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Oncolytics Biotech® Inc. Announces 2016 Year-End Results

On March 10, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company) reported its financial results and operational highlights for the year ended December 31, 2016 (Filing, Q4/Annual, Oncolytics Biotech, 2016, MAR 10, 2017, View Source [SID1234518074]).

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"It was a year of change for Oncolytics, highlighted by additional clinical data that saw our understanding of REOLYSIN’s mechanism of action evolve and grow," said Dr. Matt Coffey, President and CEO of Oncolytics. "Through this process, and with the help of our expanding senior team, we thoughtfully and deliberately put in place a plan that initially contemplates combinations with chemotherapy for late-stage clinical development, but will expand to include targeted immunotherapies over the longer term as we look to leverage the role of the immune system in patient treatment. In the coming months we will specifically define our first registration pathway. In the year ahead we expect data readouts from as many as five sponsored, randomized Phase 2 studies, including one in advanced or metastatic breast cancer."

Selected Highlights

Since January 1, 2016, selected highlights announced by the Company include:

Clinical Results

· An abstract submitted to the American Association of Cancer Research Annual Meeting by Canadian Cancer Trials Group ("CCTG") at Queen’s University in Kingston, Ontario covering results from IND 213, an open-label, randomized, non-blinded Phase 2 study to assess the therapeutic combination of intravenously-administered REOLYSIN given in combination with paclitaxel versus paclitaxel alone in patients with advanced or metastatic breast cancer;
· A poster presentation by Dr. Kevin Kelly at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on the Phase 1b Study of REOLYSIN with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma, with preliminary data suggesting evidence of activity and that the treatment combination was well tolerated;
· Additional data from a randomized, CCTG-sponsored Phase 2 clinical study of REOLYSIN in non-small cell lung cancer (IND 211), which showed: a statistically significant improvement (p=0.0201) in progression free survival (PFS) for female patients with adenocarcinoma in the test arm versus the control arm, a strong trend to improved overall survival (OS) for female patients with adenocarcinoma in the test arm versus the control arm;
· Preliminary data from a randomized, CCTG-sponsored Phase 2 clinical study of REOLYSIN in advanced or metastatic colorectal cancer (IND 210), following an abstract for the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which showed a statistically significant improvement in objective response rates in female patients (female patients in the test arm had an overall response rate (ORR) of 63.2% (n=19) versus 23.8% (n=21) in the control arm (p=0.0054)), and a trend to improvement in median OS in female patients (female patients in the test arm had median OS of 19.3 months (n=19) versus 14.5 months (n=21) in the control arm);
· Updated results from a randomized Phase 2 clinical trial of its lead product, REOLYSIN, in combination with carboplatin and paclitaxel in patients with pancreatic cancer (NCI-8601), where an intent-to-treat analysis of overall survival on patients with confirmed treatment regimes, as assessed by the percentage of patients surviving for two years, showed a doubling of patients surviving two years; 20% on the test arm versus 9% on the control arm;
· Treatment of the first patients in a Phase 1b study of pembrolizumab (KEYTRUDA) in combination with REOLYSIN and chemotherapy in patients with advanced pancreatic adenocarcinoma, the Company’s first trial examining REOLYSIN in combination with a checkpoint inhibitor;

Corporate

· The appointment of Oncolytics co-founder and long-serving senior executive Matt Coffey PhD, MBA, as President and CEO;
· The appointment of Andres Gutierrez, MD, PhD, with more than 25 years of senior clinical development expertise designing and implementing both early- and late-stage oncology clinical studies, to the role of Chief Medical Officer;
· Formation of a Science and Technology Committee charged with supporting REOLYSIN’s further development in the context of the broader oncology space with an ultimate focus on reaching a commercial endpoint; and

Financial

· At December 31, 2016, the Company reported $14.1 million in cash, cash equivalents and short-term investments. At March 9, 2017, the Company had approximately $11.3 million in cash, cash equivalents and short-term investments.

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

2016 2015
As at December 31, $ $
Assets
Current assets
Cash and cash equivalents 12,034,282 24,016,275
Short-term investments 2,088,800 2,060,977
Accounts receivable 54,406 340,059
Prepaid expenses 260,841 506,669
Total current assets 14,438,329 26,923,980

Non-current assets
Property and equipment 319,955 459,818
Total non-current assets 319,955 459,818

Total assets 14,758,284 27,383,798

Liabilities And Shareholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities 4,068,664 2,709,492
Total current liabilities 4,068,664 2,709,492

Shareholders’ equity
Share capital
Authorized: unlimited
Issued:
December 31, 2016 – 121,258,222
December 31, 2015 – 118,151,622 262,321,825 261,324,692
Contributed surplus 26,643,044 26,277,966
Accumulated other comprehensive income 554,060 760,978
Accumulated deficit (278,829,309) (263,689,330)
Total shareholders’ equity 10,689,620 24,674,306
Total liabilities and equity 14,758,284 27,383,798

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

2016 2015 2014
For the years ending December 31, $ $ $

Expenses
Research and development 9,770,007 8,601,864 13,824,252
Operating 5,524,500 5,315,837 4,998,694
Loss before the following (15,294,507) (13,917,701) (18,822,946)
Interest 163,902 197,859 210,390
Loss before income taxes (15,130,605) (13,719,842) (18,612,556)
Income tax recovery (expense) (9,374) (3,153) (6,779)
Net loss (15,139,979) (13,722,995) (18,619,335)
Other comprehensive income items that may be reclassified to net loss
Translation adjustment (206,918) 480,935 200,345

Net comprehensive loss (15,346,897) (13,242,060) (18,418,990)
Basic and diluted loss per common share (0.13) (0.12) (0.21)

Weighted average number of shares (basic and diluted) 119,880,200 112,613,845 87,869,149

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

Share Capital
$
Warrants
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Income
$
Accumulated
Deficit
$
Total
$
As at December 31, 2013 228,612,564 376,892 24,491,212 79,698 (231,347,000) 22,213,366

Net loss and other comprehensive income — — — 200,345 (18,619,335) (18,418,990)
Issued, pursuant to Share Purchase Agreement 8,861,652 — — — — 8,861,652
Issued, pursuant to "At the Market" Agreement 1,468,668 — — — — 1,468,668
Expired warrants — (376,892) 376,892 — — —
Share based compensation — — 980,325 — — 980,325
Share issue costs (1,285,828) — — — — (1,285,828)
As at December 31, 2014 237,657,056 — 25,848,429 280,043 (249,966,335) 13,819,193

Net loss and other comprehensive income — — — 480,935 (13,722,995) (13,242,060)
Issued, pursuant to Share Purchase Agreement 4,371,687 — — — — 4,371,687
Issued, pursuant to "At the Market" Agreement 20,049,693 — — — — 20,049,693
Share based compensation — — 429,537 — — 429,537
Share issue costs (753,744) — — — — (753,744)
As at December 31, 2015 261,324,692 — 26,277,966 760,978 (263,689,330) 24,674,306

Net loss and other comprehensive income — — — (206,918) (15,139,979) (15,346,897)
Issued, pursuant to incentive share award plan 41,000 — (41,000) — — —
Issued, pursuant to "At the Market" Agreement 1,456,296 — — — — 1,456,296
Share based compensation — — 406,078 — — 406,078
Share issue costs (500,163) — — — — (500,163)
As at December 31, 2016 262,321,825 — 26,643,044 554,060 (278,829,309) 10,689,620

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS

2016 2015 2014
For the years ending December 31, $ $ $

Operating Activities
Net loss for the year (15,139,979) (13,722,995) (18,619,335)
Amortization – property and equipment 162,233 180,411 163,501
Share based compensation 406,078 429,537 980,325
Unrealized foreign exchange (gain) loss (139,810) (816,319) 242,542
Net change in non-cash working capital 2,233,865 (1,105,464) (2,443,988)
Cash used in operating activities (12,477,613) (15,034,830) (19,676,955)

Investing Activities
Acquisition of property and equipment (23,527) (108,268) (152,750)
Redemption (purchase) of short-term investments (27,823) (29,292) (30,041)
Cash used in investing activities (51,350) (137,560) (182,791)

Financing Activities
Proceeds from Share Purchase Agreement — 4,305,396 7,830,409
Proceeds from "At the Market" equity distribution agreement 956,133 19,362,240 1,214,083
Cash provided by financing activities 956,133 23,667,636 9,044,492
(Decrease) increase in cash (11,572,830) 8,495,246 (10,815,254)
Cash and cash equivalents, beginning of year 24,016,275 14,152,825 25,220,328
Impact of foreign exchange on cash and cash equivalents (409,163) 1,368,204 (252,249)
Cash and cash equivalents, end of year 12,034,282 24,016,275 14,152,825

To view the Company’s Fiscal 2016 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

Bio-Path Holdings to Present Data at the 2017 AACR Annual Meeting

On March 10, 2017 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an upcoming poster presentation at the 2017 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place from April 1-5, 2017 in Washington D.C. Dr. Ana Tari Ashizawa, Director of Research at Bio-Path, will present preclinical data of BP1002 (Liposomal Bcl2 antisense), the Company’s second drug candidate, for the treatment of aggressive non-Hodgkin’s lymphoma (Filing, 8-K, Bio-Path Holdings, MAR 10, 2017, View Source [SID1234518073]).

Details for the poster presentation are as follows:

Date: Wednesday, April 5, 2017
Presentation Time: 8:00 am – 12:00 pm Eastern Time
Location: Walter E. Washington Convention Center
Session: Gene and Vector Based Therapy, Section 3
Abstract: 5091
Title: "Activity of Bcl-2 antisense therapeutic in aggressive non-Hodgkin’s lymphoma" (Link to abstract)

Endocyte and Seattle Children’s Research Institute to Collaborate on Endocyte’s Small Molecule Drug Conjugate Bi-Specific Adaptor Molecules for CAR T-cell Therapies

On March 10, 2017 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported their plan to collaborate with Seattle Children’s Research Institute and Dr. Michael Jensen for the development of Endocyte’s SMDC platform in the chimeric antigen receptor T-cell (CAR T-cell) immunotherapy setting through the use of Endocyte’s proprietary SMDC bi-specific adaptor molecules (Press release, Endocyte, MAR 10, 2017, View Source [SID1234518070]).

The aim of the research collaboration is to join Endocyte’s SMDC bi-specific adaptor technology with the CAR T-cell immunotherapy research efforts at the Ben Towne Center for Childhood Cancer Research at Seattle Children’s Research Institute, to move these potentially enabling technologies more quickly to patients in the clinic. Dr. Jensen, a recognized leader in the field of CAR T-cell research, is the director of Ben Towne Center for Childhood Cancer Research and the Janet and Jim Sinegal Endowed Chair in Pediatric Solid Tumor Research at Seattle Children’s Research Institute, and a professor of hematology-oncology at the University of Washington School of Medicine.

"This partnership brings together Dr. Jensen’s expertise in the discovery and development of CAR T-cell therapies and Endocyte’s SMDC platform, with the aim of improving the efficacy and safety of CAR T-cell therapies and enabling them in solid tumor indications," said Mike Sherman, president and CEO of Endocyte. "Together, Seattle Children’s Research Institute and Endocyte hope to make a meaningful difference in shaping the future of CAR T-cell therapies and offering an important new treatment option to cancer patients."

"This collaborative project with Endocyte represents a next-generation CAR T-cell therapeutic platform with exciting opportunities to target solid tumors," said Dr. Michael Jensen. "We have been impressed with the potential of Endocyte’s bi-specific adaptor molecules, which enable the engineering of a single universal CAR T-cell that binds with very high affinity, potentially allowing us to address several key challenges of current therapies in this novel area of development."

Research and development activities under the collaboration will be led by Dr. Michael Jensen and Dr. Phil Low, chief scientific officer at Endocyte and professor of chemistry and director of the Center for Drug Discovery at Purdue University.

About Endocyte’s SMDC Bi-Specific Adaptors

Endocyte’s SMDC bi-specific adaptors represent a novel approach that makes possible the engineering of a single universal CAR T-cell, designed to bind with high affinity to fluorescein isothiocyanate (FITC). This universal CAR T-cell can be specifically directed to cancer cells through the administration of a tumor targeted FITC-containing SMDC, known as a bi-specific adaptor, that acts to bridge the universal CAR T-cell with the cancer cells to cause localized T-cell activation. This technology may address or mitigate several challenges of current CAR T-cell therapies, such as i) the inability to control the rate of cytokine release and tumor lysis, ii) the absence of an "off switch" that can terminate cytotoxic activity when tumor eradication is complete, and iii) a requirement to generate a different CAR T-cell for each unique tumor antigen.

TRILLIUM REPORTS ANNUAL 2016 FINANCIAL AND OPERATING RESULTS

On March 10, 2017 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported a corporate update and reported financial results for the year ended December 31, 2016 (Filing, Q4/Annual, Trillium Therapeutics, 2016, MAR 10, 2017, View Source [SID1234518068]).

"2016 marked a year of significant clinical progress with our lead drug candidate TTI-621, which completed Phase 1a dose escalation and advanced into Phase 1b cohort expansion in patients with advanced hematologic malignancies. Late in the year, we also initiated a Phase 1 clinical trial of TTI-621 in solid tumors. These studies will provide data that will guide us in designing the optimal commercial development path for TTI-621. Both trials are recruiting well, and we remain on track to provide updates later this year," said Dr. Niclas Stiernholm, president and CEO of Trillium Therapeutics. "The TTI-621 program momentum continues in 2017. Recent pharmacology data from the Phase 1 a/b trial expand on our preliminary findings and suggest that with weekly dosing we are achieving biologically relevant drug levels."

Corporate Update:

•
Trillium recently presented additional pharmacology data from its ongoing Phase 1a/1b trial of TTI-621, demonstrating well-tolerated drug levels that exceed those necessary for anti-tumor activity in preclinical models. Specifically, the following scientific findings were highlighted at the February ASCO (Free ASCO Whitepaper)-SITC Conference :

o
Receptor occupancy increases with multiple infusions of TTI-621, conferring robust CD47 blockade on circulating leukemic cells;

o
Increases in cytokines associated with macrophage activation suggest rapid engagement of the innate immune system;

o
Transient thrombocytopenia due to target mediated clearance is attenuated subsequent to the first infusion of TTI-621, and

o
Weekly infusions lead to a longer half-life and accumulation of circulating drug, overcoming the platelet antigen sink.

2016 Highlights:

•
Initiated and completed the Phase 1a dose escalation phase of a first-in-human clinical trial of TTI-621 in patients with relapsed or refractory lymphoma, and began enrollment in the Phase 1b dose expansion cohorts in patients with advanced hematologic malignancies. Two additional expansion cohorts were added, including combination therapy of TTI-621 and rituximab in patients with CD20-positive malignancies.

-1-

•
Presented data from the TTI-621 hematologic malignancy Phase 1a trial at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showing one partial response and decreased tumor volume and/or reduced metabolic activity over extended intervals of continued dosing in several patients.

•
Filed a second Investigational New Drug application with the FDA and initiated in January 2017, a Phase 1 trial with intratumoral injection of TTI-621 in patients with percutaneously accessible solid tumors and mycosis fungoides. This study could lead to a more thorough understanding of the mechanism of action of TTI-621 and could provide insight into the tumor micro-environment before, during and after treatment.

•
Significantly expanded its preclinical oncology pipeline with the acquisition of Fluorinov Pharma Inc., a discovery engine with a demonstrated ability to generate high quality preclinical development candidates. This proprietary medicinal chemistry platform uses fluorine chemistry, which permits the creation of new chemical entities from validated drugs and drug candidates with improved pharmacological properties, potentially leading to increased safety and efficacy.

2016 Financial Results
(Amounts in Canadian dollars)

As of December 31, 2016, Trillium had cash of $50.5 million. For the year ended December 31, 2016, the company used $22.9 million of cash for operations; $9.6 million for the acquisition of Fluorinov Pharma Inc; and used $3.0 million for capital purchases related to its new office and laboratory facility.

Net loss for the year ended December 31, 2016 of $31.7 million was higher than the loss of $14.7 million for the year ended December 31, 2015. The net loss was higher due mainly to increased research and development program expenses of $11.7 million, higher intangible asset amortization of $3.3 million related mainly to the acquisition of Fluorinov intangible assets, and a net foreign currency loss in 2016 of $2.0 million from holding US denominated cash with a weakening US dollar, compared to a foreign currency gain in the comparable 2015 period of $6.1 million. This was partially offset by the recognition of a deferred tax recovery in relation to the acquisition of Fluorinov of $3.7 million.

-2-

Selected Consolidated Financial Information:

Consolidated statements of loss and comprehensive loss

Year ended Year ended
Amounts in Canadian dollars December 31, 2016 December 31, 2015
Research and development expenses 29,788,795 18,050,091
General and administrative expenses 3,932,910 3,184,347
Net finance costs (income) 1,691,680 (6,510,241 )
Net loss and comprehensive loss for the year 31,733,085 14,733,699
Basic and diluted loss per common share (4.06 ) (2.22 )

Consolidated Statements of Financial Position

As at As at
Amounts in Canadian dollars December 31, 2016 December 31, 2015
Cash 50,472,971 86,770,542
Total assets 66,622,691 90,039,468
Total equity 58,119,519 85,803,868

TG Therapeutics, Inc. Announces Fourth Quarter and Year-End 2016 Financial Results and Business Update

On March 10, 2017 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the fourth quarter and year ended December 31, 2016 and provided recent company developments along with a business outlook for 2017 (Press release, TG Therapeutics, MAR 10, 2017, View Source [SID1234518067]).

The Company announced that through the combination of an underwritten public offering, and proceeds raised through the utilization of an ATM program, the Company raised combined gross proceeds of approximately $89M before deducting underwriting discounts and commissions and other estimated offering expenses. The underwritten offering consisted of 5,128,206 shares of its common stock (plus a 30-day option to purchase up to an additional 769,230 shares of common stock, which has been exercised) at a price of $9.75 per share, with expected gross proceeds to TG Therapeutics of $57.5 million, less underwriting discounts and commissions. The offering is expected to close on or about March 14, 2017, subject to the satisfaction of customary closing conditions. Prior to the public offering, the Company also issued approximately 3,000,000 shares through the ATM program for gross proceeds of approximately $31 million at an average price of $10.27, these shares were issued on March 9, 2017.

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "2016 was a very productive year for the Company, laying the foundation for pivotal data read-outs in 2017 and 2018. The first of which were reported earlier this week, with the announcement of the positive topline results from our Phase 3 GENUINE clinical trial. For the remainder of 2017, we look forward to the full data presentation from the GENUINE trial in the summer and then in the second half to a meeting with the FDA to discuss a filing for accelerated approval. All along we will continue to remain highly focused on enrolling into our proprietary UNITY programs, which are proceeding nicely and on schedule." Mr. Weiss continued, "This week we also had the opportunity to solidify our cash reserves with the recently conducted offerings, which should provide us with sufficient capital to advance our key programs and get us closer to our goal of bringing our novel treatment options to patients with B-cell malignancies."

2016 Highlights

● Completed enrollment in our Phase 3 GENUINE clinical trial, which resulted in positive topline data
● Launched the UNITY-CLL Phase 3 and UNITY-DLBCL Phase 2b trials for the combination of TG-1101 + TGR-1202
● Announced the positive outcome of our UNITY-CLL Phase 3 DSMB safety review meeting, pursuant to which the study was recommended to continue enrolling both front-line and previously treated patients with no changes recommended to the study
● Launched our first clinical trial in Multiple Sclerosis (MS) for TG-1101
● Announced the issuance of composition of matter patents for both TG-1101 and TGR-1202 providing protection through 2029 and 2033, respectively, both exclusive of available patent term extensions
● Announced two publications in prestigious journals, the first in BLOOD describing a novel mechanism of TGR-1202 with potential in cMYC driven malignancies, and the second in the British Journal of Haematology with data from our Phase 2 clinical trial of TG-1101 plus ibrutinib in patients with Chronic Lymphocytic Leukemia (CLL)
● Presented data at the ASH (Free ASH Whitepaper) annual meeting including 3 oral presentations and 3 poster presentations, with a focus on combination therapy

Key Objectives for 2017

● Present updated clinical data including the full Phase 3 GENUINE data at a major medical meeting in the first half of 2017
● Present clinical data from the Phase 2 Multiple Sclerosis (MS) trial
● Initiate a global Phase 3 trial in MS
● Complete the first interim analysis in the UNITY-CLL Phase 3 trial
● Complete the first interim analysis in the UNITY-DLBCL trial
● Meet with the FDA to review the GENUINE Phase 3 data and discuss suitability for filing for accelerated approval
● Present new and updated data from ongoing trials at various scientific meetings throughout the year, including the ASH (Free ASH Whitepaper) annual meeting in December

Financial Results for the Fourth Quarter and Full Year 2016

● Cash Position: Cash, cash equivalents, investment securities, and interest receivable were $45.0 million as of December 31, 2016. During the first quarter of 2017 the Company raised approximately $84 million of net proceeds from the underwritten public offering of the Company’s common stock and the utilization of the Company’s at-the-market ("ATM") sales.

● R&D Expenses: Research and development (R&D) expenses were $22.3 million and $69.2 million for the three and twelve months ended December 31, 2016, respectively, compared to $15.3 million and $47.7 million for the three and twelve months ended December 31, 2015, respectively. Included in research and development expenses for the three and twelve months ended December 31, 2016, are $9.1 million and $27.0 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. The increase in R&D expenses for both the three and twelve months ended December 31, 2016, is primarily due to the ongoing clinical development programs and related manufacturing costs for TG-1101 and TGR-1202.

● G&A Expenses: General and administrative (G&A) expenses were $1.8 million and $9.9 million for the three and twelve months ended December 31, 2016, respectively, as compared to $2.4 million and $15.6 million for the three and twelve months ended December 31, 2015, respectively. The period-over-period decrease in G&A expenses from three and twelve months ended December 31, 2015 relates primarily to non-cash compensation expenses related to equity incentive expense recognized during 2015.

● Net Loss: Net loss was $23.7 million and $78.3 million for the three and twelve months ended December 31, 2016, respectively, compared to a net loss of $17.6 million and $62.9 million for the three and twelve months ended December 31, 2015, respectively.

● Financial Guidance: The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of December 31, 2016 combined with the additional capital raised in the first quarter of 2017 will be sufficient to fund the Company’s planned operations for approximately the next 24 months.