EX-99.1 2 ex991.htm NEWS RELEASE DATED NOVEMBER 8, 2017

Exhibit 99.1

 

 

Oncolytics Biotech® Inc. Announces 2017 Third Quarter Results

CALGARY, and SAN DIEGO, CA, Nov. 8, 2017 /CNW/ - Oncolytics Biotech® Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN®, an intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems to turn 'cold' tumors 'hot', today announced its financial results and operational highlights for the quarter ended September 30, 2017.

"Towards the end of the third quarter we made a very important announcement regarding feedback from the FDA following our End-of-Phase 2 meeting.  The favorable meeting resulted in the support of our proposed target patient population of hormone receptor positive, HER2 receptor negative metastatic breast cancer patients for our registration study," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "With this support and guidance outlining a single, four hundred patient study, we have prepared to file for breakthrough designation which we expect to do very soon, prepared for communications with the European regulators, conducted preliminary preparations to file for a special protocol assessment, or SPA, and advanced our business development activities.  We expect to be able to announce the results of these filings and communications with the European regulators over the next several months as we continue to prepare the company to relist its shares on NASDAQ in 2018."

Selected Highlights from Q2 and through the end of July 2017

Clinical Updates

·Announced a favorable End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for REOLYSIN in combination with paclitaxel, for the treatment of hormone receptor positive, HER2 receptor negative (HR+/HER2-) metastatic breast cancer (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.
·Presented mBC data 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 breast cancer – a major genetic subgroup – when treated with REOLYSIN/paclitaxel combination treatment versus paclitaxel alone.
·Announced the first patient treated in our phase 1b MUK Eleven collaborative study with Myeloma UK and Celgene, studying REOLYSIN in combination with Celgene immunomodulatory drugs (IMiDs), Revlimid® or Imnovid® as a rescue treatment in relapsing myeloma patients.
·Presented the largest ever safety database for an oncolytic virus at the ESMO 2017 Congress, that demonstrated REOLYSIN is safe and well tolerated when administered in combination with chemotherapy.

Corporate Updates

·Appointed Deborah Brown to the Board of Directors, to expand the Board's experience with product launches, market expansion, regulatory affairs, research and development and business development.

Anticipated Milestones

 First quarter 2018: Results from regulatory filings
 First half of 2018: Update on our exploration of strategic and regional alliances                                                                     
  NASDAQ
  Preliminary MUK eleven data
 Mid-2018: Initiate phase 3 registration study in mBC

Q3 2017 Financial Results

·At September 30, 2017, the Company reported $14.0 million in cash and cash equivalents.  Cash runway expected to the end of 2018.
·As at November 7, 2017, the Company had an unlimited number of authorized common shares with 140,700,722 common shares issued and outstanding, 7,448,327 options outstanding (with exercise prices ranging between $0.26 and $6.72 and expiry dates ranging from 2017 to 2027), 16,445,000 warrants outstanding (with a $0.95 strike price expiring in June 2022) and 2,428,039 RSU's and PSU's outstanding.
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
       
  September 30,
2017
$
  December 31,
2016
$
Assets      
Current assets      
Cash and cash equivalents 14,033,644   12,034,282
Short-term investments   2,088,800
Accounts receivable 33,129   54,406
Prepaid expenses 438,150   260,841
Total current assets 14,504,923   14,438,329
       
Non-current assets      
Property and equipment 343,307   319,955
Total non-current assets 343,307   319,955
       
Total assets 14,848,230   14,758,284
       
Liabilities And Shareholders' Equity      
Current Liabilities      
Accounts payable and accrued liabilities 2,781,932   4,068,664
Total current liabilities 2,781,932   4,068,664
       
Shareholders' equity      
Share capital      
  Authorized: unlimited      
  Issued:      
  September 30, 2017 – 140,671,722      
  December 31, 2016 – 121,258,222 270,899,669   262,321,825
Warrants 3,617,900  
Contributed surplus 26,887,579   26,643,044
Accumulated other comprehensive income 361,726   554,060
Accumulated deficit (289,700,576)   (278,829,309)
Total shareholders' equity 12,066,298   10,689,620
Total liabilities and equity 14,848,230   14,758,284

 

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
               
  Three
Month
Period
Ending
September
30, 2017
$
  Three
Month
Period
Ending
September
30, 2016
$
  Nine
Month
Period
Ending
September
30, 2017
$
  Nine
Month
Period
Ending
September
30, 2016
$
Expenses        
  Research and development 1,726,726   2,141,737   6,913,470   6,358,822
  Operating 1,309,607   1,222,447   4,054,450   3,708,317
Operating loss (3,036,333)   (3,364,184)   (10,967,920)   (10,067,139)
  Interest 31,759   31,691   96,637   136,849
Loss before income taxes (3,004,574)   (3,332,493)   (10,871,283)   (9,930,290)
  Income tax expense 168   19   16   333
Net loss (3,004,406)   (3,332,474)   (10,871,267)   (9,929,957)

Other comprehensive income items that may be

reclassified to net loss

       
                 
  Translation adjustment (126,846)   32,545   (192,334)   (268,341)
               
Net comprehensive loss (3,131,252)   (3,299,929)   (11,063,601)   (10,198,298)
Basic and diluted loss per common share (0.02)   (0.03)   (0.08)   (0.08)
Weighted average number of shares (basic and
diluted)
139,515,885   120,552,638   129,441,461   119,455,440

 

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, 2015 261,324,692     26,277,966   760,978   (263,689,330)   24,674,306
Net loss and other comprehensive loss       (268,341)   (9,929,957)   (10,198,298)
Issued pursuant to "At the Market" Agreement 1,339,378           1,339,378
Issued pursuant to incentive share award plan 41,000     (41,000)      
Share issue costs (486,842)           (486,842)
Share based compensation     299,635       299,635
As at September 30, 2016 262,218,228     26,536,601   492,637   (273,619,287)   15,628,179
                       
  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       (192,334)   (10,871,267)   (11,063,601)
Issued pursuant to "At the Market" Agreement 1,479,065           1,479,065
Issued pursuant to public offering 7,893,600   3,617,900         11,511,500
Issued pursuant to stock option plan 536,949     (193,509)       343,440
Share issue costs (1,331,770)           (1,331,770)
Share based compensation     438,044       438,044
As at September 30, 2017 270,899,669   3,617,900   26,887,579   361,726   (289,700,576)   12,066,298

 

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
         
  Three
Month
Period
Ending
September
30, 2017
$
  Three
Month
Period
Ending
September
30, 2016
$
  Nine Month
Period
Ending
September
30, 2017
$
  Nine Month
Period
Ending
September
30, 2016
$
         
Operating Activities        
Net loss for the period (3,004,406)   (3,332,474)   (10,871,267)   (9,929,957)
  Amortization - property and equipment 20,591   44,014   70,315   134,631
  Share based compensation 148,447   98,369   438,044   299,635
  Unrealized foreign exchange gain (6,414)   (49,400)   (119,058)   (152,019)
Net change in non-cash working capital (331,590)   216,611   (1,186,142)   978,847
Cash used in operating activities (3,173,372)   (3,022,880)   (11,668,108)   (8,668,863)
Investing Activities        
Acquisition of property and equipment (9,451)   (4,851)   (95,337)   (10,553)
Redemption (purchase) of short-term investments     2,088,800   (27,823)
Cash (used in) provided by investing activities (9,451)   (4,851)   1,993,463   (38,376)
Financing Activities        
Proceeds from "At the Market" equity distribution agreement 733,171   242,706   1,292,698   852,536
Proceeds from public offering     10,366,098  
Proceeds from exercise of options 48,090     343,440  
Cash provided by financing activities 781,261   242,706   12,002,236   852,536
(Decrease) increase in cash (2,401,562)   (2,785,025)   2,327,591   (7,854,703)
Cash and cash equivalents, beginning of period 16,676,298   18,320,981   12,034,282   24,016,275
Impact of foreign exchange on cash and cash equivalents (241,092)   76,773   (328,229)   (548,843)
Cash and cash equivalents, end of period 14,033,644   15,612,729   14,033,644   15,612,729

 

To view the Company's Fiscal 2017 Third Quarter 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' website at http://www.oncolyticsbiotech.com/investor-centre/financials/.

About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing REOLYSIN, 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 about Oncolytics, 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. Forward-looking statements, including the Company's belief as to the potential of REOLYSIN® as a cancer therapeutic; the Company's expectations as to the success of its research and development programs in 2017 and beyond, the Company's planned operations, the value of the additional patents and intellectual property; the Company's expectations related to the applications of the patented technology; the Company's expectations as to adequacy of its existing capital resources; the design, timing, success of planned clinical trial programs; 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 REOLYSIN as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize REOLYSIN, 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.

SOURCE Oncolytics Biotech Inc.

View original content: http://www.newswire.ca/en/releases/archive/November2017/08/c3223.html

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For further information: Investor Relations & Company Contact: Michael Moore, Vice President, Investor Relations & Corporate Communications, 858-886-7813, mmoore@oncolytics.ca; Media Contact: Mark Corbae, Canale Communications, 619-849-5375, mark@canalecomm.com

CO: Oncolytics Biotech Inc.

CNW 07:00e 08-NOV-17