EX-99.1 2 a80318-q2announcementfinal.htm EXHIBIT 99.1 Exhibit
a80318q2announcementf_image1.jpg

     
Oncolytics Biotech® Reports 2018 Second Quarter Results

CALGARY, AB and SAN DIEGO, CA, August 3, 2018 -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (TSX: ONC), currently developing REOLYSIN® (pelareorep), an intravenously delivered immuno-oncolytic virus turning cold tumors hot, today announced financial results and operational highlights for the quarter ended June 30, 2018.  All dollar amounts are Canadian unless otherwise noted.

“The second quarter began with clinical updates at three scientific conferences and an agreement with the FDA for our Special Protocol Assessment, followed by the announcements of two combination studies with Merck’s Keytruda and culminated in the company’s relisting on Nasdaq,” said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. “The immuno-oncology data we have presented at recent conferences, as well as the data we expect from recently announced studies supports the potential for combination with checkpoint inhibitors and other immunotherapy and anticancer agents as we broaden our pipeline to demonstrate the ultimate value of pelareorep. Our Nasdaq listing has already raised our profile with institutional investors focusing on biotech and we hope to see additional analyst coverage out of the U.S.”

Selected highlights since April 1, 2018

Clinical Updates
Reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints and statistical analysis approach for the company's phase 3 study evaluating pelareorep for the treatment of metastatic breast cancer.
Announced two combination studies with Merck’s Keytruda®:
o
Investigating pelareorep in combination with Keytruda to treat second line pancreatic cancer patients. The study, run by Dr. Devalingham Mahalingam, will plan to enroll approximately 40 patients with advanced pancreatic cancer and will be conducted at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.
o
Investigating pelareorep in combination with Keytruda, Velcade® and dexamethasone to treat multiple myeloma patients. The study, facilitated by Dr. Kevin Kelly, Associate Professor of Clinical Medicine, will be conducted at the USC Norris Comprehensive Cancer Center. 
Presented poster highlights from pelareorep studies at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting. The presentation demonstrated that pelareorep promotes the expression of gene signatures predictive of a response to immunotherapy in breast cancer and hepatocellular carcinoma and that the tumor inflammation promoting effects in breast cancer models provide a compelling explanation for the significant overall survival benefit in hormone receptor positive metastatic breast cancer patients in the phase 2, IND 213, study.
Presented posters highlighting data from pelareorep studies at the American Association for Cancer Research (AACR) Annual Meeting 2018. The presentations showed preclinical models demonstrating pelareorep increased PD-L1 expression in microsatellite stable (MSS) colorectal cancer cells (CRC) and demonstrated efficacy for pelareorep and anti-PD1 agent combination.
Presented positive pelareorep data in combination with Keytruda and anti-CD73 at the International Oncolytic Virus Conference 2018. The poster highlighted the effectiveness of pelareorep in combination with Keytruda and/or an anti-CD73 immunotherapy in prostate cancer cell lines.

Corporate Updates





Announced a share consolidation on the basis of 1 new common share for every 9.5 outstanding common shares.
Announced the listing of the company’s shares of common stock on the Nasdaq Capital Market and commenced trading on June 1, 2018, under the symbol "ONCY".
Closed an underwritten public share offering of 1,532,278 common shares at a purchase price of USD $5.83 for gross proceeds of approximately USD $8.9 million.
Expanded the clinical development team in San Diego, including Senior Medical Personnel.

Anticipated Milestones
Initiate a phase 2 window of opportunity study of pelareorep in combination with a checkpoint inhibitor and/or the standard of care in the neoadjuvant breast cancer setting in 2H 2018.
Initiate a phase 2 study in combination with Merck’s Keytruda in multiple myeloma in 2H 2018.
Initiate a phase 2 study in combination with Merck’s Keytruda in advanced pancreatic cancer in 2H 2018.
Data from window of opportunity study in mBC in 1H 2019.
Data from Keytruda combination study in multiple myeloma in 2H 2019.
Preliminary data from Keytruda combination study in advanced pancreatic cancer in 1H 2020.

Financial
At June 30, 2018, the company reported $18.7 million in cash and cash equivalents.
As at August 2, 2018, the company had an unlimited number of authorized common shares with 16,531,956 common shares issued and outstanding, 16,443,500 warrants exercisable into 1,730,894 common shares with a $9.025 strike price and 1,153,080 options and share units.



































ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)

As at
June 30,
2018
$
December 31,
2017
$
Assets
 
 
Current assets
 
 
Cash and cash equivalents
18,741,347

 
11,836,119
 
Contract receivable

 
4,767,100
 
Other receivables
89,714

 
37,726
 
Prepaid expenses
1,489,212

 
1,176,063
 
Total current assets
20,320,273

 
17,817,008
 
Non-current assets
 
 
Property and equipment
373,213

 
333,441
 
Total non-current assets
373,213

 
333,441
 
 
 
 
Total assets
20,693,486

 
18,150,449
 
Liabilities And Shareholders’ Equity
 
 
Current Liabilities
 
 
Accounts payable and accrued liabilities
2,996,438

 
3,684,023
 
Contract liability
927,400

 
1,545,645
 
Total current liabilities
3,923,838

 
5,229,668
 
Non-current liabilities
 
 
Contract liability
5,802,887

 
4,636,935
 
Total non-current liabilities
5,802,887

 
4,636,935
 
 
 
 
Total liabilities
9,726,725

 
9,866,603
 
Shareholders’ equity
 
 
Share capital
  Authorized: unlimited
  Issued:
June 30, 2018 – 16,521,430
December 31, 2017 – 141,805,722 pre-consolidation
December 31, 2017 – 14,926,918 post-consolidation
282,458,995

 
271,710,138
 
Warrants
3,617,570

 
3,617,900
 
Contributed surplus
27,710,089

 
27,028,238
 
Accumulated other comprehensive income
508,380

 
373,730
 
Accumulated deficit
(303,328,273

)
(294,446,160
)
Total shareholders’ equity
10,966,761

 
8,283,846
 
Total liabilities and equity
20,693,486

 
18,150,449
 












ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)

 
Three Month Period Ending June 30, 2018
$
Three Month Period Ending June 30, 2017
$
Six Month Period Ending June 30, 2018
$
Six Month Period Ending June 30, 2017
$
 
 
 
 
 
 
 
Expenses
 
 
 
 
 
Research and development
2,045,417
 
2,918,673
 
4,980,308
 
5,186,744
 
Operating
1,638,802
 
1,444,543
 
3,401,355
 
2,744,843
 
Loss before the following
(3,684,219
)
(4,363,216
)
(8,381,663
)
(7,931,587
)
Interest
20,538
 
14,163
 
47,428
 
64,878
 
Loss before income taxes
(3,663,681
)
(4,349,053
)
(8,334,235
)
(7,866,709
)
Income tax expense
(547,758
)
(89
)
(547,878
)
(152
)
Net loss
(4,211,439
)
(4,349,142
)
(8,882,113
)
(7,866,861
)
Other comprehensive income (loss) items that may be reclassified to net loss
 
 
 
 
 
Translation adjustment
64,029
 
(44,740
)
134,650
 
(65,488
)
Net comprehensive loss
(4,147,410
)
(4,393,882
)
(8,747,463
)
(7,932,349
)
Basic and diluted loss per common share
(0.27
)
(0.32
)
(0.58
)
(0.60
)
Weighted average number of shares (basic and diluted)
15,406,944
 
13,405,220
 
15,191,457
 
13,086,393
 








ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)

 
Share Capital
$
Warrants
$
Contributed Surplus
$
Accumulated Other Comprehensive Income
$
Accumulated Deficit
$
Total
$
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

 

 

 
(65,488

)
(7,866,861

)
(7,932,349
)
Issued pursuant to "At the Market" agreement
668,648

 

 

 

 

 
668,648
 
Issued pursuant to public offering
7,893,600

 
3,617,900

 

 

 

 
11,511,500
 
Issued pursuant to stock option plan
461,823

 

 
(166,473

)

 

 
295,350
 
Share based compensation

 

 
289,597

 

 

 
289,597
 
Share issue costs
(1,254,523

)

 

 

 

 
(1,254,523
)
As at June 30, 2017
270,091,373

 
3,617,900

 
26,766,168

 
488,572

 
(286,696,170

)
14,267,843
 
 
 
 
 
 
 
 
As at December 31, 2017
271,710,138

 
3,617,900

 
27,028,238

 
373,730

 
(294,446,160

)
8,283,846
 
Net loss and other comprehensive income

 

 

 
134,650

 
(8,882,113

)
(8,747,463
)
Issued pursuant to "At the Market" Agreement
553,650

 

 

 

 

 
553,650
 
Issued pursuant to public offering
11,606,882

 

 

 

 

 
11,606,882
 
Issued pursuant to stock option plan
38,269

 

 
(14,359

)

 

 
23,910
 
Issued pursuant to warrant agreement
1,747

 
(330

)

 

 

 
1,417
 
Share based compensation

 

 
696,210

 

 

 
696,210
 
Share issue costs
(1,451,691

)

 

 

 

 
(1,451,691
)
As at June 30, 2018
282,458,995

 
3,617,570

 
27,710,089

 
508,380

 
(303,328,273

)
10,966,761
 








ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)

 
Three Month Period Ending June 30, 2018
$
Three Month Period Ending June 30, 2017
$
Six Month Period Ending June 30, 2018
$
Six Month Period Ending June 30, 2017
$
 
 
 
 
 
Operating Activities
 
 
 
 
Net loss for the period
(4,211,439

)
(4,349,142

)
(8,882,113

)
(7,866,861

)
Amortization - property and equipment
21,126

 
25,688

 
40,984

 
49,724

 
Share based compensation
157,092

 
155,708

 
696,210

 
289,597

 
Unrealized foreign exchange gain
(97,832

)
(164,676

)
(102,345

)
(112,644

)
Net change in non-cash working capital
4,720,317

 
(216,906

)
4,227,770

 
(854,552

)
Cash provided by (used in) operating activities
589,264

 
(4,549,328

)
(4,019,494

)
(8,494,736

)
Investing Activities
 
 
 
 
Acquisition of property and equipment
(37,443

)
(80,050

)
(80,062

)
(85,886

)
Redemption of short-term investments

 

 

 
2,088,800

 
Cash (used in) provided by investing activities
(37,443

)
(80,050

)
(80,062

)
2,002,914

 
Financing Activities
 
 
 
 
Proceeds from "At the Market" equity distribution agreement

 
570,027

 
520,315

 
559,527

 
Proceeds from public offering
10,188,526

 
10,366,098

 
10,188,526

 
10,366,098

 
Proceeds from exercise of options
23,910

 
295,350

 
23,910

 
295,350

 
Proceeds from exercise of warrants
1,417

 

 
1,417

 

 
Cash provided by financing activities
10,213,853

 
11,231,475

 
10,734,168

 
11,220,975

 
Increase in cash
10,765,674

 
6,602,097

 
6,634,612

 
4,729,153

 
Cash and cash equivalents, beginning of period
7,745,255

 
10,102,393

 
11,836,119

 
12,034,282

 
Impact of foreign exchange on cash and cash equivalents
230,418

 
(28,192

)
270,616

 
(87,137

)
Cash and cash equivalents, end of period
18,741,347

 
16,676,298

 
18,741,347

 
16,676,298

 







To view the Company's Fiscal 2018 Second Quarter Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management's Discussion and Analysis, please see the Company's





filings, which will be available at www.sedar.com, www.sec.gov and on Oncolytics' website at http://www.oncolyticsbiotech.com/investor-centre/financials/.

About REOLYSIN/Pelareorep 
REOLYSIN, also known as pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

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 and immuno-therapy and immune modulator (IMiD) combinations to produce innate and adaptive immune responses. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted and IMiD therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. 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; the collaboration between Merck and USC using pelareorep, including the timing, enrollment and potential benefits to the Company thereof; 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
Jason Spark
Canale Communications              
619-849-6005
jason@canalecomm.com