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Nektar Therapeutics Reports Financial Results for the Second Quarter of 2016

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

Mateon Provides Corporate Update and Reports Second Quarter 2016 Financial Results

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]).

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.

Insys Therapeutics Reports Second Quarter 2016 Results

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]).

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.

ArQule Reports Second Quarter 2016 Financial Results

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]).

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.

Loxo Oncology Announces Second Quarter 2016 Financial Results

On August 03, 2016 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported financial results for the second quarter ended June 30, 2016 (Press release, Loxo Oncology, AUG 3, 2016, View Source [SID:1234514192]). Loxo Oncology will not be conducting a conference call in conjunction with this earnings release.

"We had a productive second quarter," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "In April, we provided an important durability update for our adult Phase 1 LOXO-101 trial at AACR (Free AACR Whitepaper), and published our first pediatric response to LOXO-101 in a peer-reviewed journal. In May, we added new investors with a follow-on financing. In June, we presented data on our pediatric formulation and development plans to an FDA advisory committee, in a public forum. And just after the close of the quarter, we secured Breakthrough Therapy Designation for LOXO-101 from the FDA."

Recent Highlights

LOXO-101 Received Breakthrough Therapy Designation: In July, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to LOXO-101 "for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments."
LOXO-101 Selected for FDA Pediatric Advisory Committee Meeting: In June, Loxo Oncology participated in a meeting of the FDA’s Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The purpose of the meeting was to improve and encourage the development of oncology and hematology drugs for pediatric use. A replay of that presentation is available. Loxo Oncology also submitted a briefing package in advance of this meeting, which is publicly available.
Strengthened Balance Sheet: Loxo Oncology raised $41.4 million in gross proceeds in an equity financing in May 2016. Loxo Oncology’s cash, cash equivalents and investments are expected to be sufficient to fund operations into late 2018.
LOXO-101 Update at AACR (Free AACR Whitepaper) and Pediatric Case Report: In April, investigators provided an update of the Phase 1 adult trial of LOXO-101, highlighting patients with TRK fusion cancers. Of note from the presentation, all responding patients remained in response, all had shown evidence of tumor regression, and five of six patients had achieved a confirmed partial response (PR) by standard RECIST criteria. Importantly, five of these six patients were treated at or below the recommended Phase 2 dose. Separately, investigators also published a peer-reviewed case report of the first pediatric patient treated with a liquid formulation of LOXO-101 in the setting of infantile fibrosarcoma. The patient achieved a confirmed partial response and began again to achieve appropriate developmental milestones.
Upcoming Milestones

Loxo Oncology continues to make significant progress across its drug development pipeline. Upcoming milestones are expected to include:

Continued enrollment of the LOXO-101 NAVIGATE Phase 2 global, multi-center, single-arm, open-label basket trial in adult patients with solid tumors that harbor a TRK fusion. Loxo Oncology plans to provide an enrollment update in the second half of 2016.
Initiation of a Phase 1 study of a selective RET inhibitor in late 2016/ early 2017.
Initiation of a Phase 1 study of next-generation TRK inhibitor LOXO-195, addressing previously treated patients with acquired resistance, in 2017. Loxo Oncology may provide access to LOXO-195 for emergency investigational use prior to 2017 if medically necessary, requested by a treating clinician, and authorized by the appropriate regulatory authorities. LOXO-195 is designed to retain potency against a common resistance mutation that has been described in two separate patients who have progressed on a competitor’s TRK inhibitor.
Second Quarter 2016 Financial Results

As of June 30, 2016, Loxo Oncology had aggregate cash, cash equivalents and investments of $171.7 million, compared to $153.9 million as of December 31, 2015.

Loxo Oncology continues to expect cash burn of $48 to $52 million in 2016. Based on the current operating plan, the company believes existing capital resources will be sufficient to fund anticipated operations into late 2018.

Research and development expenses were $12.3 million for the second quarter of 2016 compared to $5.7 million for the second quarter of 2015. This increase was primarily due to expanded clinical development activities for LOXO-101, as well as additional expenses related to the preclinical pipeline. Loxo Oncology also recognized research and development-related stock-based compensation expense of $0.2 million during the second quarter of 2016, compared to $0.9 million for the second quarter of 2015.

Research and development expenses were $20.7 million for the six months ended June 30, 2016, compared to $9.5 million for the six months ended June 30, 2015. This increase was primarily due to expanded clinical development activities for LOXO-101, as well as additional expenses related to the preclinical pipeline. Loxo Oncology also recognized research and development-related stock-based compensation expense of $0.5 million during the six months ended June 30, 2016, compared to $1.3 million for the six months ended June 30, 2015.

General and administrative expenses were $3.8 million for the second quarter of 2016 compared to $2.4 million for the second quarter of 2015. This increase was primarily attributable to employment costs and professional fees. Loxo Oncology also recognized general and administrative-related stock-based compensation expense of $1.1 million during the second quarter 2016, compared to $0.8 million for the second quarter 2015.

General and administrative expenses were $7.2 million for the six months ended June 30, 2016, compared to $4.8 million for the six months ended June 30, 2015. This increase was primarily attributable to employment costs and professional fees. Loxo Oncology also recognized general and administrative-related stock-based compensation expense of $2.1 million during the six months ended June 30, 2016, compared to $1.3 million for the six months ended June 30, 2015.

Net loss was $15.9 million and $27.5 million for the three and six months ended June 30, 2016, respectively, compared to $8.1 million and $14.2 million for the three and six months ended June 30, 2015, respectively.

About LOXO-101
LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in the NAVIGATE global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions and the SCOUT Phase 1 trial in pediatric patients including infantile fibrosarcoma. LOXO-101 has been granted Breakthrough Therapy Designation by the U.S. FDA. For additional information about the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com.