EX-99.1 2 a30918-q4ye2017results.htm EXHIBIT 99.1 Exhibit

a30918q4ye2017results_image1.jpg

Oncolytics Biotech® Inc. Announces 2017 Year-End Results

CALGARY, AB and SAN DIEGO, CA March 9, 2018 -- Oncolytics Biotech® Inc. (TSX: ONC) (OTCQX: ONCYF), currently developing REOLYSIN® (pelareorep), an intravenously delivered immuno-oncolytic virus creating an inflamed phenotype, today announced its financial results and operational highlights for the year ended December 31, 2017. All dollar amounts are expressed in Canadian currency unless otherwise noted.

“We view 2017 as a pivotal year for Oncolytics and one that positions us for a productive year ahead," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "Our IND 213 study in metastatic breast cancer, or mBC, generated compelling results and marked the first time that an oncolytic virus has demonstrated a statistically significant median overall survival advantage in a randomized clinical study. We received supportive regulatory feedback on our proposed registrational study design for pelareorep in HR-positive, HER2-negative breast cancer, the major genetic subgroup of mBC, from both the United States Food and Drug Administration and the European Medicines Agency. Looking forward, we are excited to initiate a phase 3 mBC registrational study later this year and also expand our development with highly focused phase 2 studies designed to further establish pelareorep as an immunotherapy and deliver near term clinical data. We plan to initiate three cost-effective, partner-sponsored phase 2 studies. These would include a basket study to generate efficacy data on pelareorep in combination with high profile checkpoint inhibitors in patients having specific genetic mutations across cancer types, and part two a trial using pelareorep in combination with pembrolizumab (KEYTRUDA®) in patients with relapsed metastatic adenocarcinoma of the pancreas. We are also planning to initiate a window of opportunity study using pelareorep and the standard of care in a neoadjuvant setting for treatment naïve mBC patients, potentially broadening pelareorep’s treatment applicability to include first line treatment.”

Selected Highlights

Since January 1, 2017, selected highlights announced by the Company include:

Clinical Updates
Presented findings from IND 213, an open-label, randomized, phase 2 study of intravenously-administered pelareorep given in combination with paclitaxel versus paclitaxel alone in patients with advanced or metastatic breast cancer (mBC) at the American Association for Cancer Research meeting in April 2017. Results showed a statistically significant improvement in median overall survival (OS) from 10.4 months in the control arm to 17.4 months in the test arm.
Presented additional clinical data from IND 213 at the European Society for Medical Oncology (ESMO) 2017 Congress that demonstrated a doubling of overall survival benefit for patients with HR double-positive, HER2-negative mBC when treated with pelareorep/paclitaxel combination treatment versus paclitaxel alone.
Announced a favorable End-of-Phase 2 meeting with the FDA for pelareorep in combination with paclitaxel, for the treatment of hormone receptor positive, HER2 receptor negative (HR+/HER2-) mBC patients. The agency's guidance proposed a single, 400 patient registration study to support a future Biologics License Application submission in the U.S.
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Subsequently, increased to 450 patients to ensure the completion of the study with the planned evaluable population
Received a Final Advice Letter from the EMA suggesting that a single phase 3 study may be acceptable to form the basis of a Marketing Authorization Application (MAA) in Europe.




Announced the launch of MUK eleven, a phase 1b trial studying pelareorep in combination with Celgene's Imnovid® (pomalidomide) and Revlimid® (lenalidomide), as a rescue treatment in relapsing myeloma patients. Oncolytics treated the first patient in this trial in September 2017.
Presented the largest ever safety database for an oncolytic virus at the ESMO 2017 Congress that demonstrated pelareorep is safe and well tolerated when administered in combination with paclitaxel plus/minus carboplatin.
Announced that the FDA granted Fast Track designation for pelareorep for the treatment of mBC, based on the data from IND 213. However, our request for breakthrough therapy designation (BTD) in mBC was not approved at this time based on certain data requirements. The FDA provided guidance that the Company may re-apply for BTD once additional supportive information is available.

Corporate Updates
Entered into a USD $86.6 million regional licensing agreement with Adlai Nortye for pelareorep covering China, Hong Kong, Macau, Singapore, South Korea and Taiwan. Under the terms of the agreement, Oncolytics is eligible to receive upfront, licensing fee and milestone payments of USD $21.2 million to support our phase 3 registration study and is eligible to receive up to an additional USD $65.4 million upon achievement of clinical, regulatory and commercialization milestones.
Received shareholder approval for the consolidation of the Company's common shares, which enables Oncolytics to meet requirements for listing on the NASDAQ Capital Market.
Closed an underwritten public share offering of 16,445,000 units at a purchase price of $0.70 for gross proceeds of approximately $11.5 million ($10.6 million net).
Established a Scientific Advisory Board focused on pelareorep’s registration study in mBC.
Appointed Oncolytics co-founder and long-serving senior executive Matt Coffey PhD, MBA, as President and CEO.
Appointed Andrew de Guttadauro as President of its US subsidiary, Oncolytics Biotech (U.S.) Inc. and Head of Global Business Development.

Anticipated Milestones
Initiate a phase 3 registration study of pelareorep in combination with paclitaxel, for the treatment HR+/HER2- mBC patients in Q3 2018.
Initiate a phase 2 partner-sponsored window of opportunity study of pelareorep in combination with standard of care therapy in the neoadjuvant setting in mBC in H2 2018.
Initiate a phase 2 partner-sponsored basket study to generate important biomarker and efficacy data of pelareorep in combination with checkpoint inhibitors in H2 2018.
Initiate part two of a phase 2 North-West University/Merck sponsored trial of pelareorep in combination with pembrolizumab (KEYTRUDA®) in patients with relapsed metastatic adenocarcinoma of the pancreas.
Re-list on the NASDAQ in 2Q 2018.

2017 Year-End Financial Results
At December 31, 2017, the Company reported $11.8 million in cash, cash equivalents and short-term investments.














ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

As at December 31,
2017 $
2016 $
Assets
 
 
Current assets
 
 
Cash and cash equivalents
11,836,119

 
12,034,282

 
Short-term investments

 
2,088,800

 
Contract receivable
4,767,100

 

 
Other receivables
37,726

 
54,406

 
Prepaid expenses
1,176,063

 
260,841

 
Total current assets
17,817,008

 
14,438,329

 
Non-current assets
 
 
Property and equipment
333,441

 
319,955

 
Total non-current assets
333,441

 
319,955

 
 
 
 
Total assets
18,150,449

 
14,758,284

 
Liabilities And Shareholders’ Equity
 
 
Current Liabilities
 
 
Accounts payable and accrued liabilities
3,684,023

 
4,068,664

 
Contract liability
1,545,645

 

 
Total current liabilities
5,229,668

 
4,068,664

 
Non-current liabilities
 
 
Contract liability
4,636,935

 

 
Total non-current liabilities
4,636,935

 

 
 
 
 
Total liabilities
9,866,603

 
4,068,664

 
Shareholders’ equity
 
 
Share capital
  Authorized: unlimited
  Issued:
December 31, 2017 – 141,805,722
December 31, 2016 – 121,258,222
271,710,138

 
262,321,825

 
Warrants
3,617,900

 

 
Contributed surplus
27,028,238

 
26,643,044

 
Accumulated other comprehensive income
373,730

 
554,060

 
Accumulated deficit
(294,446,160

)
(278,829,309

)
Total shareholders’ equity
8,283,846

 
10,689,620

 
Total liabilities and equity
18,150,449

 
14,758,284

 










ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

For the years ending December 31,
2017 $
2016 $
2015 $
 
 
 
 
Expenses
 
 
 
Research and development
9,392,623
 
9,770,007
 
8,601,864
 
Operating
6,212,831
 
5,524,500
 
5,315,837
 
Loss before the following
(15,605,454
)
(15,294,507
)
(13,917,701
)
Interest
130,101
 
163,902
 
197,859
 
Loss before income taxes
(15,475,353
)
(15,130,605
)
(13,719,842
)
Income tax expense
(141,498
)
(9,374
)
(3,153
)
Net loss
(15,616,851
)
(15,139,979
)
(13,722,995
)
Other comprehensive (loss) income items that may be
reclassified to net loss
 
 
 
Translation adjustment
(180,330
)
(206,918
)
480,935
 
Net comprehensive loss
(15,797,181
)
(15,346,897
)
(13,242,060
)
Basic and diluted loss per common share
(0.12
)
(0.13
)
(0.12
)
Weighted average number of shares (basic and diluted)
132,395,752
 
119,880,200
 
112,613,845
 








ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
 
Share Capital
$
Warrants
$
Contributed Surplus
$
Accumulated Other Comprehensive Income
$
Accumulated Deficit
$
Total
$
As at December 31, 2014
237,657,056

 

 
25,848,429

 
280,043

 
(249,966,335

)
13,819,193

 
 
 
 
 
 
 
 
Net loss and other comprehensive income

 

 

 
480,935

 
(13,722,995

)
(13,242,060

)
Issued pursuant to Share Purchase Agreement
4,371,687

 

 

 

 

 
4,371,687

 
Issued pursuant to "At the Market" Agreement
20,049,693

 

 

 

 

 
20,049,693

 
Share based compensation

 

 
429,537

 

 

 
429,537

 
Share issue costs
(753,744

)

 

 

 

 
(753,744

)
As at December 31, 2015
261,324,692

 

 
26,277,966

 
760,978

 
(263,689,330

)
24,674,306

 
 
 
 
 
 
 
 
Net loss and other comprehensive loss

 

 

 
(206,918

)
(15,139,979

)
(15,346,897

)
Issued pursuant to incentive share award plan
41,000

 

 
(41,000

)

 

 

 
Issue pursuant to "At the Market" Agreement
1,456,296

 

 

 

 

 
1,456,296

 
Share based compensation

 

 
406,078

 

 

 
406,078

 
Share issue costs
(500,163

)

 

 

 

 
(500,163

)
As at December 31, 2016
262,321,825

 

 
26,643,044

 
554,060

 
(278,829,309

)
10,689,620

 
 
 
 
 
 
 
 
Net loss and other comprehensive loss

 

 

 
(180,330

)
(15,616,851

)
(15,797,181

)
Issued pursuant to stock option plan
536,949

 

 
(193,509

)

 

 
343,440

 
Issued pursuant to "At the Market" Agreement
2,348,821

 

 

 

 

 
2,348,821

 
Issued pursuant to public offering
7,893,600

 
3,617,900

 

 

 

 
11,511,500

 
Share based compensation

 

 
578,703

 

 

 
578,703

 
Share issue costs
(1,391,057

)

 

 

 

 
(1,391,057

)
As at December 31, 2017
271,710,138

 
3,617,900

 
27,028,238

 
373,730

 
(294,446,160

)
8,283,846

 













ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS


For the years ending December 31,
2017 $
2016 $
2015 $
 
 
 
 
Operating Activities
 
 
 
Net loss for the year
(15,616,851

)
(15,139,979

)
(13,722,995

)
Amortization - property and equipment
90,768

 
162,233

 
180,411

 
Share based compensation
578,703

 
406,078

 
429,537

 
Unrealized foreign exchange gain
(124,793

)
(139,810

)
(816,319

)
Net change in non-cash working capital
180,855

 
2,233,865

 
(1,105,464

)
Cash used in operating activities
(14,891,318

)
(12,477,613

)
(15,034,830

)
Investing Activities
 
 
 
Acquisition of property and equipment
(105,765

)
(23,527

)
(108,268

)
Redemption (purchase) of short-term investments
2,088,800

 
(27,823

)
(29,292

)
Cash provided by (used in) investing activities
1,983,035

 
(51,350

)
(137,560

)
Financing Activities
 
 
 
Proceeds from Share Purchase Agreement

 

 
4,305,396

 
Proceeds from "At the Market" equity distribution agreement
2,103,166

 
956,133

 
19,362,240

 
Proceeds from public offering
10,366,098

 

 

 
Proceeds from exercise of stock options
343,440

 

 

 
Cash provided by financing activities
12,812,704

 
956,133

 
23,667,636

 
(Decrease) increase in cash
(95,579

)
(11,572,830

)
8,495,246

 
Cash and cash equivalents, beginning of year
12,034,282

 
24,016,275

 
14,152,825

 
Impact of foreign exchange on cash and cash equivalents
(102,584

)
(409,163

)
1,368,204

 
Cash and cash equivalents, end of year
11,836,119

 
12,034,282

 
24,016,275

 





To view the Company's Fiscal 2017 year end Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management's Discussion and Analysis, please see the Company's annual filings, which will be available under the Company's profile at www.sedar.com and on Oncolytics' investor relations website at https://ir.oncolyticsbiotech.com/reports.










About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing REOLYSIN, also known as pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype – turning “cold” tumors “hot” – through innate and adaptive immune responses to treat a variety of cancers. Oncolytics' clinical development program emphasizes three pillars: chemotherapy combinations to trigger selective tumor lysis; immuno-therapy combinations to produce adaptive immune responses; and immune modulator (IMiD) combinations to facilitate innate immune responses. Oncolytics is currently planning its first registration study in metastatic breast cancer, as well as studies in combination with checkpoint inhibitors and targeted and IMiD therapies in solid and hematological malignancies. For further information, please visit: www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's 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. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.


Company Contact
Michael Moore
Vice President, Investor Relations & Corporate Communications
858-886-7813
mmoore@oncolytics.ca

Investor Relations
Robert Uhl
Westwicke Partners
858-356-5932
robert.uhl@westwicke.com

Media Contact
Mark Corbae
Canale Communications              
619-849-5375
mark@canalecomm.com