AstraZeneca provides update on Phase III trial of Selumetinib in non-small cell lung cancer

On August 9, 2016 AstraZeneca reported results from the Phase III SELECT-1 trial of the MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment in patients with KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, AstraZeneca, AUG 9, 2016, View Source [SID:1234514372]).

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The results showed that the trial did not meet its primary endpoint of progression-free survival (PFS), and selumetinib did not have a significant effect on overall survival (OS). The adverse event profiles for selumetinib and docetaxel were consistent with those seen previously.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "A randomised Phase II trial showed promising activity of selumetinib in combination with docetaxel in patients with KRAS mutation-positive lung cancer. It is disappointing for patients that these results have not been confirmed in Phase III. We expect to present data at a forthcoming medical meeting. We remain committed to further developing treatments in the lung cancer setting, such as our immunotherapy combinations and targeted EGFR treatments."

SELECT-1 is an international trial with 510 randomised patients in over 200 centres. Patients received either selumetinib (75mg, orally, twice daily) or placebo in combination with docetaxel (intravenously, 75mg/m2, on day one of every 21-day cycle).

Selumetinib is being explored as a treatment option in registration-enabling studies in patients with differentiated thyroid cancer where the treatment received Orphan Drug Designation, and patients with neurofibromatosis type 1, a genetic disorder that causes tumours to grow along nerve tissue.1

About KRASm non-small cell lung cancer
KRAS is one of the most common genetic mutations in NSCLC, and is found in 30% of patients.2 Adenocarcinomas make up the majority of cases with KRAS mutations, which are less common in squamous cell NSCLC.2,3

KRAS mutations are associated with activation of the RAS-ERK signalling pathway, which drives tumour growth.3

About selumetinib (AZD6244, ARRY-142886)
Selumetinib is an oral, potent and highly selective MEK 1/2 inhibitor. MEK 1/2 are critical components of the RAS-ERK pathway, activation of which is implicated in driving cancer growth and progression, including in patients with KRASm NSCLC.4,5

AstraZeneca acquired exclusive worldwide rights to selumetinib from Array BioPharma Inc. (NASDAQ: ARRY) in 2003.

In May 2016, selumetinib was granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC), and AstraZeneca is committed to exploring its full potential, including in Phase III trials in patients with DTC and in a US National Cancer Institute-sponsored Phase II registration trial in patients with paediatric neurofibromatosis type 1.

About SELECT-1
SELECT-1 (NCT01933932) is a Phase III, double-blind, randomised, placebo-controlled trial. It is designed to assess the efficacy and safety of selumetinib (75 mg twice daily, given orally on a continuous schedule) in combination with docetaxel (75 mg/m2 intravenously on day 1 of every 21-day cycle), compared with matched placebo in combination with docetaxel (same schedule) in 510 patients receiving 2nd-line treatment for KRASm locally advanced or metastatic NSCLC (stage IIIB-IV), confirmed by central testing of tumour tissue using the cobas KRAS Mutation Test (Roche Molecular Systems).3

The primary endpoint is PFS, and secondary endpoints include OS, objective response rate (ORR), duration of response (DoR), and safety and tolerability.3

Q2 2016 Financial Report

On August 9, 2016 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a clinical-stage biomedicine firm engaged in the development of immunotherapies for cancer and effective stem cell therapies for degenerative diseases, reported financial results and business highlights for the second quarter and six months ended June 30, 2016 (Press release, Cellular Biomedicine Group, AUG 9, 2016, View Source [SID:1234514395]).

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"In the first half of 2016, we made several significant advancements towards the operating objectives for our dual technology platforms of immuno-oncology and stem cells," commented Tony (Bizuo) Liu, CBMG’s Chief Executive Officer. "The completion of a $43.13 million strategic investment has strengthened our capabilities to continue to invest in research and development, optimize our clinical process and expand our focus on the CAR-T pipeline. We anticipate in the coming quarters launching clinical trials in China on CAR-T CD19 and CD20 constructs and to further bolster our immuno-oncology pipeline. We have completed patient treatment in the Phase I trial of AlloJoinTM, our off-the-shelf allogeneic adipose-derived progenitor cell (haMPC) therapy for Knee Osteoarthritis (KOA) in China, and are encouraged to see no serious adverse events thus far. We continue to evaluate the feasibility of initiating a clinical study of AlloJoinTM under IND to support the same indication in the United States. As we look forward to the remainder of 2016, we will continue to prioritize our immuno-oncology and stem cell clinical pipelines for multiple indications that serve large addressable markets while facilitating future partnerships and collaborations that will enhance our ability to develop safe and effective therapies."

Second Quarter and First Half 2016 Financial Performance

1. Cash Position:Cash and cash equivalents as of June 30, 2016 were $47.5 million compared to $14.9 million as of December 31, 2015. This increase was due to a private placement financing in February and April 2016 for gross proceeds of approximately $43 million, offset by cash used in operating and investment activities.
2. Net Cash Used in Operating Activities:Net cash used in operating activities for the quarter and six months ended June 30, 2016 was $5.2 million and $8.8 million, respectively, compared to $3.3 million and $5.7 million for the same periods in 2015.
3. G&A Expenses: General and administrative expenses for the quarter and six months ended June 30, 2016 were $3.1 million and $5.8 million, respectively, compared to $3.8 million and $6.4 million for the same periods in 2015.
4. R&D Expenses: Research and development expenses for the quarter and six months ended June 30, 2016 were $3 million and $5.4 million respectively, compared to $1.3 million and $2.8 million for the same periods in 2015.
5. Net Loss:Net loss allocable to common stock holders for the quarter and six months ended June 30, 2016 was $7.2 million and $11.4 million respectively, compared to $5 million and $9.3 million for the same periods in 2015.

Recent Business and Technology Highlights

Completed treatment for eighteen patients in Phase I trial of AlloJoinTM haMPC therapy for Knee Osteoarthritis (KOA);
China Patent Office granted the Company’s patent application on genetically engineered anti-CD20 Chimeric Antigen Receptor-positive NKT cells, its production and application;
Advanced the Company’s cash position following the closing of an agreement with Wuhan Dangdai Science & Technology Industries Group Inc. to invest an aggregate of $43.13 million for 2.27 million shares of the Company’s common stock, representing a 16.2% post-money stake investment as of April 15, 2016;
Appointment of Dr. Zhou Hansheng as a member of the Board of Directors.
Pipeline Update

Conducted single-center Phase I trial of AlloJoinTM haMPC therapy for Knee Osteoarthritis (KOA) in China
Eighteen patients have received two dose intra-articular injections at three week intervals and have not been presented with any serious adverse events thus far
Patients will be monitored over the next 12 months for safety and efficacy signs
Phase I clinical research trial for AlloJoin is registered at ClinicalTrials.gov under the number NCT02641860
Anticipate announcement of sponsorship of multi-indication clinical studies with multiple institutions using CBMG’s CD19 and CD20 constructs and stem cell technologies by Q12017 after the technologies are optimized and manufacturing capabilities are in place
About Cellular Biomedicine Group

Provectus Biopharmaceuticals, Inc. Reports Second Quarter 2016 Financial Results

On August 10, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported its financial results for the quarter ended June 30, 2016 (Press release, Provectus Pharmaceuticals, AUG 9, 2016, View Source [SID:1234514452]).

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Second Quarter Results and Balance Sheet Highlights

Our cash and cash equivalents were $4,891,313 at June 30, 2016, compared with $9,760,997 at March 31, 2016.

Shareholders’ equity at June 30, 2016 was $9,140,166. This compares to shareholders’ equity of $14,184,248 at March 31, 2016.

For additional information regarding Provectus’ results of operations and financial condition for the second quarter ended June 30, 2016, please see Provectus’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2016.

Management will host its 2016 second quarter business update conference call on Wednesday, August 10, 2016 at 4 pm Eastern Daylight Time. Management will provide a business update on PV-10 and PH-10 to the investment community and answer questions from investors.

Those who wish to participate in the conference call may telephone 877-407-4019 from the U.S. International callers may telephone 201-689-8337 approximately fifteen minutes before the call. A webcast will also be available at www.provectusbio.com.

A digital replay will be available by telephone approximately two hours after the completion of the call until November 30, 2016 and may be accessed by dialing 877-660-6853 from the U.S. or 201-612-7415 for international callers, and using the Conference ID # 13641484.

QLT Announces Second Quarter 2016 Results

On August 9, 2016 QLT Inc. (NASDAQ:QLTI) (TSX:QLT) ("QLT" or the "Company") reported financial results today for the second quarter ended June 30, 2016 (Press release, QLT, AUG 9, 2016, View Source;p=RssLanding&cat=news&id=2194329 [SID:1234514572]). Unless otherwise specified, all amounts are reported in U.S. dollars and in accordance with U.S. GAAP.

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2016 SECOND QUARTER FINANCIAL RESULTS

Operating Expenses/Income

During the second quarter of 2016, research and development ("R&D") expenditures were $2.9 million compared to $3.4 million for the same period in 2015. The $0.5 million (15%) decrease was primarily due to lower stock based compensation, lower salary and overhead costs related to R&D headcount attrition, the foreign exchange impact of the weak Canadian dollar and downsizing of our lease space. Stock-based compensation expense was significantly lower in the current period relative to the prior period due to the impact of the June 2015 accelerated vesting of all outstanding stock options in connection with the investment in and subsequent distribution of the Aralez Shares (defined below) and execution of the InSite Merger Agreement (defined below). The cost decreases described above were partially offset by an increase in costs related to preparatory activities for our planned Phase III pivotal trial for QLT091001.

During the second quarter of 2016, we incurred $3.2 million of consulting and advisory fees related to our exploration of strategic alternatives and pursuit of the merger transaction with Aegerion Pharmaceuticals, Inc. ("Aegerion") described below. In comparison, we incurred $4.7 million of similar costs in 2015 related to our pursuit of a merger transaction with InSite Vision Incorporated ("InSite") and the Aralez Distribution (defined below). The agreement and plan of merger with InSite (the "InSite Merger Agreement") was terminated by InSite on September 15, 2015.

Excluding the strategic consulting and advisory fees discussed above, during the second quarter of 2016, selling, general and administrative ("SG&A") expenditures were $1.3 million compared to $2.4 million for the same period in 2015. The $1.1 million (46%) decrease was primarily related to lower stock-based compensation expense during the period due to the accelerated vesting described above, lower fees paid for director compensation and lower general operating costs related to the downsizing of our lease space. These costs savings were partially offset by a lower amount of overhead being allocated to R&D expense due to R&D headcount attrition.

Other Expenses/Income

On April 5, 2016, QLT effected a distribution of 4,799,619 common shares (the "Aralez Shares") of Aralez Pharmaceuticals Inc. ("Aralez"), which had a fair value of $19.3 million, and $15.0 million of cash to its shareholders of record as of February 16, 2016 (the "Aralez Distribution").

During the three and six months ended June 30, 2016, QLT recognized a $2.3 million fair value gain and $10.7 million fair value loss, respectively, related to the change in the value of the Aralez Shares held by QLT from the February 5, 2016 acquisition date to the April 5, 2016 distribution date.

Operating Loss and Net Loss per Share

The operating loss for the second quarter of 2016 was $7.4 million, compared to $10.7 million for the same period in 2015. As described above under "Operating Expenses/Income", the net $3.3 million change in our operating loss was primarily due to lower strategic consulting and advisory fees, significantly lower stock-based compensation expense and lower overhead costs.

Net loss per common share was $0.10 in the second quarter of 2016, compared to a net loss per common share of $0.21 for the same quarter in 2015. The change in our loss per common share was primarily due to the same factors described above.

Cash and Cash Equivalents

As at June 30, 2016, the Company’s consolidated cash and cash equivalents were $79.9 million compared to $141.8 million at December 31, 2015. The $61.9 million decrease was primarily due to: (i) the $45.0 million investment in Aralez, which was subsequently distributed to QLT’s shareholders via the Aralez Distribution described above, (ii) $5.4 million of strategic consulting and advisory fees related to the Aralez Distribution, the proposed Merger (as defined below) with Aegerion, and exploration of other strategic alternatives, (iii) $3.0 million advanced to Aegerion pursuant to the terms of the Loan Agreement (defined below) with Aegerion, and (iv) cash used in operating activities during the period.

Passive Foreign Investment Company

The Company believes that it was classified as a Passive Foreign Investment Company ("PFIC") for 2008 through 2015, and that it may be classified as a PFIC in 2016, which could have adverse tax consequences for U.S. shareholders. Please refer to our 2015 Annual Report on Form 10-K (as amended by the Form 10-K/A filed on April 29, 2016) for additional information.

Strategic Transactions

On June 14, 2016, QLT and Aegerion entered into an agreement and plan of merger (the "Merger Agreement") pursuant to which a wholly owned indirect subsidiary of QLT will be merged with and into Aegerion, with Aegerion surviving as a wholly owned indirect subsidiary of QLT (the "Merger"). On the closing of the Merger, each outstanding share of Aegerion common stock will be exchanged for 1.0256 (the "Exchange Ratio") QLT common shares, subject to potential downward adjustment in the event either the DOJ/SEC Investigations (as defined below) or the Class Action Lawsuit (as defined below) are settled for amounts in excess of the Negotiated Thresholds (as defined below) prior to the closing of the Merger. The Merger is currently expected to close before the end of 2016 and is subject to various closing conditions, including receipt of the approvals of the QLT and Aegerion shareholders.

If Aegerion does not settle either its Department of Justice or Securities and Exchange Commission investigations (the "DOJ/SEC Investigations") or its pending shareholder class action lawsuit (the "Class Action Lawsuit") prior to the closing of the Merger, QLT shareholders will receive warrants (the "Warrants"), which will become exercisable to purchase a certain number of QLT common shares for a purchase price of $0.01 in the event that (i) the DOJ/SEC Investigations are resolved for amounts in excess of $40 million, or (ii) the Class Action Lawsuit is settled for an amount that exceeds the amount, if any, available under Aegerion’s insurance coverage (the $40 million in respect of the DOJ/SEC Investigations and the available insurance coverage in respect of the Class Action Lawsuit being the "Negotiated Thresholds").

QLT plans to change its name upon closing of the Merger to Novelion Therapeutics Inc. ("Novelion") and its common shares will continue to trade on the NASDAQ Global Select Market and the Toronto Stock Exchange. Assuming no adjustment to the Exchange Ratio, QLT shareholders, including the Investors in the Private Placement (as defined and described below), are expected to own approximately 67% of the outstanding Novelion common shares following the Merger.

Concurrent with signing the Merger Agreement, QLT and Aegerion entered into a loan and security agreement (the "Loan Agreement") under which QLT has agreed to provide Aegerion with a term loan facility to support working capital needs for an aggregate principal amount not to exceed $15 million, subject to various terms and conditions. As at August 8, 2016, $3.0 million is outstanding under the Loan Agreement.

On June 14, 2016, QLT entered into a unit subscription agreement (the "Unit Subscription Agreement’) with certain investors party thereto (the "Investors") pursuant to which QLT will issue units to such investors for an aggregate subscription price of $21.8 million (the "Private Placement"). Each unit consists of one QLT common share and one Warrant, as described above. The Private Placement, which is contemplated to occur immediately prior to, and is conditional on the closing of, the Merger, is intended to provide QLT with additional capital to support future operations and business development initiatives. The completion of at least $17.5 million of the Private Placement is a condition to the closing of the Merger.

QLT Inc. – Financial Highlights
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands of U.S. dollars except share and per share information)
Three months ended Six months ended
June 30, June 30,
2016 2015 2016 2015

Expenses
Research and development $ 2,929 $ 3,404 $ 5,919 $ 5,612
Selling, general and administrative 4,451 7,154 10,349 10,773
Depreciation 23 179 61 367
7,403 10,737 16,329 16,752
Operating loss (7,403 ) (10,737 ) (16,329 ) (16,752 )
Other (expense) income
Net foreign exchange (losses) gains (31 ) (60 ) (108 ) 38
Interest income 54 51 129 83
Fair value gain (loss) on investment 2,256 – (10,704 ) –
Other 9 – 9 (2 )
2,288 (9 ) (10,674 ) 119
Loss before income taxes (5,115 ) (10,746 ) (27,003 ) (16,633 )
Provision for income taxes (5 ) (5 ) (11 ) (14 )
Net loss and comprehensive loss $ (5,120 ) $ (10,751 ) $ (27,014 ) $ (16,647 )

Basic and diluted net loss per common share
Net loss per common share $ (0.10 ) $ (0.21 ) $ (0.51 ) $ (0.32 )

Weighted average number of common shares outstanding (thousands)
Basic and diluted 52,829 51,779 52,829 51,508

CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands of U.S. dollars) June 30, 2016 December 31, 2015
ASSETS
Current assets
Cash and cash equivalents $ 79,943 $ 141,824
Accounts receivable, net of allowances for doubtful accounts 359 287
Loan receivable 3,011 -
Income taxes receivable 14 14
Prepaid and other assets 668 611
Total current assets 83,995 142,736
Accounts receivable 2,000 2,000
Property, plant and equipment 467 430
Total assets $ 86,462 $ 145,166
LIABILITIES
Current liabilities
Accounts payable $ 5,219 $ 1,656
Accrued liabilities 800 1,827
Total current liabilities 6,019 3,483
Uncertain tax position liabilities 376 342
Total liabilities 6,395 3,825
SHAREHOLDERS’ EQUITY
Share capital
Authorized
500,000,000 common shares without par value
5,000,000 first preference shares without par value, issuable in series
Issued and outstanding common shares $ 475,333 $ 475,333
June 30, 2016 – 52,829,398 shares
December 31, 2015 – 52,829,398 shares
Additional paid-in capital 63,117 97,377
Accumulated deficit (561,352 ) (534,338 )
Accumulated other comprehensive income 102,969 102,969
Total shareholders’ equity 80,067 141,341
Total shareholders’ equity and liabilities $ 86,462 $ 145,166

Cellectar Biosciences Announces $2 Million NCI SBIR Contract for a Phase 2 Clinical Study

On August 3, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) ("the company"), an oncology-focused biotechnology company, reported that it has received the second phase of a National Cancer Institute ("NCI") Fast-Track Small Business Innovation Research ("SBIR") contract award in the amount of $2 million to support funding of a Phase 2 clinical study of the company’s lead product candidate, CLR 131, for the potential treatment of hematologic malignancies, including multiple myeloma (Filing, 8-K, Cellectar Biosciences, AUG 9, 2016, View Source [SID:1234514436]).

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"The NCI SBIR contract is important to Cellectar in a variety of ways, ranging from the opportunity to receive non-dilutive funding that will significantly support a Phase 2 clinical study of our lead product candidate, CLR 131, to further advance our understanding of the potential clinical utility of CLR 131 in additional hematologic malignancies with high unmet medical needs, as well as providing further validation of the benefits of our Phospholipid Drug Conjugate (PDC) development program, " said Jim Caruso, president and CEO of Cellectar Biosciences. "Previous studies have demonstrated that hematologic malignancies are highly sensitive to radiotherapeutics. We anticipate observing the unique clinical benefits iodine–131, a cytotoxic radioisotope, may provide in combination with our cancer-selective delivery vehicle. We are also extremely pleased to be continuing our collaboration with the NCI’s SBIR program, which plays a vital role in the development of novel therapeutics."

The first phase of the NCI SBIR contract was focused on the pre-clinical development of CLR 125. However, following a comprehensive data review and product development and commercialization analysis, the company determined that the superior strategic approach would be to redeploy the contract to CLR 131, its lead product candidate. Following a review of all the data, both the NCI and the company determined that the second phase of the contract would be optimized through a multi-center, open label, study of CLR 131 in patients with hematologic malignancies.