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Celyad completes the NKR-2 Phase I trial with successful safety follow-up of the fourth dose level

On September 9, 2016 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of cell therapies, reported the successful completion of the 21-day safety follow-up of the last patient enrolled at the fourth dose level in its Phase I clinical trial evaluating the safety and feasibility of its NKR-2 T-cell therapy – in Acute Myeloid Leukemia and Multiple Myeloma patients (Press release, Celyad, SEP 9, 2016, View Source [SID1234516410]). No safety issues or toxicities were reported.

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Dr. Christian Homsy, CEO of Celyad: "We are pleased that no adverse safety signal has been reported. Based on the successful completion of the fourth cohort, we are looking forward to starting the global Ph I/IIa multiple dose trial, in the US and EU, of our NKR-2 autologous therapy in the fourth quarter of this year."

Dr. Frédéric Lehmann, Head of Immuno-Oncology at Celyad: "The absence of any safety or toxicity signal up to this point continues to support our belief that this unique engineered T-cell construct can be safely administered and potentially lead to a therapeutic effect providing hope to the thousands of patients who need better treatments for both AML and MM."

8-K – Current report

On September 12, 2016 AVEO Pharmaceuticals, Inc. ("AVEO") reported discontinuation of the FOCAL study, a Phase 2, global, randomized, double-blind, placebo controlled clinical study, evaluating ficlatuzumab, AVEO’s HGF inhibitory antibody, in combination with erlotinib (Tarceva), an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) in first line, VeriStrat (BDX 004) Poor (VSP), EGFR-mutated NSCLC patients (Filing, 8-K, AVEO, SEP 9, 2016, View Source [SID:SID1234515089]). VeriStrat is a proprietary biomarker test developed by Biodesix to select patients for entry into the trial.

The FOCAL study was prospectively designed to confirm results from a retrospective exploratory analysis of a randomized Phase 2 clinical trial ("Study P06162") comparing the combination of ficlatuzumab and gefitinib (IRESSA), an EGFR TKI therapy, to gefitinib monotherapy in previously untreated Asian patients with advanced NSCLC who had tested positive for both EGFR mutation and VSP. Study P06162 demonstrated a statistically significant improvement in overall survival (OS) and progression free survival (PFS) for patients in the gefitinib plus ficlatuzumab arm that were classified as VSP.

After experiencing slower than expected enrollment, a blinded interim analysis of the FOCAL study was conducted and found that patients who were positive for both VSP and EGFR mutations, who were known to be selected for poor prognosis, experienced materially higher discontinuation rates than observed in both the general ITT population and retrospective exploratory subgroup population of Study P06162, which was the basis for the FOCAL study design. This observation significantly compromised the feasibility of the trial. The parties have mutually agreed to discontinue the study. The parties intend to further discuss the details for the discontinuation of the study and future development of ficlatuzumab.

Champions Oncology Beats Revenue Guidance for Quarter; Reaffirms Full Year Guidance of 43 – 60% Revenue Growth

On September 9, 2016 Champions Oncology, Inc. (Nasdaq: CSBR), engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, reported its financial results for the first quarter ended July 31, 2016 (Filing, Q1, Champions Oncology, 2016, SEP 9, 2016, View Source [SID:1234515018]).

First Quarter and Recent Business Highlights:
• First quarter revenue of $3.7 million; significantly above revenue guidance range of $3.25 – $3.5 million
• Reaffirms full year revenue guidance for FY2017 of $16 – $18 million
• Delivered third consecutive quarter of record TOS bookings
• Signed significant AML study with major pharmaceutical company
• Signed second co-clinical trial
• Enrolled first patient in co-clinical trial

Joel Ackerman, Champions Oncology CEO, stated, "we continued to build momentum achieving another quarter of strong revenue growth and delivering our third consecutive quarter of record TOS bookings, setting the stage for continued positive results heading into next quarter.. We have produced this revenue growth while controlling our expenses, putting us on a path to cash flow breakeven by the end of our fiscal year."

Financial Results

For the first quarter of 2017, revenue was $3.7 million, as compared to $2.8 million for the first quarter 2016, an increase of 30%. Total operating expense for the first quarter 2017 was $6.2 million as compared to $5.7 million for the first quarter 2016, an increase of 8.3%.

For the first quarter of 2017 and 2016, Champions reported a loss from operations of $2.5 million and $2.9 million, respectively. Excluding stock-based compensation of $1.1 million and $775,000 for the three months ended July 31, 2016 and 2015, Champions recognized a loss from operations of $1.4 million and $2.1 million, respectively.

Operating Results

Translational Oncology Solutions (TOS):

Exhibit 99.1

TOS revenue was $3.2 million and $2.3 million for the three months ended July 31, 2016 and 2015, respectively, an increase of $900,000 or 35.2%. The increase is due to increased bookings in prior quarters, both in the number and size of the studies, and the addition of new customers.

TOS cost of sales was $2.0 million and $1.6 million for the three months ended July 31, 2016 and 2015, respectively, an increase of $400,000, or 27.1%. For the three months ended July 31, 2016 and 2015, gross margin for TOS was 35.1% and 31.0%, respectively. The increase in TOS cost of sales was due to an increase in TOS studies. The improvement in gross margin was due to higher TOS revenue leveraged off the fixed cost component of the lab and effective management of the variable lab costs.

Personalized Oncology Solutions (POS):

POS revenue was $511,000 and $485,000 for the three months ended July 31, 2016 and 2015, respectively, an increase of $26,000 or 5.4%. The increase is primarily the result of growth in sequencing revenue of $115,000 offset by a decline in implant and drug panel revenue of $29,000 and $60,000, respectively.

POS cost of sales was $474,000 and $661,000 for the three months ended July 31, 2016 and 2015, respectively, a decrease of $187,000, or (28.3%). For the three months ended July 31, 2016 and 2015, gross margin for POS was 7.2% and negative (36.3%), respectively. The improvement is attributed to the increase in higher margin sequencing revenue and aggressively managing our lab costs.

Research and development expense was $1.2 million and $1.1 million for the three months ended July 31, 2016 and 2015, respectively, an increase of $100,000, or 10.1%. The increase is primarily due to an increase in salary expense. Sales and marketing expense for the three months ended July 31, 2016 and 2015 was $925,000 and $1 million, respectively, a decrease of $75,000, or (10.1%). The decrease is due to the consolidation of sales and marketing personnel resources of the POS and TOS division. General and administrative expense was $1.5 million and $1.3 million for the three months ended July 31, 2016 and 2015, respectively, an increase of $200,000, or 16.5%. The increase is due to an increase of $354,000 in stock compensation expense.

University of Pittsburgh Licenses Novel Microneedle Patch to Pittsburgh Company

On September 8, 2024 SkinJect, Inc., a Pittsburgh-based company, reported its completion of a license with the University of Pittsburgh to its novel, minimally invasive treatment for common forms of non-melanoma skin cancer, basal cell and squamous cell carcinoma (Press release, University of Pittsburgh, SEP 8, 2016, View Source [SID1234646915]). Two million new cases of basal cell cancer are reported each year in the United States, and more than half of all patients suffer a recurrence. The new product under development could dramatically change the way these skin cancers are treated.

The SkinJect patch is a thumb-sized array of dissolvable microneedles that will deliver a chemotherapeutic agent to kill an existing skin cancer. The SkinJect patch will be applied once a week, for 3 weeks, in the doctor’s office. The microneedles, less than a millimeter long, dissolve within 15 minutes of application.

McGowan Institute for Regenerative Medicine affiliated faculty member Louis D. Falo, MD, PhD, who chairs Pittsburgh’s Department of Dermatology, is a co-inventor of the microneedle patch, along with O. Burak Ozdoganlar, PhD, Professor in Mechanical Engineering and Materials Science and Engineering, Carnegie Mellon University. Both inventors serve as scientific advisors to the company as it develops the array.

"The SkinJect patch is a promising novel approach to combating cancer," said Dr. Falo. "Right now, a standard of care for basal cell carcinoma is Mohs micrographic surgery, which can be expensive, painful, and disfiguring. The SkinJect patch will offer a cost-effective way to treat an existing cancer and potentially prevent it from coming back again later in life."

President and CEO of SkinJect Jim Nolan said SkinJect was being watched closely by both the medical and investment communities. "This device has the potential to transform the fields of dermatology and oncology. Its commercial future is extremely promising," said Nolan.

"We’re excited to have concluded this deal with a company headquartered in Pittsburgh," said Marc Malandro, Founding Director of the University of Pittsburgh Innovation Institute, who also serves as Chairman of Pennsylvania Bio, the state’s life sciences trade organization. "A number of local biotech entrepreneurs – including Anthony Florence, who played a pivotal role in providing early seed money for this project – have supported SkinJect. The company’s success is an affirmation of our region’s growing biotech community."

The company plans to file an IND (Investigational New Drug) application, a request to the FDA to begin administering the device to humans, by late 4th quarter 2016 or early 1st quarter 2017.

Skin cancer is the most commonly occurring cancer in the United States. After the age of 65, 50% of the population will develop skin cancer with the majority diagnosed with basal cell carcinoma (BCC). BCC occurs typically on the face, head, or neck and is a highly disfiguring disease. Current therapies involve invasive surgical procedures that are time-consuming, associated with patient recovery/morbidity and are expensive. SkinJect is novel, single use, topical drug delivery patch that, like a ‘Band-Aid’, is applied to the affected skin of those diagnosed with skin cancer. It is based on a proprietary micro-needle array drug delivery platform that uniquely delivers a potent generic chemotherapeutic agent and modifier to kill existing skin cancer and induce a memory immune response to prevent cancer re-occurrence. This project has confirmed high physician and patient acceptance from initial customer feedback.

Peregrine Pharmaceuticals Reports Financial Results for First Quarter of Fiscal Year 2017 and Recent Developments

On September 8, 2016 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, reported financial results for the first quarter of fiscal year (FY) 2017 ended July 31, 2016, and provided an update on its contract manufacturing business, clinical pipeline and other corporate developments (Press release, Peregrine Pharmaceuticals, SEP 8, 2016, View Source [SID:1234515016]).

Highlights Since April 30, 2016
"Since the start of our first quarter, we have steadily executed on our R&D and contract manufacturing objectives. On the R&D front, we recently achieved two important milestones beginning with the recent announcement that the National Comprehensive Cancer Network (NCCN) has awarded grants to three investigators to support bavituximab clinical research. In addition, we are pleased to announce today, that top-line data from our Phase III SUNRISE trial have been accepted for a late-breaking oral presentation at the upcoming meeting of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress to be held in Copenhagen in early October," stated Steven W. King, president and chief executive officer of Peregrine. "The presentation at ESMO (Free ESMO Whitepaper) will be a great opportunity to share clinical data from the trial in conjunction with initial results from our ongoing biomarker analyses which are already highly encouraging. The primary goal of the biomarker analysis is to identify a biomarker pattern for patients that receive the most benefit from a bavituximab-containing therapeutic regimen and we look forward to sharing the results of the ongoing analysis with more data expected later in the year. Our collaboration with the NCCN has been an important part of our plans for advancing the bavituximab clinical program in a cost effective way. The grants that were awarded represent clinical trials with novel bavituximab combinations in glioblastoma, head and neck cancer, and hepatocellular carcinoma including an immunotherapy combination, which is a major focus for advancing the program. Taken together, these developments are setting the stage for new data throughout the rest of 2016 and into 2017."

Mr. King continued, "On the manufacturing front, it remains an extraordinarily busy time. Based on the high demand for services, we remain on track to meet our current fiscal year revenue projections as we look to continue growing the business. Our ultimate goal remains to reach overall profitability within the next 21 months and Avid will be an important driver for achieving that goal in combination with making strategic investments in R&D while pursuing partnerships to help advance our programs."

Avid Bioservices Highlights
"Our biomanufacturing business was extremely busy this past quarter as the team remained on track according to the planned production schedule including initiating several process validation runs and ongoing commercial manufacturing activities. Despite being on track from a production standpoint, first quarter FY 2017 revenues were lower than expected due to a testing backlog at a third-party testing laboratory that delayed the shipment of manufacturing runs. As a result of the backlog being resolved, we expect revenue to exceed $20 million in the second quarter as we shift revenue recognition from the first quarter to the second quarter of fiscal year 2017. We believe this delay to be an anomaly, and we reaffirm our revenue guidance of between $50 and $55 million for the full fiscal year," stated Paul Lytle, chief financial officer of Peregrine.
The company is projecting manufacturing revenue for the full FY 2017 of $50 – $55 million.

Avid’s current manufacturing revenue backlog is $71 million, representing estimated future manufacturing revenue to be recognized under committed contracts. This backlog covers revenue to be recognized during the remainder of fiscal year 2017 and into fiscal year 2018.

In response to demand for manufacturing services, the company is designing a third manufacturing facility dedicated to clinical manufacturing that is anticipated to significantly increase Avid’s manufacturing capacity. The new clinical suite is expected to be complete and ready for clinical manufacturing activities by mid calendar year 2017.
Clinical Development Highlights
SUNRISE top-line data, including initial biomarker profile data, have been accepted for oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2016.

Peregrine’s research collaboration with NCCN is advancing as planned, with grants awarded to three investigators to support research of bavituximab in combination with other therapeutics for the following studies:

Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy (SBRT) for Unresectable Hepatitis C Associated Hepatocellular Carcinoma

Phase I/II Clinical Trial of Bavituximab with Radiation and Temozolomide for Patients with Newly Diagnosed Glioblastoma

Phase II Study of Pembrolizumab and Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
The company expects these trials to begin in early calendar year 2017.

Research Highlights
Our internal efforts and collaboration with Memorial Sloan Kettering Cancer Center continues to advance. The goal of this pre-clinical work is to evaluate combinations of bavituximab with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new and increasingly effective anti-cancer treatments. We expect initial results from our internal work and this collaboration to be presented at multiple conferences during the Fall of 2016.

Peregrine in-licensed a novel exosome technology from UT Southwestern that has potential for cancer detection and monitoring applications. This technology aligns directly with the company’s expertise, its proprietary PS-targeting platform and the bavituximab development program. As such, there are opportunities to use this technology as both a complementary tool in bavituximab’s ongoing development, as well as more broadly as the basis for novel cancer detection and monitoring tests that can be the focus of partnering efforts.
Financial Results
Total revenues for the first quarter of FY 2017 were $5,609,000, compared to $9,671,000 for the same quarter of the prior fiscal year. The first quarter FY 2017 decrease in revenues was primarily attributed to a decrease in contract manufacturing revenue.
Contract manufacturing revenue from Avid’s clinical and commercial biomanufacturing services provided to its third-party clients decreased to $5,609,000 for the first quarter of FY 2017 compared to $9,379,000 for the first quarter of FY 2016. The first quarter decrease was primarily due to a backlog at a third-party testing lab and unrelated to product quality that shifted the timing of revenue recognition from the first quarter to the second quarter of fiscal year 2017. The company does not expect this delay to further impact revenue projections for the fiscal year, and the company remains on track to generate revenue in excess of $20 million in the second quarter FY 2017.
Total costs and expenses for the first quarter of FY 2017 were $16,691,000, compared to $23,425,000 for the first quarter of FY 2016. This decrease for the first quarter of FY 2017 was primarily attributable to a decrease in research and development expenses associated with the Phase III SUNRISE trial combined with a decrease in personnel cost and manufacturing costs related to preparing bavituximab for commercial manufacturing.
For the first quarter of FY 2017, research and development expenses decreased 38% to $8,569,000, compared to $13,918,000 for the first quarter of FY 2016. In addition, cost of contract manufacturing decreased to $3,062,000 in the first quarter of FY 2017 compared to $4,608,000 for the first quarter of FY 2016, primarily due to lower reported revenue compared to the same prior year period. For the first quarter of FY 2017, selling, general and administrative expenses were $5,060,000 compared to $4,899,000 for the first quarter of FY 2016.
Peregrine’s consolidated net loss attributable to common stockholders was $12,437,000 or $0.05 per share, for the first quarter of FY 2017, compared to a net loss attributable to common stockholders of $15,101,000, or $0.08 per share, for the same prior year quarter.
Peregrine reported $44,195,000 in cash and cash equivalents as of July 31, 2016, compared to $61,412,000 at fiscal year ended April 30, 2016.
More detailed financial information and analysis may be found in Peregrine’s Annual Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.