On August 3, 2017 Oncolytics Biotech Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) reported its financial results and operational highlights for the quarter ended June 30, 2017 (Press release, Oncolytics Biotech, AUG 3, 2017, View Source [SID1234520044]). Schedule your 30 min Free 1stOncology Demo! "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."
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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) (Free ASCO Whitepaper) 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 View Source