AVEO has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, AVEO, AUG 4, 2016, View Source [SID1234514232]).

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On August 4, 2016 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) ("Oncolytics" or the "Company") reported its financial results and operational highlights for the second quarter ended June 30, 2016 (Filing, Q2, Oncolytics Biotech, 2016, AUG 4, 2016, View Source [SID:1234514385]).

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"The key highlights for the quarter were preliminary data from randomized Phase 2 studies in colorectal and non-small cell lung cancer, which together suggested a possible linkage between gender, genetic status and survival outcomes in these common cancers," said Dr. Brad Thompson, President and CEO of Oncolytics. "Our ongoing randomized Phase 2 program continues to provide important data as to indications, patient populations and pre-screening methodologies that we can use to advance our later-stage clinical program."

Selected Highlights

Since April 1, 2016, selected highlights announced by the Company include:

Clinical Program

· Preliminary data from a randomized, sponsored Phase 2 clinical study of REOLYSIN in non-small cell lung cancer (IND 211), presented following an abstract for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which correlated both patient gender (female) and genetic status to improved progression free and overall survival;
· Preliminary data from a randomized, sponsored Phase 2 clinical study of REOLYSIN in advanced or metastatic colorectal cancer (IND 210), following an abstract for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which showed a statistically significant improvement in objective response rates in female patients (female patients in the test arm had an objective response rate of 63.2% (n=19) versus 23.8% (n=21) in the control arm (p=0.0054)) and those patients of either gender with liver metastases (those treated with REOLYSIN had objective tumour response rates of 55% (n=40), versus 28.6% (n=42) for those who did not receive REOLYSIN (p=0.0077));
· Submission to the U.S. Food and Drug Administration of an Investigational New Drug Application containing the protocol titled "Phase 2 study of REOLYSIN (pelareorep) in combination with FOLFOX6, bevacizumab and pembrolizumab in female patients with KRAS-mutant colorectal cancer metastatic to the liver", which is now active;
· Updated results from a randomized Phase 2 clinical trial of its lead product, REOLYSIN, in combination with carboplatin and paclitaxel in patients with pancreatic cancer (NCI-8601), where an intent-to-treat analysis of overall survival on patients with confirmed treatment regimes, as assessed by the percentage of patients surviving for two years, showed a statistically significantly higher percentage of patients surviving two years in the test arm versus the control arm (p = 0.001), the crossover arm versus the control arm (p = 0.03) and the test plus crossover arms versus the control arm (p = 0.0004);
Basic Research

· A poster presentation covering preclinical work in squamous cell carcinoma of the head and neck being made at the 2016 American Society of Gene and Cell Therapy annual meeting;
· Two poster presentations covering preclinical work in multiple myeloma and colorectal cancer being made by the Company’s research collaborators at the 2016 American Association of Cancer Research annual meeting;
Corporate

· Formation of a Science and Technology Committee charged with supporting REOLYSIN’s further development in the context of the broader oncology space with an ultimate focus on reaching a commercial endpoint; and
Financial

· At June 30, 2016 the Company reported $20.4 million in cash, cash equivalents and short-term investments. At August 3, 2016, the Company had approximately $19.5 million in cash, cash equivalents and short-term investments, which is expected to provide sufficient funds to support several small early-stage immunotherapy combination studies and other clinical studies.

ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)


June 30,
2016
$

December 31,
2015
$
Assets
Current assets
Cash and cash equivalents 18,320,981 24,016,275
Short-term investments 2,088,800 2,060,977
Accounts receivable 54,633 340,059
Prepaid expenses 530,470 506,669
Total current assets 20,994,884 26,923,980

Non-current assets
Property and equipment 372,854 459,818
Total non-current assets 372,854 459,818

Total assets 21,367,738 27,383,798

Liabilities And Shareholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities 2,780,705 2,709,492
Total current liabilities 2,780,705 2,709,492

Shareholders’ equity
Share capital
Authorized: unlimited
Issued:
June 30, 2016 – 118,900,812
December 31, 2015 – 118,151,622 261,975,522 261,324,692
Contributed surplus 26,438,232 26,277,966
Accumulated other comprehensive loss 460,092 760,978
Accumulated deficit (270,286,813) (263,689,330)
Total shareholders’ equity 18,587,033 24,674,306
Total liabilities and equity 21,367,738 27,383,798

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)

Three
Month
Period
Ending
June 30,
2016
$ Three
Month
Period
Ending
June 30,
2015
$ Six Month
Period
Ending
June 30,
2016
$ Six Month
Period
Ending
June 30,
2015
$
Expenses
Research and development 1,490,956 2,471,554 4,217,085 4,897,093
Operating 1,125,458 1,422,055 2,485,870 2,604,789
Operating (loss) (2,616,414) (3,893,609) (6,702,955) (7,501,882)
Interest income 35,537 44,122 105,158 100,557
Loss before income taxes (2,580,877) (3,849,487) (6,597,797) (7,401,325)
Income tax 169 (771) 314 (771)
Net (loss) (2,580,708) (3,850,258) (6,597,483) (7,402,096)
Other comprehensive income items that may be reclassified to net loss
Translation adjustment (130,827) (41,117) (300,886) 184,474

Net comprehensive (loss) (2,711,535) (3,891,375) (6,898,369) (7,217,622)
Basic and diluted (loss) per common share (0.02) (0.03) (0.06) (0.07)
Weighted average number of shares (basic and diluted) 119,601,638 114,549,532 118,900,812 107,095,007

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)


Share Capital
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Loss
$
Accumulated
Deficit
$
Total
$
As at December 31, 2014 237,657,056 25,848,429 280,043 (249,966,335) 13,819,193
Net loss and comprehensive loss — — 184,474 (7,402,096) (7,217,622)
Issued, pursuant to Share Purchase Agreement 4,305,396 — — — 4,305,396
Issued, pursuant to "At the Market" Agreement 19,053,525 — — — 19,053,525
Share based compensation — 170,645 — — 170,645
As at June 30, 2015 261,015,977 26,019,074 464,517 (257,368,431) 30,131,137


Share Capital
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Loss
$
Accumulated
Deficit
$
Total
$
As at December 31, 2015 261,324,692 26,277,966 760,978 (263,689,330) 24,674,306
Net loss and comprehensive loss — — (300,886) (6,597,483) (6,898,369)
Issued, pursuant to "At the Market" Agreement 609,830 — — — 609,830
Issued, pursuant to incentive share award plan 41,000 (41,000) — — —
Share based compensation — 201,266 — — 201,266
As at June 30, 2016 261,975,522 26,438,232 460,092 (270,286,813) 18,587,033

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)

Three Month
Period Ending
June 30,
2016
$ Three Month
Period Ending
June 30,
2015
$ Six Month
Period Ending
June 30,
2016
$ Six Month
Period Ending
June 30,
2015
$

Operating Activities
Net loss for the period (2,580,708) (3,850,258) (6,597,483) (7,402,096)
Amortization – property and equipment 44,675 44,852 90,617 89,982
Share based compensation 119,626 55,675 201,266 170,645
Unrealized foreign exchange loss (gain) (243,914) 1,634 (102,619) (303,522)
Net change in non-cash working capital 37,581 (1,370,187) 762,236 (420,482)
Cash used in operating activities (2,622,740) (5,118,284) (5,645,983) (7,865,473)
Investing Activities
Acquisition of property and equipment (5,702) (17,657) (5,702) (29,597)
Purchase of short-term investments — — (27,823) (29,292)
Cash used in investing activities (5,702) (17,657) (33,525) (58,889)
Financing Activities
Proceeds from Share Purchase Agreement — 2,379,800 — 4,305,396
Proceeds from "At the Market" equity distribution agreement 710,374 4,416,607 609,830 19,053,525
Cash provided by financing activities 710,374 6,796,407 609,830 23,358,921
Increase (decrease) in cash (1,918,068) 1,660,466 (5,069,678) 15,434,559
Cash and cash equivalents, beginning of period 20,233,408 28,578,023 24,016,275 14,152,825
Impact of foreign exchange on cash and cash equivalents 5,641 (220,272) (625,616) 430,833
Cash and cash equivalents, end of period 18,320,981 30,018,217 18,320,981 30,018,217

To view the Company’s Fiscal 2016 Second Quarter Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management’s Discussion and Analysis, please see the Company’s quarterly filings, which will be available under the Company’s profile at www.sedar.com and on Oncolytics’ website at View Source

On August 4, 2016 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported that Astellas’ US holding company, Astellas US Holding, Inc. ("Astellas US Holding"), has transferred its wholly owned manufacturing subsidiary Astellas Pharma Technologies, Inc. (Location: Norman, OK, USA, "APT") to Avara Norman Pharmaceutical Services, Inc. (Headquarters: Norwalk, CT, USA, "Avara") (Press release, Astellas, AUG 4, 2016, View Source [SID:1234514333]). Astellas Pharma Technologies, Inc. will be renamed Avara Pharmaceutical Technologies, Inc.

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"We sincerely thank the Astellas Pharma Technologies employees in Norman for their dedication over many years of service. In addition, I am very grateful for the way they have kept our operation running smoothly through the last months of uncertainty as we searched for the right buyer — and we wish them the best as they transition to Avara," said Mitsunori Matsuda, president of Technology at Astellas. "We have confidence that Avara is the right company to oversee the continuing supply of the Astellas products that are made at the facility, as well as the fulfillment of capacity use at and capabilities of the facility. We look forward to working with Avara as the new owner of the facility to ensure the continuous supply of our products for the patients who need them."

Astellas is engaged in ongoing efforts to create organizations and systems that can flexibly respond to rapidly changing environments and work toward higher quality and efficiency of operations. In the areas of manufacturing and technology, Astellas strives to promote the establishment of a stable manufacturing system that will efficiently realize the steady supply of high-quality drugs through the effective use of external resources and the strengthening of Astellas’ own internal functions. As a part of these efforts, Astellas has transferred APT, which owns the plant used for the formulation and packaging of certain Astellas pharmaceutical products, to Avara.

Under the terms of the transaction, APT employees will remain employed at the site, and the plant will continue to manufacture certain Astellas products on a contract basis.

Astellas expects to continue to source a stable supply of high-quality products from the facility under the oversight of Avara.

Deloitte Corporate Finance served as financial advisor to Astellas in connection with the transaction.

1. Financial terms of this deal Financial terms including the value of this acquisition are not disclosed.

2. Outline of APT and the Norman Plant
Astellas Pharma Technologies, Inc.
Location : Norman, OK, USA
Representative : Brian McLellan, President
Capital : 100% owned by US holding company, Astellas US Holding, Inc.
Business description : Manufacturing of pharmaceutical products

Norman Plant
Site area : Approx.810,000 m2
Building area : Approx.29,000 m2
Total number of employees : Approx.200 (as of June 2016）

3. Outline of Transferee
Company name : Avara Norman Pharmaceutical Services, Inc.
Head office : Norwalk, CT, USA
Representative : Timothy C. Tyson, Chairman, Chief Executive Officer
Capital : Avara US Holdings, Ltd. 100%
Business description : Contract manufacturing of pharmaceutical products

In line with the transfer of APT, Astellas expects approximately ¥9.0 billion of one-time expenses including impairment loss of plant and equipment, among others, for the second quarter ending September 30, 2016. Astellas doesn’t revise the full-year consolidated business forecasts for FY2016 (April 1, 2016 to March 31, 2017) announced in May 2016.

On August 4, 2016 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the second quarter ended June 30, 2016 and provided an overview of key milestones for the company’s lead drug candidates (Filing, Q2, Lexicon Pharmaceuticals, 2016, AUG 4, 2016, View Source [SID:1234514319]).

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"We enter the second half of the year with significant momentum, with both telotristat etiprate and sotagliflozin," said Lexicon President and Chief Executive Officer, Lonnel Coats. "We are looking forward to our upcoming PDUFA date of November 30 for telotristat etiprate, as well as top-line data from two pivotal Phase 3 clinical trials and two Phase 2 clinical trials for sotagliflozin in type 1 diabetes by the end of the year."

Pipeline Progress

Telotristat etiprate is the first investigational drug in clinical studies to target tryptophan hydroxylase (TPH), the rate-limiting enzyme involved in serotonin production. Excess production of serotonin within metastatic neuroendocrine tumor cells can lead to carcinoid syndrome, a condition characterized by serious consequences including frequent and debilitating diarrhea, facial flushing, abdominal pain, and heart valve damage.

On May 30, 2016, Lexicon announced that the U.S. Food and Drug Administration had granted a Priority Review of the NDA filing for telotristat etiprate and set a Prescription Drug User Fee Act ("PDUFA") target action date of November 30, 2016. In addition, the European Medicines Agency recently accepted a marketing authorization application filed for telotristat etiprate by Ipsen. Lexicon previously entered into a collaboration with Ipsen to commercialize telotristat etiprate in Europe and other countries outside the U.S. and Japan.

Sotagliflozin, which is being developed as a potential treatment for type 1 and type 2 diabetes, is a dual inhibitor of sodium-glucose transporters 1 and 2 (SGLT1 and SGLT2), each of which modulates glucose levels, and is the first investigational medicine to target both of these two proteins.

Lexicon is conducting three Phase 3 clinical trials of sotagliflozin in patients with type 1 diabetes, two of which have completed enrollment and are expected to provide top-line results in the second half of 2016. Lexicon expects that Phase 3 development of sotagliflozin in patients with type 2 diabetes will be initiated by Sanofi by the end of 2016. Lexicon previously entered into a collaboration with Sanofi in which Lexicon is responsible for clinical development activities relating to type 1 diabetes and Sanofi is responsible for clinical development activities relating to type 2 diabetes.

Financial Highlights

Revenues: Lexicon’s revenues for the three months ended June 30, 2016 increased to $20.1 million from $0.4 million for the corresponding period in 2015, primarily due to revenues recognized from the collaboration and license agreement with Sanofi. For the six months ended June 30, 2016, revenues increased to $32.6 million from $2.2 million for the corresponding period in 2015.

Research and Development Expenses: Research and development expenses for the three months ended June 30, 2016 increased 132 percent to $48.2 million from $20.8 million for the corresponding period in 2015, primarily due to increases in external clinical and nonclinical research and development costs. For the six months ended June 30, 2016, research and development expenses increased 105 percent to $85.2 million from $41.6 million for the corresponding period in 2015.

Change in Fair Value of Symphony Icon Purchase Liability: In connection with the acquisition of Symphony Icon, Lexicon made an initial estimate of the fair value of the liability for the associated base and contingent payments. Changes in this liability, based on the development of the programs and the time until such payments are expected to be made, are recorded in Lexicon’s consolidated statements of operations. The change in fair value of the Symphony Icon purchase liability was $0.5 million and ($12,000) for the three months ended June 30, 2016 and 2015, respectively, and was $1.4 million and $1.7 million for the six months ended June 30, 2016 and 2015, respectively.

General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2016 increased 33 percent to $8.4 million from $6.3 million for the corresponding period in 2015, primarily due to increased costs in preparation for commercialization of telotristat etiprate. For the six months ended June 30, 2016, general and administrative expenses increased 40 percent to $16.8 million from $12.0 million for the corresponding period in 2015.

Consolidated Net Loss: Net loss for the three months ended June 30, 2016 was $38.1 million, or $0.37 per share, compared to a net loss of $28.1 million, or $0.27 per share, in the corresponding period in 2015. Net loss for the six months ended June 30, 2016 was $73.0 million, or $0.70 per share, compared to a net loss of $56.2 million, or $0.54 per share, in the corresponding period in 2015. For the three and six months ended June 30, 2016, net loss included non-cash, stock-based compensation expense of $2.0 million and $3.8 million, respectively. For the three and six months ended June 30, 2015, net loss included non-cash, stock-based compensation expense of $1.8 million and $3.7 million, respectively.

Cash and Investments: As of June 30, 2016, Lexicon had $429.4 million in cash and investments, as compared to $477.1 million as of March 31, 2016 and $521.4 million as of December 31, 2015.

On August 4, 2016 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported financial results for the second quarter 2016 and commented on recent accomplishments and clinical development plans for its lead, novel, oral Selective Inhibitor of Nuclear Export (SINE) compound selinexor (KPT-330), and other pipeline assets, including KPT-8602, its second-generation SINE compound, and KPT-9274, its oral, dual inhibitor of p21-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase (NAMPT) (Filing, Q2, Karyopharm, 2016, AUG 4, 2016, View Source [SID:1234514318])).

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"In the first half of 2016, we continued to drive rapid and meaningful progress across our development programs, including completion of enrollment in our Phase 2b STORM study in multiple myeloma (MM), the opening of a Phase 1b study arm evaluating selinexor in combination with the PD-1 inhibitor pembrolizumab in advanced solid tumors, and the advancement of KPT-9274 into the clinic," said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. "At the 2016 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, we presented exciting preliminary data from our Phase 1b STOMP study showing high response rates, along with durable activity and a favorable safety profile when selinexor is combined with standard-of-care agents in heavily pre-treated patients with MM."

Dr. Kauffman continued, "We remain on track for data readouts from several of our ongoing selinexor studies, including top-line results from the STORM and STOMP studies in relapsed/refractory MM, updated data from the SIGN study in gynecologic malignancies at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Annual Meeting, and an interim analysis from the ongoing Phase 2 SOPRA study in relapsed/refractory acute myeloid leukemia (AML) in late 2016. For KPT-8602, our second generation SINE compound, we look forward to reporting top-line safety and tolerability results from the Phase 1 portion of the ongoing study in patients with relapsed/refractory MM in late 2016. All of these efforts bring us ever closer to our goal of providing novel, first-in-class medicines to patients with cancer and other major diseases. We look forward to keeping you updated on our progress."