On November 5, 2015 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the third quarter ended September 30, 2015 (Press release, Nektar Therapeutics, NOV 5, 2015, View Source [SID:1234508036]).

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Cash and investments in marketable securities at September 30, 2015 were $267.8 million as compared to $279.7 million at June 30, 2015. Cash and investments at September 30, 2015 include a $40.0 million milestone payment received from AstraZeneca in Q3 2015 for the first commercial sale of MOVENTIG (naloxegol) in Germany. Cash and investments at September 30, 2015 do not include the proceeds from the $250 million direct private placement of 7.75% Senior Secured Notes due in 2020, which was closed on October 5, 2015. A portion of the proceeds from these new $250 million Senior Notes were used to redeem fully $125.0 million of 12% Senior Secured Notes due in 2017.

"We have made great progress in advancing our pipeline this year," said Howard W. Robin, President and Chief Executive Officer of Nektar. "MOVANTIK is performing very well with positive feedback from physicians and patients, ADYNOVATE is poised for approval, the NKTR-181 Phase 3 SUMMIT-07 efficacy study is enrolling ahead of schedule and we are exceptionally pleased to report that the FDA cleared the NKTR-214 IND earlier than anticipated. NKTR-214 has the potential to bring a new mechanism – direct and selective stimulation of a patient’s cancer-fighting T-cells — to the next generation of cancer immunotherapies. We expect to dose our first patients shortly at MD Anderson Cancer Center and Yale Cancer Center."

Year-to-date revenue for 2015 was $191.4 million as compared to $181.2 million in the first nine months of 2014. The increase in revenue in the first nine months of 2015 as compared to the same period in 2014 includes the 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. and the recognition of the $40.0 million milestone payment from AstraZeneca following the first commercial sale of MOVANTIK in a major European country. In addition, product sales and royalty revenue increased by $9.3 million in the first nine months of 2015 as compared to the same period in 2014. Revenue in the third quarter of 2015 was $60.0 million as compared to $132.9 million in the third quarter of 2014 due to the recognition of a one-time $105 million approval milestone for MOVANTIK in the third quarter of 2014.

Total operating costs and expenses in the third quarter of 2015 were $59.5 million as compared to $52.6 million in the third quarter of 2014. Year-to-date total operating costs and expenses in 2015 were $191.4 million as compared to $160.2 million for the same period in 2014. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

Research and development expense in the third quarter of 2015 was $43.2 million as compared to $34.2 million in the third quarter of 2014. Year-to-date R&D expense for 2015 was $135.7 million as compared to $109.2 million for the same period in 2014. R&D expense was higher in the third quarter and first nine months of 2015 as compared to the same periods in 2014 primarily due to the initiation of the Phase 3 efficacy trial of NKTR-181 in chronic low back pain and the long-term safety study for NKTR-181. R&D expense for the first nine months of 2015 also increased as a result of IND-enabling and clinical study start-up activities for NKTR-214.

General and administrative expense was $9.5 million in the third quarter of 2015 as compared to $9.1 million in the third quarter of 2014. G&A expense in the first nine months of 2015 was $30.0 million as compared to $28.7 million for the same period in 2014.

Net loss in the third quarter of 2015 was $8.2 million or $0.06 net loss per diluted share as compared to net income of $70.6 million or $0.53 net income per diluted share in the third quarter of 2014. Net loss in the first nine months of 2015 was $27.0 million or $0.21 net loss per diluted share as compared to net loss of $8.2 million or $0.07 net loss per diluted share in the first nine months of 2014.

The company also announced upcoming presentations at the following scientific congresses during the fourth quarter of 2015:

Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 30th Anniversary Annual Meeting, National Harbor, MD:

Abstract Title: "Synergistic antitumor activity of the CD122-biased immunostimulatory cytokine NKTR-214 when combined with anti-PD-1 in murine tumor models", Hoch, U., et al.
Date: November 6, 2015, 12:45 p.m. — 2:00 p.m. Eastern Time

2015 San Antonio Breast Cancer Symposium, San Antonio, TX:

Poster P1-13-02: "Early change in topoisomerase 1 (Top1) positive circulating tumor cells (CTCs) is associated with overall survival (OS) in patients with advanced breast cancer after treatment with etirinotecan pegol", Rugo, H., et al.
Poster Session: Advanced Chemotherapy
Date: December 9, 2015, 5:00 p.m. – 7:00 p.m. Central Time

Poster P4-11-08: "Impact of treatment on quality of life (QOL) in the BEACON study, a randomized phase III trial of etirinotecan pegol (EP) versus Treatment of Physician’s Choice (TPC) in patients (pts) with advanced breast cancer (aBC) whose disease has progressed following treatment with an Anthracycline, a Taxane and Capecitabine", Cortes, J., et al.
Poster Session: "Psychosocial, Quality of Life, and Educational Aspects: Psychosocial, QOL, and Educational Aspects — Other"
Date: December 11, 2015, 7:30 a.m. — 9:00 a.m. Central Time

On November 5, 2015 Medivation, Inc. (NASDAQ: MDVN) reported its financial results for the third quarter ended September 30, 2015. U.S. net sales of XTANDI (enzalutamide) capsules, as reported by Astellas Pharma Inc, were $313.0 million for the quarter (+73% vs. prior year) (Press release, Medivation, NOV 5, 2015, View Source [SID:1234508035]). Third quarter 2015 U.S. net sales increased by approximately 5% compared with second quarter 2015 net sales of $298.4 million. The sequential quarter increase in net sales was primarily due to an increase in underlying demand (mid-single digit percent growth, compared with June 2015 quarter) and a lower gross-to-net rate recorded by Astellas in the third quarter, which was offset by changes in channel partner inventory levels during the quarters.

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Ex-U.S. net sales of XTANDI, as reported by Astellas, were approximately $205 million for the quarter (+71% vs. prior year). Third quarter ex-U.S. net sales increased by 9% compared with second quarter 2015 net sales of approximately $188 million.

"During the third quarter Medivation made significant progress led by continued demand growth for XTANDI for the treatment of metastatic castration-resistant prostate cancer," said David Hung, M.D., president and chief executive officer of Medivation. "In October, we successfully completed the acquisition for the late stage asset talazoparib, a highly-potent, orally-available poly ADP ribose polymerase (PARP) inhibitor. With the acquisition of talazoparib, we now have further diversified our late-stage pipeline beyond XTANDI and pidilizumab to complement our early development programs, providing significant opportunities for growth."

Medivation reported GAAP net income of $79.5 million, or $0.47 per diluted share, for the quarter ended September 30, 2015, compared with GAAP net income of $78.0 million, or $0.48 per diluted share, for the same period in 2014. Non-GAAP net income for the third quarter of 2015 was $58.4 million, or $0.35 per diluted share, compared with non-GAAP net income of $16.3 million, or $0.10 per diluted share, for the same period in 2014.

Medivation’s collaboration revenue for the third quarter of 2015 was $260.7 million on a GAAP basis compared with $200.5 million for the same period in 2014 (+30% vs. prior year). Non-GAAP collaboration revenue, which excludes collaboration revenue related to upfront and milestone payments, was $190.1 million for the third quarter compared with $106.2 million for the same period in 2014 (+79% vs. prior year).

Medivation’s collaboration revenue consists of three components: collaboration revenue related to U.S. XTANDI net sales, collaboration revenue related to ex-U.S. XTANDI net sales, and collaboration revenue related to upfront and milestone payments.

Medivation’s collaboration revenue related to U.S. net sales of XTANDI for the third quarter 2015 was $156.5 million compared with $90.7 million for the same period in 2014 (+73% vs. prior year).

Medivation’s collaboration revenue related to ex-U.S. net sales of XTANDI for the third quarter 2015 was $33.6 million compared with $15.5 million for the same period in 2014 (+116% vs. prior year).

Medivation’s collaboration revenue related to upfront and milestone payments for the third quarter 2015 was $70.6 million compared with $94.2 million for the same period in 2014 (-25% vs. prior year).

Operating expenses were $121.7 million for the quarter ended September 30, 2015 on a GAAP basis compared with $108.6 million for the same period in 2014. Non-GAAP operating expenses were $98.8 million for the quarter ended September 30, 2015 compared with $79.3 million for the same period in 2014.

Selling, general and administrative (SG&A) expenses for the third quarter of 2015 were $75.8 million on a GAAP basis compared with $63.2 million for the same period in 2014. Non-GAAP SG&A expenses for the third quarter of 2015 were $58.8 million, compared with $47.5 million for the same period in 2014. The increase in non-GAAP SG&A expenses primarily relates to higher sales, marketing, administrative expenses, higher royalties to UCLA and higher personnel-related costs (excluding stock-based compensation).

Research and development (R&D) expenses for the third quarter of 2015 were $45.9 million on a GAAP basis compared with $45.4 million for the same period in 2014. Non-GAAP R&D expenses for the third quarter of 2015 were $40.0 million, compared with $31.8 million for the same period in 2014. The increase in non-GAAP R&D expenses primarily relates to higher pidilizumab (MDV9300) costs, higher facilities and information technology costs and higher personnel-related costs (excluding stock-based compensation).

At September 30, 2015, cash and cash equivalents were $488.9 million, compared with $502.7 million at December 31, 2014. During the third quarter, we completed the redemption of the 2017 Convertible Notes, utilizing $167.8 million of cash. In October 2015, we utilized $410.0 million in cash to fund an upfront payment to BioMarin Pharmaceutical Inc., for the acquisition of talazoparib (MDV3800).

Enzalutamide Development Program

Reported updated data in September 2015 from a Phase 2 trial evaluating the investigational use of enzalutamide as a single agent for the treatment of advanced androgen receptor positive, triple-negative breast cancer at the 2015 European Cancer Congress.

Recent Corporate Developments

Closed the acquisition on October 6, 2015, for all worldwide rights to talazoparib, an orally-available poly ADP ribose polymerase (PARP) inhibitor. In connection with the closing, Medivation made an up-front payment of $410.0 million to BioMarin in the fourth quarter of 2015. All other amounts to be paid to BioMarin in connection with this transaction will be subject to the successful achievement of certain regulatory and sales-based milestones and royalties relating to talazoparib.

Effected a two-for-one stock split in the form of a stock dividend on Medivation’s common stock, pursuant to which stockholders of record on August 13, 2015, received an additional share of common stock for each share they held as of the record date. Approximately 81.7 million common shares were issued as a result of the stock dividend in mid-September. Medivation’s common stock began trading on a post-dividend basis on the NASDAQ Global Select Market at the opening of trading on September 16, 2015.

Entered into a Credit Agreement with JPMorgan Chase Bank, N.A., as administrative agent, and the lenders, providing for a one-year $75.0 million revolving loan facility. On September 17, 2015, Medivation executed a borrowing of $75.0 million under the Revolving Credit Facility, which was scheduled to mature on March 17, 2016. On October 23, 2015, Medivation entered into an amendment and restatement of the credit agreement providing for a five-year $300.0 million revolving loan facility and an uncommitted accordion facility subject to the satisfaction of certain conditions. On October 23, 2015, Medivation borrowed $75.0 million under the amended revolving credit facility, which was used to repay the $75.0 million outstanding under the original credit agreement.

Announced the appointment of Mohammad Hirmand, M.D., as interim chief medical officer following the retirement of Lynn Seely, M.D.

On November 5, 2015 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its third quarter 2015 financial results and ongoing progress with its pipeline, including duvelisib, an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, and IPI-549, an oral immuno-oncology development candidate that selectively inhibits PI3K-gamma (Press release, Infinity Pharmaceuticals, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107548 [SID:1234508033]). Infinity also announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the investigation of duvelisib for the treatment of patients with follicular lymphoma (FL) who have received at least two prior therapies. Earlier this year, Infinity received Fast Track designation for the investigation of duvelisib for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Infinity is conducting registration-focused trials evaluating the safety and efficacy of duvelisib, including DYNAMO, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma (iNHL), and DUO, a Phase 3 study in patients with relapsed/refractory CLL.

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"The quarter was marked by important clinical development progress for duvelisib, particularly the completion of patient enrollment in DYNAMO. We are also pleased to have recently received Fast Track designation for the investigation of duvelisib for the treatment of follicular lymphoma in patients who have received at least two prior therapies, which complements our Fast Track designation in CLL and supports our belief in the potential of duvelisib to help fill important medical needs," stated Adelene Perkins, Infinity’s chair, president and chief executive officer. "We are making strong progress toward the completion of patient enrollment in DUO and expect to complete enrollment this quarter. We look forward to completing our regulatory requirements expeditiously to leverage the Fast Track opportunities as we pursue parallel registration paths within iNHL and CLL."

In addition to the DYNAMO and DUO studies, Infinity is conducting CONTEMPO, a Phase 1b/2 study in treatment-naive FL patients, and SYNCHRONY, a Phase 1b study in CLL patients whose disease is refractory to or has relapsed while receiving a Bruton’s tyrosine kinase (BTK) inhibitor. Infinity expects three additional clinical studies to begin this year, including the first clinical study of duvelisib in combination with venetoclax, AbbVie’s first-in-class investigational B-cell lymphoma-2 (BCL-2) selective inhibitor. Infinity and AbbVie are jointly developing duvelisib in oncology.

"At Infinity, our mission is to build a company and a community that can sustainably discover, develop and deliver first-in-class and best-in-class medicines to patients. The recent expansion of our pipeline into solid tumors with the addition of IPI-549 represents an important step toward fulfilling our mission. We are planning to initiate a Phase 1 study of IPI-549 in patients with solid tumors in the first quarter of 2016," Ms. Perkins continued.

In preclinical studies, IPI-549 inhibits immune-suppressive macrophages within the tumor microenvironment, whereas other immunotherapies such as checkpoint modulators more directly target immune effector cell function. As such, IPI-549 has the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring an anti-tumor immune response when used in combination with other immunotherapies such as checkpoint inhibitors.

Recent highlights include the following:

Duvelisib Program

Duvelisib granted Fast Track designation for the treatment of patients with FL: Infinity reported that the FDA granted Fast Track designation for the investigation of duvelisib for the treatment of patients with FL who have received at least two prior therapies. The FDA established the Fast Track designation process to facilitate the development and expedite the review of investigational medicines intended to treat serious or life-threatening conditions and that demonstrate the potential to address an unmet medical need.

Duvelisib data to be presented at ASH (Free ASH Whitepaper) Annual Meeting: Infinity reported that three duvelisib abstracts have been accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2015 Annual Meeting, which is being held December 5 – 8 in Orlando, Florida. Presentations will include data from preclinical and translational research conducted in collaboration with The Feinstein Institute for Medical Research demonstrating that inhibition of PI3K-delta and PI3K-gamma affect B-cell growth and survival through both direct effects on CLL cells as well as by disrupting the tumor microenvironment. Additionally, clinical data from two investigator-sponsored studies in patients with hematologic malignancies will be presented. The three poster presentations are as follows:

Saturday, December 5, 2015, 5:30 p.m. – 7:30 p.m. ET
Title: Dual inhibition of PI3K-delta and gamma by duvelisib (IPI-145) impairs CLL B- and T-cell migration, survival and proliferation in a murine xenograft model using primary chronic lymphocytic leukemia cells (Abstract #1753)
Lead Author: Shih-Shih Chen, Ph.D., The Feinstein Institute for Medical Research

Monday, December 7, 2015, 6:00 p.m. – 8:00 p.m. ET
Title: Preliminary results of a Phase Ib study of duvelisib in combination with FCR (dFCR) in previously untreated, younger patients with CLL (Abstract #4158)
Lead Author: Matthew Davids, M.D., Dana-Farber Cancer Institute

Title: Combination trial of duvelisib (IPI-145) with bendamustine, rituximab or bendamustine/rituximab in patients with lymphoma or chronic lymphocytic leukemia (Abstract #3928)
Lead Author: Ian Flinn, M.D., Sarah Cannon Research Institute

Target enrollment in DYNAMO reached: In September, Infinity announced it had reached target enrollment in DYNAMO, a global, Phase 2 open-label, single-arm, monotherapy study of duvelisib (25 mg BID) in approximately 120 patients with iNHL whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint is overall response rate. Topline data from the study are anticipated in the third quarter of 2016. The enrollment milestone triggered a $130 million milestone payment from AbbVie.

BRAVURA study announced: In October, Infinity announced plans to initiate BRAVURA, a Phase 3, double-blind, placebo-controlled study in patients with relapsed iNHL, in the fourth quarter of 2015. BRAVURA is designed to evaluate the safety and efficacy of duvelisib plus rituximab and bendamustine (RB) compared to placebo plus RB in approximately 600 patients. The primary endpoint is progression-free survival. Infinity is planning to meet with the FDA to ascertain that BRAVURA can serve as a confirmatory study if DYNAMO supports an accelerated approval.

FRESCO study announced: In October, Infinity announced plans to initiate FRESCO, a Phase 2 study in patients with relapsed/refractory FL, in the fourth quarter of 2015. FRESCO is designed to evaluate the safety and efficacy of duvelisib plus rituximab versus rituximab in combination with chemotherapy in approximately 200 patients. The primary endpoint is progression-free survival.

IPI-549 Program

IPI-549 expected to enter Phase 1 clinical development in the first quarter of 2016: In September, Infinity announced the expansion of its pipeline with IPI-549, an oral immuno-oncology development candidate that selectively inhibits PI3K-gamma. At the CRI-CIMT-EATI-AACR – The Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper), Infinity researchers reported preclinical data demonstrating the potential of IPI-549 to disrupt the immune-suppressive tumor microenvironment and enable a heightened anti-tumor immune response. Research also showed that IPI-549 demonstrated dose-dependent, single-agent, anti-tumor activity in multiple solid tumor models, including murine models of lung, colon and breast cancer. Additionally, mice treated with IPI-549 in combination with checkpoint inhibitors showed greater tumor growth inhibition than either treatment as a monotherapy.
In the first quarter of 2016, Infinity expects to begin a Phase 1 clinical study of IPI-549 in patients with selected solid tumors, including non-small cell lung cancer and melanoma. The study will evaluate IPI-549 as a monotherapy as well as in combination with an anti–PD-1 antibody therapy.

Corporate Updates

Senior management team augmented: In October, William Bertrand joined Infinity as executive vice president, general counsel. Prior to Infinity, Mr. Bertrand held various roles of increasing responsibility at Salix Pharmaceuticals, Inc. and most recently served as senior vice president, general manager responsible for the Salix commercial business as well as its transition and integration into Valeant Pharmaceuticals International, Inc. From 2001 to 2013, Mr. Bertrand held positions of increasing responsibility at MedImmune, Inc., serving as its first and only general counsel from 2003 to 2013, prior to and following its sale to AstraZeneca PLC in 2008. Prior to MedImmune, Mr. Bertrand served as associate general counsel at Pharmacia Corporation. He earned a B.S. in Biology from Wayne State University and a J.D. from the University of Wisconsin-Madison.

Third Quarter 2015 Financial Results

At September 30, 2015, Infinity had total cash, cash equivalents and available-for-sale securities of $163.0 million, compared to $199.5 million at June 30, 2015, which does not include the $130 milestone payment received from AbbVie in November 2015.
Total revenue during the third quarter of 2015 was $90.7 million, compared to $160.6 million in the third quarter of 2014.
Revenue included a $75.2 million license fee associated with the $130 million milestone payment from AbbVie for the completion of patient enrollment in DYNAMO and $15.5 million in research and development (R&D) services. R&D services revenue for the third quarter of 2015 was composed of $9.8 million associated with the $130 million milestone payment and $5.7 million associated with the $275 million upfront payment from AbbVie received in September 2014. Revenue during the third quarter of 2014 was composed of $159.1 million license fee and $1.5 million in R&D services, both of which related to the $275 million upfront milestone from AbbVie. Infinity will recognize the remainder of the $130 million milestone payment and $275 million upfront payment over the period in which R&D services will be provided.

R&D expense for the third quarter of 2015 was $37.7 million, compared to $44.9 million for the third quarter of 2014. The decrease in R&D expense for the third quarter of 2015 compared to the same period in 2014 was primarily due to a $5.0 million option fee payment to Takeda in the third quarter of 2014 as well as lower clinical development expenses for duvelisib.

General and administrative (G&A) expense was $9.8 million for the third quarter of 2015, compared to $8.0 million for the same period in 2014. The increase in G&A expense was primarily related to the continued build-out of the company’s commercial capabilities and the functional support related to those activities.

Net income for the third quarter of 2015 was $42.5 million, or a basic earnings per common share of $0.85 and a diluted earnings per common share of $0.84. Net income for the third quarter of 2014 was $103.2 million, or a basic earnings per common share of $2.08 and a diluted earnings per common share of $2.03.
2015 Financial Guidance

The company’s 2015 financial outlook is as follows:

Revenue: Infinity expects revenue to range from $100 million to $120 million.
Net Loss: Infinity expects net loss for 2015 to range from $125 million to $145 million.
Cash and Investments: Infinity expects to end 2015 with a year-end cash and investments balance ranging from $230 million to $250 million. This anticipated year-end cash and investments balance includes the $130 million milestone payment from AbbVie associated with the completion of patient enrollment in DYNAMO.
Conference Call Information
Infinity will host a conference call today at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) or 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 60777175. An archived version of the webcast will be available on Infinity’s website for 30 days.

About Duvelisib
Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins with predominantly non-overlapping roles known to support the growth and survival of malignant B-cells.i Preclinical data suggest that PI3K-delta signaling can lead to the proliferation of malignant B-cells, and both PI3K-gamma and PI3K-delta play a role in the formation and maintenance of the supportive tumor microenvironment.ii Duvelisib is the only investigational PI3K-delta,gamma inhibitor in Phase 3 clinical development and has the potential to be a first-in-class treatment for certain types of hematologic malignancies, or blood cancers. AbbVie and Infinity Pharmaceuticals, Inc. are jointly developing duvelisib in oncology.

About IPI-549
IPI-549 is an orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 inhibits immune suppressive macrophages within the tumor microenvironment, whereas other immunotherapies such as checkpoint modulators more directly target immune effector cell function. As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

Duvelisib and IPI-549 are investigational compounds and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On November 5, 2015 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for its quarter ended September 30, 2015, and provided an update on the Company’s clinical development programs for 2015 (Press release, Clovis Oncology, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107598 [SID:1234508032]).

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"We are entering a new phase at Clovis, transitioning into becoming a commercial biopharmaceutical company," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Our U.S. commercial organization, including the sales force, is now fully in place. This team is highly experienced, enthusiastic and ready to go, following our U.S. launch meeting last week. We are now fully prepared to launch rociletinib upon a potential U.S. approval and we are actively building our E.U. commercial organization in preparation for a late 2016 launch in Europe. Additionally, having advanced our rucaparib NDA submission timeline to Q2 2016, we are planning for a potential U.S. launch of rucaparib for advanced ovarian cancer by the end of 2016. We are very enthusiastic about the prospect of having our commercial organization support sales for both rociletinib and rucaparib."

Third Quarter 2015 Financial Results

Net loss attributable to common shareholders was $98.6 million ($2.62 per share) for the third quarter of 2015 and $233.3 million ($6.62 per share) for the first nine months of 2015, compared to a net loss of $39.6 million ($1.17 per share) and $105.1 million ($3.10 per share) for the comparable periods of 2014.

Research and development expenses totaled $76.1 million for the third quarter of 2015 and $193.3 million for the first nine months of 2015, compared to $35.0 million and $87.6 million for the comparable periods in 2014. The increase in expenses for both the three- and nine-month periods is due to the significantly expanded clinical development activities for rociletinib and rucaparib, increased launch planning activities for rociletinib and increased personnel-related expenses associated with the hiring of additional staff to support the Company’s expanded activities.

General and administrative expenses totaled $8.3 million for the third quarter of 2015 and $22.3 million for the first nine months of 2015, compared to $5.3 million and $15.9 million for the comparable periods in 2014. The year over year increase is primarily due to higher share-based compensation and personnel expense for employees engaged in general and administrative activities, increased facility costs and higher professional service fees.

Acquired in-process research and development expenses totaled $12.0 million for both the third quarter of 2015 and the first nine months of 2015. There was no acquired in-process research and development expense for the third quarter of 2014 and $8.8 million for the first nine months of 2014. During the third quarter of 2015, the Company made milestone payments totaling $12.0 million to Celgene Corporation upon acceptance of the NDA and MAA submissions for rociletinib by the FDA and EMA, respectively.

Share-based compensation expense totaled $12.4 million for the third quarter of 2015 and $29.5 million for the first nine months of 2015.

Clovis had $605.9 million in cash, cash equivalents and available-for-sale securities and approximately 38.3 million outstanding shares of common stock as of September 30, 2015. Our net cash used in operations for the third quarter of 2015 was $71.7 million and $177.4 million for the first nine months of 2015, including $12.0 million in rociletinib milestone payments. In July 2015, the Company raised net proceeds of $298.5 million through an offering of 4.1 million shares of common stock.

2015 Key Milestones and Objectives

Highlights of planned or completed objectives for each product follows:

Rociletinib

Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation. The U.S. Food and Drug Administration (FDA) has accepted Clovis’ New Drug Application (NDA) for rociletinib and has granted it priority review status with a Prescription Drug User Fee Act (PDUFA) action date of March 30, 2016. In addition, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for rociletinib.

The U.S. commercial and medical affairs organizations are now in place and efforts are currently underway to build out the E.U. commercial organization.

Rociletinib was the subject of several posters and presentations during the third quarter, including updates of data from the TIGER-X study in EGFR mutant, T790M-positive patients with a history of CNS involvement, as well as EGFR mutant, T790M-negative patients as determined by tissue as well as plasma testing. Posters and presentations for all Clovis products in development presented during the third quarter may be viewed at View Source

Rucaparib

During the third quarter, updated findings from ARIEL2 and Study 10, two ongoing studies evaluating the safety and activity of rucaparib in advanced ovarian cancer patients were presented at the 18th ECCO – 40th ESMO (Free ESMO Whitepaper) European Cancer Congress. Data from these studies demonstrated encouraging activity and safety in women with advanced, platinum-sensitive ovarian cancer with tissue BRCA (gBRCA and sBRCA) mutations. In addition, these data demonstrated that the application of Clovis’ proprietary BRCA-like tumor DNA signature to Foundation Medicine’s companion diagnostic assay successfully predicts the population of BRCA-like patients that are not gBRCA or sBRCA that respond to rucaparib therapy. Highlights of the data presented included the following (all response rates RECIST):

Data from ARIEL2 in 40 evaluable BRCA-mutant patients demonstrated an ORR of 75%, a median PFS of 12.8 months and a median duration of response of 9.5 months
Complete responses (CRs) observed in 15% of patients
Data from ARIEL2 in 77 evaluable patients with the BRCA-like signature demonstrated an ORR of 36%, a median PFS of 5.7 months and a median duration of response of 8.2 months
Data from Study 10 in 39 evaluable germline BRCA-mutant patients demonstrated an ORR of 67%, a disease control rate (DCR) of 87%, and median duration of response of 6.6 months
CRs observed in 8% of patients in this group
Rucaparib is well-tolerated with a manageable safety profile; the grade 3/4 treatment-related adverse events (AEs) observed in >15% of patients treated with the recommended 600mg BID dose were anemia/decreased hemoglobin (19%) in ARIEL2, and fatigue/asthenia (21%), and anemia (26%) in Study 10
Based on these compelling data, Clovis intends to submit an NDA to the FDA for rucaparib as treatment for advanced ovarian cancer patients with a tissue BRCA mutation in the second quarter of 2016, with the intention, pending data, to follow with a supplemental NDA for advanced ovarian cancer patients with a BRCA-like mutation. During the quarter, Clovis completed enrollment of the mutant BRCA population that will serve as the basis of its planned NDA submission.

Lucitanib

A Phase 2 program is ongoing to explore lucitanib in multiple indications, including a U.S. study in patients with treatment-refractory FGF-aberrant breast cancer and a global study in patients with advanced lung cancer with FGFR1 amplification, both of which are currently enrolling patients. In parallel with these Clovis-sponsored studies, a Servier-sponsored Phase 2 study of lucitanib in patients with advanced breast cancer is underway to identify the population of patients most likely to benefit from lucitanib therapy.

Management Update

Erle Mast, Clovis’ Executive Vice President, Chief Financial Officer and Clovis co-founder, has announced his plan to retire effective March 31, 2016. The Company is initiating a search for Erle’s successor, and intends to recruit a candidate prior to his departure date to enable a transition period during the first quarter.

"With great regret we announce today that Erle Mast, Chief Financial Officer and a co-founder of Clovis, and importantly, my friend and colleague for more than 14 years, has informed us of his plans to retire on March 31, 2016," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "While I am very sorry to see him go, I certainly understand his decision and can only add how much I have enjoyed working with him and appreciate all that he has done for Clovis. Obviously, we are confident that we will be able to recruit a highly qualified individual as a new CFO and appreciate very much Erle giving sufficient notice to allow a smooth transition."

On November 5, 2015 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company"), a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health, reported financial and operating results as at and for the third quarter ended September 30, 2015 (Filing, 6-K, AEterna Zentaris, NOV 5, 2015, View Source [SID:1234508029]).

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Commenting on third quarter results and the Company’s prospects, David A. Dodd, Chairman, President and Chief Executive Officer of the Company, stated, "Despite our continued progress in transforming the Company, the price of our common shares remained under intense pressure during the third quarter as a result of the exercise of Series B Common Share Purchase Warrants ("Series B Warrants"). At the beginning of the quarter, 26,812,308 Series B Warrants were outstanding. We finished the quarter with 6,880,170. As a result of the agreements we reached with the major holders of the Series B Warrants on November 1, only approximately 0.8 million Series B Warrants will remain outstanding, representing approximately 2.7% of the number originally issued. While the dilution caused by the Series B Warrants is substantially ended, we find it necessary to ask our fellow shareholders to approve another share consolidation. We believe that a share consolidation will permit our common shares to remain listed on The Nasdaq Capital Market, which will permit us to raise capital again on reasonable terms, further supporting our focus on developing a profitable, growth-oriented pharmaceutical business."

Commenting on the Company’s lead oncology compound, Mr. Dodd stated, "Our confidence in the commercial potential of Zoptrex, which is the brand name we selected for zoptarelin doxorubicin, was enhanced by the announcement during the third quarter of the results of an investigator sponsored Phase 2 clinical study of Zoptrex in men with in castration- and taxane-resistant prostate cancer. Zoptrex achieved its primary endpoint and demonstrated good tolerability during this early-stage study. The primary endpoint was Clinical Benefit, defined as remaining progression-free by RECIST and Prostate Specific Antigen after treatment for 12+ weeks. Shortly after quarter end, we received very encouraging news regarding Zoptrex when, following a comprehensive review of the final interim efficacy and safety data, the DSMB recommended that we continue the ZoptEC Phase 3 clinical study to its conclusion. We look forward to the successful completion of the clinical development of ZoptrexTM for our initial indication over the next year."

Continuing with his commentary, Mr. Dodd stated, "During the third quarter, we made progress promoting Saizen, a leading product in the $1.6 billion US market for the treatment of growth hormone deficiency in children and adults. Our recently commenced promotional efforts for Saizen show promise and support our belief that detailing this product will contribute to our commercial success. In addition, year-over-year new prescription growth for EstroGel in our territories increased significantly, compared to its market which is currently flat or declining. Our commercial operation, while not yet a meaningful contributor to our financial results, is an important investment we are making in the transformation of the Company. This demonstrated, effective commercial operation will position us to build our portfolio by in-licensing products. We intend to continue with this investment in parallel with our efforts to successfully in-license products."

Concluding, Mr. Dodd addressed the Company’s earlier stage development efforts as follows: "We also made significant progress with respect to our pipeline of internally developed products, selecting an optimized Erk-inhibitor compound for further development. We are looking for other parties to assist us with the further development of the compound because we believe it could represent an important new category of cancer therapy."

Third Quarter Financial Highlights
Research and development ("R&D") costs were $4.1 million for the three-month period ended September 30, 2015, as compared to $6.1 million for the same period in 2014. A substantial portion of this decrease is mainly due to the realization of cost savings in connection with the Company’s global resource optimization program, as well as to the weakening, in 2015, of the euro against the US dollar. The decrease was partly offset by higher costs associated with the Company’s ZoptEC and Macrilen Phase 3 trials.
Selling expenses were $1.7 million for the three-month period ended September 30, 2015, as compared to $0.9 million for the same period in 2014. This increase is mainly attributable to the implementation of our promotional activities associated with EstroGel, which commenced in late 2014. We also expanded the size of our contracted sales force from 19 to 23 sales representatives during the quarter in order to support our promotional efforts associated with Saizen.

General and administrative expenses were $1.9 million for the three-month period ended September 30, 2015, as compared to $2.8 million for the same period in 2014. General and administrative expenses were lower in the current-year quarter mainly due to the realization of costs savings in connection with the Company’s global resource optimization program.

Net finance costs were $7.9 million for the three-month period ended September 30, 2015, as compared to net finance costs of $1.8 million for the same period in 2014. The increase in net finance costs of $6.1 million is mainly related to the change in the estimated fair value of the Company’s warrant liability.

Net loss for the three-month period ended September 30, 2015 was $15.3 million or $0.07 per basic and diluted share, as compared to $11.3 million or $0.20 per basic and diluted share for the same period in 2014. This increase is predominantly due to higher comparative net finance costs and to higher comparative selling expenses, partially offset by lower comparative R&D costs.

At the opening of the third quarter, the Company had 139.9 million issued and outstanding common shares. On September 30 and November 4, 2015, the Company had 492.5 million and 632.7 million issued and outstanding common shares, respectively. The increase in the Company’s outstanding shares during the quarter and subsequent to quarter-end through November 4, 2015, results from the issuance of 492.8 million common shares upon the alternate cashless exercise of Series B Warrants.

Cash and cash equivalents were $38.3 million as at September 30, 2015, compared to $34.9 million as at December 31, 2014.