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.