On February 16, 2016 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported its financial results for the second quarter of the 2016 fiscal year ending December 31, 2015 (Press release, DelMar Pharmaceuticals, FEB 16, 2016, View Source [SID:1234509066]). The Company also highlighted recent corporate and clinical achievements and provided an overview of expected near-term milestones.

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DelMar management will host a business update conference call and live webcast for investors, analysts and other interested parties on Wednesday, February 17, 2016, at 5:00 pm EST.

"The progress we continued to achieve this quarter for our VAL-083 (dianhydrogalactitol) clinical program and the consistent positive data from preclinical studies, along with the recently announced collaboration with University of Texas MD Anderson Cancer Center, not only further validates the promise of VAL-083 as a potential new treatment for chemo-resistant tumors, but also sets the stage for 2016 to be a transformational year for our Company," stated Jeffrey Bacha, Chairman and CEO of DelMar Pharmaceuticals.

RECENT CORPORATE HIGHLIGHTS

Announced a collaboration with the University of Texas MD Anderson Cancer Center (MD Anderson) to extend and accelerate the clinical development of VAL-083 for glioblastoma multiforme (GBM) patients following first recurrence of the disease. MD Anderson will initiate a new Phase II clinical study with VAL-083 at first recurrence/progression, prior to Avastin (bevacizumab) exposure. Eligible patients will have recurrent GBM characterized by a high expression of MGMT, the DNA repair enzyme implicated in drug-resistance and poor patient outcomes following current front-line chemotherapy.

Completed enrollment of the Phase II expansion cohort for the GBM study at a dose of 40mg/m2. Confirmed 40mg/m2 as the maximum tolerated dose (MTD) for advancement into registration directed clinical trials. This optimized dosing regimen may enhance the potential of VAL-083 to impact a patient’s tumor as well as to improve patient outcomes.

Presented interim Phase II data at the 2015 Society for Neuro-Oncology Annual Meeting. A Kaplan Meier survival estimate, based on these preliminary interim data, projects a clinically meaningful survival benefit for refractory GBM patients whose tumors have recurred following both front-line therapy with temozolomide and second-line bevacizumab treatment.

Presented data supporting VAL-083’s potential as a treatment for pediatric brain tumors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Advances in Pediatric Research Conference. The preclinical and clinical data support advancement of VAL-083 into a clinical study in pediatric patients with recurrent or resistant medulloblastoma (MB) and high grade gliomas (HGGs).

Presented data indicating the promising potential of VAL-083 as a solution for major unmet needs in the treatment of a variety of cancers, including GBM, non-small cell lung cancer (NSCLC), ovarian cancer and pediatric brain tumors, at the AACR (Free AACR Whitepaper) New Horizons in Cancer Research Conference.

Announced additional data on the unique molecular mechanisms responsible for VAL-083 activity against cancer at the 2015 Canadian Cancer Research Conference. These data suggest that VAL-083’s activation of immune response pathways may represent a promising personalized medicine approach in the treatment of cancer.

Presented positive data on the benefit of VAL-083 in combination with platinum-based chemotherapy for non-small cell lung cancer at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). The data demonstrate that VAL-083 retains activity in chemo-resistant NSCLC tumor types and has a super-additive effect in NSCLC when used in combination with platinum-based chemotherapeutic agents.

Presented positive preclinical data supporting the activity of VAL-083 in treatment-resistant ovarian cancer. The data support VAL-083 as a viable treatment option for patients failing platinum-based chemotherapy and demonstrates a potential benefit in combination with platinum therapy.

"For the first half of 2016 we will focus on accomplishing several actionable milestones that will position DelMar to expand clinical development around VAL-083 and also serve to maximize shareholder value. We believe that DelMar’s recent data, combined with historical clinical validation, positions VAL-083 as a superior alternative to currently available chemotherapy for GBM patients whose tumors are characterized by high expression of MGMT. Our goal is nothing short of creating a paradigm-shift in the treatment of this horrific cancer," added Mr. Bacha.

"We anticipate reporting top-line survival data from the Phase II expansion cohort of our refractory GBM clinical trial in the first half of 2016. Based on our observations to date, we believe that we are well positioned to advance VAL-083 into Phase II/III registration clinical trials in refractory GBM during 2016. New non-clinical data reported in 2015 continued to demonstrate VAL-083’s unique cytotoxic anti-cancer mechanism, and we anticipate leveraging these data by expanding our clinical development programs around VAL-083 also during 2016," concluded Mr. Bacha.

EXPECTED NEAR-TERM MILESTONES

Report top-line data from the Phase II study with VAL-083 in refractory GBM in the first half of 2016;

Engage the U.S. Food and Drug Administration (FDA) regarding the design of a proposed registration-directed Phase II/III clinical trial for VAL-083 in refractory GBM;

Initiate registration-directed Phase II/III clinical trials for VAL-083 as a new treatment option for refractory GBM in 2016;

Initiate the Phase II clinical study at MD Anderson with VAL-083 in patients with GBM at first recurrence/progression;

Initiate clinical studies in newly-diagnosed GBM patients as an alternative to temozolomide in patients with high expression of MGMT;

Initiate new clinical trials with VAL-083 in refractory NSCLC;

Continue to pursue pre-clinical research with leading investigators to advance VAL-083 as a potential treatment for other chemo-resistant cancers including ovarian cancer and pediatric medulloblastoma;

Maximize the value of the VAL-083 pipeline through potential partnership opportunities in high value oncology markets;

Continue to build the Company’s intellectual property portfolio; and

Continue to implement strategies that enable DelMar to meet qualifications to list its shares on a national stock exchange.

CONFERENCE CALL DETAILS
DelMar plans to host a conference call on Wednesday, February 17, 2016, at 5:00 p.m. EST, to discuss quarterly results and provide a corporate update. For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is (800) 895‑1715 (toll-free) or (785) 424‑1059 (toll) with Conference ID "DelMar." A link to the webcast and slides will be available on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com and will be archived for 30 days.

SUMMARY OF FINANCIAL RESULTS FOR THE SECOND QUARTER OF FISCAL YEAR 2016 ENDED DECEMBER 31, 2015
For the three months ended December 31, 2015 the Company reported a net loss of $2,646,690, or a net loss per share of $0.06, compared to a net loss of $619,633, or a net loss per share of $0.02 for the three months ended December 31, 2014 as restated.

FINANCIAL SUMMARY
The following represents selected financial information as of December 31, 2015. The Company’s financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar’s consolidated financial statements and Management’s Discussion and Analysis (MD&A), as filed.

DelMar’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the company’s website at: View Source

About VAL-083
VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer, and has received orphan drug designation in Europe and the U.S. for the treatment of malignant gliomas.

DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by the expression of MGMT, a DNA repair enzyme that is implicated in chemotherapy resistance and poor outcomes in GBM patients following standard front-line treatment with Temodar (temozolomide).

DelMar recently announced the completion of enrollment in a Phase II clinical trial of VAL-083 in refractory GBM. Patients have been enrolled at five clinical centers in the United States: Mayo Clinic (Rochester, MN); UCSF (San Francisco, CA) and three centers associated with the Sarah Cannon Cancer Research Institute (Nashville, TN, Sarasota, FL and Denver, CO).

In the Phase I dose-escalation portion of the study, VAL-083 was well tolerated at doses up to 40mg/m2 using a regimen of daily x 3 every 21 days. Adverse events were typically mild to moderate; no treatment-related serious adverse events reported at doses up to 40 mg/m2. Dose limiting toxicity (DLT) defined by thrombocytopenia (low platelet counts) was observed in two of six (33%) of patients at 50 mg/m2. Generally, DLT-related symptoms resolved rapidly and spontaneously without concomitant treatment, although one patient who presented with hemorrhoids received a platelet transfusion as a precautionary measure.

Sub-group analysis of data from the Phase I dose-escalation portion of the study suggested a dose-dependent and clinically meaningful survival benefit following treatment with VAL-083 in GBM patients whose tumors had progressed following standard treatment with temozolomide, radiotherapy, bevacizumab and a range of salvage therapies.

Patients in a low dose (≤5mg/m2) sub-group had a median survival of approximately five (5) months versus median survival of approximately nine (9) months for patients in the therapeutic dose (30mg/m2 & 40mg/m2) sub-group following initiation of VAL-083 treatment. DelMar reported increased survival at 6, 9 and 12 months following initiation of treatment with VAL-083 in the therapeutic dose sub-group compared to the low dose sub-group.

Further details can be found at View Source

On February 16, 2016 Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, reported strong fourth quarter 2015 financial results (Press release, Baxalta, FEB 16, 2016, View Source [SID:1234509062]).

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"We are pleased to report another quarter of strong financial performance reflecting continued positive momentum across our entire portfolio," said Ludwig Hantson, chief executive officer and president, Baxalta. "In 2015, Baxalta achieved its strategic objectives, exceeded our financial guidance with disciplined execution and established a solid foundation for the future. We will continue to build on this success with our commitment to patient-centric innovation and new product launches to drive enhanced growth and value for patients, customers and other key stakeholders."

Financial Results for the Fourth Quarter 2015

In the fourth quarter, Baxalta generated net income on a GAAP basis of $95 million and earnings of $0.14 per diluted share. These results include net after-tax special items totaling $292 million, or $0.43 per diluted share, primarily for intangible asset amortization, expenses associated with the company’s separation from Baxter International (NYSE: BAX), and certain business development and collaboration-related items.

On an adjusted basis, excluding special items, Baxalta reported fourth quarter net income of $387 million, or $0.57 per diluted share, which compares favorably to the company’s previously-issued guidance of $0.55 to $0.57 per diluted share. These financial results reflect positive sales momentum and higher gross margins, providing enhanced flexibility for accelerated investments in research and development, marketing and launch preparedness, and global infrastructure to position the company for future success.

Positive Sales Momentum Across Differentiated Portfolio

In the fourth quarter, Baxalta’s worldwide revenues on a GAAP basis of $1.8 billion advanced 5 percent from the prior-year period. Excluding the impact of foreign currency, sales advanced 12 percent.

On a pro forma basis, worldwide revenues increased 3 percent. Excluding the impact of foreign currency, sales advanced 10 percent, exceeding the company’s previously-issued guidance of growth in the 3 to 5 percent range. Within the United States, sales of $944 million rose 13 percent; international sales of $819 million declined 7 percent. Excluding foreign currency, international sales increased 8 percent.

By business, global hematology revenues of $1.0 billion increased 6 percent (excluding the impact of foreign currency) as the company continues to focus on enhancing access and elevating standards of care worldwide. Growth was driven by the U.S. introduction of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, following U.S. Food and Drug Administration (FDA) approval in November, as well as heightened global demand for ADVATE [Antihemophilic Factor (Recombinant)] and FEIBA [Anti-Inhibitor Coagulant Complex], an inhibitor treatment. Also contributing to performance was growth of RIXUBIS [Coagulation Factor IX (Recombinant)], a treatment for hemophilia B, and OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence], for the treatment of acquired hemophilia A.

Immunology sales of $680 million advanced 8 percent (excluding the impact of foreign currency) on a pro forma basis. The company continues to capitalize on its broad and differentiated portfolio of immunoglobulin therapies, including HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], and is driving strong sales of specialty biotherapeutics.

Baxalta’s new oncology business recorded sales of $53 million in the quarter. This reflects revenues from the recent acquisition of ONCASPAR (pegaspargase), a marketed biologic treatment for acute lymphoblastic leukemia (ALL).

Full-Year 2015 Sales Results

For the full-year 2015, Baxalta reported worldwide revenues on a GAAP basis of $6.1 billion, a 3 percent increase over the prior-year period. Excluding the impact of foreign currency, sales advanced 11 percent.

On a pro forma basis, worldwide revenues grew 2 percent. Excluding the impact of foreign currency, sales advanced 10 percent, exceeding the company’s original expectations and updated projections provided in the third quarter of approximately 8 percent growth. Within the United States, sales of $3.3 billion rose 10 percent, and international sales of $2.9 billion declined 6 percent. Excluding the impact of foreign currency, international sales increased 10 percent.

2015 Highlights and Key Milestone Achievements

Baxalta has established a solid track record of executing its strategic objectives, delivering strong financial performance and achieving meaningful pipeline milestones following its separation from Baxter International in 2015.

"Our relentless quest for innovation is fostering a culture of purpose-driven performance and success," added Hantson. "Baxalta employees around the world are inspired by and committed to meeting patient needs. Our strong momentum will continue to differentiate our businesses in a highly competitive landscape and create sustainable, long-term value."

2015 highlights include:

Launching Baxalta Incorporated as a global biopharmaceutical leader dedicated to patients with orphan diseases and underserved conditions. The separation from Baxter International allowed Baxalta to advance its leadership position and continue innovation on transformative therapies in hematology, immunology and oncology.

Enhancing commercial execution and driving new product revenues of nearly $300 million for the full-year 2015 led by HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] and ONCASPAR, as well as RIXUBIS [Coagulation Factor IX (Recombinant)], OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence] and ADYNOVATE.

Expanding the company’s commitment to oncology with the ONCASPAR (pegaspargase) leukemia portfolio acquisition from Sigma-Tau Finanziaria S.p.A., which provided access to ONCASPAR as well as an established commercial and clinical infrastructure. Complementing its oncology focus in orphan diseases, Baxalta also announced a broad strategic immuno-oncology collaboration with Symphogen, a private biopharmaceutical company based in Denmark developing recombinant antibodies and antibody mixtures, to advance novel therapeutics against six checkpoint targets, with the first program expected to enter clinical studies in 2017.

Making significant progress toward Baxalta’s objective of launching approximately 20 new products by 2020 with three key regulatory approvals in 2015, bringing the total number of new products approved in the last 18 months to ten. This includes FDA approval and subsequent launch of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, and FDA approval of VONVENDI [von Willebrand factor (Recombinant)], the first and only recombinant treatment for adults living with von Willebrand Disease (VWD). In addition, Baxalta recently secured European Commission Marketing Authorization of ONCASPAR, which allows Baxalta to market this product in 28 member countries of the European Union (EU), as well as Iceland, Liechtenstein and Norway.

Advancing several breakthrough innovations with potential to transform patient care with a number of therapies awaiting regulatory approval, including Baxalta’s investigational 20% subcutaneous immune globulin (IGSC) treatment for primary immunodeficiencies in both the U.S. and Europe, and European approval of ONIVYDE (irinotecan liposome injection) for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

Progressing early-stage hematology assets with the submission of a Clinical Trial Application to the UK Medicines and Healthcare Products Regulatory Agency to initiate a clinical trial to evaluate the safety and efficacy of BAX 826, an investigational, extended half-life rFVIII treatment for hemophilia A. Baxalta also presented interim data and progress updates at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on the Phase 1/2 study of BAX 335, an investigational factor IX (FIX) gene therapy treatment for hemophilia B, which has been granted orphan designation by the FDA. At the end of 2015, a total of eight patients in three dosing cohorts had been treated.

Expanding Baxalta’s global network of quality manufacturing sites including FDA approval for a state-of-the-art recombinant biologic manufacturing facility in Singapore to produce ADVATE bulk drug substance. Additionally, the European Medicines Agency licensed the manufacturing of HYQVIA and GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] (marketed as KIOVIG in the EU) through the company’s manufacturing services agreement with Stichting Sanquin Bloedvoorziening (Sanquin Blood Supply Foundation or Sanquin) in the Netherlands.

Forming new external partnerships and acquiring novel investigational treatments that complement and build upon our leading and differentiated portfolio. In addition to key oncology and biosimilar partnerships, Baxalta also acquired SuppreMol GmbH’s early-stage development portfolio of biologic immunoregulatory therapeutics for the treatment of autoimmune and IgE-mediated allergic diseases.

Financial Outlook for First Quarter 2016

For the first quarter of 2016, Baxalta expects pro forma sales growth, excluding the impact of foreign currency, of 8 to 9 percent. Including the impact of foreign currency, the company expects pro forma sales to increase 4 to 5 percent. Baxalta also expects first quarter 2016 adjusted earnings, before special items, of $0.44 to $0.46 per diluted share.

The company’s earnings guidance for the first quarter of 2016 excludes approximately $0.03 per diluted share of projected intangible asset amortization expense. Reconciling for the inclusion of this item results in expected GAAP earnings of $0.41 to $0.43 per diluted share for the first quarter of 2016.

Additional Information

Given the proposed merger agreement with Shire plc (LSE: SHP, NASDAQ: SHPG) announced on January 11, 2016, going forward Baxalta will not be hosting an investor conference call to discuss financial results. In addition, as is customary, the company will not be updating its financial guidance for full-year 2016, and previously-issued guidance for Baxalta as a standalone entity is no longer applicable. The transaction, which is subject to customary closing conditions including regulatory approvals in several jurisdictions and approval by both Baxalta’s and Shire’s shareholders, is expected to close mid-2016.

Complementary information related to Baxalta’s fourth quarter and full-year 2015 financial results may be accessed by visiting the Baxalta corporate website at investor.baxalta.com.

On February 16, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported that Daniel J. O’Connor, president and chief executive officer, will present an overview of the company’s business strategy and corporate programs at the 2016 RBC Capital Markets Global Healthcare Conference at the New York Palace in New York City (Press release, Advaxis, FEB 16, 2016, View Source [SID:1234509060]). Advaxis’ presentation will take place on Tuesday, February 23 at 11:30 a.m. EST.

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The presentation will provide an update on the Company’s key milestones and initiatives for 2016 including its soon to be launched Phase 3 trial for axalimogene filolisbac for the treatment of high-risk locally advanced cervical cancer (AIM2CERV) and the launch of a Phase 2 trial in metastatic anal cancer (FAWCETT). The presentation will also review Advaxis’ advancing work in neo-epitopes through its partnership with Memorial Sloan Kettering Cancer Center and ongoing work in prostate cancer and with HER2-driven tumors.