Valeant has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Valeant, NOV 9, 2016, View Source [SID1234516648]).

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On November 9, 2016 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, reported financial results for the third quarter ended September 30, 2016, and provided an update on the Company’s recent activities (Press release, Ziopharm, NOV 9, 2016, View Source [SID1234516793]).

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"ZIOPHARM continues to advance a broad portfolio of immuno-oncology programs, including our gene therapy platform, and our chimeric antigen receptor, T-cell receptor, and natural killer adoptive cell-based therapies," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM Oncology. "These programs ensure that ZIOPHARM participates across the spectrum of cell-based therapies, with technologies spanning non-viral and viral T-cell gene transfer, cytokines, and controlled expression of biologics after infusion. What is particularly exciting about our progress is that most of these technologies will be in clinical testing in 2017, moving us toward realization of these transformative ideas including individualized therapies targeting neoantigens and continued shortening of cell manufacturing to infuse T cells after gene transfer. These ideas will allow us to leapfrog current technologies and address some of the most important challenges in cancer treatment today."

Francois Lebel, M.D., Chief Medical Officer of ZIOPHARM Oncology added: "In the near-term, we look forward to presenting updated results at the Society for Neuro-Oncology Annual Meeting next week from our Phase 1, multi-center study of Ad-RTS-hIL-12 + veledimex in patients with brain cancer. To date, intracranial administration of Ad-RTS-hIL-12 + veledimex has demonstrated a favorable safety profile, with a survival benefit compared to historical control that provides a strong rational for moving to a phase 2/3 trial."

Corporate and Program Updates

Gene Therapies

Ad-RTS-hIL-12 + veledimex is a gene therapy candidate for the controlled expression of interleukin 12 (IL-12), a critical protein for stimulating an anti-cancer immune response, using the RheoSwitch Therapeutic System (RTS) gene switch. ZIOPHARM is currently enrolling patients in two studies of Ad-RTS-hIL-12 + veledimex: a multi-center Phase 1 study in patients with recurrent or progressive glioblastoma multiforme (GBM), an aggressive form of brain cancer, and a Phase 1b/2 study for the treatment of patients with locally advanced or metastatic breast cancer following standard chemotherapy.

Updated Clinical Data from Phase 1 Study of Ad-RTS-hIL-12 + Veledimex in High-Grade Gliomas to be presented at Society of Neuro-Oncology (SNO) Annual Meeting. ZIOPHARM will present updated data from its Phase 1, multi-center study of Ad-RTS-hIL-12 + veledimex in patients with recurrent high-grade gliomas at the upcoming 21st Annual SNO Scientific Meeting being held November 17-20, 2016 in Scottsdale, Arizona. Subjects with relapsed high-grade gliomas undergoing re-resection were intra-tumorally injected once with Ad-RTS-hIL-12 followed by oral doses of veledimex to activate production (transcription) of IL-12. The Company previously showed that the measurement of veledimex in serum and in the brain tumor correlates with production of IL-12 and activation of IFN-gamma, demonstrating not only that this oral drug can be used to start and stop cytokine production, but the generation of IL-12 is proportional to the dosing of veledimex. These data will be updated for recipients taking veledimex at 20 mg/day, 30 mg/day and 40 mg/day. The Company previously reported 6-month overall survival in the study at 100%. Twelve month survival data will be reported at SNO.

The presentation, entitled "Phase 1 study of intra-tumoral viral delivery of Ad-RTS-hIL-12 + oral veledimex is well tolerated and suggests survival benefit in recurrent high grade glioma" will be presented on Friday, November 18, 2016. The Company will host a conference call to discuss these data on Thursday, November 17, 2016 at 8:00 am ET.

Upcoming Pre-Clinical Data of Ad-RTS-mIL-12 + Veledimex as Therapy for Pediatric Glioma to be presented at Society of Neuro-Oncology Annual Meeting. ZIOPHARM will present data on the ability of the RTS gene switch to control mouse IL-12 production to treat glioma in the pontine region. These data are based on a single injection of Ad-RTS-mIL-12 and oral administration of veledimex and serve as a basis to advance our viral therapy in 2017 for the investigational treatment of pediatric brain tumors, including diffuse intrinsic pontine glioma.

Presented Data Demonstrating Activation of Anti-Tumor Immune Response Using Ad-RTS-hIL-12 in Patients with Advanced Breast Cancer. In October, ZIOPHARM announced the presentation of preliminary data from the Company’s Phase 1b/2 study of Ad-RTS-hIL-12 + veledimex following standard chemotherapy for the treatment of patients with locally advanced or metastatic breast cancer at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress in Copenhagen, Denmark. Results show that Ad-RTS-hIL-12 + seven days of veledimex consistently elicited production of IL-12 which in turn produced IFN-gamma. It was notable that the intra-tumoral influx of CD8+ T cells and IFN-gamma were present six weeks after completion of veledimex consistent with the ability of Ad-RTS-hIL-12 to favorably impact the tumor environment over the long term. In two patients, Ad-RTS-hIL-12 + veledimex provided a meaningful chemotherapy holiday, with durable responses for 18 and 35 weeks.
Adoptive Cell Therapies

ZIOPHARM is developing various immuno-oncology programs, including chimeric antigen receptor T cell (CAR-T), T-cell receptor (TCR), T cell (TCR-T), and natural killer (NK) adoptive cell-based therapies. These programs are being advanced in collaboration with Intrexon Corporation (NYSE: XON), MD Anderson Cancer Center, and Merck Serono (CAR-T only).

Results from Four Studies of Adoptive Cell-based Therapeutic Programs to be Presented at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. In November, ZIOPHARM announced that four abstracts highlighting data from the Company’s adoptive cell-based therapeutic programs have been accepted for presentation at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. The meeting will be held December 3-6, 2016 in San Diego. The research, conducted at the MD Anderson Cancer Center and Intrexon, demonstrates, among other results, that T cells can be quickly produced with the Sleeping Beauty system and that this non-viral approach to gene therapy can be harnessed to generate CAR and TCR expressing effector cells.

Announced Plans for Phase I Clinical Trial with CD33 CAR-T Cell Therapy; Supporting Preclinical Results to be Presented at ASH (Free ASH Whitepaper) 58th Annual Meeting & Exposition. In July, following a review by the Recombinant DNA Advisory Committee, ZIOPHARM announced plans for a Phase I adoptive cellular therapy clinical trial utilizing autologous T cells transduced with lentivirus to express a CD33-specific CAR in patients with relapsed or refractory acute myeloid leukemia (AML). Preclinical studies, including in vitro data, demonstrated that lentiviral-transduced CAR-T cells targeting CD33 exhibited specific killing activity for CD33+ AML cells and a proof-of-concept study utilizing an in vivo mouse model for AML, showed that these CAR-T cells were able to eliminate disease and significantly enhance survival as compared to control groups. These positive preclinical results indicate biological activity and are suggestive of potential therapeutic effect for the treatment of AML. The Company recently announced that associated data will be presented at the 58th ASH (Free ASH Whitepaper) Annual Meeting.

Announced Publication of Data from First-In-Human Trials using Non-Viral Sleeping Beauty System to Express CD19-Specific CAR in T cells in Journal of Clinical Investigation. In August, ZIOPHARM announced the publication of data highlighting the benefits of using the non-viral Sleeping Beauty (SB) system to genetically modify T cells to express a CAR for use against CD19-expressing leukemias and lymphomas. The article, titled "Phase I trials using Sleeping Beauty to generate CD19-specific CAR T cells," was published in the Journal of Clinical Investigation (doi:10.1172/JCI86721), and is available online here.

The paper describes results for 26 patients with multiply relapsed B-lineage acute lymphoblastic leukemia (ALL, n=17) or B-cell non-Hodgkin lymphoma, (NHL, n=9) who were enrolled in two investigator-initiated clinical trials at the University of Texas MD Anderson Cancer Center infused with Sleeping Beauty-modified T cells after autologous (n=7) or allogeneic (n=19) hematopoietic stem-cell transplantation (HSCT). Although the primary objective of these trials was not to establish efficacy, the recipients’ outcomes are encouraging, with apparent doubling of survivals compared to historical controls which is attributed to the persistence of the infused T cells. Additionally, by infusing a CD19-specific CAR-T to target minimal residual disease after autologous and allogeneic HSCT, the approach may improve tolerability by avoiding cytokine release syndrome.
Milestones

Intra-tumoral IL-12 RheoSwitch programs:
Clinical data from Phase 1 of Ad-RTS-hIL-12 + veledimex for GBM to be presented at SNO 2016
Initiate Phase 2/3 clinical trial for GBM in 2017
Clinical update presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for Phase 1 study of GBM
Pre-clinical data presented at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2016 for combining with immune checkpoint inhibitor
Initiate combination study of Ad-RTS-hIL-12 + veledimex with checkpoint inhibitor therapy (PD-1) during the first half of 2017
Pre-clinical data for Ad-RTS-mIL-12 + veledimex to support pediatric brain tumors to be presented at SNO 2016
Initiate Phase 1 study in the treatment of brain tumors in children during the first half of 2017
Update on Phase 1/2 study in Breast Cancer with standard of care presented at the 2016 ASCO (Free ASCO Whitepaper) meeting
Clinical update presented at the 2016 ESMO (Free ESMO Whitepaper) meeting for Phase 1/2 Breast Cancer study
CAR-T programs:
Continuation of CD19 CAR+ T clinical study in 2016
Initiate a CD33 specific CAR+ T clinical study for relapsed or refractory AML in the first half of 2017
Preclinical data on CD33 to be presented at ASH (Free ASH Whitepaper) 2016
Preclinical data presented at ASGCT (Free ASGCT Whitepaper) 2016 and ASH (Free ASH Whitepaper) 2016 for shortening the time of ex vivo manufacture of SB-modified T cells
Initiate CAR+ T-cell preclinical studies for other hematological malignancies and solid tumors in 2016
TCR-T programs
Initiate TCR-modified T-cell preclinical studies in 2016
Preclinical data to be presented at ASH (Free ASH Whitepaper) 2016
NK cell programs
Initiate a Phase 1 study of off-the-shelf NK cells for AML in 2017
GvHD programs
Initiate preclinical studies in 2016
SNO 21st Annual Scientific Meeting Conference Call and Slide Webcast

ZIOPHARM will host a conference call and webcast slide presentation Thursday, November 17, 2016, at 8:00 am ET to discuss updated data from the Company’s Phase 1 study of Ad-RTS-hIL-12 + veledimex in high-grade glioma. The call can be accessed by dialing (844) 309-0618 (U.S. and Canada) or (661) 378-9465 (international). The passcode for the conference call is 11110235. To access the slides and live audio webcast, or the subsequent archived recording, visit the "Investors & Media" section of the ZIOPHARM website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two (2) weeks.

Third-Quarter 2016 Financial Results

Net loss applicable to common shareholders for the third quarter of 2016 was $14.5 million, or $(0.11) per share, compared to a net loss of $18.2 million, or $(0.14) per share, for the third quarter of 2015. The decrease in net loss for the three months ended September 30, 2016 is primarily due to a one-time charge of $10.0 million for in process research and development with Intrexon for GvHD programs incurred in September 2015. This decrease was offset by a $2.0 million increase in expenses related to the gene therapy and cell therapy programs, decreased revenue of $0.3 million, increased general and administrative costs of $0.4 million and income attributable to preferred stockholders of $3.6 million.

Research and development expenses were $9.0 million for the third quarter of 2016 compared to $17.0 million for the third quarter of 2015. The decrease in research and development expenses for the three months ended September 30, 2016 is primarily due to a one-time charge of $10.0 million for in process research and development with Intrexon for GvHD programs incurred in September 2015. This decrease was offset by a $2.0 million increase in expenses related to the gene therapy and cell therapy programs.

General and administrative expenses were $3.5 million for the third quarter of 2016 compared to $3.1 million for the third quarter of 2015. The increase for the three months ended September 30, 2016 was primarily due to increased employee related costs.
The Company ended the quarter with cash and cash equivalents of approximately $94.7 million, which the Company believes will be sufficient to fund its currently planned activities into the fourth quarter of 2017.

On November 9, 2016 XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, reported recent achievements and financial results for the third quarter ended September 30, 2016 (Press release, Xoma, NOV 9, 2016, View Source [SID1234516790]).

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"In the third quarter, we accelerated activity in our XOMA 358 clinical trials in patients with hypoglycemia due to congenital hyperinsulinism (CHI) or post-bariatric surgery (PBS). In mid-September, we presented promising initial data from the first nine patients in these studies, which clearly demonstrated that XOMA 358 impacts insulin signaling. We also opened our first clinical site in Germany, which is actively enrolling patients age 12 years and older into our CHI study. Additionally, our proposal to UK regulators to initiate a multi-dose Phase 2 clinical study of XOMA 358 in children over the age of two with CHI was accepted in principle. We are pleased with the progress we are making in the XOMA 358 development program and are optimistic this first-in-class allosteric modulating antibody will offer a significant benefit for the treatment of CHI and PBS patients," said John Varian, Chief Executive Officer of XOMA.

Recent Achievements

Announced promising initial Phase 2 proof-of-concept data from the first nine patients enrolled in the Company’s ongoing XOMA 358 studies. This data confirm the novel antibodies’ proof-of-mechanism is impacting insulin signaling in patients with hypoglycemia due to CHI or PBS.
Continued to advance the XOMA 358 clinical program and made significant steps toward generating additional patient data.
Treated 14 additional patients with XOMA 358 since the September data presentation.
Met with the UK’s Medicines and Healthcare Regulatory Authority (MHRA) and proposed a multi-dose Phase 2 clinical study of XOMA 358 in children older than age two diagnosed with hypoglycemia due to CHI. The Agency agreed in principle with the proposal.
Opened the Company’s first clinical site in Germany to conduct a repeat-dose study of XOMA 358 in CHI patients over the age of 12.
Unveiled a novel new IL-2 immuno-oncology antibody program. Preclinical data will be presented on November 12th at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 31st Annual Meeting. XOMA anticipates out-licensing the asset to help fund its endocrine drug development programs.
Executed a reverse split of XOMA’s common stock to regain compliance with NASDAQ listing requirements.
Third Quarter 2016 Financial Results
XOMA recorded total revenues of $0.6 million for the three months ended September 30, 2016, compared to $2.1 million during the third quarter of 2015. The decrease in third quarter 2016 revenues was due primarily to a reduction in revenues from the National Institute of Allergy and Infectious Diseases (NIAID) and Servier. Going forward, revenues are expected to result from potential new strategic partnerships and arrangements or payments under existing contracts.

Research and development (R&D) expenses for the third quarter of 2016 decreased 51 percent to $8.7 million, compared to $17.6 million in the corresponding 2015 period. The decrease was due primarily to a $3.6 million reduction in clinical trial costs, a $2.7 million reduction in salaries and related expenses, a $1.0 million reduction in external manufacturing activities, a $0.5 million reduction in outside consulting fees due to the termination of the Servier Phase 3 program, and a $0.5 million reduction in depreciation and facility expenses due to the sale of our manufacturing facility to Agenus West LLC.

Selling, general and administrative expenses (SG&A) decreased 28 percent to $4.1 million for the three months ended September 30, 2016, compared to $5.6 million during the same period in 2015. The decrease was due primarily to reduced consulting services and reduced salary and related personnel costs following the Company’s restructuring activities that were initiated in the third quarter of 2015.

"Our financial results for the quarter reflect the significant progress we have made over the past year to reduce our operating expenses across every sector of the Company. Third quarter R&D expenses were 51 percent lower year-over-year and 37 percent lower compared with the second quarter of 2016. We also reduced our SG&A expenses by 28 percent from a year ago and by 15 percent from the second quarter," said Tom Burns, Vice President, Finance and Chief Financial Officer of XOMA. "In addition, we continued our out-licensing and partnering efforts to monetize our non-core assets, as our deep pipeline of early-stage antibodies is of interest to multiple companies focused on addressing a wide variety of medical conditions. These transactions have been and continue to be an important source of non-dilutive financing for the Company. For example, we expect to earn a $10 million milestone payment within the next few months under one of our existing license or collaboration agreements."

For the third quarter ended September 30, 2016, XOMA had a net loss of $12.5 million, compared to a net loss of $0.5 million in the quarter ended September 30, 2015. The net losses in the three months ended September 30, 2016 and 2015, included a $0.3 million and $24.4 million gain, respectively, in non-cash revaluations of contingent warrant liabilities, resulting primarily from fluctuations in XOMA’s stock price. Excluding those revaluations, the net loss for the three months ended September 30, 2016, was $12.8 million, compared to a net loss of $24.9 million for the same reporting period in 2015.

On September 30, 2016, XOMA had cash and cash equivalents of $20.6 million compared with $65.8 million at December 31, 2015.

The Company expects its available capital will be sufficient to fund operations into the first quarter of 2017. The anticipated milestone, referenced above, is not included in this projection.

On November 9, 2016 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company developing topsalysin (PRX302) for the treatment of urological diseases, reported financial results for the three and nine months ended September 30, 2016 (Press release, Sophiris Bio, NOV 9, 2016, View Source [SID1234516726]).

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Business Highlights:

On August 26, 2016, the Company announced the closing of a public offering in which the Company raised net proceeds of $27.4 million. The Company plans to use the proceeds from this offering to fund a Phase 2b clinical trial for the treatment of localized prostate cancer and working capital and general corporate purposes, which may include research and development expenses, general and administrative expenses and manufacturing expenses.
During the third quarter of 2016, the Company received proceeds of $1.7 million from the exercise of warrants and stock options.
In September 2016, the Company repaid the outstanding principal balance of the loan with Oxford Finance LLC with a total payment of $4.2 million.
On October 12, 2016 the Board of Directors of Sophiris Bio Inc. approved the appointment of Allison Hulme, Ph.D., the Company’s chief operating officer and head of research and development, as a director of the Company.
"Sophiris has been successful in building on a series of positive clinical milestones that we believe will enable us to further the development of topsalysin," said Randall Woods, president and CEO of Sophiris Bio. "In the wake of announcing positive data from our Phase 2a proof-of-concept study in localized prostate cancer as well as from our Phase 3 trial in BPH that met its primary endpoint, the Company was able to raise additional funds in the public market in the third quarter to strengthen our balance sheet and enable us to fund an additional clinical trial. Over the past quarter, we have made significant progress in preparing to initiate a Phase 2b clinical trial of topsalysin for the treatment of localized prostate cancer, which is expected to report initial results by the end of 2017."

Financial Results:

At September 30, 2016, we had cash, cash equivalents and securities available-for-sale of $31.3 million and net working capital of $29.8 million. We expect that our cash and cash equivalents will be sufficient to fund our operations into the second quarter of 2018. At this point in time we do not plan on pursuing a second Phase 3 trial in BPH unless we obtain additional financing.

For the three months ended September 30, 2016

The Company reported a net loss of $4.3 million ($0.17 per share) for the three months ended September 30, 2016 compared to a net loss of $3.7 million ($0.22 per share) for the three months ended September 30, 2015.

Research and development expenses

Research and development expenses were $0.6 million for the three months ended September 30, 2016, compared to $2.6 million for the three months ended September 30, 2015. The decrease in research and development costs are primarily attributable to a decrease in the costs associated with the Company’s Phase 3 PLUS-1 clinical trial and our Phase 2a proof of concept clinical trial for localized prostate cancer both of which were completed prior to the third quarter.

General and administrative expenses

General and administrative expenses were $3.0 million for the three months ended September 30, 2016 compared to $0.9 million for the three months ended September 30, 2015. The increase is primarily due to the inclusion of $1.4 million in offering expenses which were allocated to the fair value of the warrants issued in our public offering in August 2016. The balance of the offering expenses were recorded as a reduction to equity. The increase was also related to an increase in personnel related costs and professional services.

Loss on revaluation of warrant liability.

Loss on revaluation of the warrant liability was $0.3 million for the three months ended September 30, 2016. The non-cash loss is associated with the change in the fair value of our warrant liability.

For the nine months ended September 30, 2016

The Company reported a net loss of $10.6 million ($0.51 per share) for the nine months ended September 30, 2016 compared to a net loss of $11.7 million ($0.69 per share) for the nine months ended September 30, 2015.

Research and development expenses

Research and development expenses were $2.5 million for the nine months ended September 30, 2016 compared to $8.2 million for the nine months ended September 30, 2015. The decrease in research and development costs are primarily attributable to a decrease of $5.2 million in the costs associated with the Company’s completed Phase 3 PLUS-1 clinical trial of topsalysin for the treatment of BPH and to a lesser extent a decrease in costs associated with our Phase 2a proof of concept clinical trial for localized prostate cancer and manufacturing activities for topsalysin.

General and administrative expenses

General and administrative expenses were $5.6 million for the nine months ended September 30, 2016 compared to $3.0 million for the nine months ended September 30, 2015. The increase is primarily due to the inclusion of $1.6 million in offering costs which were allocated to the warrants issued in connection with our offerings which closed in May and August of 2016. The increase, to a lesser extent, is due to an increase in personnel, legal, accounting, consulting and professional services. These increases were partially offset by a decrease in non-cash stock-based compensation expense.

Loss on revaluation of warrant liability.

Loss on revaluation of the warrant liability was $2.0 million for the nine months ended September 30, 2016. The non-cash loss is associated with the change in the fair value of our warrant liability.

On November 9, 2016 SciClone Pharmaceuticals, reported financial results for the quarter ended September 30, 2016 (Filing, 8-K, SciClone Pharmaceuticals, NOV 9, 2016, View Source [SID1234516725]).

·
Revenues: In the third quarter of 2016, SciClone reported revenues of $40.5 million, compared to $42.9 million for the same period in 2015.
·
GAAP Diluted EPS: In the third quarter of 2016, SciClone reported GAAP diluted net income per share of $0.19, compared to GAAP diluted net income per share of $0.23 for the same period in 2015.
·
Non-GAAP Diluted EPS: In the third quarter of 2016, SciClone reported non-GAAP diluted net income per share of $0.24, compared to $0.26 for the same period in 2015.

Revenues in the third quarter of 2016 were $40.5 million, a $2.4 million or 6% decrease, compared to $42.9 million for the same period in 2015. The decrease in revenue in the third quarter 2016 compared to the same period last year included $1.0 million in revenue related to initial sales of DC Bead recorded in the third quarter of 2015. ZADAXIN revenues were $37.8 million in the third quarter of 2016, a $1.4 million or 3% decrease, compared to $39.2 million for the same period in 2015. The 3% decrease in ZADAXIN revenues for the third quarter of 2016 compared to the same period last year includes a 15% revenue decrease (9% of which was due to a price decrease for ZADAXIN and 6% of which was due to the effects of foreign exchange), partially offset by a 12% increase in ZADAXIN volume sales compared to the same period last year. An agreement with the Company’s exclusive China importer and tier 1 distributer implemented on January 1, 2016, affects a portion of the price decrease which impacts the timing of when SciClone recognizes revenue from sales, but this does not materially impact the total amount of revenue recognized on an annual basis. In the third quarter 2016, ZADAXIN volume sales increased by 12% compared to the same period last year. Promotion services revenues were $1.1 million for the third quarter of 2016, a $0.2 million or 22% increase, compared to $0.9 million in the same period in 2015, reflecting continued strong growth in the Company’s oncology portfolio. For the nine months ended September 30, 2016, revenues were $116.0 million, compared to $114.4 million for the same period last year.

On a GAAP basis, SciClone reported net income in the third quarter of 2016 of $10.1 million, or $0.20 and $0.19 per share on a basic and diluted basis, respectively, compared to net income of $12.0

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million, or $0.24 and $0.23 per share on a basic and diluted basis, respectively, for the same period in 2015. SciClone’s net income for the nine months ended September 30, 2016 was $24.3 million, compared with net income of $16.9 million for the same period in the prior year, or $0.49 and $0.46 per share on a basic and diluted basis, respectively, for the nine months ended September 30, 2016, compared with $0.34 and $0.32 per share on a basic and diluted basis, respectively, for the same period in 2015.

SciClone’s non-GAAP net income in the third quarter of 2016 was $12.7 million, or $0.25 and $0.24 per share on a basic and diluted basis, respectively, compared with non-GAAP net income of $13.4 million, or $0.27 and $0.26 per share on a basic and diluted basis, respectively, for the same period last year. SciClone’s non-GAAP net income for the nine months ended September 30, 2016 was $33.1 million, compared with non-GAAP net income of $36.7 million for the same period in the prior year, or $0.66 and $0.63 per share on a basic and diluted basis, respectively, for the nine months ended September 30, 2016, compared with non-GAAP net income of $0.73 and $0.70 per share on a basic and diluted basis, respectively, for the same period in 2015.

Friedhelm Blobel, PhD, SciClone’s Chief Executive Officer, commented: "We are pleased with our performance in the third quarter and year to date, which is in line with our expectations and reflects the value and continued growth potential of our core business, led by ZADAXIN. ZADAXIN continues to significantly out-perform the growth rate of the China pharmaceuticals market, with double-digit volume growth. The decrease in revenue was in line with our expectations, and predominantly reflects a stabilizing overall growth rate of China’s pharmaceuticals market, in the range of 6%-9%, and pricing pressure at the provincial level. We continue to expect that pricing pressures on revenue in 2016 will be offset, at least in significant part, through sharing of the burden with our China distributor and through our strategies to increase volume. Moreover, we are pleased with the continuing strong cash generation of our business.

"ZADAXIN continues to have significant growth potential as a differentiated, high quality, Western-manufactured brand, and the thymalfasin marketplace demand remains strong. We achieved a major milestone with the initiation and dosing of the first patient in our investigator-initiated clinical trial in sepsis, a major unmet medical need and growth opportunity for ZADAXIN.

"We made considerable progress in advancing our development portfolio. During the third quarter, we announced a regional licensing agreement with Soligenix, Inc, for SGX942, a novel first-in-class therapy being developed for oral mucositis. We also announced that the first patient had been dosed in the Phase 1 proof-of-concept trial of PT-112 in Taiwan, a novel anticancer agent in-licensed from Phosplatin Therapeutics. SGX942 and PT-112 are valuable additions to our development portfolio, offering opportunities to participate in the Chinese Class 1 regulatory pathway including local manufacturing, and with the potential to meaningfully expand our oncology business in China and adjacent markets for the future.

"The healthcare reform movement in China continues to offer opportunities for SciClone to grow our marketed product portfolio and to advance our development pipeline of high quality, differentiated medicines. We remain confident about our prospects for near-term growth and maximizing long-term value creation."

For the third quarter of 2016, sales and marketing (S&M) expenses were $13.3 million, compared with $15.1 million for the same period in 2015. The decrease in S&M for the third quarter of 2016,

2

compared to the same period in 2015, is primarily related to decreases in sales and marketing events and lower DC Bead-related launch costs. For the nine months ended September 30, 2016, S&M expenses were $40.1 million, compared with $39.7 million, for the same period last year.

For the third quarter of 2016, research and development (R&D) expenses were $3.3 million, compared with $1.0 million of R&D expenses for the same period of 2015. For the third quarter of 2016 and 2015, we recorded $0.3 million and zero, respectively, related to in-license arrangements with certain licensees and $2.8 million and $1.0 million, respectively, related to R&D expenses for clinical and preclinical R&D activities with certain licensees. For the nine months ended September 30, 2016, R&D expenses were $9.5 million, compared with $8.7 million, for the same period last year.

For the third quarter of 2016, general and administrative (G&A) expenses were $7.9 million, compared with $7.3 million for the same period in 2015. For the nine months ended September 30, 2016, G&A expenses were $23.5 million, compared with $20.8 million for the same period last year. G&A was higher for both the third quarter and nine-month periods of 2016, compared to the same periods of 2015, related to legal costs in connection with the Company’s ongoing strategic review and stock-based compensation expenses.

For the third quarter of 2016, SciClone’s income tax expense was $1.1 million, compared with $0.6 million for the same period in 2015. Income tax expense was lower in the third quarter of 2015 related to the restructuring of the Company’s China business. For the nine months ended September 30, 2016, income tax expense was $2.6 million, compared with $0.6 million, for the same period last year, and included a $1.3 million uncertain tax provision for our China operations from 2013 to 2015.

As of September 30, 2016, cash and cash equivalents totaled $130.1 million, compared to $101.4 million as of December 31, 2015, excluding the $12.8 million of restricted cash held in escrow as of December 31, 2015 for the SEC settlement which was released and paid in February 2016.

SciClone has presented non-GAAP information above as the Company believes this non-GAAP information is useful for investors, taken in conjunction with SciClone’s GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of SciClone’s operating results as reported under GAAP. The non-GAAP calculations and reconciliation are provided in the accompanying table titled "Reconciliation of GAAP to Non-GAAP Net Income" except that for the non-GAAP EPS referenced in "2016 Non-GAAP Earnings Guidance Revised Upward" below, the Company is unable to provide a quantitative reconciliation of its forward-looking estimate of non-GAAP EPS to a forward-looking estimate of GAAP EPS because certain information needed to make a reasonable forward-looking estimate of GAAP EPS for the full fiscal year 2016 is difficult to predict and estimate and is often dependent on future events which may be uncertain or outside of the Company’s control, for example, milestone payments.

2016 Non-GAAP Earnings Guidance Revised Upward

Based on the continued volume growth of ZADAXIN and implementation of effective operating cost controls, SciClone is revising upwards its projected non-GAAP earnings per share on a fully diluted basis to be in the range of $0.78 to $0.82, up from the previously expected range of $0.70 to $0.74 for

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the year. The Company continues to project its 2016 revenue to be in the range of $158 million to $163 million.

The Company’s outlook for 2016 continues to be influenced by several factors, including the overall growth rate of the China pharmaceuticals market, anticipated pricing pressure at the provincial level and higher R&D expenses as it continues to advance its pipeline products toward commercialization. The Company further expects that pricing pressures on revenue in 2016 will be offset, at least in significant part, through sharing of the burden with its China distributors and potentially through volume increases.