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6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On August 4, 2015 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) ("Aptose" or the ‘Company") a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, reported financial results for the three months ended June 30, 2015 and provided a corporate update (Filing, 6-K, Aptose Biosciences, AUG 4, 2015, View Source [SID:1234507001]). Unless specified otherwise, all amounts are in Canadian dollars.

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Effective July 15, 2014 the Company changed its fiscal year end from May 31 to December 31. As a result of this change, the current interim period being reported is for the three months ended June 30, 2015, while the prior year comparative period is for the three months ended May 31, 2014.

Net loss for the three months ended June 30, 2015 was $3.4 million ($0.28 per share) compared with $4.2 million ($0.49 per share) during the three months ended May 31, 2014. Total cash and cash equivalents and investments at June 30, 2015 were $25.2 million.

"During the second quarter we were focused on advancing our Phase 1b clinical trial of APTO-253 for AML and other blood cancers, as we expanded the internal clinical operations capabilities, expanded the scope of preeminent investigators and centers associated with the development of this program, and initiated preclinical collaborations to explore combination treatment strategies with other drug developers. APTO-253 displays a mechanism of action that is well-differentiated and potentially complementary to currently available therapies," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "We are making progress in building a specialized oncology drug development organization dedicated to translating new understandings in transcriptional regulation and epigenetics into advanced medicines such as APTO-253 for patients with hematological malignancies."

Corporate Highlights

In June, Aptose announced that the U.S. Food and Drug Administration (FDA) granted the company orphan drug designation for APTO-253 for the treatment of acute myeloid leukemia (AML). Orphan drug status provides research and development tax credits, an opportunity to obtain grant funding, exemption from FDA application fees and other benefits. If APTO-253 is approved to treat AML, the orphan drug designation provides Aptose with seven years of marketing exclusivity.

During the quarter, Aptose continued to recruit clinical sites for the APTO-253 Phase 1b clinical trial. Baylor Cancer Center in Dallas, MD Anderson Cancer Center in Houston, Oregon Health & Sciences University (OHSU) and the University of Michigan are actively screening patients. Two additional clinical sites are undergoing IRB approvals and are expected to be active in the third quarter of this year.

Aptose and its collaborators have submitted two abstracts for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") Meeting, planned for December 5-8th, 2015 in Orlando, Florida. Aptose’s collaborator, Oregon Health and Sciences University ("OHSU"), as part of the Beat AML Initiative, has submitted an abstract evaluating the efficacy of APTO-253 as a single agent and in combination with other agents in primary cells from patients with various hematologic malignancies, including AML, myelodysplastic syndromes (MDS), chronic myelogenous leukemia (CML) and chronic lymphocytic leukemia (CLL). Additionally, Aptose has submitted an abstract on the preclinical pharmacology and clinical pharmacokinetics of APTO-253. Aptose believes that such data provide a rationale for the expectation of potential single agent efficacy against AML in the clinical setting.
Financial Results

Net loss for the three months ended June 30, 2015 was $3.4 million ($0.28 per share) compared with $4.2 million ($0.49 per share) during the three months ended May 31, 2014. Net loss for the six months ended June 30, 2015 was $6.9 million ($0.59 per share) compared with $6.7 million ($0.97 per share) during the six months ended May 31, 2014.

The decrease in net loss during the three months ended June 30, 2015 in comparison to the three months ended May 31, 2014 is due to lower general and administrative costs resulting from lower legal and patent costs, lower Board fees and severance costs incurred in the prior year related to our former President and COO, as well as increased finance income in the current year quarter related to a gain on US dollar cash balances during the period. These decreases were partially offset by higher research and development costs in the current year associated with increased clinical activity on APTO-253 and associated activities.

The increase in net loss during the six months ended June 30, 2015 compared with the six-month period ended May 31, 2014 is due to higher research and development activities associated with the development of APTO-253, as well as higher general and administrative costs related to higher stock based compensation expense, our NASDAQ listing and related expenses and clean-up and moving costs related to the Toronto office and lab relocation. These increases in expenditures were partially offset by increased finance income associated with foreign currency gains on our US dollar cash balances.

Aptose utilized cash of $4.3 million in its operating activities in three-month period ended June 30, 2015 compared with $3.9 million during the three months ended May 31, 2014. For the six months ended June 30, 2015 we utilized cash of $6.5 million compared with $6.1 million in the six months ended May 31, 2014. The cash utilized in the three-month period is higher than the three months ended May 31, 2014 despite a lower net loss due to cash used to reduce accounts payable and accrual balances in the current year period.

At June 30, 2015, the Company had cash and cash equivalents and investments of $25.2 million compared to $30.5 million at December 31, 2014.

Research and Development

Research and development expenses totaled $1.3 million in the three months ended June 30, 2015 compared to $1.0 million during the three months ended May 31, 2014 and totaled $2.2 million for the six- month period ended June 30, 2015 compared with $1.6 million in the six months ended May 31, 2014. Research and development costs consist of the following:

Components of research and development expenses:

Research and development costs in the three months ended June 30, 2015 increased compared with the three months ended May 31, 2014 primarily due to increased APTO-253 development costs including the ongoing Phase 1b clinical trial of APTO-253 in the current year period compared with no ongoing clinical development in the prior year period. In addition we have initiated studies to optimize the formulation of APTO-253 for which no comparable work was ongoing in the prior year period. Increased program expenditures were partially offset by no severance costs in the three months ended June 30, 2015 compared with $326 thousand in the three months ended May 31, 2014 related to severance payments made to our former President and COO. There were no deferred share units outstanding in the three months ended June 30, 2015 compared with a reduction in the fair value of units outstanding in the three months ended May 31, 2014.

The increase in research and development costs during the six months ended June 30, 2015 is the result of increased APTO-253 development costs primarily related to the ongoing Phase 1b clinical trial and associated activities including formulation studies and research support. Increased program expenditures were offset by no severance costs in the six months ended June 30, 2015 compared with $326 thousand in the six months ended May 31, 2014 related to severance payments made to our former President and COO.

Aptose anticipates an increase in research and development costs in the second half of 2015 due to the continuation of our Phase 1b clinical trial.

General and Administrative

General and administrative expenses totaled $2.5 million in the three-month period ended June 30, 2015 compared to $3.2 million in the three months ended May 31, 2014. For the six-month period ended June 30, 2015, general and administrative expenses were $5.2 million compared with $4.9 million in the six months ended May 31, 2014. General and administrative expenses consist of the following:

Components of general and administrative expenses:

General and administrative expenses excluding salaries decreased in the three months ended June 30, 2015 compared with the three months ended May 31, 2014. The decrease over the prior year is attributable to lower legal and patent costs and lower Board fees due to a change in annual payment structure.

General and administrative expenses excluding salaries increased in the six months ended June 30, 2015 compared with the six months ended May 31, 2014. The decreases incurred in the three months ended June 30, 2015 were partially offset by higher expenses in the three months ended March 31, 2015 related to our NASDAQ listing and related expenses and clean-up and moving costs related to the Toronto office and lab relocation.

Salary charges in the three and six months ended June 30, 2015 were consistent with the three- and six- month periods ended May 31, 2014 as staffing levels were consistent year over year.

Severance costs were incurred in the three and six months ended May 31, 2014 as our former President and COO left in March 2014. There are no ongoing costs related to the severance payments.

Stock-based compensation costs increased in both the three and six months ended June 30, 2015 compared with the three month and six months ended May 31, 2014 due to large option grants in April, June and July 2014 which vest 50% during the first year and therefore contribute to higher stock-based compensation expense during the first twelve month period.

Deferred share unit costs relate to the market to market adjustment on units which were settled in April 2014. There were no deferred share units outstanding in the six-month period ending June 30, 2015.

Endocyte Reports Second Quarter 2015 Financial Results and Provides Update on Clinical Progress

On August 4, 2015 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported financial results for the second quarter ending June 30, 2015, and provided a clinical update (Press release, Endocyte, AUG 4, 2015, View Source [SID:1234506999]).

"We are pleased with our continued success in escalating the dose of our folate and PSMA-targeted tubulysin SMDCs," said Ron Ellis, Endocyte’s president and chief executive officer. "Increasing the activity of our agents through higher doses and the use of a more potent drug payload were two key elements of our second generation SMDC strategy. We also continue to hone our patient selection process through refining our use of imaging agents to define targeted patients. We believe that all of these adjustments will increase the likelihood of success as we expand our trials for EC1456 and EC1169, once we determine the maximum tolerated dose."

"We were also pleased to announce today the appointment of Alison Armour, M.D. to the position of Chief Medical Officer," added Mr. Ellis. "Alison strengthens the team at Endocyte with her tremendous experience in both clinical practice and oncology drug development. Her leadership has been directly responsible for the regulatory approval of oncology therapies in the United States and international markets. We are very excited to engage her in the development of our pipeline of SMDCs and diagnostic imaging agents." Dr. Armour was most recently the VP of Oncology at Novartis and GSK.

The Company also announced that the final overall survival results from the Phase 2 TARGET trial of EC145 in NSCLC have been accepted for oral presentation at the IASLC World Conference on Lung Cancer to be held in Denver from September 6-9, 2015. While development efforts have focused on the second generation SMDCs, results of this trial provide insights into the effectiveness of the SMDC platform, particularly in targeting the folate receptor.

Second Quarter 2015 Financial Results

Endocyte reported a net loss of $10.6 million, or $0.25 per basic and diluted share, for the second quarter of 2015, compared to net income of $22.4 million, or $0.54 per basic share and $0.52 per diluted share, for the same period in 2014. The second quarter of 2014 included the recognition of the balance of deferred revenue related to the former collaboration with Merck.

Research and development expenses were $6.7 million for the second quarter of 2015, compared to $19.0 million for the same period in 2014. The decrease in research and development expense was primarily attributable to a decrease in expenses related to the TARGET trial, which is now completed, and the PROCEED trial, which was terminated in May 2014 and for which a termination charge of $4.7 million was recorded in the second quarter of 2014, along with a decrease in manufacturing expenses for vintafolide and etarfolatide related to pre-commercial activity.

General and administrative expenses were $4.1 million for the second quarter of 2015, compared to $8.0 million for the same period in 2014. The decrease in expenses was primarily attributable to a reduction in headcount and ceasing all commercial activities during the second quarter of 2014 following the withdrawal of the marketing applications in Europe.

Cash, cash equivalents and investments were $188.6 million at June 30, 2015, compared to $219.2 million at June 30, 2014, and $206.8 million at December 31, 2014.

Financial Expectations

The Company reiterated its expectation that its 2015 year-end cash balance will exceed $155 million. Spending is expected to increase from current levels as the trials for EC1456 and EC1169 are expanded once the maximum tolerated doses are determined.

Pfizer Receives Approval From European Commission For Pending Acquisition Of Hospira

On August 4, 2015 Pfizer Inc. (NYSE: PFE) reported that the European Commission (EC) has approved under the European Union (EU) Merger Regulation the company’s pending acquisition of Hospira, Inc. (NYSE: HSP) (Press release, Pfizer, AUG 4, 2015, View Source [SID:1234506997]). The Commission’s decision includes Pfizer’s commitment to divest certain assets.

"We are pleased to have achieved a significant milestone for Pfizer’s pending acquisition of Hospira with the EC’s approval of the transaction," said Ian Read, chairman and chief executive officer, Pfizer. "We continue to work cooperatively with the regulatory agencies to obtain the requisite approvals, and continue to expect the transaction to close in the second half of 2015."

Completion of the transaction remains subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, governmental and regulatory approvals in certain other jurisdictions and other usual and customary closing conditions.

Progenics Pharmaceuticals Announces Exclusive Worldwide Licensing Agreement With Johns Hopkins University for Agent to Image Prostate Cancer Using PET Scan

On August 4, 2015 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported that it has entered into an exclusive worldwide licensing agreement with Johns Hopkins University for [18F]DCFPyL ("PyL"), a clinical-stage prostate specific membrane antigen (PSMA)-targeted imaging agent for prostate cancer (Press release, Progenics Pharmaceuticals, AUG 4, 2015, View Source [SID:1234506994]). PyL, when used in conjunction with high-resolution PET imaging, has shown potential for use in identifying prostate cancer and sites of relapse. Financial terms of the transaction were not disclosed.

PyL was developed by a team led by Martin G. Pomper, M.D., Ph.D. at the Johns Hopkins University School of Medicine. An early stage clinical trial of PyL with PET imaging in men with prostate cancer demonstrated uptake of PyL in sites of putative metastatic disease and primary tumors not seen with currently approved imaging techniques, suggesting the potential for high sensitivity and specificity in detecting prostate cancer.

"PSMA-targeted imaging agents have the potential to change how prostate cancer is diagnosed, monitored and treated and have the potential to lead to better outcomes for patients," said Mark Baker, CEO. "Based on studies conducted by Dr. Pomper’s team, PyL, a PET imaging agent, has demonstrated the potential to detect even minimal levels of prostate cancer which will complement our SPECT/CT imaging agent 1404, currently in development. We are excited about the opportunity to advance the development of PyL."

PyL complements Progenics’ existing portfolio of candidates for the detection and treatment of prostate cancer, including 1404, the Company’s lead PSMA-targeted imaging agent that is used in conjunction with widely-available SPECT-CT imaging. Progenics intends to initiate a Phase 3 program for 1404 for initial diagnosis and early monitoring applications, while initially focusing the development of PyL with high resolution PET imaging to detect and localize recurrent disease in patients who have experienced a biochemical relapse.

About PyL for PET Imaging of Prostate Cancer

PyL (also known as [18F]DCFPyL) is a clinical-stage, fluorinated PSMA-targeted PET imaging agent for prostate cancer that was discovered and developed at the Center for Translational Molecular Imaging at the Johns Hopkins University School of Medicine. A proof-of-concept study published in the April 2015 issue of the Journal of Molecular Imaging and Biology demonstrated that PET imaging with PyL showed high levels of PyL uptake in sites of putative metastatic disease and primary tumors, suggesting the potential for high sensitivity and specificity in detecting prostate cancer.

About 1404, an Imaging Compound Targeting Prostate Specific Membrane Antigen

Progenics’ molecular imaging radiopharmaceutical product candidate 1404 targets the extracellular domain of prostate specific membrane antigen (PSMA), a protein amplified on the surface of > 95% of prostate cancer cells and a validated target for the detection of primary and metastatic prostate cancer. 1404 is labeled with technetium-99m, a gamma-emitting isotope that is widely available, is easy to prepare, and is attractive for nuclear medicine imaging applications. The image created provides the opportunity to visualize cancer, potentially allowing for improved detection and staging, more precise biopsies, and a targeted treatment plan including active surveillance as a disease management tool.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in seven men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that approximately 220,800 new cases of prostate cancer will be diagnosed and about 27,540 men will die of the disease and that approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.

Momenta Pharmaceuticals Reports Second Quarter 2015 Financial Results

On August 04, 2015 Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today reported its financial results for the second quarter ended June 30, 2015 (Press release, Momenta Pharmaceuticals, AUG 4, 2015, View Source [SID:1234506993]).

For the second quarter of 2015, the Company reported total revenues of $44.9 million, consisting primarily of product and milestone revenues relating to the approval and launch of GlatopaTM (glatiramer acetate injection). Momenta reported a net loss of $(2.2) million, or $(0.04) per share for the second quarter compared to a net loss of $(26.2) million, or $(0.51) per share for the same period in 2014. At June 30, 2015, the Company had cash, cash equivalents, and marketable securities of $377.2 million.

"Momenta reached a significant milestone in the second quarter of 2015 with the launch of Glatopa, our second approved complex generic product and the first and only generic version of daily COPAXONE available on the market. We are pleased with Sandoz’s execution of the Glatopa launch and encouraged by the strong initial uptake seen thus far," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "In the second quarter, we also strengthened our balance sheet through a successful equity financing laying the groundwork for the growth and advancement of our biosimilars and novel drug pipelines."

Second Quarter Highlights and Recent Events

Complex Generics:

GlatopaTM, generic version of daily COPAXONE 20 mg (glatiramer acetate injection)

On April 16, 2015, Glatopa was approved by the FDA as the first and only "AP-rated," substitutable generic version of daily COPAXONE 20 mg.

On June 18, 2015, the U.S. Court of Appeals for the Federal Circuit (CAFC) again found the remaining patent on daily COPAXONE 20 mg at issue in Teva’s infringement suit to be invalid.

Sandoz launched Glatopa on June 18, 2015. In the second quarter of 2015, Momenta recorded $19.2 million in product revenues from Glatopa sales, net of a deduction of $9.0 million for reimbursement to Sandoz of the Company’s share of pre-launch Glatopa-related legal expenses.

Under its collaboration agreement with Sandoz, Momenta earned a $10.0 million milestone payment upon Glatopa receiving sole FDA approval and an additional $10.0 million milestone payment upon first commercial sale of Glatopa.
The ANDA for a three-times-a-week generic COPAXONE 40 mg (glatiramer acetate injection), submitted by Sandoz in August 2014, is under FDA review.

Enoxaparin Sodium Injection

In June 2015, the Company and Sandoz amended their enoxaparin collaboration agreement replacing the royalty payment with a 50% profit share. The amendment was effective April 1, 2015. In the second quarter of 2015, Momenta earned $0.1 million in product revenues from enoxaparin sales.

The Company continues to pursue the patent infringement case related to Momenta’s U.S. Pat. 7,575,886 against Amphastar and Teva. In a 2012 decision, the CAFC vacated a preliminary injunction based on the Hatch Waxman "safe harbor" (Momenta Pharmaceuticals vs. Amphastar Pharmaceuticals, Inc. Fed. Cir. Aug. 3, 2012). On May 4, 2015, the CAFC held a hearing on the Company’s appeal of summary judgment, and requested the views of the U.S. Solicitor General on the government’s interpretation of the safe harbor provision. On July 13, 2015, the U.S. Solicitor General filed its brief providing support of Momenta’s interpretation of the "safe harbor". A CAFC decision is expected in 2015.

Biosimilars:

M923, a biosimilar version of HUMIRA (adalimumab), is currently being studied in a randomized, double-blind, single-dose study in healthy volunteers to compare its pharmacokinetics, safety, tolerability and immunogenicity versus HUMIRA. Momenta and Baxalta (formerly Baxter) expect to have data from this study in the fourth quarter of 2015. The target date for the first regulatory submission for approval is 2017.

Momenta continues to develop M834, a biosimilar version of ORENCIA (abatacept), and its portfolio of other biosimilar candidates and is in active discussions with potential collaboration partners to assist in their development and commercialization.
On July 2, 2015, Momenta filed a petition for Inter Partes Review (IPR) with the Patent Trial and Appeal Board to challenge the validity of Bristol Myers Squibb’s ORENCIA subcutaneous formulation U.S. Pat. 8,476,239. The Company expects a decision on institution of the IPR in January 2016.

Novel Drug:

Necuparanib (novel oncology candidate)

Momenta’s Phase 2 trial to evaluate the antitumor activity of necuparanib in combination with Abraxane (nab-paclitaxel) plus gemcitabine, versus Abraxane plus gemcitabine alone, is currently enrolling. The Company expects to have clinical data available in the first half of 2017.
Momenta presented updated data from its Phase 1 study evaluating necuparanib in combination with Abraxane and gemcitabine in patients with metastatic pancreatic cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting on June 1, 2015. Necuparanib showed acceptable safety, tolerability, and encouraging signals of activity in the updated Phase 1 dataset.

Autoimmune Drugs

Momenta’s three novel autoimmune candidates are in preclinical development. These candidates include a hyper-sialylated IVIg (hsIVIg), a high potency alternative to IVIg, and two recombinant molecules: M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. The Company is advancing the recombinant candidates with a goal of entering the clinic in late 2016, and is continuing its efforts to identify and explore potential partnering opportunities for the further development and commercialization of its hsIVIg program.

Second Quarter 2015 Financial Results

Total revenues for the second quarter of 2015 were $44.9 million compared to $11.0 million for the same period in 2014. Total revenues for the second quarter of 2015 include $19.2 million in product revenue, which represents 50% of contractual profit earned from net sales of Glatopa by Sandoz, net of a deduction of $9.0 million in reimbursement to Sandoz of the Company’s share of pre-launch Glatopa-related legal expenses.

Enoxaparin product revenue for the second quarter of 2015 was $0.1 million compared to $5.7 million in the same period in 2014. The decrease in enoxaparin product revenue was primarily due to the amendment of the enoxaparin sodium injection collaboration agreement in June 2015 which replaced Sandoz’ obligation to pay the Company a royalty on net sales with an obligation to pay 50% of profit on sales. The amendment became effective for the second quarter of 2015.

Collaborative research and development revenue for the second quarter of 2015 was $25.6 million, compared to the $5.3 million recorded in the same quarter last year. In the second quarter of 2015 the Company earned $20.0 million in milestone payments under the Sandoz collaboration upon receiving sole FDA approval and upon first commercial sale of Glatopa.

Research and development expenses for the second quarter of 2015 were $34.0 million, compared to $26.1 million for the same period in 2014. The increase of $7.9 million, or 30%, from the 2014 period primarily resulted from increases of: $2.2 million in third-party process development costs for the biosimilars programs; $2.0 million in preclinical and manufacturing expenditures to advance the novel autoimmune programs; $1.6 million in clinical trial expenses as the necuparanib Phase 2 clinical trial continued to enroll patients; and $1.4 million in share-based compensation expense associated with performance-based stock awards.

General and administrative expenses for the quarter ended June 30, 2015, were $13.3 million, compared with $11.2 million for the same period in 2014. The increase of $2.1 million, or 19%, from the 2014 was primarily due to an increase of $1.5 million in share-based compensation expenses associated with performance based stock awards.

At June 30, 2015, Momenta had $377.2 million in cash, cash equivalents and marketable securities. This cash position excludes restricted cash of $20.7 million, of which $17.5 million is reserved as collateral for a security bond related to enoxaparin legal proceedings, and $3.2 million for letters of credit related to the company’s two leased facilities.

In May 2015, the Company sold an aggregate of 8,337,500 shares of common stock through an underwritten public offering at a price to the public of $19.00 per share. Momenta received net proceeds of $148.4 million, after deducting underwriting discounts and commissions and customary offering expenses.

In April 2015, the Company concluded sales of its common stock under its May 2014 "At the Market" (ATM) Equity Offering Sales Agreement with Stifel, Nicolaus & Company. In the second quarter of 2015, the Company recorded net proceeds of $21.5 million from the sale of 1.4 million shares of common stock sold through the ATM.

Also in April 2015, Momenta entered into a second ATM agreement with Stifel under which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $75 million. In the second quarter of 2015, the Company recorded net proceeds of $9.3 million from the sale of 0.5 million shares of common stock sold through the 2015 ATM.

Financial Guidance

Today, Momenta provided guidance that it expects its operating expenses, excluding stock-based compensation and net of collaborative revenues, to be approximately $36 – $40 million per quarter for the second half of 2015.