On March 14, 2016 ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company developing orally-administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, reported financial results for the fourth quarter ended December 31, 2015 and provided an update on the Company’s corporate and clinical development activities expected in 2016 (Press release, ChemoCentryx, MAR 14, 2016, View Source [SID:1234509537]).

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"2015 was a period of significant accomplishments for ChemoCentryx, highlighted by the positive clinical results which we announced earlier this year from the Phase II CLEAR trial in ANCA Vasculitis (AAV) with our lead drug candidate, CCX168. Premature death is among the many dangers of chronic high dose steroids in the standard of care for AAV. At ChemoCentryx, we think such risks are unacceptable, and simply cannot be ignored," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "The single biggest cause of first year mortality associated with AAV is steroid-induced infections. Adding to this, there are other dangers of chronic high dose steroid use, such as bone fractures, incipient diabetes, and neuropsychiatric problems. Our data showed that CCX168 can eliminate the need for chronic high dose steroid administration in patients with AAV, and it was correlated with a rapid and sustained remission of disease symptoms, as well as improved quality of life, as reported by patients themselves."

Dr. Schall continued, "The momentum of last year has continued into 2016 as we await several important milestones, including potentially the initiation of our Phase III development program for CCX168. We also await clinical data for CCX872 in pancreatic cancer. With multiple programs advancing in the clinic, we believe that this is one of the most exciting moments in ChemoCentryx’s history."

Pipeline Developments Across Key Therapeutic Areas

Orphan and Rare Diseases: CCX168 is an orally-administered complement inhibitor targeting the C5a receptor (C5aR), and is being developed for several rare disease indications, including ANCA-associated vasculitis (AAV) and atypical Hemolytic Uremic Syndrome (aHUS). CCX168 acts by blocking the destructive action of neutrophils that are activated as a consequence of the complement protein known as C5a binding to C5aR on neutrophils during autoimmune inflammation events.

CCXI reported positive top-line data from the Phase II CLEAR trial with CCX168 in 63 evaluable patients with AAV. The objective of the trial was to eliminate chronic high dose steroids from the standard of care (SOC) regimen in AAV and replace them with CCX168. Chronic high dose steroid administration is associated with premature death and a spectrum of other harmful side effects in AAV therapy.

The trial was successful in meeting its primary endpoint based on the Birmingham Vasculitis Activity Score response at week 12 in patients receiving CCX168, compared to those patients receiving the high dose steroid-containing SOC.

All CCX168 treatment groups demonstrated a numerically superior and statistically significant (P=0.002 for non-inferiority) clinical efficacy outcome when compared to SOC.

Treatment with CCX168 led to improvements in kidney function as measured by improvements in estimated glomerular filtration rate (eGFR) as well as beneficial changes in proteinuria, hematuria and renal inflammation (based on MCP-1).

Patient reported improvements in "Quality of Life" were also significantly improved in CCX168 treatment groups, but not in the SOC group.

Completed enrollment in the CLASSIC Phase II trial in AAV in North America.

Immuno-Oncology: CCX872 is a potent and selective inhibitor of the chemokine receptor known as CCR2, which is being evaluated in patients with non-resectable pancreatic cancer. In an ongoing, multi-center clinical trial with CCX872, 54 patients with non-resectable pancreatic cancer have been enrolled. The primary efficacy measurement of this study is progression-free survival after at least 24 weeks of treatment.

Completed enrollment in the Phase Ib clinical trial of CCX872 in patients with non-resectable pancreatic cancer; and

Presented combination data with check point and chemokine receptor inhibitors at Triple Meeting and Society of Immunotherapy for Cancer meeting showing synergistic effect with combination treatment in triple negative breast cancer models.

Anticipated Milestones

Orphan and Rare Diseases:

Report top-line results from the CLASSIC Phase II trial in patients with AAV in North America with CCX168 in mid-2016;

Conduct End of Phase II meetings with regulatory agencies to review CLEAR and CLASSIC Phase II clinical results in mid-2016;

Initiate Phase III development program with CCX168 for the treatment of AAV by the end of 2016; and

Report early results from the Phase II pilot study of CCX168 in aHUS patients who are on dialysis in 2016.

Immuno-Oncology:

Advance Phase Ib pancreatic cancer trial of CCX872 in combination with FOLFIRINOX; report initial overall response data in the second quarter of 2016 and initial progression free survival data in the second half of 2016.

Chronic Kidney Disease:

Conduct End of Phase II meeting with the FDA to review the Phase II data and discuss the Phase III clinical development program for CCX140 in diabetic nephropathy.

Fourth Quarter 2015 Financial Results

Cash, cash equivalents and investments totaled $76.3 million at December 31, 2015.

Research and development expenses were $8.2 million for the three months ended December 31, 2015 compared to $9.1 million reported for the same period in 2014. The decrease in research and development expense from 2014 to 2015 was primarily attributable to lower expenses associated with CCX168, the Company’s C5aR inhibitor, due to the completion of the Phase II CLEAR trial in the fourth quarter of 2015 and CCX140, the Company’s CCR2 inhibitor, due to the completion of the Phase II clinical trial in patients with diabetic nephropathy in 2014. These decreases were partially offset by higher expenses associated with CCX872, the Company’s second CCR2 inhibitor, reflecting continued patient enrollment in the ongoing pancreatic cancer trial.

General and administrative expenses were $3.4 million for the three months ended December 31, 2015 compared to $3.2 million for the comparable period in 2014. The increase from 2014 to 2015 was primarily due to increases in intellectual property related expenses and professional fees.

Net loss was $11.6 million for the fourth quarter of 2015 compared to $12.2 million in the same period in 2014.

Total shares outstanding at December 31, 2015 were approximately 44.2 million shares.

2016 Financial Outlook

The Company expects to utilize cash and cash equivalents between $40 million and $50 million in 2016.

About ANCA-Associated Vasculitis

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, or AAV, is a type of rare autoimmune inflammation caused by auto-antibodies. AAV encompasses granulomatosis with polyangiitis (GPA, formerly known as Wegener’s granulomatosis), microscopic polyangiitis (MPA), eosinophilic polyangiitis (formerly Churg-Strauss syndrome) and renal limited vasculitis.

AAV represents a severe and often fatal autoimmune disease that is characterized by inflammation that can destroy different organ systems. AAV is the lead indication in the Company’s orphan and rare disease program with a clinical objective of eliminating chronic high dose steroids in the standard of care (SOC) regimen, essentially replacing steroids with the complement inhibitor CCX168.

AAV affects approximately 40,000 people in the US (with approximately 4,000 new cases each year) and greater than 75,000 people in Europe (with at least 7,500 new cases each year), and is currently treated with courses of immuno-suppressants (cyclophosphamide or rituximab) combined with high dose steroid administration. Following initial treatment, up to 30 percent of patients relapse within 6 to 18 months, and approximately 50 percent of all patients will relapse within 3 to 5 years.

Current standard of care (SOC) for AAV comprises high doses of chronic steroids combined with an immunosuppressant (either cyclophosphamide or rituximab). The SOC is associated with significant safety issues. For example, first year premature death is approximately 11 to 18 percent. The single major cause of premature mortality is not disease related adverse events, but rather infection that is thought largely to be a consequence of steroid administration. Indeed, the multiple adverse effects of courses of steroid treatment (both initial courses and those that are repeated as a consequence of relapse) are major causes of both short-term and long-term disease and death. Such therapy related adverse events contribute significantly to patient care costs, as well as to the diminution of quality of life for patients.

By damaging the body’s small blood vessels, AAV affects many organ systems, mostly the kidneys, eyes, lungs, sinuses and nerves. This damage is caused by the destructive activity of inflammatory leukocytes in the body, with neutrophils considered to be the terminal effector cell. In AAV, neutrophils are attracted to sites of vascular destruction as well as activated at those sites by the activity of the complement system product known as C5a and its receptor, C5aR, which is the target of CCX168. By blocking the C5aR, CCX168 is thought to reduce vasculitis by reducing neutrophil activation, accumulation, and adhesion, as well as vascular permeability.

About Pancreatic Cancer

It is estimated that over 337,000 cases of pancreatic cancer are diagnosed worldwide every year, accounting for 2.4 percent of all cancers. The incidence of pancreatic cancer in the US is about 45,000, with prevalence being only negligibly higher owing to the poor survival rates on current therapy. Current standards of care include surgical resection and chemotherapeutic regimens such as gemcitabine and FOLFIRINOX. These regimens are limited by marked toxicities. Almost 67 percent of cases are diagnosed in people aged 65 and over. In the United States, pancreatic cancer is the fourth most common cause of deaths due to cancer. Pancreatic cancer has a low survival rate regardless of stage of disease, with 93 percent of patients dying from their disease within five years.

On March 14, 2016 Vericel Corporation (NASDAQ: VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, reported financial results and business highlights for the fourth quarter and year ended December 31, 2015 (Filing, Q4/Annual, Vericel, 2015, MAR 14, 2016, View Source [SID:1234510447]).

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Recent Business Highlights

During and since the fourth quarter of 2015, the company:
• Announced positive top-line results from the Phase 2b ixCELL-DCM clinical trial of ixmyelocel-T in patients with heart failure due to ischemic dilated cardiomyopathy;

• Received U.S. Food and Drug Administration (FDA) approval of the Epicel (cultured epidermal autografts) HDE supplement, which revised the Epicel product label to include pediatric patients and specify the probable survival benefit for adult and pediatric patients treated with Epicel, and allows the company to sell Epicel for profit on up to 360,400 grafts per year;

• Announced that the FDA has accepted for filing the BLA for MACI (matrix applied characterized autologous cultured chondrocytes), the company’s investigational third-generation autologous cultured chondrocyte implant intended for the treatment of symptomatic full-thickness cartilage defects of the knee in adult patients;

• Announced a long-term supply agreement with Matricel GmbH for the collagen membrane used in the production of MACI;

• Achieved 14% growth in total Carticel (autologous cultured chondrocytes) and Epicel net product revenues for 2015 over pro-forma Carticel and Epicel revenues for 2014, and 5% growth in total Carticel and Epicel net product revenues in the fourth quarter versus the fourth quarter of 2014;

• Achieved 60% and 24% growth in Epicel net product revenues for 2015 and the fourth quarter, respectively, versus the same periods in 2014; and

• Entered into a $10 million credit facility and $5 million term loan agreement with Silicon Valley Bank.

"2015 was an extremely productive year during which we completed our corporate transformation into a sustainable and growing commercial enterprise, substantially increased revenues and gross margins, and made significant progress on our clinical and regulatory objectives that we expect will drive current and long-term growth for the company," said Nick Colangelo, president and CEO of Vericel. "We believe that we have positioned the company as one of the leading cell therapy and regenerative medicine companies in the industry."

Financial Highlights

Total revenues for the fourth quarter and year ended 2015 were generated primarily from net sales of Carticel implants and surgical kits and Epicel, which were acquired on May 30, 2014 as part of the acquisition of Sanofi’s cell therapy and regenerative medicine business.

Total net revenues for the quarter ended December 31, 2015 were approximately $15.4 million and included approximately $11.3 million of net sales of Carticel implants and surgical kits and approximately $4.1 million of net sales of Epicel. Total Carticel and Epicel net product revenues in the fourth quarter increased approximately 5% over the same period in 2014.

Total net revenues for the year ended December 31, 2015 were approximately $51.2 million, including approximately $35.2 million of net sales of Carticel implants and surgical kits and approximately $15.2 million of net sales of Epicel. Total Carticel and Epicel net product revenues for 2015 increased approximately 14% over pro-forma Carticel and Epicel net product revenues for 2014. Total revenues for the quarter and year ended December 31, 2015 included approximately $0.1 million and $0.7 million of sales, respectively, from our Marrow Donation business which ceased operations in December, 2015.

Gross profit for the quarter and year ended December 31, 2015 was $8.2 million, or 53% of net product sales, and $24.7 million, or 48% of net product sales, respectively, compared to $8.0 million, or 54% of net product sales, and $11.5 million, or 40% of net product sales, for the quarter and year ended December 31, 2014, respectively.

Research and development expenses for the quarter and year ended December 31, 2015 were $7.4 million and $18.9 million, respectively, versus $5.8 million and $21.3 million for the same periods in 2014. The increase in research and development expenses in the fourth quarter is primarily due to additional research, development and regulatory costs incurred for the Biologics License Application (BLA) for MACI and Humanitarian Device Exemption (HDE) supplement submitted in December 2015 to revise the labeled indications for use of Epicel, which included $2.2 million in regulatory consulting expenses and a Prescription Drug User Fee Act (PDUFA) filing fee of $2.4 million paid in the fourth quarter of 2015.

The decrease in full-year research and development expenses is primarily due to a reduction in expenses associated with the ixCELL-DCM clinical trial, which completed enrollment in January 2015, and other clinical trial expenses, and a $3.2 million payment in 2014 to the former shareholders of Verigen pursuant to a settlement agreement that eliminated all future milestone payments related to the development and commercialization of MACI in the United States.

Selling, general and administrative expenses for the quarter and year ended December 31, 2015 were $5.7 million and $22.5 million, respectively, compared to $4.5 million and $13.8 million for the same periods in 2014. The increase in SG&A expenses is primarily due to Vericel being a commercial business for all of 2015 compared to only seven months in 2014, as well as an increase in sales and marketing expenses associated with Carticel and Epicel and strategic planning activities for MACI.

Loss from operations for the quarter and year ended December 31, 2015 was $5.0 million and $16.7 million, respectively, compared to $2.3 million and $23.5 million for the same periods a year ago. The operating loss for the quarter ended December 31, 2015 included $2.2 million for MACI BLA and Epicel HDE supplement regulatory consulting expenses and a $2.4 million PDUFA filing fee for MACI. Excluding these one-time expenses, the company would have had an adjusted operating loss of $0.4 million in the fourth quarter. Material non-cash items impacting the operating loss for the quarter and year included $0.6 million and $2.7 million, respectively, of stock-based compensation expense and $0.4 million and $1.6 million, respectively, in depreciation and amortization expense.

Other income (expense) for the quarter and year ended December 31, 2015 was less than $0.1 million and $0.3 million, respectively, compared to less than ($0.1) million and $3.6 million for the same periods in 2014. The change in other income for the quarter is primarily due to a decrease in the fair value of warrants in the fourth quarter of 2015 compared to the same period in 2014. The decrease in other income for the full year 2015 is primarily due to a bargain purchase gain of $3.5 million recognized in 2014 and a decrease in the fair value of warrants in 2015 compared to 2014.

Vericel reported a net loss for the quarter and year ended December 31, 2015 of $4.9 million, or $0.28 per share, and $16.3 million, or $0.97 per share, respectively, compared to a net loss of $2.4 million, or $0.17 per share, and $19.9 million, or $2.23 per share, for the same periods in 2014.

As of December 31, 2015, the company had $14.6 million in cash and cash equivalents compared to $30.3 million in cash and cash equivalents at December 31, 2014.

On March 11, 2016 GenSpera, Inc. (OTC/QB: GNSZ), a biotech company developing a novel prodrug therapeutic for the treatment of cancer, reported that the Company’s board of directors has engaged FLG Partners, LLC and its partner Chris Lowe to provide strategic advice to further complement the Company’s efforts to strengthen its corporate and clinical development (Press release, GenSpera, MAR 11, 2016, View Source [SID:1234509501]). This includes aligning the Company’s long term-goals to optimize the clinical and regulatory development of mipsagargin, implement cost-efficient processes and advise on business development and funding initiatives.

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"We are delighted to engage the services of this highly regarded consultancy, which has a reputation for providing sound strategic and operational counsel to companies such as GenSpera. In particular, we will be calling upon Chris Lowe’s substantial expertise and proven abilities in assisting clinical-stage companies to develop well-conceived corporate and financial strategies. The full strategic review is designed with a view of enhancing shareholder value," commented the Board of Directors of GenSpera.

FLG Partners is a leading CFO consulting and services firm based in Silicon Valley and its partners have more than 500 years of collective CEO and CFO experience. Mr. Lowe is a partner at the firm and has more than 15 years of senior management experience that includes executive positions in publicly traded life sciences companies.

"It is an exciting time at GenSpera as we evaluate mipsagargin in our ongoing Phase 2 trial in patients with glioblastoma and finalize preparations to commence a Phase 2 trial in patients with prostate cancer," said Craig Dionne, Ph.D., GenSpera’s CEO. "The complementary operational and financial expertise of FLG partners and Chris Lowe will help guide us through this critical stage in our corporate development and support us in reaching our goal of commercializing an important new therapeutic for patients with cancer."

"GenSpera is ripe with opportunity and I look forward to using my experience as well as the shared expertise of my colleagues at FLG to develop a comprehensive plan that advances GenSpera’s clinical programs and puts forth financial options to provide a highly productive path forward for the Company and its shareholders," said Mr. Lowe.

On March 11, 2016 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) ("Oncolytics" or the "Company") reported its financial results and operational highlights for the year ended December 31, 2015 (Filing, Annual, Oncolytics Biotech, 2015, MAR 11, 2016, View Source [SID:1234509758]).

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"In 2015 we continued to advance our clinical program, reporting survival data from single arm Phase 2 studies in non-small cell lung and pancreatic cancers, as well as early data from a pilot study in multiple myeloma," said Dr. Brad Thompson, President and CEO of Oncolytics. "During the year we began combination therapy studies with REOLYSIN and agents that modulate the immune system. Enrollment in a GM-CSF and REOLYSIN combination therapy study in pediatric patients with gliomas began, and we recently announced our first study looking at REOLYSIN in combination with an immunotherapeutic checkpoint inhibitor in pancreatic cancer."

Selected Highlights

Since January 1, 2015, selected highlights announced by the Company include:

Clinical Program

· Treatment of the first patients in a Phase Ib 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;

· Start of enrollment in a Phase Ib study of REOLYSIN combined with standard doses of bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (REO 019);

· A poster presentation at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) titled "REOLYSIN Combined with Carfilzomib for Treatment of Relapsed Multiple Myeloma Patients," which disclosed updated findings (originally presented at the 15th International Myeloma Workshop) from a pilot study (NCI-9603) in patients with relapsed or refractory multiple myeloma treated using the combination of carfilzomib and REOLYSIN. These findings included that all seven patients treated at the full clinical dose had a clinical response, as well as significant increases in the production of caspase-3 (p=0.005) and upregulation of PD-L1 (p=0.005);

· An oral presentation at the International Association for the Study of Lung Cancer (IASLC) 16th World Conference on Lung Cancer titled "Oncolytic Reovirus in Combination with Paclitaxel/Carboplatin in NSCLC Patients with Ras Activated Malignancies, Long Term Results," covering updated results, including one- and two-year survival data (57% and 30%, respectively), from the Company’s REO 016 Phase 2 study in Non-Small Cell Lung Cancer (NSCLC);

· Presentation of final data from a single arm clinical study examining the use of REOLYSIN in combination with gemcitabine in patients with advanced pancreatic cancer (REO 017), which showed an increase in median overall survival, as well as an approximate two-fold increase in one-year survival rates, and a five-fold increase in two-year survival rates when compared to gemcitabine therapy alone as seen in historical data;

· Completion of enrollment in three randomized Phase 2 studies sponsored and conducted by the NCIC Clinical Trials Group; IND 211 is a study of REOLYSIN in combination with chemotherapy in patients with previously treated advanced or metastatic non-small cell lung cancer; IND 210 is a study of REOLYSIN in patients with advanced or metastatic colorectal cancer; and IND 209 is a study of REOLYSIN in combination with chemotherapy in patients with recurrent or metastatic castration resistant prostate cancer;

· An update on the planned registration program for REOLYSIN including an initial focus on two indications: the neoadjuvant treatment of muscle-invasive bladder cancer and the treatment of glioblastoma;

· Activation of an Investigational New Drug Application containing the protocol titled "MC1472: Phase 1 Study of Replication Competent Reovirus (REOLYSIN) in Combination with GM-CSF in Pediatric Patients with Relapsed or Refractory Brain Tumors";

· Presentation of data showing up-regulation of PD-1 and PD-L1 from a single arm clinical study examining the use of REOLYSIN in patients with primary glioblastomas or brain metastases (REO 013b) at the Royal Society of Medicine’s Immuno-oncology: Using the Body’s Own Weapons Conference, held in London, UK;
Regulatory

· Granting of Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for REOLYSIN in the treatment of pancreatic, gastric, ovarian, primary peritoneal, and fallopian tube cancers, as well as malignant gliomas;

· Granting of Orphan Drug Designation by the European Medicines Agency for REOLYSIN in the treatment of ovarian and pancreatic cancers;
Basic Research

· Presentation of preclinical data at the 9th International Conference on Oncolytic Virus Therapeutics in Boston, MA, including findings around REOLYSIN’s mechanism of action and its potential in new indications including chronic lymphocytic leukemia;

· Presentation of clinical and preclinical data at the 2015 Immune Checkpoint Inhibitors Meeting in Boston, MA, including content showing the combination of REOLYSIN, GM-CSF, anti-PD-1 and anti-CTLA-4 improved survival in immune competent mice versus REOLYSIN and GM-CSF alone, and REOLYSIN and GM-CSF plus either one of the checkpoint inhibitors alone;

· A series of presentations made by the Company’s research collaborators at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held in Philadelphia, PA covering preclinical research in a range of indications, with a variety of treatment combinations including REOLYSIN;
Financial

· At December 31, 2015 the Company reported $26.1 million in cash, cash equivalents and short-term investments. At March 10, 2016, the Company had approximately $23.6 million in cash, cash equivalents and short-term investments, which is expected to provide sufficient funds to support several small early-stage immunotherapy combination studies as well as both a run-in and a registration study in muscle-invasive bladder cancer; and

· Subsequent to year-end, entry into an "at-the-market" equity distribution agreement with Canaccord Genuity Corp. permitting Oncolytics at its sole discretion, from time to time and until March 16, 2018, to sell common shares having an aggregate offering value of up to $4.6 million.

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

As at December 31, 2015
$ 2014
$
Assets
Current assets
Cash and cash equivalents 24,016,275 14,152,825
Short-term investments 2,060,977 2,031,685
Accounts receivable 340,059 191,751
Prepaid expenses 506,669 291,553
Total current assets 26,923,980 16,667,814

Non-current assets
Property and equipment 459,818 525,376
Total non-current assets 459,818 525,376

Total assets 27,383,798 17,193,190

Liabilities And Shareholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities 2,709,492 3,373,997
Total current liabilities 2,709,492 3,373,997

Shareholders’ equity
Share capital
Authorized: unlimited
Issued:
December 31, 2015 – 118,151,622
December 31, 2014 – 93,512,494 261,324,692 237,657,056
Contributed surplus 26,277,966 25,848,429
Accumulated other comprehensive income 760,978 280,043
Accumulated deficit (263,689,330) (249,966,335)
Total shareholders’ equity 24,674,306 13,819,193
Total liabilities and equity 27,383,798 17,193,190

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

For the years ending December 31, 2015
$ 2014
$ 2013
$

Expenses
Research and development 8,601,864 13,824,252 18,506,064
Operating 5,315,837 4,998,694 5,392,660
Loss before the following (13,917,701) (18,822,946) (23,898,724)
Interest 197,859 210,390 371,485
Loss before income taxes (13,719,842) (18,612,556) (23,527,239)
Income tax (expense) recovery (3,153) (6,779) (5,408)
Net loss (13,722,995) (18,619,335) (23,532,647)
Other comprehensive income items that may be
reclassified to net loss
Translation adjustment 480,935 200,345 136,813

Net comprehensive loss (13,242,060) (18,418,990) (23,395,834)
Basic and diluted loss per common share (0.12) (0.21) (0.28)

Weighted average number of shares (basic and diluted) 112,613,845 87,869,149 83,530,981

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, 2012 198,155,091 376,892 24,126,265 (57,115) (207,814,353) 14,786,780

Net loss and other comprehensive income — — — 136,813 (23,532,647) (23,395,834)
Issued, pursuant to a bought deal financing 30,218,796 — — — — 30,218,796
Exercise of stock options 238,677 — (59,437) — — 179,240
Share based compensation — — 424,384 — — 424,384
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 7,830,409 — — — — 7,830,409
Issued, pursuant to "At the Market" Agreement 1,214,083 — — — — 1,214,083
Expired warrants — (376,892) 376,892 — — —
Share based compensation — — 980,325 — — 980,325
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 4,305,396 — — — — 4,305,396
Issued, pursuant to "At the Market" Agreement 19,362,240 — — — — 19,362,240
Share based compensation — — 429,537 — — 429,537
As at December 31, 2015 261,324,692 — 26,277,966 760,978 (263,689,330) 24,674,306

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS

For the years ending December 31, 2015
$ 2014
$ 2013
$

Operating Activities
Net loss for the year (13,722,995) (18,619,335) (23,532,647)
Amortization – property and equipment 180,411 163,501 131,623
Share based compensation 429,537 980,325 424,384
Unrealized foreign exchange (gain) loss (816,319) 242,542 (89,721)
Net change in non-cash working capital (1,105,464) (2,443,988) (1,374,172)
Cash used in operating activities (15,034,830) (19,676,955) (24,440,533)
Investing Activities
Acquisition of property and equipment (108,268) (152,750) (254,834)
Redemption (purchase) of short-term investments (29,292) (30,041) (32,416)
Cash used in investing activities (137,560) (182,791) (287,250)

Financing Activities
Proceeds from exercise of stock options and warrants — — 179,240
Proceeds from Share Purchase Agreement 4,305,396 7,830,409 —
Proceeds from "At the Market" equity distribution agreement 19,362,240 1,214,083 —
Proceeds from public offering — — 30,218,796
Cash provided by financing activities 23,667,636 9,044,492 30,398,036
(Decrease) increase in cash 8,495,246 (10,815,254) 5,670,253
Cash and cash equivalents, beginning of year 14,152,825 25,220,328 19,323,541
Impact of foreign exchange on cash and cash equivalents 1,368,204 (252,249) 226,534
Cash and cash equivalents, end of year 24,016,275 14,152,825 25,220,328


To view the Company’s Fiscal 2015 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

On March 11, 2016 PharmaMar reported that the creation of a network of centres of reference and adopting measures that promote research and access to treatments are two key aspects for improving the prognosis of patients with soft tissue sarcoma (STS), an uncommon type of cancer that originates in the tissues that connect, support and surround other body structures, such as muscles, fat, blood vessels, nerves, tendons and lining of the joints (Press release, PharmaMar, MAR 11, 2016, View Source [SID:1234510444]).

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This is one of the conclusions of the renowned international oncologists during the presentation of the Soft Tissue Sarcoma: Evidence and Experience seminar. This meeting, organised by PharmaMar, will bring leading world experts in this disease to Barcelona on 11 and 12 March from, among other countries, the United Kingdom, France, Italy, Germany, Spain and the United States, to analyse the latest advances in its diagnosis and treatment.

"We are proud to lead this meeting, where the most influential oncologists in the world in sarcoma management share opinions, present new case reports, discuss the latest advances and the most effective treatments for these patients", explained Mr Luis Mora, General Manager of the PharmaMar Oncology Unit.

Incidence of sarcoma

According to figures quoted by Prof Jean-Yves Blay, Chair of the European Organisation for the Research and Treatment of Cancer (EORTC), STS represents less than 1% of adult cancersi. "There are more than 50 histological subtypes of soft tissue sarcoma. The most common are leiomyosarcoma and liposarcoma. In Europe, the incidence of this type of tumour in adults (not including gastrointestinal stromal tumour) is from 4 to 5 cases per 100,000 inhabitantsii and approximately 2 half of the patients diagnosed with soft tissue sarcoma have developed metastases or are expected to do so", said Prof Blay.

To prevent patients reaching the expert sarcoma team after having been operated on, measures are required to guarantee an appropriate diagnosis and treatment agreed upon by a multidisciplinary team. Dr Javier Martín Broto, Chair of the Spanish Sarcoma Research Group (GEIS), maintains that this coordination requires the creation of a network of centres of reference to guarantee that patients with suspected soft tissue sarcoma are diagnosed and treated by teams of experts in the disease. "Studies show that patients who are diagnosed and treated in a centre of reference specialising in soft tissue sarcoma survive for longer than those diagnosed and treated in a centre without such specialisation", he explained.

This is precisely one of the lines of research of the Spanish Sarcoma Research Group which, according to Dr Martin Broto, has been collaborating for years with the Ministry of Health for the recognition of sarcoma hospitals and CSUR (Centres, Services and Units of Reference) teams. In his opinion, "we are currently in the final phase and we expect these centres to be made official in the near future".

The Spanish Sarcoma Research Group was created in 1994 and has led 47 research projects that have included thousands of patients. In the last few years, it has sponsored a large number of international clinical trials and its protocols are used worldwide.

Advances in the treatment of soft tissue sarcoma

Professor George Demetri, Director of the Centre for Sarcoma and Bone Oncology at the Dana-Farber Cancer Institute (Boston), presented the latest research projects related to the treatment of sarcoma, including the study conducted with trabectedin (Yondelis) in the United States, in which the compound was shown to reduce the risk of disease progression versus conventional treatment. Yondelis is developed and marketed by PharmaMar in Europe, while Janssen Products, L.P. has the rights to develop and sell Yondelis in the rest of the world except Japan, where PharmaMar has signed a licensing agreement with Taiho Pharmaceutical. 3

"Since Yondelis was first approved in Europe in 2007, approximately 50,000 patients in 80 countries have benefited from this therapy in all its indications", said Prof. Demetri, who explained that "advanced soft tissue sarcoma is a complex set of uncommon diseases that are virtually always life-threatening for patients with advanced stage disease. Patients need new treatment options that are more effective and well tolerated, and renewed hope has come with new drug approvals in the past decade based on sophisticated scientific research".

According to the data provided by this expert, the Phase 3 multicentre trial in the United States, Brazil and Australia is one of the largest conducted to date in sarcoma patients. This study showed a significant improvement in disease control (called "progression-free survival") with trabectedin versus dacarbazine in patients with advanced liposarcoma (LPS) or leiomyosarcoma (LMS) after failure of prior standard therapy with an anthracycline and at least one other chemotherapy.

All the experts present highlighted the importance of these advances in the treatment of sarcoma, a rapidly progressing form of cancer that requires new treatment options. "In soft tissue sarcoma, disease stabilisation is useful for evaluating the success of the treatment in advanced stage patients. The data from the latest clinical trials with Yondelis offer a more hopeful future for patients and a path forward for even more research to improve clinical outcomes", concluded Dr Demetri.