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.

On August 6, 2015 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported financial results for the second quarter 2015 (Press release, ImmunoCellular Therapeutics, AUG 6, 2015, View Source [SID:1234507093]).

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Andrew Gengos, ImmunoCellular Chief Executive Officer, commented: "We are pleased with our progress year to date in advancing ICT-107 toward the start of the registrational phase 3 trial in patients with newly diagnosed glioblastoma, which is on track to begin enrolling patients in the late third quarter or early fourth quarter of this year. All of the critical components needed to get the ICT-107 phase 3 program up and running are coming into alignment. In addition, we have made significant progress advancing our Stem-to-T-cell program, with the goal of identifying product candidates for clinical testing. Our ICT-121 phase 1 trial continues to enroll patients with recurrent glioblastoma. We believe that we are on track to achieve our clinical, operational and financial goals, underscoring our confidence that 2015 will be a year of accomplishment and potential value creation for our company."

For the quarter ended June 30, 2015, the Company reported a net loss of $3.2 million, or $0.03 per basic and diluted share, compared to a net loss of $2.2 million, or $0.04 per basic and diluted share for the quarter ended June 30, 2014. During the quarter ended June 30, 2015, the Company incurred $2.2 million in research and development expenses compared to $1.5 million in the same quarter of 2014. The increase reflects costs related to the ramp-up of the phase 3 trial of ICT-107, patient enrollment in the ICT-121 phase 1 trial and ramp-up of expenses related to the Company’s Stem-to-T-cell program. These expenses were partially offset by reductions in the ICT-107 phase 2 trial, which continued to wind down, and suspension of the Company’s ICT-140 ovarian cancer program.

For the six months ended June 30, 2015, the Company reported a net loss of $4.6 million, or $0.05 per basic and diluted share, compared to $5.4 million, or $0.09 per basic and diluted share during the same period in 2014. During the six months ended June 30, 2015, the Company incurred additional research and development expenses. Also, during the six months ended June 30, 2015, the Company recorded a gain of $2.0 million related to a reduction in the valuation of its derivative warrants compared to a revaluation charge of $200,000 in the same period of 2014.

The Company reported that cash used in operations during the six months ended June 30, 2015 was $6.9 million compared to $5.3 million during the same period of 2014. The increase in cash used in operations primarily reflects additional research and development expenses. Other expenses were consistent between periods. The Company expects that research and development expenses will continue to increase in future periods as it prepares for the phase 3 trial of ICT-107 and as it expands its Stem-to-T-cell program.

In February 2015, the Company raised net proceeds of $14.5 million from an underwritten public offering and as of June 30, 2015, had $30.9 million in cash.

On August 6, 2015 GlycoMimetics, Inc. (NASDAQ: GLYC) reported financial results for the second quarter ended June 30, 2015. As of June 30, 2015, GlycoMimetics had cash and cash equivalents of $40.2 million (Filing, 8-K, GlycoMimetics, AUG 6, 2015, View Source [SID:1234507091]). GlycoMimetics has also received a $20.0 million milestone payment from Pfizer upon the initiation of a Phase 3 clinical trial for rivipansel.

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"Perhaps the single most important highlight of the quarter was the initiation of the Phase 3 rivipansel trial by our strategic partner, Pfizer, Inc.," said Rachel King, CEO of GlycoMimetics. "In June, we announced the dosing of the first patient in the RESET (Rivipansel: Evaluating Safety, Efficacy and Time to Discharge) trial – a Phase 3 clinical trial assessing the efficacy and safety of rivipansel for the treatment of vaso-occlusive crisis (VOC) in patients hospitalized with sickle cell disease who are at least six years old. This triggered a $20 million milestone payment, which we received after the close of the quarter. Recruitment of patients and clinical site initiations are ongoing, and we are looking toward the goal of bringing a paradigm-changing therapy to the underserved sickle cell patient population."

"In addition to rivipansel, we have initiated a Phase 1/2 clinical trial to evaluate our wholly-owned drug candidate, GMI-1271, a novel and proprietary E-selectin antagonist," Ms. King added. "The ongoing trial is studying the safety, pharmacokinetics (PK) and efficacy of GMI-1271, when used in combination with chemotherapy in patients with acute myeloid leukemia (AML). In May 2015, the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to this compound for the treatment of AML."
GlycoMimetics recorded revenue of $20.0 million during the quarter ended June 30, 2015 versus $15.0 million in revenue for the quarter ended June 30, 2014. Revenue for the second quarter 2015 was due to the $20.0 million non-refundable milestone payment from Pfizer. The revenue received for the quarter ended June 30, 2014 was based on the $15.0 million non-refundable milestone payment received from Pfizer.

The company’s research and development expenses increased to $7.8 million for the quarter ended June 30, 2015 as compared to $5.4 million for the second quarter of 2014. This increase reflects spending on manufacturing and process development of GMI-1271 and the costs of the Phase 1/2 clinical trial for which the company enrolled the first patient in May 2015.

The company’s general and administrative expenses increased to $1.8 million for the quarter ended June 30, 2015 as compared to $1.6 million for the second quarter of 2014.