CALGARY and SAN DIEGO, CA, Aug. 3, 2017 /CNW/ - Oncolytics Biotech® Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) today announced its financial results and operational highlights for the quarter ended June 30, 2017.

"After selecting metastatic breast cancer as our registration pathway for REOLYSIN® and announcing statistically significant clinical data in this indication in the second quarter, obtaining Fast Track designation was a key development as we prepare for our End-of-Phase 2 meeting with the FDA," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "We expect to receive guidance from the FDA that will help form the basis of our Phase 3 registration study and expect to announce the outcome of our filings in the fourth quarter.  In parallel, we will continue to pursue additional clinical collaborations to study REOLYSIN's therapeutic potential in combination with other immunotherapies as part of our previously announced clinical development plan."

Selected Highlights from Q2 and through the end of July 2017

Clinical Updates

  • Announced that the United States Food and Drug Administration (FDA) granted Fast Track designation for REOLYSIN, also known as pelareorep, for the treatment of metastatic breast cancer (mBC). The designation is based on the data from IND 213, an open-label, randomized, phase 2 study to assess the therapeutic combination of intravenously-administered REOLYSIN and paclitaxel. 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.
  • Announced a registration pathway and clinical development plan with the primary objective of obtaining regulatory approval for REOLYSIN based on compelling mBC survival data from IND 213. The plan's secondary objective is expanding REOLYSIN into commercially valuable new treatment areas, including immunotherapy and immunomodulatory (IMiD) agents, in collaboration with pharmaceutical partners.
  • Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting preliminary results of REO 024, an open-label phase 1b trial of patients with histologically confirmed metastatic adenocarcinoma of the pancreas (MAP) who have failed, or did not tolerate, first-line treatment. The study was designed to assess the safety (primary endpoint) and dose-limiting toxicity of REOLYSIN in combination with pembrolizumab (KEYTRUDA®) and chemotherapy. Investigators concluded that the combination therapy showed manageable safety profiles and anti-tumour activity in previously treated MAP patients.

Corporate Updates

  • 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 ($10.4 million net). Proceeds are to be used to prepare for a Phase 3 registration study in mBC, to expand partnering activities and for general corporate purposes.
  • Appointed Andrew de Guttadauro as President of its US subsidiary, Oncolytics Biotech (U.S.) Inc., who will primarily be responsible for pursuing both global and regional licensing, partnership and commercialization opportunities for REOLYSIN.
  • Opened San Diego office to support business development, clinical operations and investor relations activities.

Anticipated Milestones

  • Summer 2017: End-of-Phase 2 meeting in August
  • Third quarter 2017: First patient enrollment in our multiple myeloma collaboration with Celgene and Myeloma UK
  • Fourth quarter 2017: Results from regulatory filings
  • First half of 2018: Update on our exploration of strategic and regional alliances

Q2 2017 Financial Results

  • At June 30, 2017, the Company reported $16.7 million in cash and cash equivalents. Cash runway expected to the end of 2018.
  • As at August 2, 2017, the Company had an unlimited number of authorized common shares with 139,426,222 common shares issued and outstanding, 7,532,827 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 2,370,388 RSU's and PSU's outstanding.

 

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





June 30,
2017
$

December 31,
2016
$

Assets



Current assets



Cash and cash equivalents

16,676,298

12,034,282

Short-term investments

2,088,800

Accounts receivable

62,109

54,406

Prepaid expenses

485,075

260,841

Total current assets

17,223,482

14,438,329




Non-current assets



Property and equipment

355,309

319,955

Total non-current assets

355,309

319,955




Total assets

17,578,791

14,758,284




Liabilities And Shareholders' Equity



Current Liabilities



Accounts payable and accrued liabilities

3,310,948

4,068,664

Total current liabilities

3,310,948

4,068,664




Shareholders' equity



Share capital




Authorized: unlimited




Issued:




June 30, 2017 – 139,231,722




December 31, 2016 – 121,258,222

270,091,373

262,321,825

Warrants

3,617,900

Contributed surplus

26,766,168

26,643,044

Accumulated other comprehensive loss

488,572

554,060

Accumulated deficit

(286,696,170)

(278,829,309)

Total shareholders' equity

14,267,843

10,689,620

Total liabilities and equity

17,578,791

14,758,284

 

 

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



Three
Month
Period
Ending
June 30,
2017
$

Three
Month
Period
Ending
June 30,
2016
$

Six Month
Period
Ending
June 30,
2017
$

Six Month
Period
Ending
June 30,
2016
$

Expenses






Research and development

2,918,673

1,490,956

5,186,744

4,217,085


Operating

1,444,543

1,125,458

2,744,843

2,485,870

Operating loss

(4,363,216)

(2,616,414)

(7,931,587)

(6,702,955)


Interest income                                                                                 

14,163

35,537

64,878

105,158

Loss before income taxes

(4,349,053)

(2,580,877)

(7,866,709)

(6,597,797)


Income tax (recovery) expense

(89)

169

(152)

314

Net loss

(4,349,142)

(2,580,708)

(7,866,861)

(6,597,483)

Other comprehensive income items that may be 
reclassified to net loss






Translation adjustment

(44,740)

(130,827)

(65,488)

(300,886)






Net comprehensive loss

(4,393,882)

(2,711,535)

(7,932,349)

(6,898,369)

Basic and diluted loss per common share

(0.03)

(0.02)

(0.06)

(0.06)

Weighted average number of shares (basic and diluted)

127,349,643

119,601,638

124,320,760

118,900,812

 

 

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



Share Capital

$

Warrants

$

Contributed
Surplus

$

Accumulated
Other
Comprehensive
Loss

$

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 comprehensive loss

(300,886)

(6,597,483)

(6,898,369)

Issued pursuant to "At the Market" Agreement

1,078,193

1,078,193

Issued pursuant to incentive share award plan

41,000

(41,000)

Share issue costs

(468,363)

(468,363)

Share based compensation

201,266

201,266

As at June 30, 2016

261,975,522

26,438,232

460,092

(270,286,813)

18,587,033









Share Capital

$

Warrants

$

Contributed
Surplus

$

Accumulated
Other
Comprehensive
Loss

$

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 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 issue costs

(1,254,523)

(1,254,523)

Share based compensation

289,597

289,597

As at June 30, 2017

270,091,373

3,617,900

26,766,168

488,572

(286,696,170)

14,267,843

 

 

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







Three Month
Period Ending
 June 30, 
2017
$

Three Month
Period Ending
June 30, 
2016 
$

Six Month
Period Ending
June 30,
 2017
$

Six Month
Period Ending
June 30,
 2016
$






Operating Activities





Net loss for the period

(4,349,142)

(2,580,708)

(7,866,861)

(6,597,483)


Amortization - property and equipment

25,688

44,675

49,724

90,617


Share based compensation

155,708

119,626

289,597

201,266


Unrealized foreign exchange gain

(164,676)

(243,914)

(112,644)

(102,619)

Net change in non-cash working capital

(216,906)

37,581

(854,552)

762,236

Cash used in operating activities

(4,549,328)

(2,622,740)

(8,494,736)

(5,645,983)

Investing Activities





Acquisition of property and equipment

(80,050)

(5,702)

(85,886)

(5,702)

Redemption (purchase) of short-term






investments

2,088,800

(27,823)

Cash used in investing activities

(80,050)

(5,702)

2,002,914

(33,525)

Financing Activities





Proceeds from "At the Market" equity






distribution agreement

570,027

710,374

559,527

609,830

Proceeds from public offering

10,366,098

10,366,098

Proceeds from exercise of options

295,350

295,350

Cash provided by financing activities

11,231,475

710,374

11,220,975

609,830

Increase (decrease) in cash

6,602,097

(1,918,068)

4,729,153

(5,069,678)

Cash and cash equivalents, beginning of period

10,102,393

20,233,408

12,034,282

24,016,275

Impact of foreign exchange on cash and cash






equivalents

(28,192)

5,641

(87,137)

(625,616)

Cash and cash equivalents, end of period

16,676,298

18,320,981

16,676,298

18,320,981

 

To view the Company's Fiscal 2017 Second 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://oncolyticsbiotech.com/investor-centre/financials/.

About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing REOLYSIN, an immuno-oncology viral-agent, as a potential treatment for a variety of tumor types. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype 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 breast cancer, as well as studies in combination with checkpoint inhibitors and IMiD/targeted 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 (pelareorep) 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.