine has been shown in preclinical studies to
be more effective than gemcitabine or reovirus alone at killing certain cancer cell lines.
This trial has two components. The first is an open-label, dose-escalating, non-randomized study of
REOLYSIN® given intravenously with gemcitabine every three weeks. A standard dosage of
gemcitabine will be delivered with escalating dosages of REOLYSIN® intravenously. A
maximum of three cohorts will
be enrolled in the REOLYSIN® dose escalation portion. The second component of the trial
will immediately follow and will include the enrolment of a further 12 patients at the maximum
dosage of REOLYSIN® in combination with a standard dosage of gemcitabine.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours
such as pancreatic, lung and ovarian cancers that are refractory to standard therapy or for which
no curative standard therapy exists. The primary objective of the trial is to determine the MTD,
DLT, recommended dose and dosing schedule and safety profile of REOLYSIN® when
administered in combination with gemcitabine. Secondary objectives include the evaluation of
immune response to the drug combination, the body’s response to the drug combination compared to
chemotherapy alone and any evidence of anti-tumour activity.
U.S. National Cancer Institute Phase II Melanoma Clinical Trial
In the second quarter of 2007, the NCI filed a protocol with the U.S. Food and Drug Administration
for a Phase II clinical trial for patients with metastatic melanoma using systemic administration
of REOLYSIN®. The NCI is sponsoring the trial under our Clinical Trials Agreement that
requires us to provide clinical supplies of REOLYSIN®. The trial is expected to enroll
up to 47 patients with metastatic melanoma.
Pre-Clinical Trial and Collaborative Program
During the second quarter of 2007, we announced that a poster by Dr. Maureen E. Lane et al. of
Cornell University, New York, entitled “In Vivo Synergy between Oncolytic Reovirus and Gemcitabine
in Ras-Mutated Human HCT116 Xenografts” was presented at the American Association for Cancer
Research Annual Meeting in Los Angeles, CA.
The researchers found that treatment of human colon cancer cell lines with the combination of
REOLYSIN® and gemcitabine resulted in both in vitro and in vivo synergy. There was no
toxicity associated with the combined treatment. Tumours treated with the combination were
significantly smaller (by area and weight) than tumours in control groups or tumours treated with
either agent alone. The researchers concluded that the synergistic combination of
REOLYSIN® and gemcitabine is a promising therapeutic regimen for study in clinical
trials.
Manufacturing and Process Development
We continued to have REOLYSIN® manufactured in order to supply our current and
future clinical trial program. In the second quarter of 2007, we successfully completed initial
scale up of our manufacturing process for REOLYSIN®. The process improvements and scale
up to 40-litre batch size has resulted in increased total yields which are a result of advancements
in the media formulation used in the primary production of REOLYSIN® and in the
downstream processing steps required to generate finished product.
Intellectual Property
In the second quarter of 2007, two U.S. and one Canadian patents were issued. At the end of
the second quarter of 2007, we had been issued a total of 21 U.S., six Canadian and three European
patents as well as issuances in other jurisdictions. We also have other patent applications filed
in the U.S., Europe and Canada and other jurisdictions.
Financial Impact
We estimated at the beginning of 2007 that our monthly cash usage would be approximately
$1,400,000 for 2007. Our cash usage for the first half of 2007 was $7,618,488 from operating
activities and $525,363 for the purchases of intellectual property and capital assets which is in
line with our estimate. Our net loss for the first six month of 2007 was $7,792,813.
Cash Resources
We exited the second quarter of 2007 with cash resources totaling $31,533,291 (see “Liquidity
and Capital Resources”).
Expected
REOLYSIN® Development for the Remainder of 2007
We believe that we will commence enrollment in our third co-therapy clinical trial with
docetaxel (see “Recent 2007 Progress”) and continue to enroll patients in all seven of our clinical
trials in 2007. We also believe that the NCI sponsored melanoma clinical trial will receive
approval to commence in 2007. We believe we will complete enrollment in our U.K. Phase Ia/Ib and
Phase II combination REOLYSIN®/radiation clinical trials by the end of 2007 and complete
enrollment in our chemotherapy co-therapy studies in 2008. We expect to produce
REOLYSIN® in 2007 to supply our clinical trial program.
Based on our expected activity in 2007, we continue to estimate our average monthly cash usage to
be $1,400,000 per month (see “Liquidity and Capital Resources”).
Recent 2007 Progress
On July 23, 2007, we commenced patient enrolment in our U.K. clinical trial to evaluate the
anti-tumour effects of systemic administration of REOLYSIN® in combination with
docetaxel (Taxotere®) in patients with advanced cancers including bladder, prostate,
lung and upper gastro-intestinal.
The trial has two components. The first is an open-label, dose-escalating, non-randomized study of
REOLYSIN® given intravenously with docetaxel every three weeks. A standard dosage of
docetaxel will be delivered with escalating dosages of REOLYSIN® intravenously. A
maximum of three cohorts will be enrolled in the REOLYSIN® dose escalation portion. The second
component of the trial will immediately follow and will include the enrolment of a further 12
patients at the maximum dosage of REOLYSIN® in combination with a standard dosage of
docetaxel.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours
such as bladder, prostate, lung or upper gastro-intestinal cancers that are refractory to standard
therapy or for which no curative standard therapy exists. The primary objective of the trial is to
determine the MTD, DLT, recommended dose and dosing schedule and safety profile of
REOLYSIN® when administered in combination with docetaxel. Secondary objectives include
the evaluation of immune response to the drug combination, the body’s response to the drug
combination compared to chemotherapy alone and any evidence of anti-tumour activity.
SECOND QUARTER RESULTS OF OPERATIONS
(for the three months ended June 30, 2007 and 2006)
(for the three months ended June 30, 2007 and 2006)
Net loss for the three month period ending June 30, 2007 was $3,679,582 compared to $2,987,714 for
the three month period ending June 30, 2006.
Research and Development Expenses (“R&D”)
| 2007 | 2006 | |||||||
| $ | $ | |||||||
Manufacturing and related process development expenses |
828,602 | 648,351 | ||||||
Clinical trial expenses |
983,896 | 685,265 | ||||||
Pre-clinical trial and research collaboration expenses |
331,379 | 235,302 | ||||||
Other R&D expenses |
562,498 | 391,701 | ||||||
Research and development expenses |
2,706,375 | 1,960,619 | ||||||
For the second quarter of 2007, R&D increased to $2,706,375 compared to $1,960,619 for the second
quarter of 2006. The increase in R&D was due to the following:
Manufacturing & Related Process Development (“M&P”)
| 2007 | 2006 | |||||||
| $ | $ | |||||||
Product manufacturing expenses |
774,883 | 124,110 | ||||||
Technology transfer expenses |
— | 273,214 | ||||||
Process development expenses |
53,719 | 251,027 | ||||||
Manufacturing and related process development expenses |
828,602 | 648,351 | ||||||
Our M&P expenses for the second quarter of 2007 increased to $828,602 compared to $648,351 for the
second quarter of 2006.
In the second quarter of 2007, our production activity increased compared to the second quarter of
2006 as we completed the production runs scheduled earlier in 2007. In the second quarter of 2006,
our production activity was lower as we were focused on completing manufacturing process
improvements and transferring changes in our production process to our cGMP manufacturer prior to
commencing new production runs. Our process development activity in the second quarter of 2007
focused on completing our 40-litre scale up studies.
Clinical Trial Program
| 2007 | 2006 | |||||||
| $ | $ | |||||||
Direct clinical trial expenses |
913,360 | 643,786 | ||||||
Other clinical trial expenses |
70,536 | 41,479 | ||||||
Clinical trial expenses |
983,896 | 685,265 | ||||||
During the second quarter of 2007, our direct clinical trial expenses increased to $913,360
compared to $643,786 in the second quarter of 2006. In the second quarter of 2007, we incurred
direct patient costs in our six actively enrolling clinical trials compared to only three enrolling
clinical trial studies in the second quarter of 2006. As well in the second quarter of 2007, we
incurred clinical site start up costs associated with our U.K. co-therapy and U.S. sarcoma clinical
trials compared to incurring clinical site start up costs for our U.S. glioma study in the second
quarter of 2006.
Pre-Clinical Trial Expenses and Research Collaborations
| 2007 | 2006 | |||||||
| $ | $ | |||||||
Research collaboration expenses |
331,379 | 235,302 | ||||||
Pre-clinical trial expenses |
— | — | ||||||
Pre-clinical trial expenses and research collaborations |
331,379 | 235,302 | ||||||
During the second quarter of 2007, our research collaboration expenses were $331,379 compared to
$235,302 for the second quarter of 2006. Our research collaboration activity continues to focus on
the interaction of the immune system and the reovirus, the use of the reovirus as a co-therapy with
existing chemotherapeutics, the use of new RAS active viruses as potential therapeutics, and to
investigate new uses of the reovirus as a therapeutic.
Other Research and Development Expenses
| 2007 | 2006 | |||||||
| $ | $ | |||||||
R&D consulting fees |
50,114 | 31,371 | ||||||
R&D salaries and benefits |
395,166 | 286,767 | ||||||
Other R&D expenses |
117,218 | 73,563 | ||||||
Other research and development expenses |
562,498 | 391,701 | ||||||
Our R&D salaries and benefits costs were $395,166 in the second quarter of 2007 compared to
$286,767 in the second quarter of 2006. The increase is a result of increases in salary and staff
levels along with the addition of our Vice President of Intellectual Property in 2007.
Operating Expenses
| 2007 | 2006 | |||||||
| $ | $ | |||||||
Public company related expenses |
753,949 | 664,917 | ||||||
Office expenses |
257,806 | 240,176 | ||||||
Operating expenses |
1,011,755 | 905,093 | ||||||
During the second quarter of 2007, our public company related expenses increased to $753,949
compared to $664,917 for the second quarter of 2006. In the second quarter of 2007, we increased
our investor relations activity in the United States and Europe compared to the second quarter of
2006.
Stock Based Compensation
| 2007 | 2006 | |||||||
| $ | $ | |||||||
Stock based compensation |
82,573 | 222,376 | ||||||
Stock based compensation for the second quarter of 2007 was $82,573 compared to $222,376 in the
second quarter of 2006. In the second quarter of 2007, we incurred stock based compensation
associated with the vesting of previously granted stock options. In the second quarter of 2006, we
incurred stock based compensation associated with the issue and immediate vesting of stock options
to our two newly appointed directors and the vesting of previously granted options.
YEAR TO DATE RESULTS OF OPERATIONS
(for the six months ended June 30, 2007 and 2006)
(for the six months ended June 30, 2007 and 2006)
Net loss for the six month period ending June 30, 2007 was $7,792,813 compared to $5,982,250 for
the six month period ending June 30, 2006.
Research and Development Expenses (“R&D”)
| 2007 | 2006 | |||||||
| $ | $ | |||||||
Manufacturing and related process development expenses |
2,666,795 | 1,491,490 | ||||||
Clinical trial expenses |
1,705,513 | 1,232,033 | ||||||
Pre-clinical trial and research collaboration expenses |
437,660 | 390,388 | ||||||
Other R&D expenses |
1,114,643 | 763,030 | ||||||
Research and development expenses |
5,924,611 | 3,876,941 | ||||||
For the six month period ending June 30, 2007, R&D increased to $5,924,611 compared to $3,876,941
for the six month period ending June 30, 2006. The increase in R&D was due to the following:
Manufacturing & Related Process Development (“M&P”)
| 2007 | 2006 | |||||||
| $ | $ | |||||||
Product manufacturing expenses |
2,523,301 | 767,532 | ||||||
Technology transfer expenses |
— | 273,214 | ||||||
Process development expenses |
143,494 | 450,744 | ||||||
Manufacturing and related process development expenses |
2,666,795 | 1,491,490 | ||||||
For the six month period ending June 30, 2007, our production and vial filling activity increased
compared to 2006. During the first half of 2007, we completed production runs that commenced in
2006 and initiated additional production runs to manufacture REOLYSIN® at the beginning
of 2007. As well, we incurred costs associated with vial filling and packaging of these production
runs.
For the six month period ending June 30, 2006, we completed the production runs that were ongoing
at the end of 2005 for our Phase I trials. At the same time, our process development activity
helped improve the virus yields from our manufacturing process. These improvements were then
transferred to our cGMP manufacturer in the second quarter of 2006.
Our process development expenses for the six month period ending June 30, 2007 were $143,494
compared to $450,744 for the six month period ending June 30, 2006. During the six month period
ending June 30, 2007, our main process development focus was on our scale up to 40-litre studies
which were completed in the second quarter of 2007. During the six month period ending June 30,
2006, our process development activity included scale up studies and the validation of the fill
process used in our manufacturing process.
We now expect that our overall manufacturing and related process development expenses for 2007 will
be in line with 2006. We expect to complete the vial filling of our planned 2007 production runs
in the third quarter of 2007. We also expect that our process development activity will begin to
examine the commercial formulation of REOLYSIN®.
We are also examining ways to reduce our economic dependence resulting from having only a single
cGMP manufacturer. This might include building up a level of inventory, increasing the scale of
each production run, engaging another cGMP manufacturer or manufacturing REOLYSIN®
ourselves. Depending on how we mitigate our risk of economic dependence our expectation of our
2007 M&P expenses may change.
Clinical Trial Program
| 2007 | 2006 | |||||||
| $ | $ | |||||||
Direct clinical trial expenses |
1,596,467 | 1,143,420 | ||||||
Other clinical trial expenses |
109,046 | 88,613 | ||||||
Clinical trial expenses |
1,705,513 | 1,232,033 | ||||||
During the six month period ending June 30, 2007, our direct clinical trial expenses were
$1,705,513 compared to $1,145,420 for the six month period ending June 30, 2006. In the first half
of 2007, we incurred direct patient costs in our six ongoing clinical trials. As well, we incurred
clinical site start up costs for our three co-therapy trials in the U.K. and our Phase II sarcoma
clinical trial in the U.S. which were recently approved to commence. In the first half of 2006, we
incurred direct patient costs in three ongoing clinical trials along with clinical site start up
costs associated with our U.S. recurrent malignant glioma trial.
We expect our clinical trial expenses will continue to increase for the remainder of 2007 compared
to 2006. We expect that our third U.K. co-therapy clinical trial will commence enrollment in the
third quarter of 2007 increasing the number of ongoing clinical trials to seven.
Pre-Clinical Trial Expenses and Research Collaborations
| 2007 | 2006 | |||||||
| $ | $ | |||||||
Research collaboration expenses |
400,530 | 381,738 | ||||||
Pre-clinical trial expenses |
37,130 | 8,650 | ||||||
Pre-clinical trial expenses and research collaborations |
437,660 | 390,388 | ||||||
During the six month period ending June 30, 2007, our research collaboration expenses were $400,530
compared to $381,738 for the six month period ending June 30, 2006. Our research collaboration
activity continues to focus on the interaction of the immune system and the reovirus, the use of
the reovirus as a co-therapy with existing chemotherapeutics, the use of new RAS active viruses as
potential therapeutics, and to investigate new uses of the reovirus as a therapeutic.
During the six month period ending June 30, 2007, our pre-clinical trial expenses were $37,130
compared to $8,650 for the six month period ending June 30, 2006. The frequency of our
pre-clinical trial expenses change from period to period as we move through our clinical trial
program. As well, we may increase our pre-clinical activity depending on the results of our
research collaborations.
For the remainder of 2007, we still expect that pre-clinical trial expenses and research
collaborations will decline compared to 2006. We expect to continue with our various
collaborations in order to provide support for our expanding clinical trial program. As well, we
may expand our collaborative activities to include other viruses.
Other Research and Development Expenses
| 2007 | 2006 | |||||||
| $ | $ | |||||||
R&D consulting fees |
141,891 | 64,326 | ||||||
R&D salaries and benefits |
767,553 | 607,892 | ||||||
Quebec scientific research and experimental development refund |
(15,927 | ) | (52,344 | ) | ||||
Other R&D expenses |
221,126 | 143,156 | ||||||
Other research and development expenses |
1,114,643 | 763,030 | ||||||
During the six month period ending June 30, 2007, our R&D consulting fees were $141,891 compared to
$64,326 for the six month period ending 2006. In the first half of 2007, we incurred consulting
activity associated with our ongoing clinical trials and assistance with our clinical trial
applications. In the first half of 2006, our consulting activity related to our ongoing clinical
trials.
Our R&D salaries and benefits costs were $767,553 for the first half of 2007 compared to $607,892
for the first half of 2006. The increase is a result of increases in salary and staff levels along
with the addition of our Vice President of Intellectual Property in 2007.
We now expect that our other research and development expenses for the remainder of 2007 will
increase compared to 2006. We expect that salaries and benefits will increase to reflect increased
compensation levels and the salary and benefit costs for our Vice President of Intellectual
Property. Our R&D consulting fees are expected to remain consistent with 2006. However, we may
choose to engage additional consultants to assist us in the development of protocols and regulatory
filings for our additional combination therapy and phase II clinical trial studies, possibly
causing our R&D consulting expenses to increase.
Operating Expenses
| 2007 | 2006 | |||||||
| $ | $ | |||||||
Public company related expenses |
1,335,826 | 1,499,636 | ||||||
Office expenses |
582,646 | 523,393 | ||||||
Operating expenses |
1,918,472 | 2,023,029 | ||||||
During the six month period ending June 30, 2007, our public company related expenses were
$1,335,826 compared to $1,499,636 for the six month period ending June 30, 2006. In the first half
of 2007, our financial advisory expenses decreased compared to the first half of 2006. This
decrease was offset by an increase in expenses associated with our investor relations activity in
the U.S. and Europe and professional fees during the six month period ending June 30, 2007 compared
to 2006.
In the first half of 2007, our office expenses were $582,646 compared to $523,393 in the first half
of 2006. Our office expense activity has remained consistent in 2007 to date compared to 2006 with
increases mainly due to increased compensation levels and a general increase in office costs.
Stock Based Compensation
| 2007 | 2006 | |||||||
| $ | $ | |||||||
Stock based compensation |
103,969 | 259,209 | ||||||
Stock based compensation for the six month period ending June 30, 2007 was $103,969 compared to
$259,209 for the six month period ending June 30, 2006. In the first half of 2007, we incurred
stock based compensation associated with the vesting of options granted previously. In the first
half of 2006, we incurred stock based compensation associated with the issue and immediate vesting
of stock options to our two newly appointed directors and the vesting of previously granted
options.
Commitments
As at June 30, 2007, we are committed to payments totaling $1,021,000 during the remainder of 2007
for activities related to clinical trial activity and collaborations. All of these committed
payments are considered to be part of our normal course of business.
SUMMARY OF QUARTERLY RESULTS
The following unaudited quarterly information is presented in thousands of dollars except for
per share amounts:
| 2007 | 2006 | 2005 | ||||||||||||||||||||||||||||||
| June | March | Dec. | Sept. | June | March | Dec. | Sept. | |||||||||||||||||||||||||
Revenue |
— | — | — | — | — | — | — | — | ||||||||||||||||||||||||
Interest income |
359 | 268 | 286 | 320 | 335 | 292 | 160 | 211 | ||||||||||||||||||||||||
Net loss(3), |
3,680 | 4,156 | 4,890 | 3,425 | 2,988 | 2,995 | 3,941 | 3,510 | ||||||||||||||||||||||||
Basic and diluted loss per common
share(3) |
$ | 0.09 | $ | 0.11 | $ | 0.13 | $ | 0.09 | $ | 0.08 | $ | 0.08 | $ | 0.12 | $ | 0.11 | ||||||||||||||||
Total assets(1), (4) |
37,670 | 41,775 | 33,566 | 37,980 | 40,828 | 43,660 | 46,294 | 34,538 | ||||||||||||||||||||||||
Total cash(2), (4) |
31,533 | 35,681 | 27,614 | 31,495 | 34,501 | 37,687 | 40,406 | 28,206 | ||||||||||||||||||||||||
Total long-term debt(5) |
— | — | 150 | 150 | 150 | 150 | 150 | 150 | ||||||||||||||||||||||||
Cash dividends
declared(6) |
Nil | Nil | Nil | Nil | Nil | Nil | Nil | Nil | ||||||||||||||||||||||||
| (1) | Subsequent to the acquisition of Oncolytics Biotech Inc. by SYNSORB in April 1999, we applied push down accounting. See note 2 to the audited financial statements for 2006. | |
| (2) | Included in total cash are cash and cash equivalents plus short-term investments. | |
| (3) | Included in net loss and loss per common share between June 2007 and July 2005 are quarterly stock based compensation expenses of $82,573, $21,396, $109,670, $34,671, $222,376, $36,833, $38,152, and $4,173, respectively. | |
| (4) | We issued 4,600,000 common shares for net cash proceeds of $12,063,394 during 2007 (2006 – 284,000 common shares for cash proceeds of $241,400; 2005 – 4,321,252 common shares for cash proceeds of $18,789,596). | |
| (5) | The long-term debt recorded represents repayable loans from the Alberta Heritage Foundation. On January 1, 2007, in conjunction with the adoption of the CICA Handbook section 3855 “Financial Instruments”, this loan was recorded at fair value (see note 1 of the June 30, 2007 interim financial statements). | |
| (6) | We have not declared or paid any dividends since incorporation. |
LIQUIDITY AND CAPITAL RESOURCES
Liquidity
As at June 30, 2007, we had cash and cash equivalents (including short-term investments) and
working capital positions of $31,533,291 and $30,002,209, respectively compared to $27,613,748 and
$25,719,870, respectively for December 31, 2006. The increase in 2007 reflects the cash inflow
from financing activities of $12,063,394 offset by cash usage from operating activities and
additions to our intellectual property of $7,618,488 and $487,058, respectively.
We desire to maintain adequate cash and short-term investment reserves to support our planned
activities which include our clinical trial program, product manufacturing, administrative costs,
and our intellectual property expansion and protection. For the remainder of 2007, we are
expecting to commence patient enrollment in our third co-therapy trial and to continue to enroll
patients in our existing trials throughout 2007. We also expect to continue to expand our clinical
trial program. As well, we expect to continue with our collaborative studies pursuing support for
our future clinical trial program. We will therefore need to ensure that we have enough
REOLYSIN® to supply our clinical trial and collaborative programs. We continue to
expect our cash usage in 2007 to be $1,400,000 per month and we believe our existing capital
resources are adequate to fund our current plans for research and development activities well into
2009. Factors that will affect our anticipated monthly burn rate include, but are not limited to,
the number of manufacturing runs required to supply our clinical trial program and the cost of each
run, additional activities reducing our economic dependence on a single supplier, the number of
clinical trials ultimately approved, the timing of patient enrollment in the approved clinical
trials, the actual costs incurred to
support each clinical trial, the number of treatments each patient will receive, the timing of the
NCI’s R&D activity, and the level of pre-clinical activity undertaken.
In the event that we choose to seek additional capital, we will look to fund additional capital
requirements primarily through the issue of additional equity. We recognize the challenges and
uncertainty inherent in the capital markets and the potential difficulties we might face in raising
additional capital. Market prices and market demand for securities in biotechnology companies are
volatile and there are no assurances that we will have the ability to raise funds when required.
Capital Expenditures
We spent $487,058 on intellectual property in the first half of 2007 compared to $365,036 in the
first half of 2006. The change in intellectual property expenditures reflects the timing of filing
costs associated with our expanded patent base. As well, we have benefited from a stronger
Canadian dollar as our patent costs are typically incurred in U.S. currency. In the second quarter
of 2007, two U.S. patents and one Canadian patent were issued bringing our total patents issued to
21 in the U.S., six in Canada and three in Europe.
Investing Activities
Under our Investment Policy, we are permitted to invest in short-term instruments with a rating no
less than R-1 (DBRS) with terms less than two years. We have $24,356,007 invested under this
policy and we are currently earning interest at an effective rate of 4.14% (2006 – 3.86%).
OTHER MD&A REQUIREMENTS
We have 41,120,748 common shares outstanding at July 26, 2007. If all of our warrants
(4,972,000) and options (3,497,950) were exercised we would have 49,590,698 common shares
outstanding.
Additional information relating to Oncolytics Biotech Inc. is available on SEDAR at www.sedar.com.
Financial Statements
Oncolytics Biotech Inc.
June 30, 2007
Oncolytics Biotech Inc.
BALANCE SHEETS
(unaudited)
(unaudited)
As at,
| June 30, | December 31, | |||||||
| 2007 | 2006 | |||||||
| $ | $ | |||||||
ASSETS |
||||||||
Current |
||||||||
Cash and cash equivalents |
6,923,889 | 3,491,511 | ||||||
Short-term investments [note 7] |
24,609,402 | 24,122,237 | ||||||
Accounts receivable |
46,717 | 84,003 | ||||||
Prepaid expenses |
798,191 | 638,540 | ||||||
| 32,378,199 | 28,336,291 | |||||||
Property and equipment |
168,037 | 149,596 | ||||||
Intellectual property |
5,153,575 | 5,079,805 | ||||||
| 37,699,811 | 33,565,692 | |||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY |
||||||||
Current |
||||||||
Accounts payable and accrued liabilities |
2,375,990 | 2,616,421 | ||||||
Alberta Heritage Foundation loan [notes 1 and 8] |
— | 150,000 | ||||||
Shareholders’ equity |
||||||||
Share capital [note 2] |
||||||||
Authorized: unlimited number of common shares
Issued: 41,120,748 (December 31, 2006 – 36,520,748) |
92,708,665 | 83,083,271 | ||||||
Warrants [note 2] |
6,654,740 | 4,216,740 | ||||||
Contributed surplus [note 4] |
8,633,295 | 8,529,326 | ||||||
Deficit [notes 1 and 5] |
(72,672,879 | ) | (65,030,066 | ) | ||||
| 35,323,821 | 30,799,271 | |||||||
| 37,699,811 | 33,565,692 | |||||||
See accompanying notes
Oncolytics Biotech Inc.
STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
(unaudited)
| Cumulative | ||||||||||||||||||||
| Six Month | Six Month | Three Month | Three Month | from inception | ||||||||||||||||
| Period | Period | Period | Period | on April 2, | ||||||||||||||||
| Ending June | Ending June | Ending June | Ending June | 1998 to June | ||||||||||||||||
| 30, 2007 | 30, 2006 | 30, 2007 | 30, 2006 | 30, 2007 | ||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
Revenue |
||||||||||||||||||||
Rights revenue |
¾ | ¾ | ¾ | ¾ | 310,000 | |||||||||||||||
| ¾ | ¾ | ¾ | ¾ | 310,000 | ||||||||||||||||
Expenses |
||||||||||||||||||||
Research and development |
5,924,611 | 3,876,941 | 2,706,375 | 1,960,619 | 49,145,805 | |||||||||||||||
Operating |
1,918,472 | 2,023,029 | 1,011,755 | 905,093 | 18,689,053 | |||||||||||||||
Stock based compensation [note 3] |
103,969 | 259,209 | 82,573 | 222,376 | 4,269,618 | |||||||||||||||
Foreign exchange loss/gain |
(16,088 | ) | (7,832 | ) | (10,855 | ) | 2,219 | 632,760 | ||||||||||||
Amortization – intellectual property |
469,588 | 427,119 | 238,596 | 216,679 | 4,506,422 | |||||||||||||||
Amortization – property and equipment |
19,864 | 30,694 | 10,009 | 15,416 | 427,547 | |||||||||||||||
| 8,420,416 | 6,609,160 | 4,038,453 | 3,322,402 | 77,671,205 | ||||||||||||||||
Loss before the following: |
8,420,416 | 6,609,160 | 4,038,453 | 3,322,402 | 77,361,205 | |||||||||||||||
Interest income |
(627,603 | ) | (626,910 | ) | (358,871 | ) | (334,688 | ) | (5,430,608 | ) | ||||||||||
Gain on sale of BCY LifeSciences Inc. |
¾ | ¾ | ¾ | ¾ | (299,403 | ) | ||||||||||||||
Loss on sale of Transition Therapeutics Inc. |
¾ | ¾ | ¾ | ¾ | 2,156,685 | |||||||||||||||
Loss before taxes |
7,792,813 | 5,982,250 | 3,679,582 | 2,987,714 | 73,787,879 | |||||||||||||||
Future income tax recovery |
¾ | ¾ | ¾ | ¾ | (1,115,000 | ) | ||||||||||||||
Net loss and comprehensive loss for the period |
7,792,813 | 5,982,250 | 3,679,582 | 2,987,714 | 72,672,879 | |||||||||||||||
Basic and diluted loss per share |
0.20 | 0.16 | 0.09 | 0.08 | ||||||||||||||||
Weighted average number of shares (basic and
diluted) |
39,701,859 | 36,250,836 | 41,120,748 | 36,264,770 | ||||||||||||||||
See accompanying notes
Oncolytics Biotech Inc.
STATEMENTS OF CASH FLOWS
(unaudited)
(unaudited)
| Cumulative | ||||||||||||||||||||
| Three Month | Three Month | from inception | ||||||||||||||||||
| Six Month | Six Month | Period | Period | on April 2, | ||||||||||||||||
| Period Ending | Period Ending | Ending June | Ending June | 1998 to June | ||||||||||||||||
| June 30, 2007 | June 30,2006 | 30, 2007 | 30, 2006 | 30, 2007 | ||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
OPERATING ACTIVITIES |
||||||||||||||||||||
Net loss for the period |
(7,792,813 | ) | (5,982,250 | ) | (3,679,582 | ) | (2,987,714 | ) | (72,672,879 | ) | ||||||||||
Deduct non-cash items |
||||||||||||||||||||
Amortization – intellectual property |
469,588 | 427,119 | 238,596 | 216,679 | 4,506,422 | |||||||||||||||
Amortization – property and equipment |
19,864 | 30,694 | 10,009 | 15,416 | 427,547 | |||||||||||||||
Stock based compensation |
103,969 | 259,209 | 82,573 | 222,376 | 4,269,618 | |||||||||||||||
Other non-cash items [note 6] |
¾ | ¾ | ¾ | ¾ | 1,383,537 | |||||||||||||||
Net changes in non-cash working capital
[note 6] |
(419,096 | ) | (296,360 | ) | (522,374 | ) | (567,132 | ) | 1,485,825 | |||||||||||
| (7,618,488 | ) | (5,561,588 | ) | (3,870,778 | ) | (3,100,375 | ) | (60,599,930 | ) | |||||||||||
INVESTING ACTIVITIES |
||||||||||||||||||||
Intellectual property |
(487,058 | ) | (365,036 | ) | (268,881 | ) | (134,088 | ) | (5,986,338 | ) | ||||||||||
Other capital assets |
(38,305 | ) | (21,048 | ) | (3,558 | ) | 6,333 | (661,653 | ) | |||||||||||
Purchase of short-term investments |
(487,165 | ) | (539,878 | ) | (253,395 | ) | (290,435 | ) | (48,606,632 | ) | ||||||||||
Redemption of short-term investments |
¾ | 10,158,000 | ¾ | 4,258,000 | 23,578,746 | |||||||||||||||
Investment in BCY LifeSciences Inc. |
¾ | ¾ | ¾ | ¾ | 464,602 | |||||||||||||||
Investment in Transition Therapeutics Inc. |
¾ | ¾ | ¾ | ¾ | 2,532,343 | |||||||||||||||
| (1,012,528 | ) | 9,232,038 | (525,834 | ) | 3,839,810 | (28,678,932 | ) | |||||||||||||
FINANCING ACTIVITIES |
||||||||||||||||||||
Proceeds from exercise of warrants and
stock options |
¾ | 42,500 | ¾ | 42,500 | 15,208,468 | |||||||||||||||
Proceeds from private placements |
¾ | ¾ | ¾ | ¾ | 38,137,385 | |||||||||||||||
Proceeds from public offerings [note 2] |
12,063,394 | ¾ | (4,778 | ) | ¾ | 42,856,898 | ||||||||||||||
| 12,063,394 | 42,500 | (4,778 | ) | 42,500 | 96,202,751 | |||||||||||||||
Increase (decrease) in cash and cash
equivalents during the period |
3,432,378 | 3,712,950 | 4,401,390 | 781,935 | 6,923,889 | |||||||||||||||
Cash and cash equivalents, beginning of the
period |
3,491,511 | 3,511,357 | 11,325,279 | 6,442,372 | ¾ | |||||||||||||||
Cash and cash equivalents, end of the period |
6,923,889 | 7,224,307 | 6,923,889 | 7,224,307 | 6,923,889 | |||||||||||||||
See accompanying notes
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
June 30, 2007 (unaudited)
1. ACCOUNTING POLICIES
These unaudited interim financial statements have been prepared in accordance with Canadian
generally accepted accounting principles. The notes presented in these unaudited interim financial
statements include only significant events and transactions occurring since the Company’s last
fiscal year end and are not fully inclusive of all matters required to be disclosed in the
Company’s annual audited financial statements. Accordingly, these unaudited interim financial
statements should be read in conjunction with the Company’s most recent annual financial
statements. The information as at and for the year ended December 31, 2006 has been derived from
the Company’s audited financial statements.
The accounting policies used in the preparation of these unaudited interim financial statements
conform with those used in the Company’s most recent annual financial statements except the
following:
Adoption of New Accounting Policy
Financial Instruments
On January 1, 2007, the Company prospectively adopted, without restatement, CICA Handbook section
3855 “Financial Instruments – Recognition and Measurement” and section 1530 “Other Comprehensive
Income”. Pursuant to the transitional provisions of Section 3855, the Company classified its
short-term investments as held-to-maturity fixed income securities and recorded its Alberta
Heritage Foundation interest free loan at fair value. As a result, there were no adjustments made
to short-term investments or other comprehensive income and there was a decrease in the Alberta
Heritage Foundation loan of $150,000 with a corresponding decrease of $150,000 in the Company’s
deficit.
Financial Assets
Financial assets are comprised of cash and cash equivalents, accounts receivable (mainly goods and
service tax receivable), and short-term investments.
Cash and cash equivalents
Cash and cash equivalents consist of cash on hand and interest bearing deposits with the Company’s
bank.
Short-term investments
The Company determines the appropriate classification of its short-term investments at the time of
purchase and reevaluates such designation as of each balance sheet date. Short-term investments
can be classified as held-for-trading, available-for-sale or held-to-maturity. Currently, the
Company has classified all of its short-term investments as held-to-maturity as it has the positive
intent and ability to hold the securities to maturity. Held-to-maturity securities are stated at
original cost, adjusted for amortization of premiums and accretion of discounts to maturity
computed under the effective interest rate method. Such amortization and interest on securities
classified as held-to-maturity are included in interest income.
Financial Liabilities
Financial liabilities are comprised of trade accounts payable and accrued liabilities.
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
June 30, 2007 (unaudited)
2. SHARE CAPITAL
Authorized:
Unlimited number of common shares
| Issued: | Shares | Warrants | ||||||||||||||
| Amount | Amount | |||||||||||||||
| Number | $ | Number | $ | |||||||||||||
Balance, December 31, 2005 |
36,236,748 | 82,841,871 | 2,784,800 | 4,429,932 | ||||||||||||
Exercise of options |
284,000 | 241,400 | — | — | ||||||||||||
Expired warrants |
— | — | (112,800 | ) | (213,192 | ) | ||||||||||
Balance, December 31, 2006 |
36,520,748 | 83,083,271 | 2,672,000 | 4,216,740 | ||||||||||||
Issued for cash pursuant
to February 22, 2007
public offering
(a) |
4,600,000 | 11,362,000 | 2,300,000 | 2,438,000 | ||||||||||||
Share issue costs |
(1,736,606 | ) | — | — | ||||||||||||
Balance, June 30, 2007 |
41,120,748 | 92,708,665 | 4,972,000 | 6,654,740 | ||||||||||||
| (a) | Pursuant to a public offering, 4,600,000 units were issued at an issue price of $3.00 per unit for gross proceeds of $13,800,000. Each unit included one common share (ascribed value of $2.47) and one-half of one common share purchase warrant (ascribed value of $0.53) for a total of 2,300,000 warrants. The ascribed value was determined using the relative fair value method. Each whole common share purchase warrant entitles the holder to acquire one common share in the capital of the Company upon payment of $3.50 per share until February 22, 2010. Share issue costs for this offering were $1,736,606. |
The following table summarizes the weighted average assumptions used in the Black Scholes Model
with respect to the valuation of warrants:
| 2007 | ||||
Risk-free interest rate |
4.08 | % | ||
Expected hold period to exercise |
3 years | |||
Volatility in the price of the Company’s shares |
62.8 | % | ||
Dividend yield |
— | |||
There were no warrants issued during the six month period ending June 30, 2006.
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
June 30, 2007 (unaudited)
The following table summarizes the Company’s outstanding warrants as at June 30, 2007:
| Weighted | ||||||||||||||||||||
| Average | ||||||||||||||||||||
| Outstanding, | Granted | Exercised | Expired | Remaining | ||||||||||||||||
| Exercise | Beginning of | During the | During the | During the | Outstanding, | Contractual | ||||||||||||||
| Price | the Period | Period | Period | Period | End of Period | Life (years) | ||||||||||||||
$3.50
|
— | 2,300,000 | — | — | 2,300,000 | 2.65 | ||||||||||||||
$5.65
|
320,000 | — | — | — | 320,000 | 1.50 | ||||||||||||||
$6.15
|
1,600,000 | — | — | — | 1,600,000 | 1.50 | ||||||||||||||
$8.00
|
752,000 | — | — | — | 752,000 | 0.40 | ||||||||||||||
| 2,672,000 | 2,300,000 | — | — | 4,972,000 | 1.87 | |||||||||||||||
3. STOCK BASED COMPENSATION
Stock Option Plan
The Company has issued stock options to acquire common stock through its stock option plan of
which the following are outstanding:
| 2007 | 2006 | |||||||||||||||
| Weighted | Weighted | |||||||||||||||
| Average | Average | |||||||||||||||
| Stock | Share Price | Stock | Share Price | |||||||||||||
| Options | $ | Options | $ | |||||||||||||
Outstanding, January 1 |
3,537,950 | 4.88 | 3,634,550 | 4.66 | ||||||||||||
Granted during period |
100,000 | 3.28 | 100,000 | 3.85 | ||||||||||||
Exercised during period |
— | — | (50,000 | ) | 0.85 | |||||||||||
Outstanding, June 30 |
3,637,950 | 4.84 | 3,684,550 | 4.69 | ||||||||||||
Options exercisable, June 30, 2007 |
3,380,450 | 4.96 | 3,452,050 | 4.79 | ||||||||||||
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
June 30, 2007 (unaudited)
The following table summarizes information about the stock options outstanding and exercisable at
June 30, 2007:
| Weighted | Weighted | Weighted | ||||||||||||||||||
| Average | Average | Average | ||||||||||||||||||
| Remaining | Exercise | Exercise | ||||||||||||||||||
| Range of Exercise | Number | Contractual | Price | Number | Price | |||||||||||||||
| Prices | Outstanding | Life (years) | $ | Exercisable | $ | |||||||||||||||
$0.75 - $1.00 |
348,550 | 2.3 | 0.85 | 348,550 | 0.85 | |||||||||||||||
$1.65 - $2.37 |
368,400 | 6.4 | 1.95 | 348,400 | 1.95 | |||||||||||||||
$2.70 - $3.50 |
828,750 | 6.9 | 3.15 | 603,750 | 3.13 | |||||||||||||||
$4.00 - $5.00 |
1,240,750 | 7.3 | 4.86 | 1,228,250 | 4.86 | |||||||||||||||
$6.77 - $9.76 |
708,500 | 4.7 | 8.66 | 708,500 | 8.66 | |||||||||||||||
$12.15 - $13.50 |
143,000 | 3.3 | 12.63 | 143,000 | 12.63 | |||||||||||||||
| 3,637,950 | 6.0 | 4.84 | 3,380,450 | 4.96 | ||||||||||||||||
Options granted vest immediately or annually over one, three or four years at the discretion
of the Board. The outstanding options vest annually or after the completion of certain milestones.
The Company has reserved 4,052,075 common shares for issuance relating to outstanding stock
options.
As the Company is following the fair value based method of accounting for stock options, the
Company recorded compensation expense of $82,573 and $103,969 for the three and six month periods
ending June 30, 2007, respectively (June 30, 2006 $222,376 and $259,209, respectively) with respect
to the granting of options in the period and vesting of options issued in prior periods with an
offsetting credit to contributed surplus.
The estimated fair value of stock options issued during the six month period ending June 30, 2007
was determined using the Black-Scholes model using the following weighted average assumptions and
fair value of options:
| 2007 | 2006 | |||||||
Risk-free interest rate |
4.11 | % | 4.24 | % | ||||
Expected hold period to exercise |
3.5 years | 3.5 years | ||||||
Volatility in the price of the Company’s shares |
63 | % | 64 | % | ||||
Dividend yield |
Zero | Zero | ||||||
Weighted average fair value of options |
$ | 1.56 | $ | 1.86 | ||||
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
June 30, 2007 (unaudited)
4. CONTRIBUTED SURPLUS
| Amount | ||||
| $ | ||||
Balance, December 31, 2005 |
7,912,584 | |||
Expired warrants |
213,192 | |||
Stock based compensation |
403,550 | |||
Exercise of stock options |
— | |||
Balance, December 31, 2006 |
8,529,326 | |||
Stock based compensation |
103,969 | |||
Balance, June 30, 2007 |
8,633,295 | |||
5. DEFICIT
| Amount | ||||
| $ | ||||
Balance, December 31, 2005 |
50,732,542 | |||
Net loss for the year |
14,297,524 | |||
Balance, December 31, 2006 |
65,030,066 | |||
Adjustment – Alberta Heritage Foundation loan [note 1] |
(150,000 | ) | ||
Net loss and comprehensive loss, June 30, 2007 |
7,792,813 | |||
Balance, June 30, 2007 |
72,672,879 | |||
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
June 30, 2007 (unaudited)
6. ADDITIONAL CASH FLOW DISCLOSURE
Net Change In Non-Cash Working Capital
For the periods ending:
| Six | Six | Three | Three | |||||||||||||||||
| Month | Month | Month | Month | Cumulative | ||||||||||||||||
| Period | Period | Period | Period | from inception | ||||||||||||||||
| Ending | Ending | Ending | Ending | on April 2, | ||||||||||||||||
| June 30, | June 30, | June 30, | June 30, | 1998 to June | ||||||||||||||||
| 2007 | 2006 | 2007 | 2006 | 30, 2007 | ||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
Change in: |
||||||||||||||||||||
Accounts receivable |
37,286 | (6,757 | ) | 4,231 | 63,164 | (46,717 | ) | |||||||||||||
Prepaid expenses |
(159,651 | ) | (457,410 | ) | (16,234 | ) | (470,182 | ) | (798,191 | ) | ||||||||||
Accounts payable and accrued liabilities |
(240,431 | ) | 214,240 | (473,371 | ) | (109,214 | ) | 2,375,990 | ||||||||||||
Change in non-cash working capital |
(362,796 | ) | (249,927 | ) | (485,374 | ) | (516,232 | ) | 1,531,082 | |||||||||||
Less portion related to investing activities |
(56,300 | ) | (46,433 | ) | (37,000 | ) | (50,900 | ) | 45,257 | |||||||||||
Net change associated with operating
activities |
(419,096 | ) | (296,360 | ) | (522,374 | ) | (567,132 | ) | 1,485,825 | |||||||||||
Other Non-Cash Items
| Three | Three | Cumulative | ||||||||||||||||||
| Six Month | Six Month | Month | Month | from | ||||||||||||||||
| Period | Period | Period | Period | inception on | ||||||||||||||||
| Ending | Ending | Ending | Ending | April 2, 1998 | ||||||||||||||||
| June 30, | June 30, | June 30, | June 30, | to June 30, | ||||||||||||||||
| 2007 | 2006 | 2007 | 2006 | 2007 | ||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
Foreign exchange loss |
— | — | — | — | 425,186 | |||||||||||||||
Donation of medical equipment |
— | — | — | — | 66,069 | |||||||||||||||
Loss on sale of Transition Therapeutics Inc. |
— | — | — | — | 2,156,685 | |||||||||||||||
Gain on sale of BCY LifeSciences Inc. |
— | — | — | — | (299,403 | ) | ||||||||||||||
Cancellation of contingent payment
obligation settled in common shares |
— | — | — | — | 150,000 | |||||||||||||||
Future income tax recovery |
— | — | — | — | (1,115,000 | ) | ||||||||||||||
| — | — | — | — | 1,383,537 | ||||||||||||||||
7. SHORT-TERM INVESTMENTS
Short-term investments, mainly consisting of government of Canada treasury bills, are liquid
investments that are readily convertible to known amounts of cash and are subject to an
insignificant risk of changes in value. The objectives for holding short-term investments are to
invest the Company’s excess cash resources in investment vehicles that provide a better rate of
return compared to the Company’s interest bearing bank account with limited risk to the principal
invested. The Company also intends to match the maturities of these short-term investments with
the cash requirements of the Company’s activities.
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
June 30, 2007 (unaudited)
| Effective | ||||||||||||||||||||
| Original | Accrued | Carrying | Fair | Interest | ||||||||||||||||
| Cost | Interest | Value | Value | Rate | ||||||||||||||||
June 30, 2007
Short-term investments |
24,287,868 | 321,534 | 24,609,402 | 24,574,467 | 4.14 | % | ||||||||||||||
December 31, 2006
Short-term investments |
23,672,719 | 449,518 | 24,122,237 | 24,124,810 | 3.95 | % | ||||||||||||||
Fair value is determined by using published market prices provided by the Company’s investment
advisor.
8. ALBERTA HERITAGE LOAN
The Company received an interest free loan of $150,000 from the Alberta Heritage Foundation
for Medical Research. Pursuant to the terms of the agreement, the Company is required to repay
this amount in annual installments from the date of commencement of sales in an amount equal to the
lesser of: (a) 5% of the gross sales generated by the Company; or (b) $15,000 per annum until the
entire loan has been paid in full.
9. COMPARATIVE FIGURES
Certain comparative figures have been reclassified to conform with the current period’s
presentation.
Shareholder Information
For public company filings please go to www.sedar.com or contact us at:
Oncolytics Biotech Inc.
Suite 210, 1167 Kensington Crescent NW
tel: 403.670.7377 fax: 403.283.0858
Calgary, Alberta, Canada T2N 1X7
www.oncolyticsbiotech.com
Suite 210, 1167 Kensington Crescent NW
tel: 403.670.7377 fax: 403.283.0858
Calgary, Alberta, Canada T2N 1X7
www.oncolyticsbiotech.com
Officers
Brad Thompson, PhD
Chairman, President and CEO
Doug Ball, CA
Chief Financial Officer
Matt Coffey, PhD
Chief Scientific Officer
Karl Mettinger, MD, PhD
Chief Medical Officer
George Gill, MD
Senior Vice President, Clinical and Regulatory Affairs
Mary Ann Dillahunty
Vice President, Intellectual Property
Chairman, President and CEO
Doug Ball, CA
Chief Financial Officer
Matt Coffey, PhD
Chief Scientific Officer
Karl Mettinger, MD, PhD
Chief Medical Officer
George Gill, MD
Senior Vice President, Clinical and Regulatory Affairs
Mary Ann Dillahunty
Vice President, Intellectual Property
Directors
Brad Thompson, PhD
Chairman, President and CEO, Oncolytics Biotech Inc.
Doug Ball, CA
CFO, Oncolytics Biotech Inc.
Ger van Amersfoort
Biotech Consultant
William. A. Cochrane, OC, MD
Biotech Consultant
Jim Dinning
Chairman, Western Financial Group
Ed Levy, PhD
Adjunct Professor, University of British Columbia
J. Mark Lievonen, CA
President, Sanofi Pasteur Limited
Bob Schultz, FCA
Corporate Director
Fred Stewart, QC
Chairman, President and CEO, Oncolytics Biotech Inc.
Doug Ball, CA
CFO, Oncolytics Biotech Inc.
Ger van Amersfoort
Biotech Consultant
William. A. Cochrane, OC, MD
Biotech Consultant
Jim Dinning
Chairman, Western Financial Group
Ed Levy, PhD
Adjunct Professor, University of British Columbia
J. Mark Lievonen, CA
President, Sanofi Pasteur Limited
Bob Schultz, FCA
Corporate Director
Fred Stewart, QC
President, Fred Stewart and Associates Inc.
Oncolytics Biotech Inc.
Suite 210, 1167 Kensington Crescent NW, Calgary, AB T2N 1X7
Phone: (403) 670.7377 Fax: (403) 283.0858
www.oncolyticsbiotech.com
Suite 210, 1167 Kensington Crescent NW, Calgary, AB T2N 1X7
Phone: (403) 670.7377 Fax: (403) 283.0858
www.oncolyticsbiotech.com