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8-K – Current report

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.

Medivation Reports Second Quarter 2015 Financial Results

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.

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.

ImmunoCellular Therapeutics Announces Second Quarter 2015 Financial Results

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]).

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.

8-K – Current report

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.

"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.

8-K – Current report

On August 6, 2015 Galena Biopharma, Inc. (NASDAQ: GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, reported its financial results for the quarter ended June 30, 2015 and provided a business update (Filing, 8-K, Galena Biopharma, AUG 6, 2015, View Source [SID:1234507090]).

"With our balance sheet strengthened, we made significant clinical progress in the second quarter as we reached a critical milestone with completion of enrollment in our Phase 3 PRESENT trial and had promising data readouts from two of our Phase 2 clinical trials with GALE-301 and GALE-401," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "Our cancer immunotherapy programs continue to advance with our multiple NeuVax programs as well as with GALE-301. Our early Phase 2a data with GALE-301 in ovarian and endometrial cancer was positive, and we will present a more mature data set at the European Society for Medical Oncology Congress in September. In addition, we presented preliminary Phase 2 data on our hematology asset, GALE-401, at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress demonstrating encouraging efficacy and safety data. We expect to present final data from the GALE-401 Phase 2 trial later this year."

Dr. Schwartz added, "On the commercial side of our business, last week we launched Zuplenz within our existing commercial infrastructure to treat patients suffering from nausea and vomiting as a result of their chemotherapy, radiation and surgical treatments. And, today we reported improved Abstral sales quarter over quarter resulting in our strongest net revenue quarter to date. Based on current projections, we anticipate that we will come in closer to the lower end of our guidance range, at around $15 million for the year."

Galena will host a webcast and conference call today at 2:00 p.m. P.T./5:00 p.m. E.T. to discuss financial and business results. The live webcast will include slides that can be accessed on the Company’s website under the Investors section/Events and Presentations: View Source The conference call can be accessed by dialing (844) 825-4413 toll-free in the U.S., or (973) 638-3403 for participants outside the U.S. The Conference ID number is: 96966749. The archived webcast replay will be available on the Company’s website for 90 days.

FINANCIAL HIGHLIGHTS AND GUIDANCE

We recognize revenue from the sale of Abstral to wholesale pharmaceutical distributors, net of product-related discounts, allowances, product returns, rebates, chargebacks, and patient assistance benefits, as applicable. Because the launch of Zuplenz occurred in July, there is no revenue recorded for Zuplenz through Q2, 2015, and all revenue to date is from Abstral sales. Net revenue was $3.4 million in the second quarter of 2015, a 48% increase compared to $2.3 million reported for the same period in 2014. Net revenue was $6.1 million in the first half of 2015, a 36% increase compared to $4.5 million reported for the same period in 2014.

Operating loss for the second quarter of 2015 was $11.3 million, including $0.6 million in stock based compensation, compared to an operating loss of $15.8 million, including $1.5 million in stock-based compensation for the same period last year. Operating loss for the first half of 2015 was $22.4 million, including $1.3 million in stock based compensation, compared to an operating loss of $27.6 million, including $3.2 million in stock-based compensation for the same period in 2014. The decrease in net operating loss year-over-year is primarily the result of the completion of enrollment in our Phase 3 PRESENT trial for NeuVax, as well as the decrease in stock based compensation and professional fees associated with ongoing legal proceedings.

Non-operating income or expenses include non-cash charges related to changes in the fair value estimates of the company’s warrant liabilities, contingent purchase price liability, and interest expense. The non-cash expense related to the changes in the value of our warrant liability for the second quarter of 2015 was $4.3 million versus a non-cash expense of $3.4 million for the same period in 2014, respectively. The non-cash expense related to the changes in the value of our warrant liability for the first half of 2015 was $3.1 million versus a non-cash benefit of $6.4 million for the same period in 2014, respectively.

Net loss for the second quarter of 2015 was $15.7 million, including $4.3 million in a non-cash expense described above, or $0.10 per basic and diluted share. Net loss for the second quarter of 2014 was $19.9 million, including a $3.4 million non-cash expense described above, or $0.17 per basic and diluted share. The lower net loss this quarter compared to the same quarter last year is a function of the lower operating loss, partially offset by the increase in the non-cash loss on the change in our warrant values, as described above. Net loss for the first half of 2015 was $26.2 million, including $3.1 million in a non-cash expense described above, or $0.18 per basic and diluted share. Net loss for the first half of 2014 was $22.5 million, including a $6.4 million non-cash benefit described above, or $0.19 per basic and diluted share. The higher net loss through the first two quarters of this year compared to the same period last year is a function of the lower operating loss, which was more than offset by the non-cash loss on the change in our warrant values this year, compared to a non-cash gain last year, as described above.

As of June 30, 2015, Galena had cash and cash equivalents of $45.3 million, compared with $23.7 million as of December 31, 2014. The $21.6 million increase in cash during the first half of 2015 represents $47.4 million raised from issuance of common stock, partially offset by $23.4 million used in operating activities, a $0.5 million milestone payment for Zuplenz, and $1.9 million in debt service payments.

SECOND QUARTER AND RECENT HIGHLIGHTS

Launched Zuplenz (ondansetron) oral soluble film in the U.S. The active pharmaceutical ingredient in Zuplenz is ondansetron, and Zuplenz is approved in adult patients for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV). Zuplenz is also approved for moderately emetogenic CINV in pediatric patients four years and older. Ondansetron belongs to a class of medications called serotonin 5-HT3 receptor antagonists and works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting. Zuplenz is clinically bioequivalent to ondansetron orally disintegrating tablets (ODT) with a safety profile equivalent to ondansetron. The novel, PharmFilm, oral soluble film technology utilized by Zuplenz provides for convenient delivery and several key patient benefits including: rapidly dissolves in the mouth in about 10 seconds; eliminates the burden of swallowing pills during emesis; does not require water to administer, making it ideal in cases of oral irritation; pleasant peppermint flavor with no gritty aftertaste, and it is non-sedating. Zuplenz is now available nationwide and is supplied in both 4 mg and 8 mg ondansetron strengths.

Presented GALE 401 Phase 2 clinical trial data at the European Hematology Association (EHA) (Free EHA Whitepaper) 20th Congress. The poster presentation entitled, "Phase 2 Study of a Novel Controlled-Release Formulation of Anagrelide (GALE-401) in Subjects with Myeloproliferative Neoplasm (MPN)-Related Thrombocytosis," was presented in June 2015. The Phase 2 study demonstrated that GALE-401 was well tolerated with primarily Grade 1 and 2 toxicities in 16 of the 18 subjects enrolled. The efficacy shown in the trial compares favorably to historical anagrelide immediate release (IR) response rates with the following platelet response: overall response rate (ORR) of 78% (14/18); complete response (CR) of 39% (7/18); partial response (PR) of 39% (7/18). The median time to response was 5 weeks (range, 3-10), and the median duration of response has not yet been reached. Based on the data, the investigators concluded that GALE-401 remains a viable potential treatment option for MPNs, and a randomized trial comparing GALE-401 versus anagrelide IR is warranted.

Published GALE-301 abstract at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2015 Annual Meeting. The abstract, entitled, "Preliminary Results of the Phase I/IIa Dose Finding Trial of a Folate Binding Protein Vaccine (E39+GM-CSF) in Ovarian and Endometrial Cancer Patients to Prevent Recurrence", demonstrated that GALE-301 is well tolerated and elicits a strong and dose-dependent in vivo immune response. The trial is ongoing and is designed as a safety and dose optimization trial and is not powered for a disease free survival efficacy endpoint. However, early efficacy results from the trial are promising in the 1000 mcg vaccine dose cohort. Of the 51 patients enrolled in the trial, 29 were in the vaccinated group (15 patients at 1000 mcg vs. 14 patients at < 1000 mcg) and 22 were in the control group. With 9.8 months median follow-up, the 1000 mcg dose group had only one clinical recurrence vs 11 in the vaccine group (6.7% VG vs. 50% CG, p = 0.01). Combining all dose groups, the complete response (CR) rate was 38% in the vaccine group vs. 50% in the control group (p = 0.41). Currently, the estimate for disease free survival at two years is 85.7% (1000 mcg dose group) vs. 19.2% for the control group (p = 0.09), for a 78% reduction in relative risk of recurrence.

NeuVax (nelipepimut-S) achieves critical milestone with completion of over-enrollment in its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial. NeuVax is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent cancer recurrence after standard of care treatment in the adjuvant setting in breast and gastric cancers. Galena over-enrolled the trial by 7.7% with a total of 758 patients now in the intent-to-treat (ITT) population. The protocol for the PRESENT trial, being conducted under an FDA approved Special Protocol Assessment (SPA), called for 700 patients; and, the Company expects this higher number of ITT patients will increase the confidence in the timing, the statistics, and the final outcome of the trial. The primary endpoint is currently expected to be reached in 2018, after the last patient dosed reaches her 36th month of follow-up, or a total of 141 events (recurrence or death) occur, whichever comes later. PRESENT is a randomized, double blind, placebo controlled, international, Phase 3 trial and is being conducted in 13 countries at approximately 140 sites.

CORPORATE HIGHLIGHTS

Enhanced the balance sheet with the closing of a public offering of common stock, receiving gross proceeds of $43.7 million. With the closing of the over-allotment in the second quarter, total net proceeds to Galena from the offering were approximately $40.8 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by Galena.