On November 14, 2016 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, reported unaudited financial results for the three months ended September 30, 2016 and reported on corporate developments (Press release, Aptose Biosciences, NOV 14, 2016, View Source;p=RssLanding&cat=news&id=2222358 [SID1234516605]). Unless specified otherwise, all amounts are in Canadian dollars.

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Net loss for the three months ended September 30, 2016 was $4.0 million ($0.31 per share) compared with $3.3 million ($0.27 per share) during the three months ended September 30, 2015. Total cash and cash equivalents at September 30, 2016 were $10.3 million.

"During the third quarter of this year we focused on collecting and delivering to the U.S. Food and Drug Administration (FDA) the manufacturing information required to get our clinical trial of APTO-253 for acute myeloid leukemia (AML) back on track, as returning APTO-253 to the clinic is a major event for the company and for patients with AML," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "Simultaneously, we advanced the development of CG’806, which we believe can be a transformational drug for patients with FLT3-driven AML and for patients with B cell malignancies driven by the Cys481Ser mutant of the BTK enzyme."

Corporate Highlights
During the quarter, Aptose submitted a formal response and data package to the FDA, providing responses to all of the questions cited in the clinical hold letter issued by the FDA. The response to the FDA was based on a prototype drug product that was developed and manufactured to demonstrate the root cause and the corrective actions taken by Aptose to deliver ultimately a drug product that meets FDA standards for the return to the clinic.

As announced in October, the FDA requested that Aptose provide the FDA with the Chemistry, Manufacturing and Control (CMC) package for the actual GMP drug substance and drug product intended to serve as the clinical supply for the trial.

Aptose has now manufactured a batch of APTO-253 drug product that is intended to serve as the clinical supply for the trial, and vials of this new drug product batch have been placed on an accelerated and long-term stability-testing program. Data generated from this drug product batch will comprise much of the CMC package that Aptose will provide to the FDA.

In parallel, Aptose’s clinical team has identified and prepared multiple new clinical sites for the Phase 1b trial of APTO-253. The clinical sites, at major cancer research and treatment centers in the U.S., will be prepared to start the study as soon as the company resumes trial activities and re-initiates dosing and enrollment after the approval by FDA to do so.

Aptose recently announced that new preclinical data for APTO-253 will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting, being held December 3-6, 2016 in San Diego, CA. The poster presentation, Inhibition of c-Myc By Apto-253 As an Innovative Therapeutic Approach to Induce Cell Cycle Arrest and Apoptosis in Acute Myeloid Leukemia, abstract # 1716, can be viewed at the ASH (Free ASH Whitepaper) conference website.

Aptose continued to profile the mechanistic properties and range of action of CG’806. This once daily, oral, first-in-class FLT3/BTK inhibitor demonstrates potent inhibition of mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain), and the molecule is being positioned as a potential best-in-class therapeutic for patients with FLT3-driven AML. Likewise, CG’806 demonstrates potent, non-covalent inhibition of the Cys481Ser mutant of the BTK enzyme, suggesting the agent may be developed for CLL and MCL patients that are resistant/refractory/intolerant to covalent BTK inhibitors.
Financial Results
Net loss for the three months ended September 30, 2016 was $4.0 million ($0.31 per share) compared with $3.3 million ($0.27 per share) in the same period in the prior year. Net loss for the nine months ended September 30, 2016 was $14.7 million ($1.19 per share) compared with $10.2 million ($0.86 per share) during the nine months ended September 30, 2015.
Aptose utilized cash of $3.3 million in operating activities in the three months ended September 30, 2016 compared with $2.6 million during the three months ended September 30, 2015. For the nine months ended September 30, 2016 Aptose utilized cash of $12.4 million compared with $9.0 million in the nine months ended September 30, 2015. The cash utilized in the three months ended September 30, 2016 is higher than the three months ended September 30, 2015 due to a higher net loss as well as cash used to reduce accounts payable and accrual balances in the prior year period. The cash utilized in the nine months ended September 30, 2016 increased compared to the prior year period predominantly due to an increased net loss in the current year period.
Research and Development
Research and development expenses totaled $2.2 million in the three months ended September 30, 2016 compared to $1.7 million during the three months ended September 30, 2015 and totaled $7.8 million for the nine month period ended September 30, 2016 compared with $3.9 million in the same period in the prior year. Research and development costs consist of the following:
Components of research and development expenses:
Three months ended Nine months ended
September 30, September 30,
(in thousands) 2016 2015 2016 2015

Program costs $ 2,081 $ 1,633 $ 6,207 $ 3,750
CrystalGenomics Option Fee − − 1,294 −
Stock-based compensation 71 79 236 145
Depreciation of equipment 12 10 35 19
$ 2,164 $ 1,722 $ 7,772 $ 3,914
The increase in program costs in the three and nine months ended September 30, 2016 compared with the three and nine months ended September 30, 2015 is due to the following reasons:
Costs associated with the LALS/Moffitt collaboration developing epigenetic single molecule inhibitors of multiple targets, including the BET proteins, and other kinases for which no comparable expenses existed in the prior year periods;
Increased research and clinical operations headcount and related costs;
Formulation and manufacturing costs associated with APTO-253 and the root cause analysis of the filter clogging identified in November 2015; and
Increased Contract Research Organization costs related to consultants and advisors as Aptose works towards returning APTO-253 to the clinic.
As of November 2016, Aptose and Laxai Avanti Life Sciences (LALS) have, as part of their drug discovery partnership, generated novel compounds that inhibit both the bromodomain proteins and oncogenic kinases, while improving pharmaceutical properties that could serve as a basis for further optimization towards a lead preclinical candidate. However, due to a prioritization of development efforts, Aptose and LALS have suspended work on the program, and the collaboration with LALS has been terminated. During the hiatus of this program, Aptose and LALS may choose to resume the collaboration in the future.
During the nine months ended September 30, 2016, the Company paid US$1.0 million (CA$1.294 million) for an option fee related to the CG’806 technology. No comparable expense existed in the same period in the prior year.
Stock-based compensation was consistent in the three months ended September 30, 2016 compared with the three months ended September 30, 2015. While the number of option grants in the current year was higher than the prior year, the fair value of those grants was lower in the current year due to a lower stock price.
Stock-based compensation costs allocated to research and development increased in the nine months ended September 30, 2016 to reflect option grants to new employees hired in the second half of 2015 as the expense related to those grants was amortized 50% in the first 12 months.
General and Administrative
General and administrative expenses totaled $1.9 million in the three-month period ended September 30, 2016 compared to $2.2 million in the three months ended September 30, 2015. For the nine month period ended September 30, 2016, general and administrative expenses totaled $6.9 million compared with $7.5 million in the same period in the prior year. General and administrative expenses consist of the following:
Components of general and administrative expenses:
Three months ended Nine months ended
September 30, September 30,
(in thousands) 2016 2015 2016 2015

G&A expenses excluding salaries $ 733 $ 819 $ 2,688 $ 2,997
Salaries 858 838 2,656 2,348
Stock-based compensation 320 572 1,476 2,091
Depreciation of equipment 21 19 63 45
$ 1,932 $ 2,248 $ 6,883 $ 7,481
General and administrative expenses excluding salaries, decreased in the three months ended September 30, 2016 compared with the three months ended September 30, 2015. The decrease is primarily attributable to lower travel, legal and consulting costs associated with projects completed in the prior year offset by higher patent costs in the current year due to new programs acquired in late 2015 and 2016.
General and administrative expenses excluding salaries, decreased in the nine months ended September 30, 2016 compared with the nine months ended September 30, 2015. The decrease is the result of lower travel, consulting and legal costs in the current year related to transactions completed in the prior year as well as lower press release and filing costs associated with a lower cost service provider in the current year periods.
Salary charges in the three months ended September 30, 2016 were consistent with the prior year period as headcount was consistent year over year in the three month period.
Salary charges in the nine months ended September 30, 2016 increased in comparison with the nine months ended September 30, 2015 due to additional headcount in the first half of 2016 compared with the first half of 2015 as well as a higher average CA/US exchange rate which increased the cost of our US denominated salaries in the first six months of 2016 in comparison with the prior year.
Stock-based compensation decreased in the three months ended September 30, 2016 compared with the three months ended September 30, 2015 due to options granted in the current year having a lower valuation and therefore expense compared with options granted in the prior year.
Stock-based compensation decreased in the nine months ended September 30, 2016 compared with the nine months ended September 30, 2015 due to large option grants in April, June and July 2014 which vested 50% during the first year and therefore contribute to higher stock-based compensation expense during the first twelve month period captured in the prior year period.
Finance Expense
Finance expense for the three months ended September 30, 2016 totaled $nil compared with $8 thousand for the three months ended September 30, 2015. For the nine months ended September 30, 2016, finance expense totaled $138 thousand compared with $43 thousand for the same period in the prior year. Finance expense includes the following items:
Three months ended Nine months ended
September 30,
September 30,
(in thousands) 2016 2015 2016 2015
Interest expense $ − $ 8 $ − $ 43
Foreign exchange loss − − 138 −
$ − $ 8 $ 138 $ 43
Interest expense for the three and nine months ended September 30, 2015 relates to interest accrued at a rate of 10% on the remaining balance of convertible promissory notes issued in September 2013 as well as accretion expense related to the conversion feature of the notes. As the promissory notes were converted before September 2015, no interest expense was incurred in 2016.
Foreign exchange loss is the result of the fluctuation of exchange rates between US and Canadian dollars and the impact on our US dollar denominated cash balances.
Finance Income
Finance income totaled $79 thousand in the three months ended September 30, 2016 compared to $717 thousand in the three months ended September 30, 2015. For the nine months ended September 30, 2016, finance income totaled $92 thousand compared with $1.2 million in the same period in the prior year. Finance income includes the following items:
Three months ended Nine months ended
September 30, September 30,
(in thousands) 2016 2015 2016 2015
Interest income $ 12 $ 56 $ 92 $ 232
Foreign exchange gain 67 661 − 1,011
$ 79 $ 717 $ 92 $ 1,243
Interest income represents interest earned on our cash and cash equivalent and investment balances. Foreign exchange gains are the result of an increase in the value of US dollar denominated cash and cash equivalents balances during such periods due to a depreciation of the Canadian dollar compared to the US dollar.
Aptose Biosciences Inc.
Condensed Consolidated Interim Statements of Loss and Comprehensive Loss
(unaudited)
Three Three Nine Nine
months ended months ended months ended months ended
(amounts in 000’s of Canadian Dollars except for per common share data) Sept. 30, 2016 Sept. 30, 2015 Sept. 30, 2016 Sept. 30, 2015
REVENUE $ - $ - $ - $ -
EXPENSES
Research and development 2,164 1,722 7,772 3,914
General and administrative 1,932 2,248 6,883 7,481
Operating expenses 4,096 3,970 14,655 11,395
Finance expense – 8 138 43
Finance income (79 ) (717 ) (92 ) (1,243 )
Net financing (income) expense (79 ) (709 ) 46 (1,200 )
Net loss and comprehensive loss for the period 4,017 3,261 14,701 10,195
Basic and diluted loss per common share $ 0.31 $ 0.27 $ 1.19 $ 0.86
Weighted average number of common shares
outstanding used in the calculation of
basic and diluted loss per common share (000’s) 12,882 11,964 12,390 11,889
The press release, the financial statements and the management’s discussion and analysis for the quarter ended September 30, 2016 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml

On November 14, 2016 Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or the "Company"), reported the presentation of data on PV-10 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2016 Annual Meeting (Press release, Provectus Pharmaceuticals, NOV 14, 2016, View Source [SID1234516603]).

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The abstract for the presented data, titled "Intralesional Injection with Rose Bengal and Systemic Chemotherapy Induces Anti-Tumor Immunity in a Murine Model of Pancreatic Cancer," poster 264, is available at
View Source
Dr. Shari Pilon-Thomas, Associate Member, Department of Immunology, Moffitt Cancer Center, presented the poster on Saturday, November 12, 2016. The published abstract concludes that, in the murine model studied, "Regression of untreated pancreatic tumors by IL injection of PV-10 in concomitant tumor supports the induction of a systemic anti-tumor response. Addition of [Gemcitabine] chemotherapy enhances the effects of IL PV-10 therapy." The presented poster concludes that, "These results may warrant a clinical trial to evaluate the combination of IL PV-10 with gemcitabine in metastatic pancreatic cancer patients."
Eric Wachter, Ph.D., Chief Technology Officer of Provectus, noted, "According to statistics from the American Cancer Society, pancreatic cancer has grown from 33,730 new cases in the U.S. in 2006 to 53,070 new cases expected in 2016. Over the same period, deaths increased from 32,300 to 41,780, and this is now the 4th most common cause of cancer death in men and women alike. The 5-year overall survival rate is 8%. Thus, this is an area in oncology with a large and growing unmet need."

Wachter continued, "The work reported by Pilon-Thomas and colleagues shows that PV-10 has therapeutic activity in murine models of pancreatic cancer, and that this is augmented when intralesional PV-10 is combined with systemic gemcitabine (GEM), a standard chemotherapeutic agent used to treat this disease. Supporting this observation, their poster showed that PV-10 elicited interferon-gamma production, a hallmark of the induction of an anti-tumor immune response, along with regression of uninjected bystander tumors. They also showed that myeloid derived suppressor cells (MDSC) decreased when GEM was used alone or in combination with PV-10. Since MDSC have an inhibitory effect on a number of immune effector cells, including CD8+ T cells, dendritic cells and NK T cells, the apparent combination effect could result from reduced immune suppression by GEM coupled with immunologic stimulation by PV-10. PV-10 has previously been shown to produce tumor-specific anti-tumor immune responses in melanoma and colorectal carcinoma that includes activation of CD8+ T cells."

Wachter concluded, "We agree with the conclusions of the poster, that these results warrant clinical testing. Since pancreatic cancer frequently metastasizes to the liver, this could be a logical extension of our current investigations of PV-10 administered percutaneously to hepatic tumors."

The SITC (Free SITC Whitepaper) 2016 Annual Meeting was held at the Gaylord National Hotel & Convention Center in National Harbor, Maryland, November 9-13, 2016.

On November 14, 2016 Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based on its Targeting Protein Therapeutics (TPTs) platform, reported financial results for the third quarter ended September 30, 2016, and recent business highlights (Press release, Eleven Biotherapeutics, NOV 14, 2016, View Source [SID1234516598]).

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"This is an exciting period for Eleven. We completed the Roche licensing deal, including $30 million in upfront and milestone payments received to date. We also completed the acquisition of Viventia Bio Inc. which allowed us to become a late-stage oncology company. Perhaps most excitingly, we are making significant progress in moving forward what we believe could be therapeutics that materially improve patients’ lives. We anticipate complete enrollment in the first half of next year for our Phase 3 clinical trial of Vicinium as a potential treatment for high-grade non-muscle invasive bladder cancer, and expect topline data in the first half of 2018," said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. "We also plan to initiate our Phase 2 trial in late-stage squamous cell carcinoma of the head and neck with Proxinium in combination with a checkpoint inhibitor in the first half of 2017. Also in 2017, we plan on submitting an IND with the FDA for our lead product in our systemic pipeline based on our proprietary payload deBouganin. With the combined expertise of Eleven and the Viventia team, I am very excited about the opportunities we have ahead."

Third Quarter and Recent Business Highlights:

Completed acquisition of Viventia Bio Inc., creating a company focused on the development of novel therapies based upon antibody fragments genetically fused to cytotoxic proteins, or TPTs, as new treatments in areas of oncology. Eleven’s pipeline now includes Viventia’s lead product candidates Vicinium and Proxinium. Both product candidates are anti-EpCAM (epithelial cell adhesion molecule) fusion proteins that have been optimized for local tumor administration.
Vicinium is in a Phase 3 clinical trial for high grade non-muscle invasive bladder cancer (NMIBC) with topline data expected in the first half of 2018. In a Phase 2 clinical trial, Vicinium demonstrated a complete response rate of 40% at three months with no patients discontinuing treatment due to treatment related serious adverse events. To date, Vicinium has been evaluated in more than 100 patients in previously completed clinical trials.
Proxinium is expected to enter a Phase 2 clinical trial in combination with a checkpoint inhibitor in the first half of 2017 for the treatment of late-stage squamous cell carcinoma of the head and neck. In previous clinical trials, Proxinium was generally well-tolerated and showed signs of anti-tumor activity. Proxinium has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and Fast Track designation from the FDA.
Completed exclusive License Agreement with Roche for IL-6 antagonist antibody technology, including EBI-031. Eleven granted Roche an exclusive, worldwide license to develop and commercialize EBI-031 and all other IL-6 antagonist antibody technology owned by Eleven. Eleven has received $30 million in payments from Roche, including a $7.5 million upfront payment in connection with the effectiveness of the License agreement, and a $22.5 million milestone payment based on the IND application for EBI-031 becoming effective. Under the terms of the License Agreement, Eleven could receive up to an additional $240 million upon the achievement of certain future regulatory, development and commercialization milestones. In addition, Eleven is entitled to receive royalties based on net sales of potential future products containing EBI-031 or any other potential future products containing other Eleven IL-6 compounds.
Third Quarter 2016 Financial Results:

Revenue: Revenue was $28.7 million for the three months ended September 30, 2016, compared to $0.1 million for the same period in 2015. The increase was due to the revenue recognized from the License Agreement with Roche.
R&D Expenses: Research and development expenses were $2.8 million for the three months ended September 30, 2016, compared to $6.7 million for the same period in 2015. The decrease was primarily due to a decrease of isunakinra-related development expenses, for which development activities are no longer ongoing, as well as decreases in EBI-031 related development expenses due to the License Agreement with Roche.
G&A Expenses: General and administrative expenses were $6.4 million for the three months ended September 30, 2016, compared to $2.7 million for the same period in 2015. The increase was primarily due to increased severance, retention and stock-based compensation expenses and professional fees related to our review of strategic alternatives and the acquisition of Viventia.
Net Income (Loss): Net income was $19.5 million, or $0.95 per basic share and $0.91 per diluted share, for the three months ended September 30, 2016, compared to a net loss of $9.7 million, or $0.50 per basic and diluted share, for the same period in 2015. The change was primarily the result of the revenue recognized from the License Agreement with Roche.
Cash and Cash Equivalents: Cash and cash equivalents were $30.7 million as of September 30, 2016. We believe that our cash and cash equivalents as of September 30, 2016 will enable us to fund our operating expenses into 2018.
Events and Presentations:

Protein & Antibody Engineering Summit (PEGS) Europe, October 31-November 4, 2016 in Lisbon, Portugal.
European Antibody Congress, November 14-16, 2016 in Basel, Switzerland.

On November 14, 2016 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, reported the presentation of positive data from multiple new preclinical studies of the company’s phosphatidylserine (PS)-targeting antibodies (Press release, Peregrine Pharmaceuticals, NOV 14, 2016, View Source [SID1234516592]). Study results highlight that PS-targeting antibodies similar to bavituximab synergize with checkpoint inhibitors and radiation to improve anti-tumor activity in various animal tumor models. Importantly, the improved anti-tumor activity seen in these studies was even greater when PS-targeting therapy was a part of triple combination treatment including anti-PD-1 and another therapy. Data were presented by Peregrine scientists, as well as researchers from Memorial Sloan Kettering Cancer Center (MSK), at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2016 Annual Meeting, which was held November 9-13, 2016 in National Harbor, MD.

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Initial results from Peregrine’s ongoing collaboration with MSK researchers were featured in a poster presented by Sadna Budhu, Ph.D., at SITC (Free SITC Whitepaper) 2016. A team of MSK researchers led by cancer immunotherapy thought-leaders, Taha Merghoub, Ph.D. and Jedd D. Wolchok, M.D., Ph.D., evaluated the effects of combining PS-targeting, anti-PD-1 and radiation therapies in the mouse B16 melanoma model. Study data showed that PS-targeting antibodies synergize with both anti-PD-1 and radiation therapy to improve anti-cancer activity. PS-targeting treatment in combination with radiation, as well as triple combination of PS-targeting treatment, anti-PD-1 and radiation, led to a reduction in tumor burden. Median survival for the triple combination treatment still had not been reached at the end of the 80-day observation period with other arms in the study showing median survival that ranged from 24-70 days.

Researchers also evaluated the impact of the PS-targeting and radiation combination treatment on the level and type of immune activity. These results demonstrated that the combination led to a change in the tumor microenvironment, shifting it from immunosuppressive in which tumors are protected to immune active in which tumors are more susceptible to treatment. Analysis of local immune responses in the tumors of the treated animals showed that the combination treatment increased the number of tumor associated macrophages and shifted the macrophage polarization from the immunosuppressive M2 type to the immune active M1 type. When systemic immune responses were analyzed following triple combination of PS-targeting treatment, anti-PD-1 and radiation, researchers also saw evidence of increased immune activity. This was illustrated by key indicators of immune activity, including increases in CD8+ T-cell activation, effector cytokine production and differentiation into effector memory cells.
"Based on these study results, we believe that the targeting of PS is having meaningful activity within the tumor microenvironment in the B16 melanoma model," stated Dr. Wolchok. "It appears that this activity creates a more immune active environment in which other treatments, including radiation, are able to have a greater anti-tumor impact."

"We have noted that the combination of PS-targeting treatment and radiation, as well as triple combination of PS-targeting treatment, radiation and anti-PD-1, resulted in clear advantages in anti-tumor activity in the mouse B16 melanoma model," said Taha Merghoub, Ph.D., co-director of the Ludwig Collaborative Laboratory at MSK. "We believe that these findings suggest the potential benefit of combining these agents to improve the outcomes of patients with cancer. With this in mind, we think this research may play an important role in designing future clinical trials of PS-targeting agents in melanoma and other cancers."
A second study, conducted by Peregrine, evaluated the effects of combining PS-targeting, anti-PD-1 and anti-LAG3 therapies in the E0771 triple negative breast cancer (TNBC) model. Initial findings from this study were previously reported and demonstrated that eight of the ten (80%) animals receiving the PS-targeting, anti-PD-1 and anti-LAG3 treatment combination experienced complete tumor regressions, whereas there were no animals (0/10) in the anti-PD-1 and anti-LAG3 combination treatment arm that had a complete regression. New data presented for the first time at SITC (Free SITC Whitepaper) demonstrated that the triple combination established a specific and prolonged anti-tumor immune response which protected those eight animals that achieved a complete tumor regression against a re-challenge with the same E0771 TNBC model tumor cells. This sustained anti-tumor response demonstrates the ability of the triple combination treatment to trigger immune system memory and support adaptive immune responses against reemerging disease in the E0771 TNBC model.

Further highlighting the immune impact of the PS-targeting/anti-PD-1/anti-LAG3 treatment combination were initial results of a new analysis from this study using the nCounter PanCancer Immune Profiling Panel from NanoString Technologies. Data from the analysis demonstrated that the triple combination induced a greater shift in the tumor microenvironment from immunosuppressive to immune active as compared to all other treatment groups. This was evidenced by greater increases in the activity of several critical immune activating pathways, including presentation and processing of antigens and signaling and activation of T-cells, for the triple combination as compared to all other treatments.

"It is very encouraging to see the consistent increase in anti-tumor activity triggered by triple combination treatments that combine PS-targeting agents and anti-PD-1 with other cancer treatments. By demonstrating this activity across multiple studies in multiple tumor models, we are continuing to build scientific support for the therapeutic potential of adding PS-targeting therapies in combination with other cancer treatments, including checkpoint inhibitors such as anti-PD-1," said Jeff T. Hutchins, Ph.D., Peregrine’s vice president, preclinical research. "As cancer research continues to explore the potential of combination treatments that marry complementary mechanisms, we are pleased to see that our efforts continue to generate data supporting the role that PS-targeting agents such as bavituximab may play in this area."

Bavituximab is an investigational monoclonal antibody that targets PS. Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. Previous studies demonstrated PS-targeting antibodies shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor responses. Peregrine continues to support and guide clinical development through the evaluation of the preclinical equivalent of bavituximab, ch1N11, in animal model studies.

Peregrine’s clinical development strategy for bavituximab currently focuses on small, early-stage, proof-of-concept trials evaluating the drug in combination with other cancer treatments. This approach includes the recently announced grants awarded by the National Comprehensive Cancer Network (NCCN) to support three different clinical trials of bavituximab treatment combinations. These trials will evaluate novel bavituximab combinations in glioblastoma, head and neck cancer, and hepatocellular carcinoma including an immunotherapy combination. Additionally, Peregrine continues to advance its pre-clinical collaboration with Memorial Sloan Kettering Cancer Center with the goal of evaluating combinations of bavituximab with other checkpoint inhibitors and immune stimulatory agents. The intent behind this strategy is to focus our research and development spending to further validate bavituximab’s combination potential as we seek to advance the program though a pharmaceutical or biotechnology partner.

On November 14, 2016 Mateon Therapeutics, Inc. (Nasdaq:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported a corporate update and reported financial results for the third quarter of 2016 (Press release, Mateon Therapeutics, NOV 14, 2016, View Source [SID1234516590]).

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Recent Corporate Highlights

Entered into a collaboration with U.S. Oncology Research for their participation in Mateon’s Phase 2/3 FOCUS Study evaluating CA4P in combination with bevacizumab (Avastin) and chemotherapy for the treatment of patients with platinum-resistant ovarian cancer.
Continued to expand the number of U.S. investigator sites participating in the FOCUS Study.
Expanded the FOCUS Study into Europe, with sites in Belgium now actively recruiting patients.
Completed enrollment in the second cohort and initiated the third cohort of OX1222, an open-label dose-ranging study of OXi4503 in combination with cytarabine, in patients with relapsed/refractory acute myeloid leukemia (AML).
Received an issued patent for pre-clinical cathepsin-inhibiting compounds from the U.S. Patent and Trademark Office.
Expanded Board of Directors with appointment of two experienced biopharmaceutical executives.
"I am pleased that our most advanced clinical trial, the FOCUS Study, remains on track and now has 20 investigator sites qualified to enroll patients," stated William D. Schwieterman, M.D., Mateon’s President and Chief Executive Officer. "Importantly, we are seeking to demonstrate improvement over the current standard of care in platinum-resistant ovarian cancer, and positive results from this trial could ultimately change the treatment paradigm in ovarian cancer, as well as the much broader field of vascular-targeted therapy in a variety of other solid tumor cancers. Therefore, the results of this clinical trial are critical to our goal of creating long-term shareholder value."

Financial Results for the Third Quarter of 2016

For the third quarter of 2016, Mateon reported a net loss of $3.2 million compared to a net loss of $3.6 million for the third quarter of 2015. R&D expenses decreased to $2.1 million in the third quarter of 2016, compared to $2.5 million in the third quarter of 2015, while general and administrative expenses increased to $1.2 million for the third quarter of 2016 compared to $1.1 million for the third quarter of 2015.

At September 30, 2016, Mateon had cash, cash equivalents and short-term investments of $16.3 million, which the Company currently believes is sufficient to fund operations through the availability of key clinical data from the FOCUS Study, which is expected in the second half of 2017.