Oncolytics Biotech® Inc. Announces 2017 Second Quarter Results
CALGARY and SAN DIEGO, CA, Aug. 3, 2017 /PRNewswire/ - 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, December 31,
2017 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 Three Six Month Six Month
Month Month Period Period
Period Period Ending Ending
Ending Ending June 30, June 30,
June 30, June 30, 2017 2016
2017 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 Accumulated Accumulated Total
Surplus Other Deficit
$ $ Comprehensive $
$ Loss $
$
--- ---
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 Accumulated Accumulated Total
Surplus Other Deficit
$ $ Comprehensive $
$ Loss $
$
--- ---
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 Three Month Six Month Six Month
Period Ending Period Ending Period Ending Period Ending
June 30, June 30, June 30, June 30,
2017 2016 2017 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://www.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.
