On August 03, 2016 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy for treatment of cancer, reported that it has received notice from the U.S. Food and Drug administration that a partial clinical hold has been placed on its planned pivotal study of NY-ESO SPEAR T-cell therapy in myxoid round cell liposarcoma (MRCLS) (Press release, Adaptimmune, AUG 3, 2016, View Source;p=RssLanding&cat=news&id=2192667 [SID:1234514215]). This trial is not yet active at any investigational sites, and has not recruited any patients. This notification of partial clinical hold does not apply to any other Adaptimmune study.

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The FDA notification is not based on safety concerns. In its correspondence, the FDA requested additional CMC information and answers to certain trial design questions prior to the trial start. Adaptimmune intends to provide a full response to the FDA shortly.

"Adaptimmune is running a number of different studies with its NY-ESO program and continues to enroll patients in synovial sarcoma, ovarian, and lung cancer trials in the U.S.," said James Noble, Adaptimmune CEO. "We have been in dialogue with the FDA since achieving breakthrough status earlier this year and this partial clinical hold requires a number of questions to be answered before we can start a new MRCLS trial intended to be used for registration purposes. We will be providing a full response to the FDA shortly and will update the markets when we have further news to report."

The company will discuss this notice of partial clinical hold during its conference call to discuss the second quarter ended June 30, 2016, scheduled for 8:00 a.m. Eastern Time (1:00 p.m. BST) on Monday August 8, 2016.

On August 03, 2016 Insys Therapeutics, Inc. (NASDAQ:INSY) ("Insys" or "the Company") reported financial results for the three-month period ended June 30, 2016 (Press release, Insys Therapeutics, AUG 3, 2016, View Source;p=RssLanding&cat=news&id=2192279 [SID:1234514202]).

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Highlights of and subsequent to the second quarter of 2016 include:

Total net revenue was $67.1 million, compared to $77.6 million for the second quarter of 2015;

Net income totaled $4.4 million, or $0.06 per basic and $0.06 per diluted share, compared to net income of $7.3 million, or $0.10 per basic and $0.10 per diluted share, for the second quarter of 2015;

Cash, cash equivalents and investments were $193.7 million as of June 30, 2016; and

Insys received FDA approval for the marketing of SyndrosTM (dronabinol oral solution), a proprietary, orally administered liquid formulation of dronabinol.
"We are pleased that despite the recent drop-off in volume, Subsys has maintained an approximately 44% market share. We believe that Subsys will continue to provide a very solid financial foundation for the Company, and we remain focused on restoring Subsys scripts to a growth path," said Dr. John N. Kapoor, Chairman, President and Chief Executive Officer of Insys Therapeutics. "The recent FDA approval to market Syndros is excellent news. We are eager to expand our commercial portfolio with a product that we believe has distinct advantages over the current formulation of dronabinol in soft gel capsule and one that will provide significant long-term growth opportunities for Insys. We are proud of our pipeline and believe that product candidates in both sprays and cannabinoids hold great promise. As always, we remain committed to serving the patients who rely on our compounds, while striving to deliver value to Insys stockholders," he concluded.

Second Quarter 2016 Financial Results

Net revenue for the second quarter of 2016 was $67.1 million compared to $77.6 million for the second quarter of 2015, a decrease of 13.5%. The results reflect a decline in Subsys prescription volumes due to softness in overall demand in the TIRF category, including Subsys, and continued pressure from third-party payers.

Gross margin was 91% for the second quarter of 2016 compared with 89% for the comparable quarter of 2015.

Sales and marketing expense was $19.7 million during the second quarter of 2016, or 29% of net revenue, compared to $22.0 million, or 28% of net revenue, for the second quarter of 2015.

Research and development expense increased to $22.9 million for the second quarter of 2016, compared to $17.8 million for the second quarter of 2015, as we continue to advance the multistage products in our pipeline.

General and administrative expense decreased to $13.9 million for the second quarter of 2016, down from $15.3 million for the second quarter of 2015.

Income tax expense was $240,000 for the second quarter of 2016, compared to $4.8 million during the second quarter of 2015.

Net income for the second quarter of 2016 was $4.4 million, or $0.06 per basic and $0.06 per diluted share, compared to net income of $7.3 million, or $0.10 per basic and $0.10 per diluted share, for the second quarter of 2015. Non-GAAP adjusted net income for the second quarter of 2016 was $9.5 million, or $0.13 per diluted share, compared to non-GAAP adjusted net income of $15.6 million, or $0.21 per diluted share, in the prior-year quarter. The reconciliation of net income to non-GAAP adjusted net income is included at the end of this press release.

Liquidity

The Company had $193.7 million in cash, cash equivalents, and short-term and long-term investments, no debt, and $259 million in stockholders’ equity as of June 30, 2016.

On August 03, 2016 Mateon Therapeutics, Inc. (Nasdaq:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported a corporate update and reported financial results for the second quarter of 2016 (Press release, Mateon Therapeutics, AUG 3, 2016, View Source [SID:1234514204]).

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Recent Corporate Highlights

Presented new data reflecting improved survival outcomes for CA4P-treated patients from Study GOG-0186I at an investor event in New York. These data showed an improvement of 5.6 months in overall survival and 3.7 months in progression-free survival in patients with measurable disease.
Published positive results from Study GOG-0186I, an open-label randomized Phase 2 study evaluating CA4P in recurrent ovarian cancer, in the Journal of Clinical Oncology, the official journal of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).
Announced name change to Mateon Therapeutics, Inc. to reflect the Company’s new focus on combination vascular targeted therapy in orphan oncology indications.
Initiated the FOCUS Study, a Phase 2/3 clinical trial of CA4P in combination with bevacizumab (Avastin) and chemotherapy, for the treatment of patients with platinum-resistant ovarian cancer.
Enrolled the first patient into the Phase 2 portion of the PAZOFOS Study, a Phase 1b/2 clinical trial of CA4P in combination with pazopanib (Votrient), in patients with recurrent ovarian cancer.
Received orphan drug designation for CA4P for the treatment of glioma from the U.S. Food and Drug Administration (FDA).
Completed enrollment of the first cohort and initiated the second cohort of OX1222, an open-label dose ranging study of OXi4503 in combination with cytarabine, in patients with relapsed/refractory acute myeloid leukemia (AML).
"We have accomplished a great deal over the last several months and believe we are well-positioned for long-term success," said William D. Schwieterman, M.D., Mateon’s President and Chief Executive Officer. "Most importantly, we announced significant new overall survival and progression-free survival findings from the Phase 2 GOG-0186I Study. I am confident in our strategic direction, pleased with the continued development of our clinical pipeline and look forward to creating long-term shareholder value."

Financial Results for the Second Quarter of 2016

For the second quarter of 2016, Mateon reported a net loss of $3.6 million compared to a net loss of $3.3 million for the second quarter of 2015. R&D expenses increased to $2.4 million in the second quarter of 2016, compared to $2.0 million in the second quarter of 2015, while general and administrative expenses were $1.3 million for both the second quarter of 2016 and the second quarter of 2015.

At June 30, 2016, Mateon had cash, cash equivalents and short-term investments of $19.3 million, which the Company currently believes is sufficient to fund operations through the availability of key clinical data from the FOCUS Study, expected in the second half of 2017.

On August 3, 2016 Eisai Co., Ltd. reported financial results for the first quarter ended June 30, 2016 (Presentation, Eisai, AUG 3, 2016, View Source [SID:1234514345]).

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Gross profit for the first quarter of 2016 was 36.9 billions of Yen in comparison to that of 139.2 billions of Yen in the first quarter of 2015 . Sales of Oncology products amounted to 28.5 billions of Yen

For Eisai’s detailed sales figures, View Source

Idera Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Idera Pharmaceuticals, AUG 2, 2016, View Source [SID1234514177]).

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