On August 6, 2015 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported operating results for second-quarter 2015 and provided an update on the Company’s development programs (Press release, TESARO, AUG 6, 2015, View Source [SID:1234507105]).

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"TESARO continues to make significant progress in advancing its pipeline of product candidates, and preparations for the commercial launch of oral rolapitant are well underway to support product introduction in the fourth quarter," said Lonnie Moulder, CEO of TESARO. ‎ "We have established our medical science liaison, nurse educator, and regional sales leadership teams, and the build-out of our field sales organization is nearly complete. The second half of 2015 ‎will be an exciting time for the Company, as we look ahead to the expected niraparib Phase 3 NOVA trial data in the fourth quarter of 2015, the NDA submission for IV rolapitant, and the initiation of our immuno-oncology clinical program in early 2016‎."

Recent Business Highlights

The New Drug Application (NDA) for oral rolapitant is under review by the U.S. Food and Drug Administration (FDA), with a PDUFA goal date of September 5, 2015.

Commercial preparations are well underway in support of a potential oral rolapitant product launch in the fourth quarter of 2015.
The rolapitant bioequivalence trial successfully achieved its primary endpoint, demonstrating similar exposure for a dose of intravenous (IV) rolapitant as compared to a dose of oral rolapitant.

Expansion of the TESARO commercial organization is ongoing, with sales management, medical science liaison, and nurse educator teams now in place and the build-out of the field sales team is nearly complete in preparation for launch.

TESARO and Jiangsu Hengrui Medicine Co., Ltd. announced an exclusive license agreement for the development, registration, manufacture, and commercialization of rolapitant in China.

Phase 3 data from the NOVA trial of niraparib for patients with high-grade serous, platinum-sensitive, relapsed ovarian cancer is expected in the fourth quarter of 2015, following completion of enrollment in both cohorts earlier this year.

Enrollment of the QUADRA trial of niraparib is ongoing for the treatment of patients with ovarian cancer who have received three or more prior lines of chemotherapy.

TESARO and Merck announced a collaboration and have finalized the protocol to evaluate the combination of niraparib plus Merck’s anti-PD1 therapy, KEYTRUDA (pembrolizumab) in a Phase 1/2 clinical trial in patients with triple-negative breast cancer or ovarian cancer.

Patient enrollment continues in the Phase 3 BRAVO trial of niraparib for the treatment of patients with breast cancer, and planning is ongoing in support of the initiation of a trial of niraparib in the first-line ovarian cancer setting (PRIMA).
The Phase 1/2 AVANOVA three-arm trial of niraparib, comparing the tolerability and efficacy of niraparib plus bevacizumab versus bevacizumab versus niraparib in patients with ovarian cancer, continues to enroll in collaboration with The European Network for Gynaecological Oncological Trial groups (ENGOT).

Patient enrollment continues in the Phase 1 study of niraparib plus chemotherapy in patients with Ewing’s sarcoma in partnership with the Sarcoma Alliance for Research through Collaboration (SARC).

The clinical activity of a fractionated dose of TSR-011 continues to be evaluated in ALK-positive patients who have not been previously treated with an ALK inhibitor, and a controlled release formulation is being evaluated within the ongoing Phase 1 study.
Antibody drug candidates targeting PD-1, TIM-3, and LAG-3 continue to advance, and GLP toxicology studies are now underway for TSR-042.

Second-Quarter 2015 Financial Results

TESARO reported a net loss of $60.6 million, or ($1.51) per share, for the second quarter of 2015, compared to a net loss of $37.1 million, or ($1.03) per share, for the second quarter of 2014.

Research and development expenses increased to $38.9 million for the second quarter of 2015, compared to $30.6 million for the second quarter of 2014, driven primarily by higher costs related to expanded development activities and increased headcount.
General and administrative expenses increased to $16.8 million for the second quarter of 2015, compared to $5.6 million for the second quarter of 2014, primarily due to pre-launch commercial activities in support of oral rolapitant, increased headcount, and higher professional service fees.

In-process research and development expense was $1.0 million in the quarter and related to a development milestone achieved for our immuno-oncology programs, compared to $0.9 million for the second quarter of 2014, which related to initiation of patient treatment within the BRAVO trial of niraparib.

Operating expenses, as described above, include total non-cash, stock-based compensation expense of $5.5 million for the second quarter of 2015, compared to $3.1 million for the second quarter of 2014.

Net interest expense increased to $3.9 million for the second quarter of 2015, primarily due to the accrual of interest payable and non-cash amortization of the debt discount associated with the 3.00% senior convertible notes due 2021, issued in September 2014.

As of June 30, 2015, TESARO had approximately $354.4 million in cash and cash equivalents and approximately 40.0 million outstanding shares of common stock. TESARO continues to expect cash utilization to increase over the course of 2015 and to average in the mid-$50 million range per quarter for the remainder of 2015, excluding a $15 million milestone payment that will be due upon first commercial sale of rolapitant, which is expected in the fourth quarter.
Corporate Objectives

TESARO anticipates achieving the following key objectives:

Launch oral rolapitant into the U.S. market in Q4 2015, pending approval by the FDA;

Submit the NDA for IV rolapitant following the commercial launch of oral rolapitant;

Submit the oral rolapitant Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2016;
Report data from the Phase 3 NOVA trial of niraparib in Q4 2015;

Advance the QUADRA trial of niraparib as a treatment for patients with ovarian cancer who have received three or more prior lines of therapy and report initial data in early 2016;

Advance the Phase 3 BRAVO trial of niraparib in breast cancer patients with germline BRCA mutations throughout 2015;

Initiate niraparib/KEYTRUDA (pembrolizumab) combination trial in partnership with Merck in Q4 2015;

Initiate the clinical trial of niraparib in first line ovarian cancer (PRIMA) in Q4 2015;

Continue to evaluate the clinical activity of a controlled release formulation of TSR-011 within the ongoing Phase 1 study; application to the U.S. FDA in late 2015; and

Advance the IND-enabling studies for the anti-TIM-3 clinical candidate.

On August 6, 2015 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported financial results for the three-month period ended June 30, 2015 (Press release, Spectrum Pharmaceuticals, AUG 6, 2015, View Source [SID:1234507104]).

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"The results from this quarter demonstrate our ability to maintain financial discipline while continuing to fund our highest priority projects," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "The second half of 2015 marks key milestones for several of Spectrum’s drugs. With the potential approval of Evomela in October, we could have six drugs on the market. Pending alignment with the FDA, we expect to initiate a non-inferiority Phase 3 study for SPI-2012 which would be powered at 80% to show superiority against pegfilgrastim. Also, our potentially best-in-class novel pan-HER inhibitor, poziotinib, will target breast cancer in a Phase 2 clinical program. Additionally, with apaziquone, we plan to file an NDA and initiate a confirmatory Phase 3 trial under a SPA by year end. Our pipeline has never been as exciting as it is today, and provides a sound foundation for future growth of the company."

Pipeline Update:

Two Potential Blockbusters, One Near-term FDA Decision and One Near-term NDA Submission

SPI-2012, a novel long-acting GCSF: In Phase 2 trials earlier this year, SPI-2012’s efficacy was shown to be non-inferior at the middle dose, and superior to the blockbuster drug pegfilgrastim at the higher dose tested. Based on discussion with the FDA, the Company plans to initiate a Phase 3 study this year, and is seeking an SPA for this study that would be powered at over 90% to demonstrate non-inferiority and at 80% to demonstrate superiority to pegfilgrastim.

EVOMELA, a propylene-glycol free formulation of melphalan with improved stability: NDA review is ongoing and is on track for an FDA decision on October 23, 2015. This drug is expected to be launched using Spectrum’s existing sales force, and pre-launch activities have commenced.

Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: The Company plans to initiate a U.S. based breast cancer program based on compelling Phase 1 efficacy data demonstrated in breast cancer patients who had failed multiple other HER-2 directed therapies. In addition, multiple Phase 2 studies funded by Hanmi Pharmaceuticals are currently ongoing.

Apaziquone, a potent pro-drug being investigated for non-muscle-invasive bladder cancer: Apaziquone is a bio-reductive agent activated by reductase enzymes, such as DT-diaphorase, expressed by bladder tumor cells, to form a cytotoxic alkylating agent. Spectrum expects to file an NDA by year-end. Additionally, the Company is seeking an SPA with the FDA before commencing an additional confirmatory Phase 3 Study.

Three-Month Period Ended June 30, 2015 (All numbers are approximate)

GAAP Results

Total product sales were $35.1 million in the second quarter of 2015. Total product sales decreased 25% from $46.9 million in the second quarter of 2014.

Product sales in the second quarter included: FUSILEV (levoleucovorin) net sales of $14.3 million, FOLOTYN (pralatrexate injection) net sales of $12.2 million, ZEVALIN (ibritumomab tiuxetan) net sales of $4.8 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $2.1 million and BELEODAQ (belinostat for injection) net sales of $1.7 million.

Spectrum recorded net loss of $2.3 million, or $(0.04) per basic and diluted share in the three-month period ended June 30, 2015, compared to net loss of $3.6 million, or $(0.06) per basic and diluted share in the comparable period in 2014. Total research and development expenses were $9.6 million in the quarter, as compared to $11.3 million in the same period in 2014. Selling, general and administrative expenses were $22.6 million in the quarter, compared to $25.4 million in the same period in 2014.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $0.5 million, or $(0.01) per basic share and diluted share in the three-month period ended June 30, 2015, compared to non-GAAP net income of $6.8 million, or $0.11 per basic share and $0.09 per diluted share in the comparable period in 2014. Non-GAAP research and development expenses were $9.1 million, as compared to $10.8 million in the same period of 2014. Non-GAAP selling, general and administrative expenses were $19.7 million, as compared to $21.8 million in the same period in 2014.

2015 Financial Guidance

Spectrum projects year-end aggregate cash and cash equivalents and marketable securities of over $110 million, up from the Company’s previous guidance of $100 million excluding any new business development transactions.

On August 6, 2015 Oncothyreon Inc. (NASDAQ:ONTY) reported financial results for the second quarter ended June 30, 2015 (Press release, Oncothyreon, AUG 6, 2015, View Source [SID:1234507100]).

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Net loss for the three months ended June 30, 2015 was $10.9 million, or $0.11 per basic and diluted share, compared with a net loss of $6.0 million, or $0.09 per basic and diluted share, for the comparable period in 2014. The $4.9 million increase in net loss was primarily attributable to the difference in the change in the fair value of warrant liability of $4.3 million. The increase in net loss was also due to increases in research and development expenses of $0.3 million and increases in general and administrative expenses of $0.2 million.

Net loss for the six months ended June 30, 2015 was $18.8 million, or $0.19 per basic and diluted share, compared with a net loss of $15.6 million, or $0.22 per basic and diluted share, for the comparable period in 2014. The $3.2 million increase in net loss was attributable to the difference in the change in the fair value of warrant liability of $1.7 million, increases in research and development expenses of $1.3 million and increases in general and administrative expenses of $0.2 million.

As of June 30, 2015, Oncothyreon’s cash, cash equivalents and investments were $70.0 million, compared to $63.7 million at December 31, 2014, an increase of $6.3 million, or 9.9 percent. The increase was primarily attributable to net proceeds of $22.4 million from the closing of concurrent but separate underwritten offerings of common stock and Series B convertible preferred stock in February 2015, partially offset by $15.6 million of cash used in operations during the six months ended June 30, 2015.

Financial Guidance

Oncothyreon believes the following financial guidance to be correct as of the date provided. Oncothyreon is providing this guidance as a convenience to investors and assumes no obligation to update it.

Oncothyreon currently expects operating expenses in 2015 to be lower than in 2014, which included the upfront payment to Array BioPharma Inc. for the exclusive license to ONT-380. Oncothyreon currently expects cash used in operations in 2015 to be approximately $32.0 – $34.0 million.

On August 6, 2015 Mirati Therapeutics, Inc. ("Mirati") (NASDAQ: MRTX) reported financial results for the second quarter ended June 30, 2015 and provided an update on its drug development programs (Filing, 8-K, Mirati, AUG 6, 2015, View Source [SID:1234507097]).

"At this year’s ASCO (Free ASCO Whitepaper) meeting, we presented initial clinical data on our lead tyrosine kinase inhibitor, MGCD265, which clearly demonstrated significant tumor regression in non-small lung cancer patients with MET gene alterations. With pre-clinical and clinical data showing anti-tumor activity, we are confident that targeting MET driver alterations is a clinically valid approach, and we look forward to initiating a Phase 2 registration-enabling study by the end of the year," said Charles M. Baum, M.D., Ph.D., president and CEO, Mirati. "We also recently announced a clinical trial collaboration with our spectrum-selective HDAC inhibitor, mocetinostat. The Phase 1-2 study will evaluate the safety and efficacy of mocetinostat, in combination with durvalumab, an investigational anti-PD-L1 immune checkpoint inhibitor, in patients with non-small cell lung cancer. We are excited about this combination, as mocetinostat may enhance the efficacy of immune checkpoint inhibitors, potentially leading to improved therapies for patients."

Recent and Upcoming Pipeline Highlights

MGCD265: Molecularly targeted kinase inhibitor

· 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting: Presented data demonstrating preliminary evidence of clinical activity in non-small cell lung cancer (NSCLC) patients, including clear tumor regression and improvement in clinical symptoms such as pain and shortness of breath

· The first three patients selected for MET gene alterations in the dose expansion cohort showed clear evidence of tumor regression as early as the first scan. All three patients have extensive disease and failed several prior therapies before being treated with MGCD265

· Demonstrated that MGCD265 was well tolerated

· The poster can be found on the Company’s website at www.mirati.com

· Additional information about this clinical trial of MGCD265 is available at www.clinicaltrials.gov using identifier: NCT00697632

· The Company expects to initiate a single arm Phase 2 registration-enabling study in NSCLC by the end of the year

MGCD516: Molecularly targeted kinase inhibitor

· 2015 ASCO (Free ASCO Whitepaper) Annual Meeting: Presented the clinical trial design of the Phase 1, open label, single agent study designed to evaluate the safety, pharmacokinetics/pharmacodynamics (PK/PD) and clinical activity of MGCD516 in patients with advanced solid tumors, with an initial focus on NSCLC

· The poster can be found on the Company’s website at www.mirati.com

· Additional information about this clinical trial of MGCD516 is available at www.clinicaltrials.gov using identifier: NCT02219711

· The Company expects to establish a Phase 2 dose and initiate expansion cohorts in selected patients by the end of the year

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Mocetinostat: Molecularly targeted epigenetic inhibitor

· Announced a clinical trial collaboration to evaluate the safety and efficacy of mocetinostat in combination with durvalumab (MEDI4736), an investigational anti-PD-L1 immune checkpoint inhibitor. The initial Phase 1-2 study will be evaluated in patients with NSCLC

· 2015 Annual ASCO (Free ASCO Whitepaper) Meeting: Presented the clinical trial design of the mocetinostat Phase 2 study in patients with previously treated, locally advanced, unresectable or metastatic urothelial carcinoma of the bladder harboring inactivating mutations or deletions of the histone acetyltransferase genes CREBBP and/or EP300

· The poster can be found on the Company’s website at www.mirati.com

· Additional information about this clinical trial of mocetinostat is available at www.clinicaltrials.gov using identifier: NCT02236195

· The two Phase 2 trials evaluating mocetinostat (one in bladder cancer, the other in diffuse large B-cell lymphoma and follicular lymphoma) are ongoing with initial clinical data anticipated later in the year

Second Quarter 2015 Financial Results

Cash, cash equivalents, and short-term investments were $58.9 million at June 30, 2015, compared to $29.3 million at December 31, 2014. In February 2015, the Company successfully completed a public offering of 2.6 million shares of its common stock, generating net proceeds of $48.4 million.

Research and development expenditures for the second quarter of 2015 were $11.3 million, compared to $7.1 million for the same period in 2014. Research and development expenses for the six months ended June 30, 2015 were $19.5 million, compared to $12.1 million for the same period in 2014. The increases in research and development expenses primarily reflect costs to advance the clinical development of its three oncology development programs, MGCD265, MGCD516 and mocetinostat. General and administrative expenses for the first quarter of 2015 were $4.2 million, compared to $3.0 million for the same period in 2014. General and administrative expenses for the six months ended June 30, 2015 were $8.0 million, compared to $5.7 million for the same period in 2014. The increases in general and administrative expenses primarily reflect higher, non-cash stock-based compensation expense.

Other income and expense, net, for the second quarter of 2015 was income of $0.1 million compared to expense of $0.9 million for the same period in 2014. Other income and expense, net, for the six months ended June 30, 2015 was income of $0.1 million compared to expense of $6.6 million for the same period in 2014. Other income and expense, net, for the second quarter and six months ended June 30, 2014 primarily reflects losses arising from the change in fair value of our warrant liability. During 2014, we amended the warrant agreements to allow for the warrants to be denominated in U.S. dollars. The amended warrants qualified for equity classification and were reclassified into stockholders’ equity.

Net loss for the second quarter of 2015 was $15.4 million, or $0.95 per share, compared to net loss of $11.0 million, or $0.82 per share for the same period in 2014. Net loss for the six months ended June 30, 2015 was $27.4 million, or, $1.74 per share, compared to net loss of $24.7 million, or $1.83 per share for the same period in 2014.

On August 6, 2015 Medivation, Inc. (NASDAQ: MDVN) reported its financial results for the second quarter ended June 30, 2015 (Press release, Medivation, AUG 6, 2015, View Source [SID:1234507094]). U.S. net sales of XTANDI (enzalutamide) capsules, as reported by Astellas Pharma Inc., were $298.4 million for the quarter (+108% vs. prior year). Second quarter U.S. net sales increased by 33% compared with first quarter 2015 net sales of $224.0 million. We estimate second quarter 2015 unit demand increased by a low- to mid-teens percentage rate, compared with unit demand in the first quarter 2015. In addition, based on information provided by Astellas, a lower gross-to-net discount rate was applied to second quarter gross sales (compared with the first quarter rate), and a $2.8 million favorable adjustment was recorded in the second quarter by Astellas with respect to gross-to-net discount related to previous period gross sales.

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Ex-U.S. net sales of XTANDI, as reported by Astellas, were approximately $188 million for the quarter (+121% vs. prior year). Second quarter ex-U.S. net sales increased by 42% compared with first quarter 2015 net sales of approximately $133 million. U.S. dollar equivalent net sales for the quarter ended June 30, 2015, were adversely affected by a strengthening U.S. dollar vs. other currencies by approximately $3 million, or 2% compared with net sales in the quarter ended March 31, 2015.

"XTANDI’s performance, in both the U.S. and outside the U.S., demonstrates continued traction toward becoming a foundation of therapy for the treatment of metastatic castration-resistant prostate cancer," said David Hung, M.D., president and chief executive officer of Medivation. "Medivation will continue to pursue innovative programs that have the potential to make a meaningful impact in the quality of life of patients with serious disease."

Medivation reported GAAP net income of $25.8 million, or $0.31 per diluted share, for the quarter ended June 30, 2015, compared with GAAP net income of $47.9 million, or $0.60 per diluted share, for the same period in 2014. Non-GAAP net income for the second quarter of 2015 was $48.7 million, or $0.58 per diluted share, compared with non-GAAP net income of $4.4 million, or $0.05 per diluted share, for the same period in 2014.

Medivation’s collaboration revenue for the second quarter of 2015 was $175.7 million on a GAAP basis compared with $148.1 million for the same period in 2014 (+19% vs. prior year). Non-GAAP collaboration revenue, which excludes collaboration revenue related to upfront and milestone payments, was $174.8 million for the second quarter compared with $81.9 million for the same period in 2014 (+114% 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 second quarter 2015 was $149.2 million compared with $71.9 million for the same period in 2014 (+108% vs. prior year).

Medivation’s collaboration revenue related to ex-U.S. net sales of XTANDI for the second quarter 2015 was $25.6 million compared with $10.0 million for the same period in 2014 (+156% vs. prior year).

Medivation’s collaboration revenue related to upfront and milestone payments for the second quarter 2015 was $0.8 million compared with $66.2 million for the same period in 2014 (-99% vs. prior year). In the three months ended June 30, 2014, Medivation earned $62.0 million of development milestone payments from Astellas. Upfront and milestone payments are excluded from non-GAAP collaboration revenue.

Operating expenses were $122.0 million for the quarter ended June 30, 2015 on a GAAP basis compared with $93.1 million for the same period in 2014. Non-GAAP operating expenses were $98.8 million for the quarter ended June 30, 2015 compared with $73.3 million for the same period in 2014.

Selling, general and administrative (SG&A) expenses for the second quarter of 2015 were $74.7 million on a GAAP basis compared with $52.8 million for the same period in 2014. Non-GAAP SG&A expenses for the second quarter of 2015 were $57.5 million, compared with $43.6 million for the same period in 2014. The increase in non-GAAP SG&A expenses primarily relates to higher sales, marketing, medical affairs, administrative expenses, and personnel-related costs (excluding stock-based compensation).

Research and development (R&D) expenses for the second quarter of 2015 were $47.3 million on a GAAP basis compared with $40.3 million for the same period in 2014. Non-GAAP R&D expenses for the second quarter of 2015 were $41.3 million, compared with $29.6 million for the same period in 2014. The increase in non-GAAP R&D expenses primarily relates to higher MDV9300 costs, certain pre-clinical expenses for other programs, and higher facilities and technology costs and personnel-related costs (excluding stock-based compensation).

At June 30, 2015, cash, cash equivalents, and short-term investments were $497.5 million, compared with $502.7 million at December 31, 2014. In the second quarter and in July 2015, respectively, Medivation utilized approximately $93 million and $168 million of its cash balances to redeem the remaining outstanding Convertible Notes.

Enzalutamide Development Program

Reported positive top-line results in April 2015 from the Phase 2 STRIVE trial comparing enzalutamide with bicalutamide in patients with non-metastatic or metastatic prostate cancer whose disease progressed despite treatment with a luteinizing hormone-releasing hormone (LHRH) analogue therapy or following surgical castration. Presented additional results in May 2015 from the Phase 2 STRIVE trial at the 2015 Annual Meeting of the American Urological Association.

Reported new data in June 2015 from a Phase 2 trial evaluating the investigational use of enzalutamide as a single agent for the treatment of advanced androgen receptor (AR) positive, triple-negative breast cancer at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Enrolled first patient in TRUMPET (Treatment Registry for Outcomes in CRPC Patients), a prospective observational patient registry designed to better understand the unique needs and treatment patterns for patients with castration-resistant prostate cancer (CRPC).

In July 2015, the U.S. Food and Drug Administration (FDA) approved a label update for XTANDI based on an updated overall survival analysis of the Phase 3 PREVAIL trial.

Initiated start up activities for a Phase 2 study evaluating enzalutamide in hepatocellular carcinoma.

Corporate Developments

Issued a notice of redemption in June 2015 to redeem all of Medivation’s outstanding 2.625% Convertible Notes due 2017. In July, Medivation paid approximately $168 million in cash and issued 1.77 million common shares related to the redemption of the remaining outstanding Convertible Notes.

Appointed Andrew Powell as senior vice president, general counsel and corporate secretary. Mr. Powell brings to Medivation more than 25 years of leadership experience in the life sciences industry.

Announced a two-for-one stock split of Medivation’s common stock to be effected through a stock dividend. Shareholders of record as of August 13, 2015, will receive one additional share of Medivation common stock, par value $0.01, for each share they hold as of the record date. The share distribution is scheduled for September 15, 2015.