On March 14, 2016 Stemline Therapeutics, Inc. (Nasdaq:STML) reported financial results for the quarter ended December 31, 2015 (Press release, Stemline Therapeutics, MAR 14, 2016, View Source [SID:1234509512]).

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Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, "During the fourth quarter, we made significant progress across all three of our development programs. Key achievements included 1) generating and presenting data from our ongoing Phase 2 trial of SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN) which we have designed to support potential registration, 2) treating our first patient in the second stage of our Phase 2 program of SL-701 in advanced brain cancer, and 3) the opening of our IND for SL-801 on schedule. At the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December, we presented very strong data from our ongoing SL-401 trial in BPDCN, demonstrating a high overall response rate in BPDCN, with multiple complete responses. We are also very pleased with the pace of enrollment in BPDCN, and note that we are tracking in-line with our expectations. We look forward to sharing key clinical and regulatory updates on SL-401 throughout this year."

Dr. Bergstein continued, "We continue to evaluate SL-401 in several additional malignancies that overexpress IL-3R. Specifically, we have single agent trials enrolling AML patients with minimal residual disease and patients with advanced high-risk myeloproliferative neoplasms. We also expect our first clinical studies that combine SL-401 with other therapies will begin this year."

Dr. Bergstein concluded, "Our other pipeline candidates, SL-701 and SL-801, continue to advance. Our SL-701 trial is currently enrolling patients and we expect updates from this program in the second half of the year. The SL-801 IND is open, and we are on track to treat our first patient this quarter. With our strong cash position, we believe we have sufficient financial resources to achieve significant clinical and regulatory milestones this year and beyond."

Fourth Quarter 2015 Financial Results Review

Stemline ended the fourth quarter of 2015 with $97.5 million in cash, cash equivalents and investments, as compared to $104.0 million as of September 30, 2015, which reflects a cash burn of $6.5 million for the quarter. The company ended the fourth quarter of 2015 with 18.2 million shares outstanding.

For the fourth quarter of 2015, Stemline had a net loss of $10.2 million, or $0.58 per share, compared with a net loss of $6.9 million, or $0.53 per share, for the same period in 2014. The net loss for full year 2015 was $37.2 million, or $2.15 per share, as compared with a net loss of $28.8 million, or $2.23 per share, in the prior year.

Research and development expenses were $7.9 million for the fourth quarter of 2015, which reflects an increase of $2.8 million, or 56%, compared with $5.1 million for the fourth quarter of 2014. The increase in expenses during the current quarter was primarily attributable to the ramp up in our clinical trial activities for SL-401 and SL-801.

General and administrative expenses were $2.6 million for the fourth quarter of 2015, which reflects an increase of $0.6 million, or 30%, compared with $2.0 million for the fourth quarter of 2014. The increase in expenses during the current quarter was primarily attributable to an increase in compensation expense relating to administrative employees.

On March 11, 2016 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported positive preclinical findings generated using the Company’s Immune Repertoire Capture technology, presented at the Keystone Symposia Conference "Antibodies as Drugs", which took place in Whistler, British Columbia, Canada, March 6-10, 2016 (Press release, Atreca, MAR 11, 2016, View Source [SID1234522968]). Atreca’s programs are advancing multiple therapeutic agents that have shown they can enhance elimination of cancer cells, based on the analysis of successful anti-tumor responses in patients .

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In a poster titled, "Expanded IgG Lineages in Lung Cancer Non-Progressors Reveal Anti-Tumor Antibodies" (Abstract No. X2 1014), a research team of scientists at Atreca and collaborators at leading institutions reported key preclinical research findings, including:

Immune Repertoire Capture technology generated the sequences of native antibodies from the active immune response of an individual with Stage 4 lung adenocarcinoma who had experienced long-term non-progression of disease.
Several of these antibodies have been shown to bind tumor tissue but not normal tissue, and some bind multiple tumor types beyond the cancer type of the original patient from which the antibodies were discovered.
Select antibodies demonstrated they can destroy tumor cells, as measured by antibody-dependent cellular cytotoxicity (ADCC) in in vitro assays.
Daniel Emerling, Ph.D., Atreca’s Senior Vice President, Research, stated, "By analyzing blood samples from one patient at the single cell level using Atreca’s Immune Repertoire Capture platform, we identified thousands of antibodies and were able to generate natively paired antibody heavy and light chain sequences from blood plasmablasts, which are activated B cells that play a critical role in immune responses. Analysis of these antibody sequences allowed us to select and express functional antibodies for further analysis. Multiple patient-derived antibodies were found to bind cells from multiple tumor types, which highlights the utility and efficiency of our approach."

Select antibodies discovered in Atreca’s research have progressed to preclinical testing in in vivo models of cancer, with the goal of selecting candidates to enter into more advanced preclinical studies, based on a detailed understanding of anti-tumor immune responses.

"The results disclosed at Keystone this week demonstrate the power of Atreca’s Immune Repertoire Capture platform and its ability to generate novel antibodies that can target cancer," commented Tito A. Serafini, Ph.D., Atreca’s President, Chief Executive Officer, and Co-Founder. "Our technology allows Atreca to mine the key phenomenon driving efficacious anti-cancer immune responses—a patient’s own anti-tumor immunity—with the goal of using this knowledge to help other patients fight their disease." Dr. Serafini added, "We are grateful to our collaborators for their dedication to this research and look forward to the continued progress of our lead efforts into the clinic."

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.

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