On August 03, 2016 Aduro Biotech, Inc. (NASDAQ:ADRO) reported financial results for the second quarter 2016 (Press release, Aduro BioTech, AUG 3, 2016, View Source;p=RssLanding&cat=news&id=2192550 [SID:1234514210]). Net income for the three months ended June 30, 2016 was $2.3 million, or $0.04 per share, and for the six months ended June 30, 2016 net loss was $26.5 million, or $0.41 per share, compared to a net loss of $26.3 million, or $0.50 per share, and $42.9 million, or $1.61 per share respectively, for the same periods in 2015.

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Cash, cash equivalents and marketable securities totaled $396.9 million at June 30, 2016, compared to $431.0 million at December 31, 2015.

"We are uniquely positioned in the field of immunotherapy with three distinct, proprietary technology platforms, as well as a strong cash position," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "As we continue to advance our programs, we anticipate a number of upcoming milestones across our three platforms, including data from our LADD platform in multiple tumor types, initial clinical results from ADU-S100, our first STING Pathway Activator, and IND-enabling studies for multiple B-select monoclonal antibodies."

Recent Progress

Preclinical data published in Blood highlighting the potential of Aduro’s proprietary monoclonal antibody BION-1301 targeting a proliferation-inducing ligand (APRIL) for the treatment of multiple myeloma
Initiated a Phase 1 clinical trial of ADU-S100, the first STING Pathway Activator compound to enter the clinic, for the treatment of cutaneously accessible tumors
Reported results from the Phase 2b ECLIPSE trial in pancreatic cancer
Reported data from the Phase 1b clinical trial in mesothelioma at ASCO (Free ASCO Whitepaper) 2016
Second Quarter 2016 Financial Results

Revenue was $39.0 million for the second quarter of 2016 and $43.0 million for the six months ended June 30, 2016, compared to $9.9 million and $19.5 million, respectively, for the same periods in 2015. The increase was primarily due to the receipt of a $35.0 million milestone payment from Novartis in connection with the initiation of the Phase 1 ADU-S100 trial in the second quarter of 2016.

Research and development expenses were $26.9 million for the second quarter of 2016 and $47.8 million for the six months ended June 30, 2016, compared to $13.5 million and $24.2 million, respectively, for the same periods in 2015. This increase was primarily due to clinical development expenses associated with our ongoing trials in pancreatic cancer, ovarian cancer and mesothelioma, including manufacturing and personnel costs.

General and administrative expenses were $8.7 million for the second quarter of 2016 and $17.7 million for the six months ended June 30, 2016, compared to $5.9 million and $12.1 million, respectively, for the same periods in 2015. This increase was primarily due to continued growth of the company and the associated increased expenses related to personnel, facilities and professional services.

There was no loss from remeasurement of fair value of warrants for either the second quarter of 2016 or six months ended June 30, 2016, compared to $16.7 million and $26.1 million, respectively, for the same periods in 2015. In April 2015, all such warrants ceased being liability-classified as the contingency surrounding the number of shares issuable upon the warrant exercise expired. All outstanding warrants were equity-classified and not subject to future remeasurement.

Provision for income taxes was $1.5 million for the second quarter of 2016 and $4.7 million for the six months ended June 30, 2016. There was no provision for income taxes in the same periods in 2015. The income tax expense recorded for the second quarter of 2016 was primarily related to current and deferred federal income taxes.

On August 3, 2016 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the second quarter ended June 30, 2016 (Press release, Nektar Therapeutics, AUG 3, 2016, View Source [SID:1234514207]).

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Cash and investments in marketable securities at June 30, 2016 were $274.9 million as compared to $308.9 million at December 31, 2015. This balance includes the $28.0 million payment received from AstraZeneca in April of 2016 for the sublicense of MOVENTIG (naloxegol) to ProStraken in Europe. The balance does not include the $20 million upfront payment for the licensing of European rights for ONZEALD to Daiichi Sankyo Europe, which occurred in Q2 2016.

"We continue to execute on the development and business objectives for Nektar," said Howard W. Robin, President and CEO of Nektar. "Following our licensing agreement with Daiichi Sankyo Europe, the MAA for ONZEALD was accepted by the EMA in July, and with an accelerated assessment review granted by the CHMP, we expect a decision on the recommendation for conditional approval in Q1 2017. Our Phase 3 study of NKTR-181 in patients with chronic low back pain has now completed enrollment and is on track to have topline data in the first quarter of 2017. Finally, NKTR-214 continues to advance in its Phase 1/2 study in cancer patients at MD Anderson and Yale Cancer Centers, with initial topline data expected before the end of this year. As the first medicine designed to selectively stimulate the in vivo growth of endogenous tumor-killing T cells and natural killer cells within the tumor micro-environment, we are extremely excited about the potential of NKTR-214 to transform the immuno-oncology landscape."

Year-to-date revenue for 2016 was $91.6 million as compared to $131.5 million in the first half of 2015. Revenue in 2016 included recognition of the $28.0 million cash payment received from AstraZeneca for the sublicense of MOVENTIG (naloxegol) to ProStrakan (Kyowa Kirin) in Europe. In addition, product sales, royalty revenue, and non-cash royalty revenue increased in the first half of 2016 compared to the first half of 2015. Revenue in the first half of 2015 included recognition of $90.0 million of the $100.0 million milestone payment from AstraZeneca following the first commercial sale of MOVANTIK in the U.S. in Q1 2015. Revenue in the second quarter of 2016 was $32.8 million as compared to $22.7 million in the second quarter of 2015.

Revenue included non-cash royalty revenue, related to our 2012 royalty monetization, of $8.1 million and $14.7 million in the second quarter and first half of 2016, respectively, and $4.7 million and $8.7 million in the second quarter and first half of 2015, respectively. This non-cash royalty revenue is offset by non-cash interest expense incurred in connection with the 2012 royalty monetization of $5.0 million and $10.0 million in the second quarter and first half of 2016, respectively and $5.2 million and $10.2 million in the second quarter and first half of 2015, respectively.

Total operating costs and expenses in the first half of 2016 were $139.5 million as compared to $131.9 million in the first half of 2015. Total operating costs and expenses in the second quarter of 2016 were $71.1 million as compared to $66.1 million in the second quarter of 2015. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

Research and development expense in the second quarter of 2016 was $52.4 million as compared to $45.4 million in the second quarter of 2015. For the first half of 2016, R&D expense was $101.6 million as compared to $92.4 million in the first half of 2015. R&D expense was higher in the second quarter and first half of 2016 as compared to the same periods in 2015 primarily due to expenses for the NKTR-181 Phase 3 studies and the initiation of the Phase 1/2 study of NKTR-214.

General and administrative expense was $11.0 million in the second quarter of 2016 as compared to $10.2 million in the second quarter of 2015. G&A expense in the first half of 2016 was $21.3 million as compared to $20.5 million in the first half of 2015.

Net loss in the second quarter of 2016 was $48.6 million or $0.36 loss per share as compared to $52.7 million or $0.40 loss per share in the second quarter of 2015. Net loss in the first half of 2016 was $68.1 million or $0.50 loss per share as compared to $18.8 million or $0.14 loss per share in the first half of 2015.

The company also announced the following upcoming presentations and events:

Fourth Annual Immuno-Oncology Summit, Boston, MA:

Oral Abstract: "Of Mice and Men: Translating the Immune Oncology Mechanism of Action of NKTR-214." Presented by: Jonathan Zavelsky, Ph.D.
Date: August 31, 2016, 5:15 p.m. Eastern Time
Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper), New York, NY:

Abstract/Poster #311: "The CD122-biased immunostimulatory cytokine NKTR-214 combined with checkpoint blockade leads to mobilization of antitumor immunity and synergistic activity", Langowski, J., et al.
Date: September 26, 2016, 5:15 – 7:45 p.m. Eastern Time
ESMO 2016 Congress, Copenhagen, Denmark:

Abstract #3048: "Combining Complementary Mechanisms of Immune Activation: NKTR-214, a Biased IL-2 Pathway Agonist, and Immune Checkpoint Antagonists", Charych, D., et al.
Date: October 9, 2016, 1:00 – 2:00 p.m. Central European Time
10th Annual Pain and Migraine Therapeutics Conference, Chicago, IL:

Oral Abstract: "Clinical Development of a Novel Opioid Molecule with Inherent Anti-abuse Properties", Presented by Carlo DiFonzo, Ph.D.
Date: October 19, 2016, 1:00 – 1:30 p.m. Central Time

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 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 3, 2016 ArQule, Inc. (Nasdaq: ARQL) reported its financial results for the second quarter of 2016 (Press release, ArQule, AUG 3, 2016, View Source [SID:1234514200]).

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For the quarter ended June 30, 2016, the Company reported a net loss of $5,100,000 or $0.07 per share, compared with a net loss of $4,017,000 or $0.06 per share, for the second quarter of 2015. For the six-month period ended June 30, 2016, the Company reported a net loss of $10,081,000 or $0.15 per share, compared with a net loss of $8,568,000 or $0.14 per share, for the six-month period ended June 30, 2015.

At June 30, 2016, the Company had a total of approximately $43,115,000 in cash, equivalents and marketable securities.

Key Highlights

ARQ 087, our proprietary FGFR inhibitor, demonstrated strong anticancer activity in an ongoing phase 1/2 trial in intrahepatic cholangiocarcinoma (iCCA), a rare form of liver cancer. A 75% disease control rate, including a 25% objective response rate, was observed from the preliminary data presented at the 2016 ESMO (Free ESMO Whitepaper) GI Congress. Since the Congress presentation, a fourth partial response has been observed.
ARQ 531, our proprietary and novel BTK inhibitor, demonstrated in preclinical studies that it is a potent and reversible inhibitor of both wild type and ibrutinib resistant C481S-mutant BTK. In preclinical testing, ARQ 531 demonstrated biochemical inhibition of both wild type and C481S-mutant BTK at sub-nanomolar levels and potent cellular inhibition in C481S-mutant BTK cells that are resistant to ibrutinib. These data were presented at the 2016 Pan Pacific Lymphoma Conference in July marking the first public showing of data on this potential best-in-class molecule.
ARQ 092, our lead AKT inhibitor, continues in the phase 1 trial for Proteus syndrome. The three patients enrolled in the first cohort are approaching nine months of therapy.
Tivantinib – METIV-HCC phase 3 trial in hepatocellular carcinoma is scheduled to conclude by year-end 2016 or early 2017. Top-line data is expected according to that timeline.
"We are starting to realize the benefits of our precision medicine strategy through the advancement of our proprietary pipeline as evidenced by the strong clinical data recently presented at ESMO (Free ESMO Whitepaper) GI for ARQ 087 in iCCA, the initiation of a biomarker driven phase 1 trial for our next generation AKT inhibitor, ARQ 751, and the emerging preclinical profile of our novel BTK inhibitor, ARQ 531, recently presented at the Pan Pacific Lymphoma Conference," said Paolo Pucci, Chief Executive Officer of ArQule. "While AKT and FGFR are emerging targets, with ARQ 531 we have the opportunity to work in a well-established target such as BTK and to address a growing therapeutic need of patients who develop resistance to ibrutinib. We look forward to sharing additional data on ARQ 087, ARQ 092 and ARQ 531 later this year."

"With the four partial responses recorded thus far in the iCCA trial, we are nearing a decision for the next stage of clinical development for ARQ 087 and expect to meet with regulatory authorities in the near future," said Dr. Brian Schwartz, M.D., Head of Research and Development and Chief Medical Officer at ArQule. "The initiation of a pivotal biomarker driven trial in iCCA with FGFR2 genetic alterations would create an opportunity for a fast-to-market strategy in this orphan disease. With clear signs of clinical utility and a manageable safety profile, ARQ 087 has the potential to become a best-in-class compound."

Revenues and Expenses

Revenues for the quarter ended June 30, 2016, were $1,072,000 compared with revenues of $3,004,000 for the quarter ended June 30, 2015. Revenues in the six-months ended June 30, 2016 were $2,299,000 compared with revenues of $5,789,000 in the six-months ended June 30, 2015. Revenue in the three and six-month periods of 2016 and 2015 is comprised of revenue from the Daiichi Sankyo tivantinib development agreement and the Kyowa Hakko Kirin exclusive license agreement.

The revenue decreases in the quarter ended June 30, 2016 of $1.0 million from our Daiichi Sankyo METIV-HCC trial and $0.9 million from our Kyowa Hakko Kirin JET-HCC trial were principally due to the March 2016 extension of the development period through December 31, 2016 for both programs. The revenue decreases in the six months ended June 30, 2016 of $1.6 million from our Daiichi Sankyo METIV-HCC trial and $1.9 million from our Kyowa Hakko Kirin JET-HCC trial were also principally due to the extension of the development period through December 31, 2016.

Research and development expense in the second quarter of 2016 was $4,337,000, compared with $4,327,000 for the second quarter of 2015. The increase in outsourced clinical and product development costs of $0.4 million in the second quarter of 2016 was offset by lower labor and related costs of $0.3 million and facility costs reductions of $0.1 million.

Research and development expense in the six-months ended June 30, 2016 was $8,535,000 compared with $8,740,000 in the six-months ended June 30, 2015. The $0.2 million decrease in research and development expense in the six-months ended June 30, 2016 was primarily due to lower labor and related costs of $0.5 million, facility costs of $0.5 million, partially offset by increased outsourced clinical and product development costs of $0.8 million.

General and administrative expense was $1,887,000 in the second quarter of 2016 compared with $2,776,000 in the second quarter 2015. General and administrative expense decreased by $0.9 million in the second quarter of 2016 primarily due to lower facility costs of $0.7 million and professional fees of $0.2 million.

General and administrative expense was $3,931,000 in the six-months ended June 30, 2016 compared with $5,963,000 in the six-months ended June 30, 2015. General and administrative expense decreased by $2.0 million in the six-months ended June 30, 2016 primarily due to lower facility costs of $1.6 million, labor related costs of $0.2 million and professional fees of $0.2 million.