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(AEHR) Receives $4.5 Million Order for New FOX-XP™
FREMONT, Calif., June 07, 2016 — Aehr Test Systems (NASDAQ:AEHR), a worldwide supplier of semiconductor test and burn-in equipment, today announced that it has received the first order for its new FOX-XP production test cell. The order totals over $4.5 million and includes a FOX-XP Multi-Wafer Test and Burn-in System, a FOX-XP WaferPakTM Aligner, and an initial set of FOX-XP WaferPak Contactors. $1.4 million of the order is shippable and payable immediately, and the remaining shipments and revenue from this sale are expected to continue through early calendar 2017.
Gayn Erickson, President and CEO of Aehr Test Systems, commented, “We are very excited about this new customer for our FOX-XP multi-wafer burn-in and test system and to receive the first order for a full production test cell of this new product. The customer is one of the world’s largest semiconductor manufacturers and has selected the FOX-XP solution for a high-volume production application where extended burn-in is required to meet their stringent quality standards. The customer’s end product will be used for high-speed communications in enterprise and server applications. It is much more cost-effective to do the burn-in required for this critical application at the wafer level on our new FOX-XP platform instead of in package form.
“The key features of our new FOX-XP test cell that contributed to the cost-effectiveness of the solution include the ability to provide up to 2,048 independent device power supplies per wafer which allows the system to test all the devices on the wafer in parallel, our proprietary WaferPak full wafer contactor which allows us to meet the very high pin count and small pad size and pad pitch requirements of the devices, and our high performance thermal chucks that enable us to manage the temperature of the high power density of the devices on the wafer. The footprint of our 18 wafer test cell is similar to the footprint of typical Semiconductor Test Equipment that can only test one wafer at a time.
“We have worked very closely with this customer to meet their wafer’s special test requirements by using our proprietary WaferPak full-wafer contactor and enhancing the FOX-XP system capabilities to meet their needs. We believe that the FOX-XP test cell is a perfect fit for this new and exciting application. The customer is forecasting device capacity growth that will drive the need for additional production burn-in capacity for multiple years into the future.
“With this new customer, we now have two very high quality lead customers for our new FOX-XP system. We could not be more pleased and believe that both of these customers represent a significant opportunity for Aehr Test with our FOX Wafer Level Test and Burn-in products in not only the initial applications but also with other application areas at both of these customers. We look forward to expanding our initial customer list as we address the many other opportunities where our multi-wafer test and burn-in systems can deliver significant cost and quality of test advantages to our customers.”
Aehr Test’s FOX-XP system is the company’s next-generation multi-wafer test solution that is capable of functional test and burn-in/cycling of flash memories, microcontrollers, sensors, optical devices, laser diodes, VCSELs, LEDs and other leading-edge ICs in wafer form before they are assembled into multi-die packages or other applications where known good die are critical. These end applications can span enterprise solid state drives, automotive devices, highly valuable mobile applications, communications and mission critical integrated circuits and sensors.
The FOX-XP system utilizes Aehr Test’s FOX WaferPak contactor, which provides a cost effective solution for making full wafer electrical die contact in a multi-wafer environment. Aehr Test’s WaferPak contactors contain up to tens of thousands of probes to contact all die simultaneously on wafers and substrates up to 300mm. FOX-XP systems may be configured to test more than 50 wafers in parallel using multiple FOX-XP systems in a single test cell which occupies a very efficient manufacturing space footprint. Aehr Test estimates the test equipment and consumables for the emerging multi-wafer level test and burn-in market will add $200 million to $300 million to its served available market.
About Aehr Test Systems
Headquartered in Fremont, California, Aehr Test Systems is a worldwide provider of test systems for burning-in and testing logic and memory integrated circuits and has an installed base of more than 2,500 systems worldwide. Increased quality and reliability needs of the Automotive and Mobility integrated circuit markets are driving additional test requirements, capacity needs and opportunities for Aehr Test products in package and wafer level test. Aehr Test has developed and introduced several innovative products, including the ABTSTM and FOX families of test and burn-in systems and the DiePak® carrier. The ABTS system is used in production and qualification testing of packaged parts for both lower-power and higher-power logic as well as all common types of memory devices. The FOX system is a full wafer contact test and burn-in system used for burn-in and functional test of complex devices, such as leading-edge memories, digital signal processors, microprocessors, microcontrollers and systems-on-a-chip. The DiePak carrier is a reusable, temporary package that enables IC manufacturers to perform cost-effective final test and burn-in of bare die. For more information, please visit the Company’s website at www.aehr.com.
Safe Harbor Statement
This press release contains certain forward-looking statements based on current expectations, forecasts and assumptions that involve risks and uncertainties. These statements are based on information available to Aehr Test as of the date hereof and actual results could differ materially from those stated or implied due to risks and uncertainties. Forward-looking statements include statements regarding Aehr Test’s expectations, beliefs, intentions or strategies regarding the FOX products, including statements regarding future market opportunities and conditions, expected product shipment dates and customer orders or commitments. These risks and uncertainties include, without limitation, acceptance by customers of the FOX and WaferPak contactor technologies, acceptance by customers of the FOX-XP system, WaferPak Aligner and WaferPak contactors shipped upon receipt of a purchase order and the ability of new products to meet customer needs or perform as described, as well as general market conditions, customer demand and acceptance of Aehr Test’s products and Aehr Test’s ability to execute on its business strategy. See Aehr Test’s recent 10-K, 10-Q and other reports from time to time filed with the Securities and Exchange Commission for a more detailed description of the risks facing Aehr Test’s business. Aehr Test disclaims any obligation to update information contained in any forward-looking statement to reflect events or circumstances occurring after the date of this press release.
Aehr Test Systems Carl Buck Vice President of Marketing (510) 623-9400 x381 Investor Relations Contact: Todd Kehrli or Jim Byers MKR Group, Inc. (323) 468-2300 aehr@mkr-group.com
(CALI) Sells Zhonghe for Approximately $62.3 Million
Transaction Improves Financial Position; Also Positions Company for Expansion of its Financing Services and High End Imported Vehicle Businesses
TIANJIN, CHINA / June 7, 2016 / China Auto Logistics Inc. (the “Company” or “CALI”) (NASDAQ: CALI), a top seller in China of luxury imported automobiles and a leading provider of auto-related services, announced today that effective June 1, 2016, 100% of the equity in its Zhonghe subsidiary — the owner and operator of the Airport International Auto Mall in Tianjin and 40% owner of Tianjin Car King — has been sold to Wuxi Huitong Automobile Sales and Service Co., Ltd. (Huitong) for approximately $62.3 million. Approximately $25.8 million of this amount is payable in cash to Shisheng. The remaining amount of approximately $36.5 million is being paid for by Huitong assuming Shisheng’s payment obligation to Zhonghe’s former owner.
As described in the pro-forma financial statements included in the 8-K filed by the Company this morning with the U.S. Securities and Exchange Commission, the net proceeds to CALI, assuming completion of the equity and debt transfers on March 31, 2016, are approximately $21 million (net of approximately $5 million to repay an amount due to Zhonghe), resulting in an approximately $5.6 million increase in CALI’s total equity and positive working capital.
Commenting on the transaction, Mr. Tong Shiping, Chairman and CEO of the Company, stated, “The timing of our acquisition of the Airport International Auto Mall ahead of the unforeseen persisting downturn in China’s economy saddled us with significant costs and losses. Becoming unburdened by these costs opens the door to profitable growth once again going forward.”
Mr. Tong noted that interest expense in 2015 related to the outstanding Zhonghe acquisition payable was approximately $2.7 million, with a related tax effect of about $523,000. Additionally, depreciation expense relating to the Airport International Auto Mall was approximately $2.2 million in 2015.
“We can now see the interest expense relating to the Zhonghe payable disappearing, as well as significantly lower depreciation expense,” Mr. Tong said. “Of course,” he added, “we will be losing in the period ahead any possible contributions to our operating results from the used car joint venture, whose market is still far from mature, as well as some auto sales tied to Zhonghe. However, we anticipate reducing our operating loss and perhaps generating an operating profit. Moreover, with our improved working capital position, the way will be clear for us to pursue future growth more aggressively. We see this mainly coming from a national expansion of our imported luxury auto business beyond the port of Tianjin, combined with expansion of our higher margin financing services as well as other possible auto related services further down the road.”
About China Auto Logistics Inc.
China Auto Logistics Inc. is one of China’s top sellers of imported luxury vehicles. It also provides a growing variety of “one stop” automobile related services such as short term dealer financing. Future growth is anticipated to come from expansion throughout China of the Company’s Auto Sales business as well as further growth in the Company’s higher margin financing services.
Information Regarding Forward-Looking Statements
Except for historical information contained herein, the statements in this press release are forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which may cause our actual results in future periods to differ materially from forecasted results. These risks and uncertainties include, among other things, product demand, market competition, and risks inherent in our operations. These and other risks are described in our filings with the U.S. Securities and Exchange Commission. We do not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACTS:
Ken Donenfeld
DGI Investor Relations Inc.
kdonenfeld@dgiir.com
Tel: 212-425-5700
Fax: 646-381-9727
(CYCC) Reports Updated Data From Its DNA Damage Response Program
Combination Showed 35.6% Disease Control Rate and Durable Responses including CR and PR in Heavily-Pretreated Patients with BRCA Mutations
BERKELEY HEIGHTS, N.J., June 06, 2016 — Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) (Cyclacel or the Company), reported today updated Phase 1 data from its DNA damage response program evaluating a combination regimen of two Cyclacel product candidates, seliciclib, a cyclin dependent kinase (CDK) inhibitor, and sapacitabine, a nucleoside analogue. The regimen was orally-administered as sequential (Part 1) or concomitant (Part 2) treatment to 67 heavily-pretreated patients with advanced solid tumors. Antitumor activity was demonstrated in a subgroup of 45 patients with breast, ovarian and pancreatic cancers who tested positive for BRCA mutations (44 germline and 1 sporadic) with a 35.6% disease control rate (1 CR, 5 PR and 10 SD). Treatment durations in responders ranged between 16 and over 240 weeks. No CR or PR was observed in BRCA negative patients. Data were presented at an oral presentation at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
“We are encouraged by the durable responses and stable disease seen with the seliciclib and sapacitabine combination in patients with BRCA mutations, in particular because most were heavily pretreated and many are able to remain on study for extended periods,” said Sara M. Tolaney, M.D., M.P.H., Associate Director, Clinical Research, Breast Oncology, Dana-Farber Cancer Institute, Boston. “Our findings from Parts 1 and 2 of the study have shown that the orally-administered regimen is well tolerated with manageable toxicities. Based on the results, we believe that further clinical evaluation of this combination regimen is warranted. A Part 3 extension of the study is currently enrolling advanced breast cancer patients with BRCA mutations.”
“The findings reported in Dr. Tolaney’s presentation show that the combination treatment of seliciclib and sapacitabine is active and tolerable,” said Judy Chiao, M.D., Vice President, Clinical Development and Regulatory Affairs of Cyclacel. “This clinical observation may be directly related to the drugs interference with the capacity of BRCA-mutated cancer cells to repair and survive sapacitabine-induced breaks in their DNA. If these preliminary findings are confirmed by further data, this regimen may provide an important treatment option for patients with BRCA-mutated cancers.”
“The ASCO data build on earlier data from our DNA damage response program highlighted by the American Association for Cancer Research (AACR) Annual Meeting Program Committee in a 2013 press conference,” said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. “The updated data support and extend clinical evidence of efficacy with different schedules of the combination in this patient population. We are encouraged with the durability of responses and stable disease, with ongoing responding patients achieving treatment durations exceeding 1 and 4.5 years respectively. We look forward to reporting data from the ongoing Part 3 extension in BRCA positive patients with breast cancer and increasing our understanding of the potential benefits of this differentiated treatment strategy in a targeted patient population with significant unmet medical need.”
Results
The trial is a dose escalation study conducted in patients with advanced and incurable solid tumors. The orally-administered regimen consists of sapacitabine administered twice daily for 7 days sequentially followed by seliciclib twice daily for 3 days over a 21 day cycle (Part 1, n=38); and sapacitabine dosed each morning followed by seliciclib each evening, each once daily for 5 days per week for 2 weeks of a 28 day cycle (Part 2, n=29). The primary objective of the trial is to determine the maximum tolerated dose with a secondary objective of antitumor activity of the combination. Sixty-seven patients have been treated in Parts 1 and 2 of the study, of which 44 were found to carry BRCA mutations and one a sporadic BRCA mutation.
| Best Responses | ||||||||||||
| PART 1 | PART 2 | |||||||||||
| BRCA carriers | Others | BRCA carriers | Others | |||||||||
| (n=16) | (n=22) | (n= 28) | (n=1) | |||||||||
| CR | 1 | – | – | – | ||||||||
| PR | 3 | – | 2 | – | ||||||||
| SD | 2 | 6 | 7 | 1* | ||||||||
| ORR (CR/PR) | 25 | % | 0 | % | 7 | % | 0 | % | ||||
| Disease Control (CR/PR/SD) | 6 (37.5%) | 6 (27.3%) | 9 (32.1%) | 1 (100.0 | %) | |||||||
* One patient had a sporadic BRCA mutation. CR=complete response, PR=partial response, SD=stable disease.
One CR and five PR were observed in BRCA mutation carriers with breast, ovarian and pancreatic cancers. Treatment durations for the 3 breast/ovarian cancer responders in Part 1 are 54, 93, over 240 weeks and the one breast cancer responder in Part 2 over 76 weeks respectively. Treatment durations for the two pancreatic cancer responders, one each in Parts 1 and 2, are 21 and 16 weeks respectively. Responders included patients who underwent prior treatment with PARP inhibitors and PARP naïve patients. SD was observed in 9 BRCA mutation carriers and 1 sporadic BRCA positive patient with treatment durations ranging from 16 to 88 weeks.
Overall in BRCA positive patients (Parts 1 and 2, n=45), disease control rate is 35.6% and overall response rate (ORR) is 11% (Part 1 ORR 25% and Part 2 7%). The difference in Part 1 and Part 2 ORRs may suggest that the seliciclib dose in the Part 2 schedule may be too low for enhancing the activity of sapacitabine.
Pharmacodynamic effects of the seliciclib and sapacitabine combination were observed in skin biopsies. Part 1 biopsies following treatment showed a 2.3-fold increase in DNA damage induced by sapacitabine, as measured by gamma-H2AX immunohistochemistry. Additional DNA damage occurred after treatment with seliciclib with a 0.58-fold further increase in gamma-H2AX staining.
In Part 1 recommended Phase 2 doses (RP2D) are: sapacitabine 50 mg b.i.d./seliciclib 800 mg b.i.d. Most frequent grade 3/4 adverse events were neutropenia (16%) and elevation in AST (16%). In Part 2 RP2D are: sapacitabine 250 mg q.d./seliciclib 200 mg q.d. Most frequent grade 3/4 adverse events were neutropenia (28%) and elevation in AST (10%). Dose limiting toxicities were reversible elevations in transaminase and bilirubin, neutropenia or febrile neutropenia and pneumonia.
| Abstract: | 2503 |
| Title: | Phase I study of sapacitabine and seliciclib in patients with advanced solid tumors |
| Date/Time: | June 6, 2016 9:00 a.m. – 9:12 a.m. CDT |
| Location: | E354b |
| Session Title: | Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics |
| Authors: | SM Tolaney1, J Hilton1, JM Cleary1, L Gandhi1, EL Kwak1, JW Clark1, A Wolanski1, T Bell1, SJ Rodig3, JH Chiao2, D Blake2, G Shapiro1 |
| 1Dana-Farber Cancer Institute, Boston, MA; Massachusetts General Hospital Cancer Center, Boston, MA; 2 Cyclacel Ltd, Dundee, United Kingdom; 3 Brigham and Women’s Hospital, Boston, MA. | |
The abstract can be accessed through the ASCO website, http://www.asco.org/internal/meetings/2016-asco-annual-meeting.
About sapacitabine
Sapacitabine is an oral nucleoside analogue prodrug whose metabolite, CNDAC, generates single-strand DNA breaks (SSB), either leading to arrest of the cell cycle at G2 phase or development of double-strand DNA breaks (DSB). CNDAC-induced DSB repair is dependent on homologous recombination (HR). BRCA mutations in cancer cells are a cause of HR deficiency, making them susceptible to cell death induced by sapacitabine. Sapacitabine is the subject of SEAMLESS, a Phase 3 trial, which has completed enrollment and is being conducted under an SPA with the U.S. Food and Drug Administration (FDA) as front-line treatment for acute myeloid leukemia (AML) in the elderly. Sapacitabine has been evaluated to date in over 1000 patients including randomized Phase 2 and 3 trials in patients with hematological malignancies and previously treated solid tumors, including lung cancer.
About seliciclib
Seliciclib is an orally-available CDK inhibitor molecule that selectively inhibits enzyme targets, CDK2 and CDK9, which are central to the process of cell growth, survival and cell cycle control. Seliciclib treatment has been reported to inhibit the two major DNA double-strand break (DSB) repair pathways, homologous recombination (HR) and non-homologous end joining (NHEJ), by reducing expression of components of each pathway. It may potentiate the activity of sapacitabine by compromising HR protein expression and activation or by potentiating apoptosis following sapacitabine-induced DNA damage. Seliciclib has been evaluated to date in approximately 450 patients including randomized Phase 2 trials in patients with previously treated lung cancer and nasopharyngeal cancer.
About Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company using cell cycle control and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases. The SEAMLESS randomized Phase 3 trial of sapacitabine as front-line treatment for AML in the elderly under an SPA with FDA has completed enrollment. Cyclacel’s pipeline includes an oral combination of seliciclib (CDK2/9 inhibitor) and sapacitabine in Phase 1 in advanced solid tumors including patients with BRCA mutations; sapacitabine in Phase 2 in MDS; and CYC065 (CDK2/9 inhibitor) in Phase 1 in solid tumors and lymphomas with potential utility based on preclinical data in other hematological malignancies. Cyclacel’s strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. Please visit www.cyclacel.com for more information.
Forward-looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel’s product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts for Cyclacel Pharmaceuticals, Inc.
Company: Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
Investor Relations: Russo Partners LLC, Robert Flamm, (212) 845-4226, robert.flamm@russopartnersllc.com
© Copyright 2016 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.
(VBLT) VB-111 Clinical Cancer Data Presented at ASCO
- VB-111 demonstrated a statistically significant increase in overall survival at therapeutic vs. low dose level (810 days vs. 172 days, p=0.042)
- 60% (9 of 15) durable response rate (as measured by reduction in CA-125) observed with VB-111, approximately 2x the historical response with Avastin® plus chemotherapy in ovarian cancer
- Clinical data supported by immunotherapeutic effect observed in biopsies following treatment with VB-111
TEL AVIV, Israel, June 06, 2016 — VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced the presentation of updated clinical results from a Phase 1/2 trial of VB-111 in the treatment of patients with recurrent platinum resistant ovarian cancer. The data are being presented today in a poster at the 2016 American Society of Clinical Oncology (ASCO) annual meeting, in Chicago. They demonstrate a median overall survival of 810 days in the VB-111 therapeutic dose arm, versus 172 days in the low dose arm, a result that was statistically significant. There was also a durable doubling in the response rate, as measured by a reduction in the CA-125 biomarker, compared to historical rates of Avastin plus chemotherapy in ovarian cancer. Durable RECIST responses and disease stabilizations were also observed.
“The demonstration of improved overall survival with the therapeutic dose, in combination with 60% durable response rate, is particularly impressive, given this trial focused on women with poor prognosis disease,” said Richard Penson, MD, MRCP, Associate Professor of Medicine, Harvard Medical School, Clinical Director of Medical Gynecologic Oncology, Massachusetts General Hospital, and Primary Investigator for this trial.
“We are excited by this data set from our Phase 1/2 ovarian cancer trial which show durable disease control and responses with VB-111,” said Dror Harats, MD, Chief Executive Officer of VBL Therapeutics. “The data reinforce our confidence in VB-111 as, together with the positive data we have generated in GBM, this is the second cancer indication in which we have observed a significant survival benefit. We are now preparing for an end-of-Phase 2 meeting with the FDA which will guide the next steps in our ovarian cancer clinical program.”
This trial was designed as a Phase 1/2 dose escalation study. The primary objectives were to evaluate the safety and tolerability and identify dose limiting toxicity in combination of VB-111 and weekly paclitaxel; and explore the efficacy in an expanded cohort of the optimally tolerated dose of combination VB-111 and weekly paclitaxel, based on RECIST response, CA-125 response, progression free survival (PFS) and overall survival (OS) in patients with recurrent platinum-resistant ovarian cancer.
Twenty one patients with recurrent platinum-resistant Müllerian/ovarian cancer were enrolled at Massachusetts General Hospital and Dana Farber Cancer Institute, and received up to 7 doses of treatment. Patients were treated in two consecutive cohorts: Low Dose Treatment (n=4, 3×1012 VPs + 40mg/80 paclitaxel) or a Therapeutic Dose (n=17, 1×1013 VPs + 80 paclitaxel). All patients had measurable disease, with a grade at diagnosis of: 1A (1, 5%), 1B (1, 5%), 1C (1, 5%); IIIC (12, 57%); or IV (6, 29%). The patients included in the study were of particularly adverse prognosis as 48% of the patients were primary platinum refractory and 52% had tumors that failed to respond to prior anti-angiogenic agents, including Avastin®.
The results showed a significant increase in overall survival at the therapeutic dose of VB-111 vs. the low dose level (810 vs. 172 days, p=0.042). Nine of the 15 evaluable patients (60%) on the therapeutic dose had a response, as defined by a 50% reduction in CA-125. Durable RECIST responses and disease stabilizations were seen. This represents an approximate doubling in response rate, compared to historical data with ovarian cancer patients treated with a combination of Avastin® and chemotherapy in the AURELIA1 trial.
An immunotherapeutic effect was also observed in biopsies taken from patients. H&E and immunohistochemistry staining showed regions of apoptotic cancer cells and infiltration of cytotoxic CD8 T-cells following treatment with VB-111.
VB-111 was found to be safe and well tolerated. Toxicity was similar to what would be expected with antiangiogenics and taxanes in this patient population. Eight serious adverse events were reported, 2 were considered by the investigator to be possibly related to be VB-111. No dose limiting toxicities were reported at any dose level.
About VBL Therapeutics
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer. The Company’s lead oncology product candidate, VB-111, is a first-in-class, targeted anti-cancer gene-therapy agent that is positioned to treat a wide range of solid tumors. VB-111 is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in >170 cancer patients and we have observed its efficacy signals in an ”all comers“ Phase 1 trial as well as in three tumor-specific Phase 2 studies. The mechanism of VB-111 combines blockade of tumor vasculature with an anti-tumor immune response. This mechanism retains activity regardless of baseline tumor mutations or the identity of the pro-angiogenic factors secreted by the tumor. VB-111 is currently being studied in a Phase 3 pivotal trial for Recurrent Glioblastoma (rGBM) and in Phase 2 trials for Ovarian Cancer and Thyroid Cancer. The GLOBE trial for rGBM is being conducted under an FDA Special Protocol Assessment (SPA), and VB-111 has obtained fast track and Orphan designations.
Forward Looking Statements:
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements include, but are not limited to, statements regarding the clinical development of VB-111 and its therapeutic potential and clinical results, including statements related to the Phase 3 pivotal trial for rGBM. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and the risk that historical clinical trial results may not be predictive of future trial results. A further list and description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. VBL Therapeutics undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
- AURELIA was an open-label randomized phase III trial designed to determine the efficacy, safety, and quality of life of combining bevacizumab (Avastin®) with chemotherapy for platinum-resistant recurrent ovarian cancer.
Avastin® is a registered trademark of Genentech Inc.
INVESTOR CONTACT: Michael Rice LifeSci Advisors, LLC (646) 597-6979
(HMNY), Matheson Analytics & Zone Technologies Announce Pending Merger
Hi-Tech Companies Partner to Expand RedZone Maps’ Crime Aggregation Technology
MIAMI and NEW YORK, June 6, 2016 — Helios and Matheson Analytics Inc. (NASDAQ: HMNY), a provider of integrated Big Data technology, advanced analytics and data visualization solutions to Fortune 500 companies, and Zone Technologies, Inc., creator of RedZone Maps, a GPS-driven, real-time crime and navigation map application, announced today that they plan to merge. With the new partnership, Helios and Matheson plans to leverage its artificial intelligence capabilities and deep learning and analytics expertise to enable RedZone Maps to further expand its crime mapping capabilities globally. The pending merger is subject to approval by the NASDAQ Stock Market, among other customary closing conditions.
Having achieved fourth place in the App Store’s navigation category behind Google and Waze in its first week out of beta, RedZone Maps’ GPS-driven, real-time crime and navigation map application empowers consumers to identify “red zones” – concentrations of highly reported crime in an area – and helps navigators obtain optimal cautionary alerts that can be shared with others. In addition to expanding RedZone Maps’ mapping capabilities, RedZone Maps expects Helios and Matheson’s expertise to enable it to monitor chatter on all social media platforms internationally and instantaneously retrieve real-time crime data from around the world.
In discussing the pending merger, Ted Farnsworth, Founder and CEO of RedZone Maps, said, “Upon discovering Helios and Matheson’s cutting edge capabilities in Big Data analytics and artificial intelligence, we saw the synergy immediately. I believe the combined company will be able to offer the most sophisticated and advanced technology in global crime mapping. Our mission is to enhance personal safety worldwide.”
Pat Krishnan, Helios and Matheson’s CEO agrees. “With my many years of computer sciences and engineering management experience in Silicon Valley, I recognized our synergy immediately. Helios and Matheson has worked tirelessly to empower its clients and customers to unlock the value of data to make better decisions. We plan to expand that mission through our pending merger with RedZone Maps.”
About Helios and Matheson
Helios and Matheson Analytics Inc. (NASDAQ: HMNY), headquartered in New York City with offices and facilities in Silicon Valley and India, including an offshore development center in Chennai, India, provides Big Data technology and advanced analytics services, with extensive domain expertise in Banking, Financial Services and Insurance (BFSI), including data visualization to empower its clients to unlock the value of data to make better decisions. With its client roster including Fortune 500 corporations, it focuses mainly on the BFSI and Technology verticals. Helios and Matheson’s solutions cover the entire spectrum of information technology needs, including applications, data and infrastructure. For more information visit Helios and Matheson at http://www.hmny.com.
About RedZone Maps
RedZone Maps (Zone Technologies, Inc.), headquartered in Miami, Florida, with offices in Israel, is a state-of-the-art mapping and spatial analysis company. Its eye-opening safety map application enhances mobile GPS navigation by providing advanced proprietary technology, to easily and safely guide travelers to avoid potentially risky areas deemed “red zones,” due to high groupings of crime data. More than that, the app incorporates a social media component allowing for real-time “It’s happening now” crime reporting coupled with up-to-the-minute data from over 1,400 local, state, national and global sources. Currently available to iOS users with an Android version scheduled to launch shortly. More information is available on the RedZone Maps website and the free app is available for download in the App Store.
Cautionary Statement on Forward-looking Information
Certain statements in this communication contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (collectively, “forward-looking statements”) that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words “believe,” “may,” “plan,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect” and similar expressions. All statements other than statements of historical fact included in this communication are forward-looking statements, including statements regarding Helios and Matheson’s ability to regain compliance with all of Nasdaq’s continued listing criteria, obtain a decision of the Nasdaq Hearings Panel to continue Helios and Matheson’s listing on Nasdaq, and receive Nasdaq approval of any listing application that may be required in connection with the pending merger with Zone Technologies, Inc.
Such forward-looking statements are based on a number of assumptions. Although management of Helios and Matheson believes that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Risk factors and other material information concerning Helios and Matheson are described in its Annual Report on Form 10-K, as amended, for the fiscal year ended December 31, 2015, and other filings, including current and periodic reports, filed with the U.S. Securities and Exchange Commission. You are cautioned to review such reports and other filings at www.sec.gov.
Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on Helios and Matheson’s current expectations and Helios and Matheson does not undertake an obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
(CNCK) to Present at the LD Micro Invitational
LOS ANGELES, CA / June 6, 2016 / Content Checked Holdings, Inc. (OTCQB: CNCK), a revolutionary marketplace for people with dietary restrictions and the manufacturers who cater to them by creating and introducing easy to use smartphone apps, today announced that Director of Business Development, Victoria Nunez, will present at the 6th annual LD Micro Invitational on Wednesday, June 8 at 3:00 p.m. PT. The conference will be held June 7-9, 2016 at Luxe Sunset Bel Air Hotel in Los Angeles and will feature 195 companies in the small / micro-cap space.
Management will be available during the conference for one-on-one meetings. For more information about the conference or to schedule a one-on-one meeting, please contact Victoria Nunez at vnunez@contentchecked.com.
View Content Checked’s profile here: http://www.ldmicro.com/profile/CNCK
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About Content Checked Holdings, Inc.
Content Checked (www.contentchecked.com) has created a revolutionary marketplace for people with dietary restrictions and the organizations who cater to them by creating and introducing the ContentChecked, MigraineChecked and SugarChecked smartphone applications. ContentChecked and MigraineChecked are the first applications with comprehensive and accurate content information, and in-depth allergen and migraine definitions for over 70% of conventional U.S. food products.
Each app gives consumers the ability to scan a product’s bar code and determine if it is safe for consumption based on their allergy settings. The apps will recommend a suitable alternative if a product does contain one or more of a user’s allergens. This enables the applications to meet the needs of millions of people in the U.S. In the U.S. alone, there are more than 15 million people who suffer from food allergies and 38 million people who suffer from migraines and chronic headaches. The food allergy and intolerances market has been valued at approximately US$13 billion in 2015. As a result, Content Checked has created a pivotal way for food manufacturers and producers to showcase their products to consumers who are actively seeking them at the point of purchase.
Content Checked has created a robust database of allergens, migraine triggers and food ingredients that directly correlate with food allergies, intolerances, migraines and chronic headaches. There are currently hundreds of thousands of products in its database, updated regularly. All applications serve as easy shopping tools for consumers to decipher often misleading food labels and receive recommendations for healthier alternative products as they shop in real time. Content Checked’s mission is to offer fast, reliable and efficient mobile apps that help consumers make more informed purchasing decisions and live healthier lives in accordance to their dietary preferences.
For more information on the Company, please visit its social media channels via Facebook (www.facebook.com/contentchecked), (www.facebook.com/migrainechecked) and (www.facebook.com/sugarchecked); Instagram (www.instagram.com/contentchecked), (www.instagram.com/migrainechecked) and (www.instagram.com/sugarchecked); or
YouTube (www.youtube.com/channel/UCMihoaZILlRZ2C3hmx5vXhQ).
About LD Micro
LD Micro was founded in 2006 with the sole purpose of being an independent resource in the microcap space. What started out as a newsletter highlighting unique companies has transformed into an event platform hosting several influential conferences annually (Invitational, Summit, and Main Event).
In 2015, LDM launched the first pure microcap index (the LDMi) to exclusively provide intraday information on the entire sector. LD will continue to provide valuable tools for the benefit of everyone in the small and microcap universe.
For those interested in attending, please contact David Scher at david@ldmicro.com or visit www.ldmicro.com for more information.
Contact:
Investors:
Christine J. Petraglia
Managing Director
PCG Advisory
646.731.9817
Media:
Sean Leous
Managing Director
PCG Advisory
646.863.8998
(AKAO) $20M Contract, $25M Private Placement, 50 Pct. Enrollment Phase 3 EPIC Trial
Option Funding Focused on Phase 3 EPIC Registration Trial of Plazomicin in cUTI; Company Expects Top-Line EPIC Study Results in the First Quarter of 2017
SOUTH SAN FRANCISCO, Calif., June 02, 2016 — Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that it has been awarded $20 million for an additional option, Option 3, on its existing contract with the Biomedical Advanced Research and Development Authority (BARDA) to support the development of plazomicin. Plazomicin is the Company’s lead product candidate being developed to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).
The BARDA contract was originally awarded to Achaogen under BARDA’s Broad Spectrum Antimicrobials program in August 2010. The original contract consisted of a base award as well as three options that, effective today, have all been exercised. With the granting of this last option, the unspent funding currently committed under the contract with BARDA now totals approximately $41 million. The funding from Option 3 is focused on the Phase 3 pivotal clinical trial of plazomicin, the EPIC study, in complicated urinary tract infections (cUTI). Achaogen expects to release top-line results from the EPIC study in the first quarter of 2017, and plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2017.
“We appreciate BARDA’s overall support of the plazomicin program, including this additional financial support for the Phase 3 EPIC study,” said Kenneth Hillan, M.B. Ch.B., Achaogen’s Chief Executive Officer. “Multi-drug resistant gram-negative infections continue to be a serious public health threat, especially given the high mortality rates associated with CRE infections.”
In a separate press release, the Company announced today that it has entered into an agreement to sell shares of its common stock and warrants to purchase shares of common stock for aggregate gross proceeds of approximately $25 million in a private placement to a syndicate of new investors. In addition to this equity financing, the Company plans to draw $10 million in additional debt under its existing loan agreement with Solar Capital Ltd.
About the EPIC Study
EPIC (Evaluating plazomicin in cUTI) is a multi-national, randomized, controlled, double-blind clinical trial in patients with complicated urinary tract infections (cUTI) including acute pyelonephritis (AP), which is expected to create a substantial opportunity for plazomicin to address unmet medical needs arising from multi-drug resistant (MDR) infections. EPIC is expected to serve as a single pivotal trial supporting a New Drug Application (NDA) for plazomicin in the United States.
Proceeds to Support Advancement of Development Programs Addressing Multi-Drug Resistant Gram-Negative Infections
SOUTH SAN FRANCISCO, Calif., June 02, 2016 (GLOBE NEWSWIRE) — Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that it has entered into an agreement to sell shares of its common stock and warrants to purchase shares of its common stock for aggregate gross proceeds of approximately $25 million in a private placement. New Enterprise Associates (NEA), one of the largest biotechnology investors worldwide, led the placement and was joined by EcoR1 Capital, LLC and additional new investors. Achaogen expects to use proceeds of the financing to advance its research and development programs and for general corporate purposes. The Company’s lead product candidate, plazomicin, is being developed to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).
As a result of this equity financing, the Company expects to meet certain funding conditions under an existing loan agreement with Solar Capital Ltd. and plans to draw an additional $10 million term loan from Solar Capital.
In a separate press release, the Company also announced today that it has been awarded $20 million for an additional option, Option 3, on its existing contract with the Biomedical Advanced Research and Development Authority (BARDA) to support the development of plazomicin. The remaining available funding currently committed under the contract with BARDA now totals approximately $41 million.
“We welcome a distinguished group of new investors to Achaogen,” said Kenneth Hillan, M.B. Ch.B., Achaogen’s Chief Executive Officer. “We are excited to advance plazomicin to top-line data from the EPIC study in patients with cUTI and the CARE study in patients with serious bacterial infections due to CRE.”
About the Private Placement
Achaogen has agreed to sell approximately 8 million shares of common stock and warrants to purchase approximately 2 million shares of common stock for aggregate gross proceeds of approximately $25 million before deducting offering expenses. The price to be paid for the common stock, $3.15 per share, is equal to the consolidated closing bid price on the Nasdaq Global Market on the day of pricing, June 1, 2016. The warrants have a per share exercise price of $3.66, are exercisable immediately, and expire five years from the date of issuance.
The Company expects the offering to close by June 3 subject to satisfaction of specified customary closing conditions.
The securities to be sold in this private placement have not been registered under the Securities Act of 1933, as amended, or any state securities laws, and will be sold in a private placement pursuant to Regulation D of the Securities Act. The securities may not be offered or sold in the United States absent registration or pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws. Achaogen has agreed to file a registration statement covering the resale of the shares of common stock acquired by the investors and shares of common stock issuable upon exercise of the warrants acquired by the investors.
This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.
Company Expects Completion of Enrollment in Phase 3 EPIC Study in 2016, Top-Line Data in First Quarter of 2017 and NDA Submission in Second Half of 2017
SOUTH SAN FRANCISCO, Calif., June 02, 2016 (GLOBE NEWSWIRE) — Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that it has achieved over 50 percent patient enrollment in its ongoing Phase 3 EPIC registration clinical trial of plazomicin. Achaogen is developing plazomicin, its lead product candidate, to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).
“Enrollment in the EPIC clinical trial has been progressing well and we are pleased that we have enrolled half of the approximately 530 patients that we intend to recruit for the trial,” said Kenneth Hillan, Achaogen’s Chief Executive Officer. “We look forward to completing enrollment in the EPIC trial this year and expect to report top-line data in first quarter of 2017.”
EPIC (Evaluating plazomicin in cUTI) is a multi-national, randomized, controlled, double-blind clinical trial in patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP), which is expected to create a substantial opportunity for plazomicin to address the unmet medical need arising from multi-drug resistant (MDR) infections. The EPIC trial is expected to serve as a single pivotal trial and support a New Drug Application (NDA) submission in the second half of 2017. The Company also expects to announce top-line results for the CARE (Combating Antibiotic Resistant Enterobacteriaceae) study, a Phase 3 clinical trial in patients with serious bacterial infections due to CRE, in the first half of 2017.
About Achaogen
Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen’s lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen’s plazomicin program is funded in part with a contract from the Biomedical Advanced Research and Development Authority. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine, and Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections. For more information, please visit www.achaogen.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen’s expectations regarding (i) the timeline for enrollment of Achaogen’s ongoing Phase 3 EPIC trial and Phase 3 CARE trial, (ii) the expectation that the Phase 3 EPIC trial will serve as a single pivotal trial supporting an NDA for plazomicin, and (iii) the timing for completion of Achaogen’s Phase 3 trials and submission of an NDA to the U.S. Food and Drug Administration. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; specific risks related to the ongoing Phase 3 EPIC trial and Phase 3 CARE trial, including the lack of a prior clinical trial in patients with CRE infections and challenges in enrolling an adequate number of patients with rare infections; the risk of failure to successfully validate, develop and obtain regulatory clearance or approval for the in vitro diagnostic (IVD) assay for plazomicin; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk that bacteria may evolve resistance to plazomicin; risks and uncertainties as to Achaogen’s ability to raise additional capital to support the development of plazomicin and its other programs; uncertainties regarding the availability of adequate third-party coverage and reimbursement for newly approved products; Achaogen’s reliance on third parties to conduct certain preclinical studies and all of its clinical trials; Achaogen’s reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; Achaogen’s dependence on its President and Chief Executive Officer; risks and uncertainties related to the acceptance of government funding for certain of Achaogen’s programs, including the risk that BARDA could terminate Achaogen’s contract for the funding of the plazomicin development program; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen’s patents or proprietary rights; and the risk that Achaogen’s proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Achaogen’s business in general, see Achaogen’s current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, and its Annual Report on Form 10-K for the fiscal year ended December 31, 2015. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.
Investor Contact: Hans Vitzthum 212.915.2568 hans@lifesciadvisors.com Media Contact: Denise Powell 510.703.9491 denise@redhousecomms.com
(CLRB) to Present at the LD Micro Invitational
MADISON, WI and LOS ANGELES, CA / June 2, 2016 / Cellectar Biosciences (Nasdaq: CLRB), an oncology-focused biotechnology company, today announced that it will be presenting at the 6th annual LD Micro Invitational on Thursday, June 9 at 9:30 AM PST/12:30 PM EST. Jim Caruso, president and CEO of Cellectar, will present the company and meet with investors.
“As we continue to successfully advance our operating plan and clinical programming, we remain committed to providing performance updates with existing and potential shareholders,” said Mr. Caruso. “The LD Micro Invitational conference provides an excellent venue to further share the Cellectar story and we are appreciative of the opportunity to participate.”
The conference will be held at the Luxe Sunset Bel Air Hotel and will feature 195 companies in the small/micro-cap space.
View Cellectar Biosciences’ profile here: http://www.ldmicro.com/profile/CLRB
Profiles powered by LD Micro – News Compliments of Accesswire
About Cellectar Biosciences, Inc.
Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells. Cellectar’s PDC Delivery Platform is based on the company’s proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar’s PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company’s lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 is currently being evaluated under an orphan drug designated Phase 1 study in patients with relapsed or refractory multiple myeloma. The company is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1603-PTX), a preclinical stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For additional information please visit www.cellectarbiosciences.com.
About LD Micro
LD Micro was founded in 2006 with the sole purpose of being an independent resource in the microcap space. What started out as a newsletter highlighting unique companies has transformed into an event platform hosting several influential conferences annually (Invitational, Summit, and Main Event).
In 2015, LDM launched the first pure microcap index (the LDMi) to exclusively provide intraday information on the entire sector. LD will continue to provide valuable tools for the benefit of everyone in the small and microcap universe.
For those interested in attending, please contact David Scher at david@ldmicro.com or visit www.ldmicro.com for more information.
Contact:
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com
(ISCO) Publication of Preclinical Parkinson’s Cell Transplantation Treatment Results
CARLSBAD, CA–(June 02, 2016) – International Stem Cell Corporation (OTCQB: ISCO), a California-based clinical stage biotechnology company developing stem cell-based therapies and biomedical products, announced today that it has published the results of a 12-month pre-clinical, non-human primate study. The data demonstrates the safety and efficacy of the company’s proprietary ISC-hpNSC® readily expandable neural stem cell derived treatment of Parkinson’s disease.
“The publication of the data in the peer-reviewed and highly-respected journal, Cell Transplantation, brings to conclusion the preclinical stage of ISCO’s Parkinson’s disease program. The data provides further evidence that parthenogenetic neural stem cells can be effective in treating the symptoms of Parkinson’s disease and, along with the previously safety data, formed the basis of our application to the Australian regulatory authorities to move this program into the clinic,” said Russell Kern, Ph.D., ISCO’s Chief Scientific Officer.
The 12-month GLP study demonstrated the safety and efficacy of transplanting ISC-hpNSC® into non-human primates with induced moderate to severe clinical Parkinson’s disease symptoms. Transplantation of neural cells was safe and well tolerated by the animals with no dyskinesia, tumors, ectopic tissue formation or other test article related serious adverse events. It was shown that ISC-hpNSC® improved Parkinson’s disease symptoms by increasing the number of dopaminergic neurons and dopamine concentration in the brain through neurotrophic support and dopamine neuron replacement. This data from this study was closely reviewed by the Australian Therapeutic Goods Administration (TGA) and supported the clinical trial approval of ISC-hpNSC® for the treatment of Parkinson’s disease (ClinialTrials.gov NCT02452723).
The article and abstract can be found at:
http://www.ingentaconnect.com/content/cog/ct/pre-prints/content-CT-1518_Gonzalez_et_al
About the Parkinson’s disease clinical study
The Phase I clinical study is a dose escalation safety and preliminary efficacy study of ISC-hpNSC®, intracranialy transplanted into patients with moderate to severe Parkinson’s disease. The open-label, single center, uncontrolled clinical trial will evaluate three different dose regimens. A total of 12 participants with moderate to severe Parkinson’s disease will be treated. Following transplantation, the patients will be monitored for 12 months at specified intervals, to evaluate the safety and biologic activity of ISC-hpNSC®. PET scans will be performed at baseline, as part of the screening assessment, and at 6 and 12 months after surgical intervention. Clinical responses compared to baseline after the administration of ISC-hpNSC® will be evaluated using various neurological assessments such as Unified Parkinson Disease Rating Scale (UPDRS), Hoehn and Yahr and other rating scales.
The study will be performed at Royal Melbourne Hospital in Australia. The study’s submission is overseen by ISCO subsidiary, Cyto Therapeutics Pty Ltd.
About Parkinson’s disease
Parkinson’s disease (PD) is a degenerative disorder of the central nervous system mainly affecting the motor system. The motor symptoms of Parkinson’s disease result from the death of dopamine-generating cells in the substantia nigra, a region of the midbrain. Early in the course of the disease, the most obvious symptoms are movement-related; these symptoms include shaking, rigidity, slowness of movement and difficulty with walking and gait. Later, thinking and behavioral problems may arise, with dementia commonly occurring in the advanced stages of the disease, and depression is the most common psychiatric symptom. Parkinson’s disease is more common in older people, with most cases occurring after the age of 50.
Currently, medications typically used in the treatment of Parkinson’s, L-DOPA and dopamine agonists, improve the early symptoms of the disease. As the disease progresses and dopaminergic neurons continue to be lost, the drugs eventually become ineffective while at the same time frequently producing a complication marked by involuntary writhing movements. In 2013 PD resulted in about 103,000 deaths globally, up from 44,000 deaths in 1990.
About ISC-hpNSC®
International Stem Cell Corporation’s proprietary ISC-hpNSC® consists of a highly pure population of neural stem cells derived from human parthenogenetic stem cells. ISC-hpNSC® is a suspension of clinical grade cells manufactured under cGMP conditions that have undergone stringent quality control measures and are clear of any microbial and viral contaminants. Preclinical studies in rodents and non-human primates have shown improvement in Parkinson’s disease symptoms and increase in brain dopamine levels following the intracranial administration of ISC-hpNSC®. ISC-hpNSC® provides neurotrophic support and cell replacement to the dying dopaminergic neurons of the recipient PD brain. Additionally, ISC-hpNSC® are safe, well tolerated and do not cause adverse events such as dyskinesia, systemic toxicity or tumors in preclinical models. International Stem Cell Corporation believes that ISC-hpNSC® may have broad therapeutic applications for many neurological diseases affecting the brain, the spinal cord and the eye.
About International Stem Cell Corporation
International Stem Cell Corporation (ISCO) is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
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Safe harbor statement
Statements pertaining to anticipated developments, expected results and timing of clinical studies, potential applications of ISC-hpNSC® to other diseases, progress of research and development initiatives, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products (including clinical trial results that differ from expectations based on earlier studies), regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.
Contacts:
International Stem Cell Corporation
Russell Kern, PhD
Executive Vice President, CSO
Phone: 760-940-6383
Email: ir@intlstemcell.com
Media:
Alex Fudukidis
Phone: (646) 942-5632
Email: alex.fudukidis@russopartnersllc.com
Tony Russo, Ph.D.
Phone: (212) 845-4251
Email: tony.russo@russopartnersllc.com
(EXPI) CEO Invited to Speak at Mendix World
BELLINGHAM, WA–(June 02, 2016) – eXp World Holdings, Inc. (OTCQB: EXPI) today announced that Founder and Chief Executive Officer Glenn Sanford will be presenting at Mendix World, a two day conference in Rotterdam, Netherlands focused on strategic technology trends, digital transformation, and insight into making technology a defining characteristic of your business.
Sanford will be participating in a panel discussion titled Disrupting Traditional Markets through Technology. Since 2009, eXp World Holdings, Inc. and subsidiaries have focused on leveraging technology to create efficiencies within the services industries and unprecedented opportunities for professional development and income for affiliated industry members. The Company’s achievement in these areas is most notable within the residential real estate brokerage industry through the launch and growth of eXp Realty, the Agent-Owned Cloud Brokerage.
Mendix, based in Rotterdam, Netherlands, is a cloud-based, platform-as-service company or rapid application development platform that, through an agile project management process, allows organizations to transform ideas using visual modeling tools into owned applications that can provide enterprise solutions at a rate that is up to 6X faster than using traditional programming platforms and methods.
Since launching in 2009, eXp World Holdings, Inc. and eXp Realty have challenged the traditional brokerage model and its dependence upon physical bricks and mortar through the utilization of 3D – avatar-based environments and other cloud-based technologies, breaking down geographic barriers and developing a supporting and engaging community without the costs traditionally associated with brokerage.
Glenn Sanford, the Company’s Chairman and Chief Executive Officer, stated, “We’re looking forward to attending Mendix world and participating in the panel discussion. Mendix allows businesses to innovate faster and, as a company, we have succeeded in disproving the notion that physical office space is an indispensable element of a successful real estate brokerage model or a necessary ingredient to building a community of professionals in a collaborative setting. In that sense, we have been disruptive in favor of our agents and brokers and we look forward to sharing our experience and insight with Mendix World attendees.”
About eXp World Holdings, Inc.
eXp World Holdings, Inc. is the holding company for a number of companies most notably eXp Realty LLC, the Agent-Owned Cloud Brokerage™ as a full-service real estate brokerage providing 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an aggressive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.
eXp World Holdings, Inc. also owns 89.4% of First Cloud Mortgage, Inc. a Delaware corporation launched in 2015 and now licensed to originate mortgages in Arizona, California, and New Mexico. First Cloud Mortgage has positioned itself as a Planet Friendly Mortgage Company via the purchase of carbon offsets for homeowners offsetting the first year of the Carbon Footprint of the typical home on each mortgage originated through First Cloud Mortgage, Inc.
As a publicly-traded company, eXp World Holdings, Inc. uniquely offers professionals within its ranks opportunities to earn equity awards for production and contributions to overall company growth.
For more information you can follow eXp World Holdings, Inc. on Twitter, LinkedIn, Facebook, YouTube, or visit eXpWorldHoldings.com. For eXp Realty please visit: eXpRealty.com and for First Cloud Mortgage, Inc. check out FirstCloudMortgage.com.
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Such forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update them. These statements include, but are not limited to, statements about the Company’s expansion, revenue growth, operating results, financial performance and net income changes. Such statements are not guarantees of future performance. Important factors that may cause actual results to differ materially and adversely from those expressed in forward-looking statements include changes in business or other market conditions; the difficulty of keeping expense growth at modest levels while increasing revenues; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including but not limited to the most recently filed Annual Report on Form 10-K.
Investor Relations Contact Information:
Glenn Sanford
Chairman & CEO
eXp World Holdings, Inc.
glenn@expworldholdings.com
360-389-2426
Trade and Media Contact Information:
Jason Gesing
President
eXp World Holdings, Inc.
jason@expworldholdings.com
617-970-8518
(NERV) to Present at Jefferies 2016 Healthcare Conference on June 8, 2016
WALTHAM, Mass., June 01, 2016 — Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat central nervous system (CNS) disorders, today announced that it will present at the Jefferies 2016 Healthcare Conference on June 8, 2016 at 11:00 a.m. Eastern Time.
The Company will present further data from the Phase IIb trial with MIN-101 in schizophrenia and the Phase IIa trial with MIN-117 in major depressive disorder (MDD). Top line results from these studies were announced on May 26, 2016. Additional information from recent MIN-202 studies carried out in insomnia and MDD will also be presented. Top line results from both of these studies were announced earlier this year. MIN-202 is under joint development with Janssen Pharmaceutica NV.
The presentation will be web cast and accessible through the investor relations section of the Company’s web site, http://ir.minervaneurosciences.com.
About Minerva Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of products to treat CNS diseases. Minerva’s proprietary compounds include: MIN-101, which has successfully completed Phase IIb development for schizophrenia; MIN-202 (JNJ-42847922), which has successfully completed Phase IIa and Phase Ib clinical trials in insomnia and MDD, respectively; MIN-117, which has successfully completed Phase IIa development for MDD; and MIN-301, in pre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.” For more information, please visit www.minervaneurosciences.com.
Contact: William B. Boni VP, Investor Relations/ Corp. Communications Minerva Neurosciences, Inc. (617) 600-7376
(SPEX) Featured in International Patent Publication
IP Business-Focused Site Profiles Spherix and Evolving Strategy
NEW YORK, June 1, 2016 — Spherix Incorporated (SPEX) –a company committed to the fostering of technology and the monetization of intellectual property, today announced the Company was featured in a story published in IAM, a publication universally acknowledged as the world’s leading IP business media platform.
The article, written by Richard Lloyd and published on www.iam-media.com on May 27, 2016, can be accessed as originally published at:
http://www.iam-media.com/blog/Detail.aspx?g=9b69fa9c-889b-42ba-aa2c-7fe225d4a34e
The article discusses the benefits of the recent $4.375M licensing agreements and plans for the Company moving forward. In the article, Spherix CEO Anthony Hayes discussed the changes to the IP monetization market and how Spherix is actively pivoting along with it to provide value and growth opportunities for its shareholders.
Anthony Hayes, CEO of Spherix, stated about the IAM article, “Spherix is committed to keeping shareholders up to date and communicating both our recent accomplishments and plans moving forward. The Company has turned a corner and we expect more investor outreach, such as this article, in the future. We thank our loyal shareholders and IAM for the article.”
About Spherix
Spherix is committed to advancing innovation by active participation in all areas of the patent market. Spherix draws on portfolios of pioneering technology patents to partner with and support product innovation. Spherix has acquired over 100 patents from Rockstar Consortium Inc., and several hundred patents issued to Harris Corporation, covering a variety of methods and components involved in switching, routing, networking, optical and telephone technologies, as well as in the wireless communications and telecommunication sectors.
Forward Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
Contact:
Investor Relations Contact:
Hayden/ MS-IR
Brett Mass
Phone: (646) 536-7331
Email: brett@haydenir.com
www.haydenir.com
Spherix Contact:
Phone: (703) 992-9325
Email: info@spherix.com
www.spherix.com
(GALE) Receives Fast Track for NeuVax™ (nelipepimut-S) PRESENT Clinical Trial
SAN RAMON, Calif., June 01, 2016 — Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced the U.S. Food and Drug Administration (FDA) has designated NeuVax™ (nelipepimut-S), combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF), as a Fast Track development program for the treatment of patients with early stage, node positive breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, following standard of care. Galena’s PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial is an international, Phase 3 study to evaluate NeuVax plus GM-CSF versus placebo plus GM-CSF to prevent cancer recurrence.
“This Fast Track designation by the FDA reflects the importance of NeuVax as a potential treatment option addressing an unmet medical need in a serious medical condition,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “With the number of cancer survivors in the United States projected to increase by 31% to almost 19 million by 20241, there is a clear need to prevent recurrence in women with breast cancer who have completed their standard of care, but have limited therapies to maintain their disease free status. As we approach our interim safety and futility analysis for PRESENT, and initiate our efforts towards the filing of a Biologics License Application (BLA), this Fast Track designation will be extremely valuable to us as we seek marketing authorization for NeuVax.”
“Fast Track designation provides us with opportunities for frequent interactions with the FDA review team for our NeuVax development program in breast cancer, including the PRESENT trial, as we prepare our BLA for filing. As such, assuming a successful clinical readout in the PRESENT trial, we may be eligible for a rolling review. We look forward to collaborating closely with the FDA at this critical stage for NeuVax development,” added Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer.
The Fast Track designation provides for the designation of a drug as a fast track product if it is intended for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.2 This designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.3 Designation as a Fast Track product means that the FDA will take such actions as are appropriate to expedite the development and review of the application for approval of such product. If FDA determines, after preliminary evaluation of clinical data submitted by a sponsor, that a fast track product may be effective, the Agency may consider reviewing portions of a marketing application before the sponsor submits the complete application (rolling review).4 In addition, such a product could be eligible for priority review if supported by clinical data at the time of BLA submission.5
Sources:
1ASCO Connection, October 28, 2014: From Patient to Survivor: ASCO Programs and Resources for Cancer Survivorship Continue to Grow
2-5FDA Guidance for Industry on Expedited Programs for Serious Conditions – Drugs and Biologics
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. It is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to specific HLA molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. In clinical studies, NeuVax is combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF).
NeuVax is currently in an international, Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). PRESENT is targeting node positive HER2 IHC 1+/2+ patients (clinicaltrials.gov identifier: NCT01479244). Galena has two additional breast cancer studies ongoing with NeuVax in combination with trastuzumab (Herceptin®; Genentech/Roche): a Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ (clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial in high risk, node positive or negative HER2 IHC 3+ patients (clinicaltrials.gov identifier: NCT02297698). Phase 2 clinical trials with NeuVax are also planned in patients with ductal carcinoma in situ (DCIS), and in patients with gastric cancer.
About PRESENT
PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) is an international, Phase 3 study to evaluate NeuVax plus GM-CSF versus placebo plus GM-CSF to prevent cancer recurrence. The trial is being run under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). PRESENT is targeting patients who are node positive, HER2 IHC 1+/2+, and HLA A2+ and/or A3+. The study is double blind, randomized 1:1, and is stratified by stage, type of surgery, hormone receptor status, and menopausal status. Galena enrolled a total of 758 patients who constitute the Intention to Treat (ITT) population, and the primary endpoint for the trial is disease free survival (DFS) upon reaching 141 events with 3 years minimum follow-up. Additional information on the trial can be found here and at clinicaltrials.gov identifier: NCT01479244.
About HER2 1+/2+ Breast Cancer
According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets approximately 50%-60% of these women who are HER2 low to intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.
About Galena Biopharma
Galena Biopharma, Inc. is a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs. Galena’s development portfolio is focused primarily on addressing the rapidly growing patient populations of cancer survivors by harnessing the power of the immune system to prevent cancer recurrence. The Company’s pipeline consists of multiple mid- to late-stage clinical assets, including novel cancer immunotherapy programs led by NeuVax™ (nelipepimut-S) and GALE-301. NeuVax is currently in a pivotal, Phase 3 breast cancer clinical trial with several concurrent Phase 2 trials ongoing both as a single agent and in combination with other therapies. GALE-301 is in a Phase 2a clinical trial in ovarian and endometrial cancers and in a Phase 1b given sequentially with GALE-302. For more information, visit www.galenabiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the progress of the development of Galena’s product candidates, patient enrollment in our clinical trials, as well as other statements related to the progress and timing of our development activities, present or future licensing, collaborative or financing arrangements, expected outcomes with regulatory agencies, and projected market opportunities for product candidates or that otherwise relate to future periods. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under “Risk Factors” in Galena’s Annual Report on Form 10-K for the year ended December 31, 2015 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.
NeuVax is a trademark of Galena Biopharma, Inc.
Contact: Remy Bernarda SVP, Investor Relations & Corporate Communications (925) 498-7709 ir@galenabiopharma.com
(OPTT) Enters Into First Commercial PB3 Agreement with Mitsui
PENNINGTON, N.J., June 01, 2016 — Ocean Power Technologies, Inc. (NASDAQ:OPTT) (“OPT” or “the Company”) announced today that the Company has entered into a PB3 PowerBuoy® lease agreement (“Agreement”) with Mitsui Engineering and Shipbuilding (“MES”), which is valued at approximately $975,000. The PB3 PowerBuoy leased by MES is planned to be deployed off Kozu-island in Japan following a planned stage gate review. Under the Agreement, OPT will also provide engineering support, associated deployment planning and logistics and ocean performance data collection and analysis. OPT and MES will also jointly develop and test an advanced control algorithm with the goal of assessing increased ocean wave energy capture and electric power generation for potential customers in Japan and surrounding countries. Work on the project began in March 2016 following the signing of a letter of intent by OPT and MES.
George H. Kirby, President and Chief Executive Officer of OPT, stated, “This first commercial agreement with MES is a significant and exciting commercialization milestone for OPT. MES has been a strong strategic partner in the development of the PowerBuoy, and this milestone will allow MES to demonstrate the flexibility of the PB3 power and communications platform in sea conditions off the coast of Japan. We believe that the deployment under this Agreement could provide access to a potentially huge market in Japan and the surrounding areas, and we’re looking forward to potentially leveraging these events with other interested parties. Market applications could include national defense and security, such as early detection and warning systems for subsea and surface threats, or oil field management and metocean applications for the oil and gas industry and scientific communities.”
“We’re looking forward to working closely with MES to commercialize the PB3 throughout Asia. We hope that it will serve the many markets in need of new and better power and communications solutions.”
About Ocean Power Technologies
Headquartered in Pennington, New Jersey, Ocean Power Technologies (NASDAQ:OPTT) is a pioneer of ocean wave power generation and energy storage systems. OPT’s proprietary PowerBuoy® technology is based on a cost-effective, scalable, modular, and environmentally sound design which provides power and communications for a number of markets and applications.
Forward-Looking Statements
This release may contain “forward-looking statements” that are within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by certain words or phrases such as “may”, “will”, “aim”, “will likely result”, “believe”, “expect”, “will continue”, “anticipate”, “estimate”, “intend”, “plan”, “contemplate”, “seek to”, “future”, “objective”, “goal”, “project”, “should”, “will pursue” and similar expressions or variations of such expressions. These forward-looking statements reflect the Company’s current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the Company. Please refer to the Company’s most recent Forms 10-Q and 10-K and subsequent filings with the SEC for a further discussion of these risks and uncertainties. The Company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release.
Company Contact: Mark A. Featherstone, Chief Financial Officer of OPT Phone: 609-730-0400 Investor Relations Contact: Andrew Barwicki Barwicki Investor Relations Inc. Phone: 516-662-9461
(MKGI) Shareholder Update
Company Anticipates Revenue Acceleration for Balance of Year
WESTON, FL–(Jun 1, 2016) – Monaker Group (OTCQB: MKGI), a technology driven travel company focused on the alternative lodging rental (ALR) market, today provided a shareholder update for first half of 2016.
“During the first five months of 2016, Monaker has built the foundation for significant growth within one of the fastest growing travel sectors. We look forward to strong revenue acceleration for the balance of the year, tied to the launch of our state-of-the-art alternative lodging and timeshare booking platforms later this month under our NextTrip.com brand,” said Bill Kerby, Chairman and CEO of Monaker Group.
Highlights and accomplishments of the first half of 2016:
Increasing Inventory
The Company has increased the number of alternative lodging rental units available from 125,000 upon the launch of its beta site on February 1, 2016, to its current level of approximately 1.1 million under contract. Additionally, the Company expects to add a further 200,000 – 300,000 timeshare or resort units for rental on the Company’s NextTrip Resorts platform during 2016.
Increasing Distribution
Monaker’s next generation NextTrip site is targeted to launch this month with over 600,000+ properties. The platform incorporates new features, functionality and advanced technology combining proprietary and licensed technology to give consumers comprehensive vacation alternatives at the best price. This next generation platform has been developed to serve three major constituents: vacationers/travelers, property owners/managers, and other large travel distributors. The Company and platform will serve the entire travel spectrum with travel licenses including ARC, IATA, CLIA & Florida Seller of Travel.
Consumers will be able to comprehensively search vacation travel destinations for our lodging products as well as air, car, hotel, tour activities, restaurants and other travel details supported by maps, rich content, imagery, video and collaboration/social sharing tools. The site will be powered by Monaker’s proprietary ALR Booking Engine which has been designed to fully maximize the consumer’s experience and assist them in the decision and purchasing process. Additionally, the booking engine acts as the bridge needed to begin to supply ALR products to channel partners for broad distribution. With each new channel partner integration to the platform there should be corresponding revenue acceleration via the partners’ already existing distribution.
Beyond established channel partnerships, the Company has been structuring new areas to distribute its ALR inventory over the past few months. Monaker and its travel brands are building access and distribution through recently announced travel clubs and the over 100,000 established travel agents. These relationships include the Recruiter.com Travel Club and 20,000 travel agents via International Travel Organization. The Company is also continuing discussions with other large travel operator and distributor groups interested in access to Monaker’s inventory and platform.
Increased Functionality
Earlier this year, Monaker engaged Primero Systems, a globally recognized award-winning technology solutions provider based in San Diego, CA, to complete the next generation architecture and partner integrations and to build out the flagship travel website NextTrip.com. The Company’s platforms will also include real time booking, a rarity for the industry, along with the ability to search and book airlines, hotels, rental cars, tours and other travel products such as activities and attractions all from the same website for the convenience and benefit of the consumer.
Increasing Revenue Outlook
Currently the Company is increasing revenue because of Maupintour, one of the oldest luxury tour companies in the US. Revenues for this segment have grown drastically during the first four months of the calendar year. The Company anticipates revenue run rates to accelerate as partners are linked to the new platform through the balance of the year. The Company also anticipates being cash flow positive this year.
About Monaker Group:
Monaker Group is a technology driven Travel Company with multiple divisions and brands, leveraging more than 60 years of operation in leisure travel. Monaker’s flagship is NextTrip.com, the industry’s first booking engine featuring alternative lodging (vacation home rentals, resort residences and unused timeshares) as well as a vast array of airlines, hotels, cruises, rental cars, tours and concierge services all combined in one platform to give customers the power of choice when booking their vacations. With key partnerships and established travel brands used as cornerstones, the Company’s mission is to continue to expand offerings to become the “one stop” vacation center. Headquartered in South Florida, the Company employs a dedicated team of travel and technology professionals. For more information, visit www.MonakerGroup.com
Safe Harbor Statement:
This press release contains forward-looking statements that involve risks and uncertainties concerning the plans and expectations of Monaker Group. These statements are only predictions and actual events or results may differ materially from those described in this press release due to a number of risks and uncertainties, some of which are out of our control. The potential risks and uncertainties include, among others, or the expectations of future growth may not be realized. These forward-looking statements are made only as of the date hereof, and Monaker Group, undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise. All forward looking statements are expressly qualified in their entirety by the “Risk Factors” and other cautionary statements included in Monaker Group’s annual, quarterly and special reports, proxy statements and other public filings with the Securities and Exchange Commission (“SEC”), including, but not limited to, the Company’s Annual Report on Form 10-K for the period ended February 29, 2016 which has been filed with the SEC and is available at the SEC’s website at www.sec.gov.
CONTACT:
Monaker Group
Attention: Richard Marshall
Director of Corporate Development
Email: rmarshall@monakergroup.com
Tel: (954) 888-9779
Chesapeake Group
Investor Relations
Tel: (410) 825-3930
info@chesapeakegp.com
(OPCO) Sponsors 65th Annual BetterInvesting National Convention
FAIRPORT HARBOR, OH–(June 01, 2016) – OurPet’s Company (OTCQX: OPCO) (www.ourpets.com), a leading proprietary pet supply company, recently presented its corporate story to a group of 450 independent investor club representatives at the 65th Annual BetterInvesting National Convention (B.I.N.C.) in Chantilly, Virginia.
OurPet’s CEO Dr. Steven Tsengas, along with CFO Scott Mendes, on May 21 spoke to a packed audience of potential investors about OurPet’s history, business strategy, product line, markets and financial performance.
The presentation is available for viewing on the OurPet’s website.
In his presentation, Dr. Tsengas shared his investment philosophy that, “Not every good investment opportunity is inherently right in front of you. Sometimes you need to explore and search for wise investment opportunities to balance your portfolio; and if you look hard enough, you’ll find well-performing ‘gems’ like OurPet’s Company.”
Mendes added that interested potential investors flocked to the OurPet’s booth at the conference, providing the Company the opportunity to showcase its potential to a key target audience.
“We just want to get the OurPet’s story out to the investor community,” says Mendes. “Hopefully this presentation and others will help expand our investor base, which is currently comprised of over 600 investors.”
About OurPet’s Company
The OurPet’s Company (OTCQX: OPCO) designs, produces and markets a broad line of innovative, trend-setting pet products and accessories sold under the OurPets® and Pet Zone® brands domestically and internationally. OurPets® and Pet Zone® products are sold through leading pet specialty retailers, food, drug and mass merchandisers, direct-mail catalog and internet retailers. Since its founding in 1995, the OurPet’s Company has been building an extensive intellectual property portfolio with more than 160 patents in either issued or pending status all devoted to solving problems related to the human/pet bond. OurPet’s was named a Weatherhead Top 100 Fastest Growing Company in Northeast Ohio in 2013 and has been a Lake-Geauga County Fast Track 50 Hall of Fame local business success winner for the last eight consecutive years. In addition, the OurPet’s Company was named 2015 Business of the Year by the Painesville Area Chamber of Commerce. Investors and customers may visit www.ourpets.com and www.petzonebrand.com for more information about the Company, its products and brands.
Certain of the matters set forth in this press release are forward-looking and involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially are the following: business conditions; growth in the industry; general economic conditions; addition or loss of significant customers; the loss of key personnel; product development; competition; risks of doing business abroad; foreign government regulations; fluctuations in foreign currency rates; rising costs for raw materials and sources of supply that may be limited or unavailable from time to time; the timing of orders booked; and the other risks that are described from time to time in OurPet’s SEC reports. For further information, contact:
CONTACTS
OurPet’s Company
Dr. Steven Tsengas
CEO
(440) 343-6500, x111
INVESTOR RELATIONS
Dream Team.Network
Austin, Texas
(512) 758-8877
www.DreamTeamNetwork.com
Editor@DreamTeamNetwork.com
(MRUS) Announces Closing of Partial Exercise of Underwriters’ Over-Allotment Option
UTRECHT, the Netherlands, May 31, 2016 — Merus N.V. (“Merus”) (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics, today announced the closing of a partial exercise of the over-allotment option by the underwriters of its previously announced initial public offering in the amount of an additional 639,926 common shares at the initial public offering price of $10.00 per share. The sale of the additional shares closed on May 26, 2016, bringing the total number of common shares sold by Merus in its initial public offering to 6,139,926. Including the proceeds from the sale of the additional shares, the total net proceeds, after deducting the underwriting discounts and commissions and estimated offering expenses, to Merus from its initial public offering are approximately $53.3 million.
Citigroup Global Markets Inc. and Jefferies LLC acted as joint book-running managers for the offering, Guggenheim Securities, LLC acted as lead manager for the offering and Wedbush PacGrow acted as co-manager for the offering.
A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission on May 18, 2016. The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained by contacting Citigroup by mail, c/o Broadridge Financial Solutions, at 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (800) 831-9146, or by email at prospectus@citi.com; or Jefferies LLC, by mail at 520 Madison Avenue, 2nd Floor, New York, New York 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340 or by email at prospectus_department@jefferies.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.
Contact Information:
Investor Relations
Argot Partners
Eliza Schleifstein – eliza@argotpartners.com
1-917-763-8106
(PXLW) Enhancement Chip Makes Smartphone Debut in ASUS ZenFone 3 Ultra
New ASUS 6.8” smartphone utilizes Pixelworks’ True Clarity® video display processing technology to bring HDTV experience to mobile
Pixelworks, Inc. (NASDAQ:PXLW), an innovative provider of video display processing technology, today announced that ASUS, a leading enterprise in the new digital era, is launching the world’s first smartphone using the Pixelworks Iris video display processor with True Clarity® video enhancement features. Incorporating the Iris processor in the 6.8” phone, dubbed the ZenFone 3 Ultra, will establish a new standard for HDTV quality mobile video, and in the process provide a more enjoyable user experience.
“We’re very pleased to be the first to offer a smartphone with Pixelworks’ Iris video enhancement processor,” said Rangoon Chang, ASUS General Manager, Mobile Computing Business Unit. “Mobile video is extremely important to our customers and every indication suggests this trend will only accelerate. Being able to watch true HD quality video on this larger screen ZenFone 3 Ultra will be a real pleasure, and consumers will be treated to a dramatically different viewing experience.”
In addition to the video quality enhancement provided by Iris, the ASUS ZenFone 3 Ultra sports a gorgeous 6.8” LCD panel with full HD (1920×1080) resolution, and a state-of-the-art QCOM 8976 applications processor. Iris also offers back light control to extend battery life and usage time of the ZenFone 3 Ultra, an essential capability given the larger screen.
“Pixelworks has always been about improving picture quality, regardless of the screen it’s viewed on or the technology used to deliver it,” said Richard Miller, Pixelworks Executive Vice President. “We’re very pleased that Iris and our True Clarity technology is able to help ASUS bring their vision of an industry-changing video viewing experience to life.”
Pixelworks’ Iris family of mobile display processors work at the pixel level to dramatically improve the mobile viewing experience by removing annoying video artifacts that degrade the viewing experience, while freeing the central processor of these tasks. In fact, this advanced technology improves all aspects of the mobile viewing experience, including gaming, video, photos, web browsing and productivity.
With Iris’ True Clarity video enhancement features on the ZenFone 3 Ultra, consumers can look forward to live sports, for instance, that will be easier and more enjoyable to watch; users will now be able to follow the ball and read scrolling news across the bottom of the screen, free of judder and motion blur.
For additional information on Iris family of video display processors, as well as a product demo, please contact your local Pixelworks office (http://www.pixelworks.com/locations.php) to obtain an invitation.
About Pixelworks, Inc.
Pixelworks creates, develops and markets video display processing technology for digital video applications that demand the very highest quality images. At design centers around the world, Pixelworks engineers constantly push video performance to keep manufacturers of consumer electronics, mobile devices and professional displays worldwide on the leading edge. The company is headquartered in San Jose, CA. For more information, please visit the company’s Web site at www.pixelworks.com.
Note: Pixelworks, the Pixelworks logo, and True Clarity are registered trademarks of Pixelworks, Inc. All other names and brands are trademarks or registered trademarks of their respective holders.
Pixelworks, Inc.
Investor Contact:
Shelton Group
Brett L Perry, +1-214-272-0070
bperry@sheltongroup.com
or
Media Contact:
Pixelworks, Inc.
info@pixelworks.com
(PARN) Announces Contract Manufacturing Agreement with Merial
OVERLAND PARK, Kan., May 31, 2016 — Parnell Pharmaceuticals Holdings Ltd (NASDAQ:PARN), a fully integrated, commercial-stage pharmaceutical company focused on developing, manufacturing and marketing innovative animal health solutions, today announced the commencement of a Contract Manufacturing Agreement with Merial, the animal health division of Sanofi.
Under the terms of the Contract Manufacturing Agreement, Merial will purchase certain sterile injectable products, exclusively from Parnell, with minimum annual purchase commitments over the 10-year term of the agreement. Merial will pay an upfront establishment fee in return for Parnell commencing immediate supply of product. Parnell estimates the total value of the agreement between USD$7 million and USD$20 million depending on volume of product purchased by Merial over the 10-year term.
Robert Joseph, President and CEO said “We are very pleased to announce the commencement of our first contract manufacturing agreement with a major multinational. Merial has a fantastic reputation in the industry and we are excited that Parnell will be supplying sterile injectable products from our state-of-the-art, FDA and EMA approved manufacturing facility. Our Business Development team has been pursuing contract manufacturing opportunities to leverage the 75% available capacity we have in our facility, and this agreement with Merial generates cashflows that will contribute to our goal of seeing our manufacturing division become a profit center for us in the future. We hope to announce further contract manufacturing deals in 2016.”
About Parnell
Parnell (PARN) is a fully integrated, veterinary pharmaceutical company focused on developing, manufacturing and commercializing innovative animal health solutions. Parnell currently markets five products for companion animals and production animals in 14 countries and augments its pharmaceutical products with proprietary digital technologies – FETCH™ and mySYNCH®. These innovative solutions are designed to enhance the quality of life and/or performance of animals and provide a differentiated value proposition to our customers. Parnell also has a pipeline of 7 drug products covering valuable therapeutic areas in orthopedics, dermatology, anesthesiology, nutraceuticals and metabolic disorders for companion animals as well as reproduction and mastitis for cattle.
For more information on the company and its products, please visit www.parnell.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements and information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Words such as “may,” “anticipate,” “estimate,” “expects,” “projects,” “intends,” “plans,” “develops,” “believes,” and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify forward-looking statements. Forward-looking statements represent management’s present judgment regarding future events and are subject to a number of risk and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks include, but are not limited to, Parnell’s expectations regarding the completion, timing and size of the public offering and the expected proceeds therefrom, risks and uncertainties regarding Parnell’s research and development activities, its ability to conduct clinical trials of product candidates and the results of such trials, as well as risks and uncertainties relating to litigation, government regulation, economic conditions, markets, products, competition, intellectual property, services and prices, key employees, future capital needs, dependence on third parties, and other factors, including those described in Parnell’s Annual Report on Form 20-F filed with the Securities and Exchange Commission, or SEC, on March 4, 2016, along with its other reports filed with the SEC. In light of these assumptions, risks, and uncertainties, the results and events discussed in any forward-looking statements contained in this press release might not occur. Investors are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Parnell is under no obligation, and expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events, or otherwise.
CONTACT: For more information, contact: Parnell Pharmaceuticals Holdings Robert Joseph, 913-274-2100 info@parnell.com
(ELRC) and Platinum Equity Sign Definitive Merger Agreement
Platinum Equity and Electro Rent Corporation (Nasdaq:ELRC) today announced that they have entered into a definitive agreement under which Electro Rent would be acquired by Platinum Equity for approximately $323.4 million.
Under the agreement, Platinum Equity would acquire all of Electro Rent’s common stock. Electro Rent stockholders will receive $13.12 per share, representing a premium of 24.4% over the closing price on May 27, 2016, and 34.8% over the average closing price of Electro Rent’s common stock over the past three (3) months. In light of the agreement, Electro Rent will not pay its next quarterly common stock dividend scheduled for July 2016.
The agreement followed the unanimous recommendation of Electro Rent’s board of directors. Completion of the transaction, which is expected to close in the next 90 to 120 days, is subject to customary closing conditions, including approval of Electro Rent’s stockholders and various regulatory agencies.
Electro Rent Chairman Daniel Greenberg and a member of his immediate family, who collectively own approximately 29% of the company’s outstanding shares of common stock, have entered into voting agreements in support of the sale and have granted an affiliate of Platinum Equity irrevocable proxies to execute those agreements.
Steven Markheim, recently named Chief Executive Officer of Electro Rent, and Allen Sciarillo, recently named Chief Financial Officer, will retain their current roles under the ownership of Platinum Equity.
Upon completion of the transaction, Electro Rent’s common stock will cease to be publicly traded. Houlihan Lokey acted as financial advisor to the Strategic Alternatives Committee of the Board of Directors of Electro Rent and Sheppard Mullin acted as Electro Rent’s legal counsel. Latham & Watkins LLP is serving as legal counsel to Platinum Equity.
“Electro Rent has built an excellent reputation as one of the most well respected companies in its industry. Its team of dedicated employees will continue to play an essential role in providing Electro Rent’s customers and OEM partners with the first-class service for which the company is known,” said Platinum Equity Partner Louis Samson. “We look forward to working closely with the company’s experienced leadership to put Electro Rent in the best position to take full advantage of future opportunities.”
“We are excited to begin this new phase in Electro Rent’s history, and look forward to partnering with Platinum as we continue to meet and exceed the needs of our customers and manufacturing partners around the globe,” said Markheim. “The transaction presents an outstanding opportunity for all of our stakeholders, as we should greatly benefit from additional resources and experience to further enhance our already high inventory, service and support standards. Platinum is fully committed to our industry and to ensuring Electro Rent’s success.”
About Platinum Equity
Founded in 1995 by Tom Gores, Platinum Equity (www.platinumequity.com) is a global investment firm with more than $6 billion of assets under management and a portfolio of more than 25 operating companies that serve customers around the world. Platinum Equity specializes in mergers, acquisitions and operations – a trademarked strategy it calls M&A&O® – acquiring and operating companies in a broad range of business markets, including manufacturing, distribution, transportation and logistics, equipment rental, metals services, media and entertainment, technology, telecommunications and other industries. Over the past 20 years Platinum Equity has completed more than 175 acquisitions.
About Electro Rent
Electro Rent Corporation (www.ElectroRent.com) is one of the largest global organizations devoted to the rental, leasing and sales of general purpose electronic test equipment, personal computers and servers.
Important Additional Information will be Filed with the SEC
In connection with the proposed transaction, Electro Rent Corporation will file or furnish relevant documents, including a proxy statement, concerning the proposed transaction with the SEC. Investors and stockholders of Electro Rent Corporation are urged to read the proxy statement and other relevant materials when they become available because they will contain important information about Electro Rent Corporation and the proposed transaction. The final proxy statement will be mailed to the company’s stockholders.
Investors and stockholders may obtain a free copy of the proxy statement and any other relevant documents filed or furnished by Electro Rent Corporation with the SEC (when available) at the SEC’s Web site at www.sec.gov. In addition, copies of the proxy statement and other filings made by the Company with the SEC can also be obtained, free of charge, by directing a request to Electro Rent Corporation, 6060 Sepulveda Boulevard, Van Nuys, CA 91411, Attention: Corporate Secretary.
Electro Rent Corporation and its directors and certain executive officers may be deemed to be participants in the solicitation of proxies from Electro Rent Corporation stockholders in respect of the proposed transaction. Information about the directors and executive officers of Electro Rent Corporation and their respective interests in Electro Rent Corporation by security holdings or otherwise is set forth in its proxy statement for the 2015 Annual Meeting of Stockholders, which was filed with the SEC on September 9, 2015 and its Annual Report on Form 10-K for the year ended May 31, 2015, which was filed with the SEC on August 13, 2015. Stockholders may obtain additional information regarding the interests of Electro Rent Corporation and its directors and executive officers in the Merger, which may be different than those of Electro Rent Corporation’s stockholders generally, by reading the proxy statement and other relevant documents regarding the Merger, when filed with the SEC. Each of these documents is, or will be, available as described above.
“Safe Harbor” Statement
Except for the historical statements and discussions in this press release, the company’s statements above constitute forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934. These forward-looking statements reflect Electro Rent’s management’s views and expectations at this time with respect to future events and financial performance, based on currently available information. Forward looking statements in this press release include statements regarding the completion of the sale transaction to Platinum Equity. When used, the words “anticipate”, “believe”, “expect” and “will” and other similar expressions identify forward-looking statements. Forward-looking statements are based on assumptions about future operations and market conditions, and are subject to certain risks and uncertainties. The company believes its assumptions are reasonable; nonetheless, it is likely that at least some of these assumptions will not come true. Accordingly, Electro Rent’s actual results will differ from the outcomes contained in any forward-looking statement, and those differences could be material. Factors that could cause or contribute to these differences include, among others, those risks and uncertainties discussed in the company’s periodic reports on Form 10-K and 10-Q and in its other filings with the Securities and Exchange Commission, including: general macroeconomic conditions may not improve or may deteriorate; U.S. federal government spending with respect to defense and other research and development activities may not increase or may decline; Electro Rent may not succeed in retaining its key sales or other personnel; competition may cause the company to lower prices and margins to effectively compete; and manufacturers of test and measurement equipment may not be willing to enter reseller arrangements with Electro Rent or those agreements may not succeed to the level anticipated. Should one or more of the risks discussed, or any other risks, materialize, or should one or more of our underlying assumptions prove incorrect, the company’s actual results may vary materially from those anticipated, estimated, expected or projected. In light of the risks and uncertainties, there can be no assurance that any forward-looking statement will in fact prove to be correct. You should not put undue reliance on these statements. Electro Rent undertakes no obligation to update or revise any forward-looking statements.
PondelWilkinson Inc.
Roger Pondel/Laurie Berman, 310-279-5980
pwinvestor@pondel.com
(SQI) to be Acquired by Accel-KKR for $17.75 per Share, All-Cash
MORRISVILLE, N.C., May 31, 2016 — SciQuest, Inc. (Nasdaq:SQI), the leading public provider of spend management solutions delivering value beyond savings, today announced that it has entered into a definitive agreement to be acquired by affiliates of Accel-KKR (“AKKR”), a leading technology-focused private equity firm, for $17.75 per share in cash, representing a total equity value of approximately $509 million.
The offer represents a 34% premium over the Company’s closing pricing on May 27, 2016. Upon closing, AKKR will own 100% of the outstanding shares of SciQuest common stock. AKKR, which has been a stockholder since 2014, currently owns 4.9% of SciQuest’s outstanding shares.
“This transaction provides SciQuest’s stockholders with a significant premium over the pre-announcement market price and we believe it will allow us to increase our focus on long-term success that will benefit customers, employees, partners and suppliers. As a private company, we expect to continue to accelerate innovation, increase efficiency and expand our solution suite,” said Stephen Wiehe, Chief Executive Officer of SciQuest.
“As long-standing and significant investors in SciQuest, we have been impressed by the breadth, depth and cohesiveness of the Company’s leading technology,” said Tom Barnds, Managing Director of Accel-KKR. “We look forward to partnering with the SciQuest team to continue to accelerate innovation and bring value to customers in this large and growing market.”
SciQuest’s Board of Directors unanimously approved the proposed transaction and resolved to recommend that stockholders vote their shares in favor of this transaction at a stockholders meeting to be held at a later date.
The transaction, which is expected to close in the third quarter of 2016, is subject to customary closing conditions, including approval of SciQuest’s stockholders and required regulatory approvals. Under the terms of the agreement, SciQuest may solicit alternative acquisition proposals from third parties during a 25-day “go-shop” period, following the date of execution of the merger agreement. There is no guarantee that this process will result in a superior proposal, and the merger agreement provides AKKR with a customary right to match a superior proposal. The Company does not intend to disclose any developments with respect to this process unless and until its Board of Directors makes a decision regarding a potential superior proposal. Upon closing, SciQuest will become a privately held company with its headquarters remaining in Morrisville, NC.
Stifel, Nicolaus & Company, Incorporated and Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, LLP are serving as SciQuest’s financial and legal advisors, respectively, for this transaction. Kirkland & Ellis LLP is serving as AKKR’s legal advisor.
About SciQuest
SciQuest (Nasdaq:SQI) is the leading public provider of spend management solutions delivering value beyond savings. Through the continued release of key innovative technology and a fanatical drive toward making our customers successful, we deliver exceptional value in user experience, productivity and operational efficiency. Our cloud-based, mobile-enabled, source-to-settle platform addresses all stages of procurement from the automation of core processes to enabling sophisticated, strategic and multifaceted sourcing solutions. We specialize in handling simple procurement needs to the most advanced supplier and supply chain requirements. SciQuest serves a wide range of industries and organizations including many of the Global Fortune 500. For more information visit http://www.sciquest.com
To join the conversation, please visit our blog at http://www.sciquest.com/blog or follow us on Twitter @SciQuest.
About Accel-KKR
Accel-KKR is a technology-focused investment firm with $4.0 billion in capital commitments. The firm invests in software and IT enabled businesses well-positioned for topline and bottom-line growth. At the core of Accel-KKR’s investment strategy is a commitment to developing strong partnerships with the management teams of its portfolio companies and a focus on building value through significant resources available through the Accel-KKR network. Accel-KKR focuses on middle-market companies and provides a broad range of capital solutions from minority-growth investments to buyouts, recapitalizations, divisional carve-outs and going-private transactions. The firm has offices in Menlo Park, Atlanta and London. For more information, please visit www.accel-kkr.com.
Additional Information
This communication may be deemed to be a solicitation of proxies in respect of the proposed acquisition of SciQuest. In connection with the proposed acquisition, SciQuest intends to file a proxy statement and other relevant materials with the Securities and Exchange Commission (the “SEC”). Investors and stockholders of SciQuest are urged to read the proxy statement (including any amendments or supplements) and other relevant materials filed with the SEC when they become available because they will contain important information about SciQuest and the proposed acquisition. The definitive proxy statement and a proxy card will be mailed to each stockholder entitled to vote at the special meeting relating to the proposed acquisition. Investors and stockholders may obtain a free copy of the proxy statement when it becomes available, and other documents filed by SciQuest, at the SEC’s website, www.sec.gov. In addition, these documents (when they are available) may also be obtained by investors and stockholders free of charge at SciQuest’s website, www.sciquest.com, or from SciQuest upon written request to its Investor Relations at 3020 Carrington Mill Boulevard, Suite 100, Morrisville, NC 27560.
Participants in the Solicitation
SciQuest and its directors and executive officers, under SEC rules, may be deemed to be participants in the solicitation of proxies from stockholders of SciQuest in connection with the proposed acquisition. Information about SciQuest’s directors and executive officers may be found in SciQuest’s proxy statement on Schedule 14A relating to its 2016 Annual Meeting of Stockholders, which was filed with the SEC on March 14, 2016, and SciQuest’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015, which was filed on February 22, 2016. Additional information regarding the interests of such potential participants in the solicitation of proxies in connection with the proposed acquisition will be included in the proxy statement related to the proposed acquisition to be filed with the SEC.
Forward-Looking Statements
This communication contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on beliefs and assumptions of SciQuest’s management and on information currently available to SciQuest’s management and that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements include information concerning SciQuest’s possible or assumed future results of operations, business strategies, financing plans, competitive position, industry environment, potential growth opportunities, potential market opportunities, the successful closing of this transaction, effects of the transaction, operations as a private company and the location of its headquarters and the effects of competition. Forward-looking statements consist of all statements that are not historical facts and can be identified by terms such as “accelerates,” “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including, without limitation, (1) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement; (2) the possibility that the consummation of the proposed acquisition described in this communication does not occur or is delayed, either due to the failure of closing conditions, including approval of SciQuest’s stockholders, the failure to obtain required regulatory approvals or other reasons; (3) the risk that the proposed acquisition disrupts current plans and operations or increases operating costs and the potential difficulties in customer loss and employee retention as a result of the announcement and consummation of such acquisition; (4) the outcome of any legal proceedings that may be instituted against the SciQuest, the potential acquiror or others following announcement of the merger agreement and transactions contemplated therein; and (5) those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of SciQuest’s most recently filed Annual Report on Form 10-K and SciQuest’s subsequently filed Quarterly Reports on Form 10-Q. SciQuest urges you to consider those risks and uncertainties in evaluating its forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as otherwise required by the federal securities laws, SciQuest disclaims any obligation or undertaking to publicly release or otherwise provide any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in SciQuest’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
SQI-F
SciQuest Media contact:
SciQuest, Inc.
Roberta Patterson, 919-659-2230
rpatterson@SciQuest.com
Edelman for SciQuest
Megan Smith, 404-832-6776
Megan.smith3@edelman.com
SciQuest Investor contact:
Jamie Andelman
SciQuest, Inc., 919-659-2322
jandelman@sciquest.com
Accel-KKR Media contact:
KEKST for Accel-KKR
Todd Fogarty, 212-521-4854
Todd.fogarty@kekst.com
(CPXX) & (JAZZ) Acquisition Agreement, $30.25 Per Share
Transaction would add VYXEOS™, an investigational product in development as a treatment for Acute Myeloid Leukemia (AML), to Jazz Pharmaceuticals’ portfolio U.S. regulatory submission for VYXEOS planned by end of third quarter 2016 Jazz Pharmaceuticals to host investor conference call today, May 31, 2016 at 8:30 AM EDT (1:30 PM IST)
DUBLIN and EWING, N.J., May 31, 2016 — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) today announced that they have entered into a definitive agreement for Jazz Pharmaceuticals to acquire Celator for $30.25 per share in cash, or approximately $1.5 billion.
The transaction with Celator is well-suited to advance Jazz Pharmaceuticals’ growth strategy.
- VYXEOS is the first product candidate to demonstrate a statistically significant improvement in Overall Survival in patients with high-risk (secondary) AML1
- U.S. FDA Breakthrough Therapy designation granted for VYXEOS2
- U.S. FDA and European Commission Orphan Drug designation for VYXEOS for the treatment of AML
- VYXEOS is an innovative product candidate based on the Celator CombiPlex® platform
- Anticipated long-lived exclusivity for VYXEOS
- Broadens Jazz Pharmaceuticals’ hematology/oncology portfolio
- Worldwide development and commercialization rights to VYXEOS
- Synergies with Jazz Pharmaceuticals’ commercial expertise and infrastructure
- Transaction expected to close in the third quarter of 2016
- Transaction expected to be accretive to Non-GAAP adjusted EPS beginning in 2018 and beyond
| 1 Included secondary AML and de novo AML with a karyotype characteristic of myelodysplastic syndrome (MDS) |
| 2 U.S. FDA Breakthrough Therapy designation granted for VYXEOS for the treatment of adults with therapy-related AML or AML with myelodysplasia-related changes |
“Celator Pharmaceuticals is a strong strategic fit with Jazz Pharmaceuticals. VYXEOS will further diversify our product portfolio and is complementary to our clinical and commercial expertise in hematology/oncology,” said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals plc. “As Celator is currently preparing a regulatory submission in the U.S. for VYXEOS, this acquisition would add a new orphan product with the potential for short- and long-term revenue generation and expansion of our international commercial platform.”
“The planned combination of Jazz and Celator is highly complementary, as both companies are dedicated to bringing differentiated therapies to patients who have high unmet medical needs,” said Scott Jackson, chief executive officer of Celator Pharmaceuticals. “We believe that Jazz Pharmaceuticals’ clinical and commercial expertise in hematology/oncology and existing international infrastructure will help realize the value of VYXEOS as a treatment to patients with AML. After thoroughly evaluating our strategic options, our board of directors has unanimously determined that this all-cash transaction is in the best interest of our stockholders.”
Transaction Closing
The transaction is structured as a tender offer and second step merger. The closing of the tender offer is conditioned upon customary conditions, including the tender of a majority of the outstanding shares of Celator common stock and expiration or termination of the Hart Scott Rodino waiting period. The transaction is expected to close in the third quarter of 2016.
Certain stockholders of Celator holding approximately 18.4 percent of Celator’s outstanding shares of common stock, including executive officers, members of the Celator board of directors and certain investment funds affiliated with the members of the board of directors, have agreed to tender their shares in the tender offer.
Financing
Jazz Pharmaceuticals expects to finance the transaction with a combination of cash on hand and borrowings under its senior secured credit facility.
Advisors
Jazz Pharmaceuticals’ financial advisor for the transaction is RBC Capital Markets, and its primary legal advisor is Cooley LLP.
Celator Pharmaceuticals’ financial advisor for the transaction is MTS Health Partners, and its primary legal advisor is Kirkland and Ellis LLP.
Conference Call Details
Jazz Pharmaceuticals will host a conference call and live audio webcast today at 8:30 am EDT/1:30 pm IST to discuss this transaction. Interested parties may access the live audio webcast and slide presentation via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for one week.
Audio webcast/conference call:
U.S. Dial-In Number: +1 503 343 6056
Outside the U.S. Dial-In Number: +1 855 353 7924
Passcode: 20942393
A replay of the conference call will be available through June 7, 2016 and accessible through one of the following telephone numbers and entering the passcode:
Replay U.S. Dial-In Number: +1 404 537 3406
Replay Outside the U.S. Dial-In Number: +1 855 859 2056
Passcode: 20942393
About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. The company has a diverse portfolio of products and product candidates, with a focus in the areas of sleep and hematology/oncology. In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi) and Defitelio® (defibrotide sodium) in the U.S. and markets Erwinase® and Defitelio® (defibrotide) in countries outside the U.S. For more information, please visit www.jazzpharmaceuticals.com.
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is an oncology-focused biopharmaceutical company that is transforming the science of combination therapy, and developing products to improve patient outcomes in cancer. Celator’s proprietary technology platform, CombiPlex®, enables the rational design and rapid evaluation of optimized combinations of anti-cancer drugs, incorporating traditional chemotherapies as well as molecularly targeted agents to deliver enhanced anti-cancer activity. CombiPlex addresses several fundamental shortcomings of conventional combination regimens, as well as the challenges inherent in combination drug development, by identifying the most effective synergistic molar ratio of the drugs being combined in vitro, and fixing this ratio in a nano-scale drug delivery complex to maintain the optimized combination after administration and ensuring exposure of this ratio to the tumor.
Celator’s lead product is VYXEOS™ (also known as CPX-351), a nano-scale liposomal formulation of cytarabine:daunorubicin that has completed a Phase 3 trial for the treatment of acute myeloid leukemia. Celator has also conducted clinical development on CPX-1, a nano-scale liposomal formulation of irinotecan:floxuridine studied in colorectal cancer; and have a preclinical stage product candidate, CPX-8, a hydrophobic docetaxel prodrug nanoparticle formulation. More recently, Celator has advanced its CombiPlex platform and broadened its application to include molecularly targeted therapies. For more information, please visit Celator’s website at www.celatorpharma.com.
About VYXEOS
VYXEOS (cytarabine:daunorubicin) Liposome for Injection, also known as CPX-351, is a nano-scale liposomal co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ratio. VYXEOS represents a novel approach to developing combinations of drugs in which molar ratios of two drugs with synergistic anti-tumor activity are encapsulated in a nanoscale liposome in order to maintain the desired ratio following administration. The FDA granted Breakthrough Therapy designation to VYXEOS for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). VYXEOS was granted orphan drug status for the treatment of AML by the FDA and the European Commission. VYXEOS was also granted Fast Track designation for the treatment of elderly patients with secondary AML by the FDA.
In a Phase 3 trial in patients with high-risk (secondary) AML, the median overall survival for patients treated with VYXEOS in the study was 9.56 months compared to 5.95 months for patients receiving the standard of care regimen of cytarabine and daunorubicin known as 7+3, representing a 3.61-month improvement in favor of VYXEOS. The hazard ratio (HR) was 0.69 (p=0.005), which represents a 31% reduction in the risk of death versus 7+3. The percentage of patients alive 12 months after randomization was 41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm. The percentage of patients alive 24 months after randomization was 31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm.
Sixty-day all-cause mortality was 13.7% versus 21.2%, in favor of patients treated with VYXEOS. No substantial difference in Grade 3 or higher adverse events was observed between VYXEOS and 7+3. In the intent-to-treat population, Grade 3-5, hematologic adverse events were similar for overall infections, febrile neutropenia, and bleeding events. In the intent-to-treat population, Grade 3-5, non-hematologic adverse events were similar across all organ systems, including cardiac, gastrointestinal, general systems, metabolic disorders, musculoskeletal, nervous system, respiratory, skin and renal.
The final Phase 3 clinical trial data will be presented at the American Society of Clinical Oncology on June 4, 2016 and at the European Hematology Association Annual Congress on June 11, 2016.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements regarding Jazz Pharmaceuticals and Celator Pharmaceuticals, including, but not limited to, statements related to the anticipated consummation of the tender offer for Celator common stock and the timing and benefits thereof, and estimated future financial results, regulatory submissions and performance of VYXEOS, as well as other statements that are not historical facts. These forward-looking statements are based on each of the companies’ current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to Jazz Pharmaceuticals’ ability to complete the tender offer on the proposed terms and schedule, including risks and uncertainties related to the satisfaction of closing conditions; the possibility that competing offers will be made; risks associated with business combination transactions, such as the risk that the acquired business will not be integrated successfully or that such integration may be more difficult, time-consuming or costly than expected; risks related to future opportunities and plans for the combined company, including uncertainty of the expected future regulatory filings, financial performance and results of the combined company following completion of the proposed transaction; disruption from the proposed acquisition, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; and the possibility that if Jazz Pharmaceuticals does not achieve the perceived benefits of the proposed acquisition as rapidly or to the extent anticipated by financial analysts or investors, the market price of Jazz Pharmaceuticals’ ordinary shares could decline; and those other risks detailed under the caption “Risk Factors” and elsewhere in Jazz Pharmaceuticals’ and Celator’s U.S. Securities and Exchange Commission (“SEC”) filings and reports, including in Jazz Pharmaceuticals’ and Celator Pharmaceuticals’ Quarterly Reports on Form 10-Q for the quarter ended March 31, 2016, each of which is filed with the SEC, and future filings and reports by either company. Neither Jazz Pharmaceuticals nor Celator undertakes any duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations.
Additional Information and Where to Find It
The tender offer described in this communication (the “Offer”) has not yet commenced and this communication is neither an offer to purchase nor a solicitation of an offer to sell shares of Celator or other securities, nor is it a substitute for the tender offer materials that Jazz Pharmaceuticals and its acquisition subsidiary will file with the SEC upon commencement of the tender offer. At the time the Offer is commenced, Jazz Pharmaceuticals and its acquisition subsidiary will file tender offer materials on Schedule TO, and Celator will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the Offer. The tender offer materials (including an Offer to Purchase, a related Letter of Transmittal and certain other tender offer documents) and the Solicitation/Recommendation Statement, as they may be amended from time to time, will contain important information. Holders of Celator securities are urged to read these documents when they become available because they will contain important information that holders of Celator securities should consider before making any decision regarding tendering their securities. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of Celator securities at no expense to them. Investors and security holders may obtain free copies of these documents (when they are available) and other related documents filed with the SEC at the SEC’s web site at http://www.sec.gov or by (i) directing a request to Jazz Pharmaceuticals plc, c/o Jazz Pharmaceuticals, Inc., 3180 Porter Drive, Palo Alto, California 94304, U.S.A., Attention: Investor Relations, (ii) calling +353 1 634 7892 (Ireland) or + 1 650 496 2800 (U.S.) or (iii) sending an email to investorinfo@jazzpharma.com. Investors and security holders may also obtain free copies of the documents filed with the SEC on Jazz Pharmaceuticals’ website at www.jazzpharmaceuticals.com under the heading “Investors” and then under the heading “SEC Filings.”
(REGI) Prices Offering of $132 Million of Convertible Senior Notes
Renewable Energy Group, Inc. (REG) (NASDAQ:REGI) announced today the pricing of its offering of $132 million aggregate principal amount of 4.00% convertible senior notes due 2036 (the “Notes”) in a private placement to qualified institutional buyers pursuant to an exemption from the registration requirements of the Securities Act of 1933. In connection with the offering, REG has granted the initial purchasers an option to purchase up to an additional $20 million aggregate principal amount of Notes on the same terms and conditions. The sale of the Notes is scheduled to close on June 2, 2016, subject to satisfaction of customary closing conditions.
REG estimates that the net proceeds from the offering will be approximately $127.5 million, after deducting the initial purchasers’ discount and estimated offering expenses payable by REG, assuming no exercise of the initial purchasers’ option to purchase additional Notes.
Concurrently with the offering, in separate transactions, REG intends to use approximately $62.0 million of the net proceeds from the offering to repurchase approximately $63.9 million principal amount of REG’s outstanding 2.75% convertible senior notes due 2019 (the “2019 Notes”), including accrued but unpaid interest and commissions, through one of the initial purchasers or its affiliate as REG’s agent. In addition, concurrently with the offering, in separate transactions, REG intends to use approximately $35.0 million of the net proceeds from the offering to repurchase approximately 4.1 million shares of its common stock through one of the initial purchasers or its affiliate as REG’s agent. REG intends to use the remainder of the net proceeds from the offering for working capital and other general corporate purposes, which may include additional repurchases of the 2019 Notes and shares of REG’s common stock and financing potential strategic transactions. Any repurchase of the 2019 Notes could have the effect of raising or maintaining the market price of REG’s common stock above levels that would otherwise have prevailed, or preventing or retarding a decline in the market price of REG’s common stock. In particular, REG expects that certain of the sellers of 2019 Notes that REG repurchases may purchase shares of common stock in the market in connection with those sales of 2019 Notes. Any repurchase of REG’s common stock could have the effect of raising or maintaining the market price of REG’s common stock above levels that would otherwise have prevailed, or preventing or retarding a decline in the market price of REG’s common stock.
The Notes will be senior unsecured obligations of REG and will pay interest semi-annually at a rate of 4.00% per annum. The Notes will mature on June 15, 2036 unless earlier redeemed, repurchased or converted. On or after June 15, 2021, REG may redeem for cash all or part of the Notes at a redemption price equal the principal amount thereof, plus accrued and unpaid interest, if any. Unless the Notes have been called for redemption, holders may require REG to repurchase the Notes, in cash, on June 15, 2021, June 15, 2026 and June 15, 2031 or upon the occurrence of certain fundamental changes at a repurchase price equal to the principal amount thereof, plus accrued and unpaid interest, if any.
The Notes will be convertible, upon satisfaction of certain conditions, at an initial conversion rate of 92.8074 shares per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $10.78 per share, and will be subject to adjustment upon the occurrence of certain events. The initial conversion price represents a conversion premium of approximately 25.0% over the last reported sale price of $8.62 per share of REG’s common stock on The NASDAQ Global Select Market on May 26, 2016. Prior to December 15, 2035, the Notes will be convertible only under certain circumstances and during certain periods. On or after December 15, 2035, the Notes will be convertible at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. REG will settle conversions of the Notes by paying or delivering, as the case may be, cash, shares of its common stock, or a combination of cash and shares of its common stock, at its election. However, unless REG obtains stockholder approval in accordance with applicable rules of The NASDAQ Stock Market to permit settlement in stock, REG will be required to settle conversions by paying cash or, subject to certain limitations, a combination of cash and shares of its common stock.
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful. The offer and sale of the Notes and the common stock, if any, issuable upon conversion of the Notes have not been registered under the Securities Act of 1933 or applicable state securities laws and, unless so registered, the Notes and such common stock, if any, may not be offered or sold in the United States or to U.S. persons except pursuant to an exemption from the registration requirements of the Securities Act of 1933 and applicable state securities laws.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended, including statements regarding the expected closing date of the offering and expected timing of the repurchase transactions, the expected uses of net proceeds from the offering, and the possible effects of the repurchase transactions. These forward-looking statements are based on current expectations, estimates, assumptions and projections that are subject to change, and actual results may differ materially from the forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, difficulties or delays in closing the offering and repurchases, fluctuations in the price of REG’s common stock, satisfaction of the conditions to closing of the offering, the fact that REG’s management will have broad discretion in the use of the proceeds from any sale of the Notes, factors affecting REG’s business that may affect REG’s liquidity and working capital requirements, and other risks and uncertainties described from time to time in REG’s annual report on Form 10-K, quarterly reports on Forms 10-Q and other periodic filings with the Securities and Exchange Commission. All forward-looking statements are made as of the date of this press release and REG does not undertake to update any forward-looking statements based on new developments or changes in its expectations, except as required by law.
Renewable Energy Group, Inc.
(PTLA) to Present Results of Phase 3 APEX Study of Betrixaban
–Company Plans to Submit NDA and MAA for Betrixaban in Second Half of 2016–
–Webcast with APEX Study Executive Committee Members Today at 11 a.m. ET–
MONTPELLIER, France, and SOUTH SAN FRANCISCO, Calif. , May 27, 2016 — Portola Pharmaceuticals Inc.® (NASDAQ:PTLA) announced that the full results of its pivotal Phase 3 APEX (Acute Medically Ill VTE Prevention with Extended Duration Betrixaban) Study were presented today for the first time in a late-breaking clinical trial session (http://investors.portola.com/) at the 62nd Annual International Society on Thrombosis and Haemostasis (ISTH) Scientific and Standardization Committee (SSC) Meeting. Full results from the APEX trial were published simultaneously online in The New England Journal of Medicine (http://www.nejm.org/doi/full/10.1056/NEJMoa1601747). Portola announced topline results (http://topline.portola.com) from the APEX trial in March 2016.
APEX, which enrolled 7,513 patients at more than 450 clinical sites worldwide, assessed the superiority of extended-duration betrixaban for 35 days compared to standard-duration enoxaparin for 10+4 days. The trial was designed in cooperation with the FDA and EMA to incorporate a novel patient enrichment and statistical analysis plan derived from the 2012 FDA guidance document on enrichment strategies for clinical trials.
“In a pre-specified subgroup of medically ill patients who were D-dimer positive, extended- duration betrixaban demonstrated a reduction in VTE events approaching statistical significance. In the pre-specified exploratory analyses of central lab D-dimer values and in progressively larger cohorts, including all study patients, the data demonstrated a consistent and significant reduction in VTE with betrixaban with no statistical difference in major bleeding between the betrixaban and enoxaparin arms,” said C. Michael Gibson, M.S., M.D., senior author of the NEJM publication and APEX Executive Committee Member and Steering Committee Chairman.
Betrixaban, an investigational drug, is an oral, once-daily Factor Xa inhibitor anticoagulant. It is an FDA-designated Fast Track therapy for extended-duration VTE prophylaxis in acute medically ill patients. Acute medically ill patients are hospitalized for serious common medical conditions, such as heart failure, stroke, infection and pulmonary disease. Despite the use of standard of care anticoagulation, a significant number of patients will suffer a VTE event. Over half of these events will occur after discontinuation of enoxaparin and hospital discharge. Currently no anticoagulant, including any of the marketed oral Factor Xa inhibitors, is approved or guideline-recommended for extended-duration VTE prophylaxis in this patient population.
“The APEX Study results show consistent evidence that VTE events can be reduced with betrixaban with no statistical difference in major bleeding between the betrixaban and enoxaparin arms. This is particularly true for the most clinically relevant symptomatic disease where we observed a 30 to 45 percent reduction in events over the duration of the study,” said lead author of the NEJM publication Alexander (Ander) T. Cohen, MBBS, M.Sc., M.D., FRACP, APEX Co-Principal Investigator and Co-Chairman of the APEX Executive Committee and Consultant Physician at Guy’s and St Thomas’ NHS Foundation Trust. “Such meaningful results in an area where there is currently no available recommended therapy offer important potential benefits for public health worldwide. Based on the number of reduced events in APEX, this could translate into preventing over 100,000 additional VTE events per year and over 50,000 deaths from pulmonary embolism in the G7 countries if betrixaban is approved.”
Later this year, Portola plans to submit the APEX Study data as part of a New Drug Application (NDA) for betrixaban in the United States and as part of a Marketing Authorization Application (MAA) in the EU.
“We recently held a pre-NDA meeting with the FDA where we reconfirmed Fast Track Designation for betrixaban in this indication and agreed to upcoming meetings in preparation for an NDA submission in the second half of 2016,” said Bill Lis, chief executive officer of Portola.
About VTE in Acute Medically Ill Patients
An estimated 20 million acute medically ill patients in the G7 countries are at risk of developing VTE either while in the hospital or following discharge. Each year, more than 1 million VTEs and 150,000 VTE-related deaths occur in acute medically ill patients in the G7 countries, despite the standard use of injectable enoxaparin and other heparins in the hospital. Although more than half of VTE events occur after the patient is discharged from the hospital, no anticoagulant, including enoxaparin or any of the marketed oral Factor Xa inhibitors, is approved for extended VTE prophylaxis in the more than 24 million medically ill patients hospitalized in the G7 countries annually.
About Betrixaban
Betrixaban directly inhibits the activity of Factor Xa, an important validated target in the blood coagulation pathway, to prevent life-threatening thrombosis. Betrixaban has distinct properties that may allow it to demonstrate clinical benefit without the significant imbalance in the risk of major bleeding seen with other agents in the class. These include a 19-25-hour half-life for once-daily dosing; a low peak-to-trough drug concentration ratio that minimizes anticoagulant variability; low renal clearance; and no significant CYP3A4 metabolism, which may reduce the risk of drug-drug interactions.
Webcast Details
Portola will host an investor event today, May 27, 2016, at 5:00-6:00 p.m. CEST/11 a.m.-12 p.m. EDT in which members of the Company’s senior management team and Drs. Gibson and Cohen will present and discuss the full APEX Study data. Webcast participants will be able to participate in a live Q&A session via the webcast portal. To access the webcast of the live event, go to the Investor Relations section of the Company’s website at investors.portola.com. A replay will be available on the Company’s website for 30 days following the live event, also at investors.portola.com.
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company is advancing three programs, including betrixaban, an oral, once-daily Factor Xa inhibitor; AndexXa™ (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a Syk/JAK inhibitor in development to treat hematologic cancers. Portola’s partnered program is focused on developing selective Syk inhibitors for inflammatory conditions. For more information, visit portola.com and follow the Company on Twitter @Portola_Pharma.
Forward-looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential for study results to support an application for regulatory approval of betrixaban, the potential for betrixaban, subject to regulatory approval, to play a role in both in-hospital and post-discharge reduction of VTE events and deaths, our interpretation and characterization of APEX Study results and the anticipated timing of our submission of filings seeking regulatory approval. Risks that contribute to the uncertain nature of the forward-looking statements include the results of discussions with regulatory authorities regarding interpretation of full APEX Study results, that the FDA and other regulatory authorities may not approve betrixaban, whether the clinical results of betrixaban will meet the regulatory requirements for approval, whether regulatory submissions will occur or will be submitted in a timely manner and that marketing approvals may not be granted or, if granted, may have significant limitations on their use or require additional studies. These and other risks and uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our most recent quarterly report on Form 10-Q, which was filed on May 6, 2016. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact: Ana Kapor Portola Pharmaceuticals ir@portola.com 1.650.246.7252 Media Contact: Julie Normart W2O Group jnormart@w2ogroup.com 1.559.974.3245
(VIA) Renews Comprehensive Carriage Agreement with Cox Communications
Viacom (NASDAQ:VIAB)(NASDAQ:VIA) today announced the renewal and expansion of its distribution agreement with Cox Communications for carriage of Viacom’s media networks across Cox’s subscriber base.
In addition to carriage of 22 popular Viacom cable networks and EPIX, Cox subscribers will have access to an expanded selection of on-demand, full-length programming across all platforms, including television and mobile devices.
Philippe Dauman, Viacom Executive Chairman and CEO, said, “Cox has consistently been a leader in offering advanced features and services to their subscribers, and Viacom’s networks are favorites among those audiences who consume programming on digital devices, whenever and wherever they choose. Viacom and Cox have worked together for many years to provide industry-leading offerings, and are pleased to continue our strong relationship for many years to come.”
Terms of the deal were not disclosed.
About Viacom
Viacom is home to premier global media brands that create compelling television programs, motion pictures, short-form content, apps, games, consumer products, social media experiences, and other entertainment content for audiences in 180 countries. Viacom’s media networks, including Nickelodeon, Comedy Central, MTV, VH1, Spike, BET, CMT, TV Land, Nick at Nite, Nick Jr., Channel 5 (UK), Logo, Nicktoons, TeenNick and Paramount Channel, reach over 3.5 billion cumulative television subscribers worldwide. Paramount Pictures is a major global producer and distributor of filmed entertainment.
For more information about Viacom and its businesses, visit www.viacom.com. Keep up with Viacom news by following Viacom’s blog at blog.viacom.com and Twitter feed at www.twitter.com/viacom.
Viacom
Jeremy Zweig, 212-846-7503
jeremy@viacom.com
(TGTX) Enters into a Global Collaboration Over Jubilant Biosys’ BET Inhibitors
NEW YORK, May 27, 2016 — TG Therapeutics, Inc. (Nasdaq:TGTX), announced today that as part of a broader agreement with Jubilant Biosys (“Jubilant”), an Indian biotechnology company, TG Therapeutics entered into a sub-license agreement with Checkpoint Therapeutics, Inc. (“Checkpoint”), a Fortress Biotech company, to develop and commercialize Jubilant’s novel BET inhibitor program in the field of hematological malignancies. Checkpoint will develop and commercialize these small molecule inhibitors in solid tumors. The BET inhibitor program is the subject of an exclusive, worldwide license agreement pursuant to which Checkpoint in-licensed from Jubilant a family of patents covering compounds that inhibit BRD4, a member of the BET (Bromodomain and Extra Terminal) domain for cancer treatment.
Under the terms of the agreement, TG Therapeutics will pay an up-front licensing fee of $1 million and make additional payments contingent on certain preclinical, clinical, and regulatory milestones, including commercial milestones totaling up to approximately $177 million and a single-digit royalty on net sales. TG Therapeutics will also provide funding to support certain targeted research efforts at Jubilant Biosys.
Mr. Michael S. Weiss, Executive Chairman, Interim CEO and President stated, “We are very excited to add this BET inhibitor program to our growing portfolio of agents targeting hematological malignancies. BET inhibitors have shown early promise in the treatment of relapsed and refractory Non-Hodgkin lymphomas, which remains a significant area of unmet medical need. There is emerging preclinical data showing BET inhibitors may enhance the activity of immuno-oncology agents, such as anti-PD-1/PD-L1 antibodies, providing multiple opportunities for us to combine this novel mechanism within our portfolio. Epigenetic targeted agents, especially BET inhibitors, have been an area of great interest of ours for some time and are particularly attractive to us because of their effects on c-Myc driven tumors, like aggressive GCB-subtype DLBCL, an area we have seen early activity with TGR-1202 and our proprietary combination referred to as TG-1303. We want to thank our collaborators at Checkpoint for introducing us to this opportunity.” Mr. Weiss continued, “As we prepare to launch our registration directed studies in DLBCL and Follicular Lymphoma, we continue to look toward next steps in the evolution of patient care and believe the best outcome will be achieved only through the combination of multiple novel agents.”
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 recently entering clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City.
About Jubilant Drug Discovery Solutions
Jubilant Drug Discovery Solutions (JDDS) comprises of Jubilant Biosys, Jubilant Chemsys and Jubilant Innovation and has presence in India, in Bangalore and Noida, and in Malvern (USA). These subsidiaries of Jubilant Life Sciences Ltd employ over 625 employees and have demonstrated expertise in multiple therapeutic areas of Oncology, Metabolic Disorders, Pain & Inflammation, CNS and others. The business model includes proprietary in-house innovation, strategic investments as well as drug discovery services as the core components which are available for collaborative research, partnership and out-licensing.
For more info: www.jubilantbiosys.com, www.Jchemsys.com
About Checkpoint Therapeutics
Checkpoint Therapeutics, Inc. (“Checkpoint”), a subsidiary of Fortress Biotech Company, is an immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel, non-chemotherapy, immune-enhanced combination treatments for patients with solid tumor cancers. Checkpoint aims to acquire rights to these technologies by licensing the rights or otherwise acquiring an ownership interest in the technologies, funding their research and development and eventually either out-licensing or bringing the technologies to market. Currently, Checkpoint is developing a portfolio of fully human immuno-oncology targeted antibodies generated in the laboratory of Dr. Wayne Marasco, MD, PhD, a professor in the Department of Cancer Immunology and AIDS at the Dana-Farber Cancer Institute (“Dana-Farber”). The portfolio of antibodies Checkpoint licensed from Dana-Farber includes antibodies targeting programmed death-ligand 1 (“PD-L1”), glucocorticoid-induced TNFR related protein (“GITR”) and carbonic anhydrase IX (“CAIX”). Checkpoint plans to develop these novel immuno-oncology and checkpoint inhibitor antibodies on their own and in combination with each other, as published literature suggests that combinations of these targets may work synergistically together. Checkpoint has also licensed and is developing two oral targeted anti-cancer therapies, consisting of a small molecule inhibitor of poly (ADP-ribose) polymerase (“PARP”) and a small molecule inhibitor of epidermal growth factor receptor (“EGFR”) mutations. Additionally, Checkpoint will seek to add additional immuno-oncology drugs as well as other targeted therapies to create wholly-owned proprietary combinations that leverage the immune system and other complimentary mechanisms. Checkpoint is headquartered in New York City. For more information, visit www.checkpointtx.com.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials, timing of clinical trials for BET inhibitors and business prospects and potential uses for BET inhibitors may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to identify BET inhibitors suitable for clinical development, our ability to successfully and cost-effectively complete pre-clinical and clinical trials for BET inhibitors; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data analyses from prior pre-clinical and clinical trials; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101 and TGR-1202 will not be reproduced in additional patients or in future studies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue, the risk that the combination of TG-1101 and TGR-1202, referred to as TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
TGTX – G
CONTACT: Jenna Bosco Director- Investor Relations TG Therapeutics, Inc. Telephone: 212.554.4351 Email: ir@tgtxinc.com
(NVET) Provides Update on Upcoming Investor Symposium at Irish Biomanufacturing Facility
DUBLIN, Ireland, May 27, 2016 — Nexvet Biopharma (Nasdaq:NVET), a veterinary biologic therapeutics company, is pleased to provide an update on its Investor Symposium, which will be held on Friday June 3, 2016 at BioNua, its veterinary biologics manufacturing facility in Tullamore, Ireland.
The Symposium’s presentations and Q&A session will be held from 9:30AM – 10:30AM IST. In addition to providing an overview of the BioNua facility and its capabilities, the company will present a corporate and clinical update. Key topics will include progress on ranevetmab (NV-01) and NV-02, Nexvet’s anti-nerve growth factor (NGF) monoclonal antibody (mAb) therapies being developed as monthly subcutaneous injectables for the control of pain associated with osteoarthritis in dogs and cats, respectively.
“Dedicated in-house manufacturing is an important element of Nexvet’s strategy for furthering our leadership position in the emerging field of veterinary biopharmaceuticals. The BioNua facility is an asset which we anticipate will provide added control, cost advantages and overall enhanced efficiency in manufacturing, both for our advanced pain product candidates for dogs and cats as well as our emerging pipeline in immuno-oncology, allergy and inflammation. These advantages are particularly important as we plan further pivotal studies and prepare our commercial infrastructure,” commented Dr. Mark Heffernan, Chief Executive Officer of Nexvet.
The audio and presentations from this event will be made available for 30 days on the Investor Relations section of the Nexvet website at www.ir.nexvet.com.
To register to attend Nexvet’s Investor Symposium in Tullamore, please RSVP to IR@nexvet.com with your name, company and phone number.
About Nexvet (www.nexvet.com)
Nexvet is a veterinary biologics developer focused on transforming the therapeutic market for companion animals, such as dogs and cats, by developing and commercializing novel, species-specific biologics. Nexvet’s proprietary PETization™ platform is designed to rapidly design monoclonal antibodies (mAbs) that are recognized as “self” or “native” by an animal’s immune system, a property Nexvet refers to as “100% species-specificity.” Nexvet’s product candidates also build upon the safety and efficacy data from clinically tested human therapies, thereby reducing clinical risk and development cost.
Nexvet is leveraging diverse global expertise and incentives to build a vertically integrated biopharmaceutical company, which conducts drug discovery in Australia, conducts clinical development in the United States and Europe and is growing its biomanufacturing capabilities in Ireland.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements consist of all statements other than statements of historical fact, including statements regarding our future results of operations and financial position, results of any current or future pivotal safety and efficacy study, future expenditures relating to our lead product candidates, time for completion of any of our studies or facilities updates, ability to develop our pipeline of product candidates, business strategy, prospective products, ability to successfully manufacture our own product candidates, ability to meet conditions for the receipt of government grants, ability to qualify for conditional licensure or obtain product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, and future results of current and anticipated products. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. The words “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “plan,” “potential,” “predict,” “project,” “position,” “seek,” “should,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors.
Factors that could cause actual results to differ materially from our expectations expressed in this report include those summarized under Risk Factors in our reports on Forms 10-Q and 10-K and the other documents we file from time to time with the Securities and Exchange Commission. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management’s beliefs and assumptions only as of the date of this press release. Except as required by law, we do not intend, and undertake no obligation, to revise or update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
Further information: Investors Candice Knoll Blueprint Life Science Group +1 415-375-3340 Ext. 4 cknoll@bplifescience.com Media Jessica Burns Berry & Company Public Relations +1 212-253-8881 jburns@berrypr.com
(MCFT) Declares Special Cash Dividend of $4.30 Per Share
VONORE, Tenn., May 27, 2016 — MasterCraft (NASDAQ:MCFT) today announced that its Board of Directors has declared a special cash dividend of $4.30 per share of common stock. The dividend, totaling an aggregate payment of approximately $80.0 million, will be paid on June 10, 2016, to shareholders of record as of the close of business on June 6, 2016. The special dividend will be funded through existing cash and borrowings under a new credit facility.
Terry McNew, MasterCraft’s President and Chief Executive Officer, commented, “As we stated when we announced our share repurchase program in February, MasterCraft’s Board is committed to consistently evaluating the most prudent uses of the company’s strong balance sheet and free cash flow in order to maximize shareholder value, and today’s announcement demonstrates that commitment. Our currently unlevered balance sheet and access to attractive financing allow us to recognize and reward shareholders with a meaningful return of capital. In addition, our new capital structure will allow us to create additional equity value going forward by utilizing free cash flow to repay debt.”
Continued McNew, “As our investors know, MasterCraft has a very efficient business model which generates meaningful free cash flow. We believe this transaction is a prudent way to leverage that cash flow to provide a current return to our shareholders while continuing to drive long-term value creation through the sustained growth of our business.”
The special dividend will be funded with cash on hand and borrowings under an amended and restated senior secured credit facility provided by the company’s existing lenders. The amended and restated facility provides the company with a new $50 million term loan, in addition to maintaining its capacity under its existing $30 million revolving credit facility. On a pro-forma basis that reflects the transaction, MasterCraft expects to have total debt of less than 1.4x reported Adjusted EBITDA for the 12 months ended March 27, 2016, and liquidity of approximately $25 million.
Commented McNew, “Following completion of this transaction we will maintain a very conservative balance sheet, ample liquidity, and strong cash generation. Most important, we preserve the financial and operational flexibility to pursue our key strategic growth initiatives and to continue driving the sustainable, profitable growth and margin expansion our investors have come to expect from MasterCraft.”
At $4.30 per share, MasterCraft’s special dividend represents approximately 33 percent of the company’s closing stock price on May 26, 2016. Pursuant to NASDAQ rules, when a dividend is declared in a per share amount that exceeds 25 percent of its stock price, the date its shares will begin to trade without the dividend, or ex-dividend, is the first business day following the payable date. The company expects NASDAQ to apply this rule and the ex-dividend date as set by NASDAQ will be June 13, 2016, the first business day following the dividend’s payable date. Stockholders of record on the record date who sell their shares prior to the ex-dividend date will not receive the special cash dividend.
The company expects that a portion of the special dividend will be in excess of its current and accumulated earnings and profits, with this excess amount treated as a nondividend distribution for U.S. federal income tax purposes, which will reduce the tax basis of a shareholder’s common shares. If the nondividend distribution exceeds the shareholder’s basis in its common stock, the remainder of the nondividend distribution in excess of the shareholder’s basis will be treated as a capital gain. MasterCraft intends to provide a preliminary estimate of its accumulated earnings and profits through fiscal year end June 30, 2016 on or prior to July 25, 2016 in the Investor Relations section of its website (www.mastercraft.com). Since the earnings and profits amount will not be finalized until MasterCraft completes its corporate income tax returns for the June 30, 2016, fiscal year, the Company expects to provide final information as soon as it is available, but no later than January 2017.
The U.S. federal income tax treatment of holding common stock to any particular stockholder will depend on the stockholder’s particular tax circumstances. MasterCraft’s stockholders are urged to consult their tax advisor regarding the U.S. federal, state, local and foreign income and other tax consequences to them, in light of their particular investment or tax circumstances, of the receipt of the special dividend.
Forward-Looking Statements
This press release contains statements that may constitute “forward-looking statements” within the meaning of the federal securities laws. Statements regarding future events and future performance, as well as our expectations relating to the future, are forward-looking statements within the meaning of these laws. We believe these forward-looking statements are reasonable; however, you should not place undue reliance on these statements. These statements are based on current expectations and speak only as of the date of such statements. Important risk factors regarding the company and these statements are included in the reports we file with the SEC.
About MCBC Holdings, Inc.:
Headquartered in Vonore, Tenn., MCBC Holdings, Inc. (NASDAQ:MCFT) is the parent of MasterCraft Boat Company, a world-renowned innovator, designer, manufacturer, and marketer of premium performance sport boats. Founded in 1968, MasterCraft has cultivated its iconic brand image through a rich history of industry-leading innovation, and more than four decades after the original MasterCraft made its debut the company’s goal remains the same – to continue building the world’s best ski, wakeboard, wakesurf and luxury performance powerboats. For more information, visit www.mastercraft.com.
CONTACT: Tim Oxley Chief Financial Officer (423) 884-2221 Tim.Oxley@mastercraft.com Matt Sullivan (612) 455-1709 Matt.Sullivan@padillacrt.com
(SPIL) & (ASE) Joint Share Exchange Memorandum of Understanding Statement
TAIPEI, Taiwan, May 26, 2016 — Advanced Semiconductor Engineering, Inc. (TWSE Code: 2311, NYSE Code: ASX) (“ASE“) and Siliconware Precision Industries Co., Ltd. (“SPIL“)(Taiwan Stock Exchange: 2325, NASDAQ: SPIL) announced today that the boards of directors of ASE and SPIL have separately passed resolutions today for the execution by ASE and SPIL of the “Joint Share Exchange Memorandum of Understanding.” Both companies agree to promote plans for the establishment of a holding company (“HoldCo“). The main terms and purpose of the plans to jointly establish HoldCo are as follows:
1. HoldCo will be jointly established by ASE and SPIL, and will be listed on the Taiwan Stock Exchange (American depositary shares of HoldCo will be listed on the New York Stock Exchange). Upon the completion of its establishment, HoldCo will simultaneously hold 100% equity interests in both ASE and SPIL (the “Transaction” or “Joint Share Exchange“). As parallel sibling companies under HoldCo, ASE and SPIL can, through maintaining an operating model which incentivizes healthy competition while promoting cooperation between the two companies, improve their individual operating efficiencies and economies of scale as well as research innovation achievements. In doing so, both companies will jointly create a mutually beneficial platform that can strengthen competitiveness, improve the performance of HoldCo, and seek to attain the goals of improving customer service quality, creating shareholder value and improving employee well-being.
2. After the establishment of HoldCo, ASE and SPIL will each maintain its separate legal entity status, retain its legal entity name, and maintain its current independent operations and operating model. ASE and SPIL will each retain its full management team and employees, and their current organizational structure, compensation, relevant benefits and personnel regulations will continue to remain unchanged.
3. The Joint Share Exchange will result in (1) Holdco issuing new HoldCo shares as consideration in exchange for all of ASE’s shares at the exchange ratio of 1 ASE common share in exchange for 0.5 HoldCo common shares and (2) HoldCo paying NT$55 in cash per SPIL common share as consideration for all of SPIL’s shares. HoldCo will simultaneously hold 100% equity interests in both ASE and SPIL upon the consummation of the Transaction.
4. The Joint Share Exchange Memorandum of Understanding is not binding. After separately convening their respective boards of directors to approve the Transaction, both parties will execute a “Joint Share Exchange Agreement” on or before June 25, 2016. The completion of the Transaction is conditioned upon the completion of the execution of the Joint Share Exchange Agreement, all necessary approvals from foreign and domestic competent authorities and the satisfaction of all other closing conditions.
After sincere communication and exchange of opinions, the management teams of ASE and SPIL have agreed to jointly plan, with utmost sincerity and determination and on the basis of equality, reciprocity and mutual benefit, the establishment of HoldCo to consolidate the current operating models and excellent talents of ASE and SPIL. The collaboration between the parties will result in synergies that can create a high point and opportunities for the future development and sustained operations of the semiconductor industry by enhancing efficiency and economies of scale as well strengthening deep research and development and innovation capabilities, thereby providing customers with higher quality, more efficient, and well-rounded packaging and testing services. ASE and SPIL have always strived to innovate research and development and improve economies of scale and operating efficiency to maximize shareholder value. Both parties believe their main task and social responsibility is to continue maintaining and improving the semiconductor packaging and testing industry’s advantage, and at the same time consolidate the excellent talents nurtured over the decades.
Safe Harbor Notice:
This press release contains “forward-looking statements” within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended, including statements regarding ASE’s or HoldCo’s future results of operations and business prospects. Although these forward-looking statements, which may include statements regarding ASE’s or HoldCo’s (if established) future results of operations, financial condition or business prospects, are based on ASE’s or HoldCo’s (if established) own information and information from other sources we believe to be reliable, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan” and similar expressions, as they relate to ASE or HoldCo (if established), are intended to identify these forward-looking statements in this press release. These statements discuss future expectations, identify strategies, contain projections of results of operations of ASE’s or HoldCo’s (if established) financial condition, or state other forward-looking information. Known and unknown risks, uncertainties and other factors could cause the actual results to differ materially from those contained in any forward-looking statement. ASE cannot promise that its expectations expressed in these forward-looking statements will turn out to be correct. ASE’s or HoldCo’s (if established)actual results could be materially different from and worse than those expectations. For a discussion of important risks and factors that could cause ASE’s or HoldCo’s (if established) actual results to be materially different from its expectations, please see the documents we file from time to time with the U.S. Securities and Exchange Commission (“U.S. SEC”), including ASE’s 2015 Annual Report on Form 20-F filed on April 29, 2016.
This press release is not an offering of securities for sale in any jurisdiction:
ASE may file a registration statement on Form F-4 with the U.S. SEC in connection with the proposed Joint Share Exchange. The Form F-4 (if filed) will contain a prospectus and other documents. The Form F-4 (if filed) and prospectus, as they may be amended from time to time, will contain important information about ASE, SPIL, the Joint Share Exchange and related matters. U.S. shareholders of ASE are urged to read the Form F-4 (if filed), the prospectus and the other documents, as they may be amended from time to time, that may be filed with the U.S. SEC in connection with the Joint Share Exchange carefully before they make any decision at any shareholders’ meeting of ASE with respect to the Joint Share Exchange. The Form F-4 (if filed), the prospectus and all other documents filed with the U.S. SEC in connection with the Joint Share Exchange will be available when filed, free of charge, on the U.S. SEC’s website at www.sec.gov. In addition, the Form F-4 (if filed), the prospectus and all other documents filed with the U.S. SEC in connection with the Joint Share Exchange will be made available, free of charge, to U.S. shareholders of ASE who make a written request to ir@aseglobal.com.
Investor Relations Contact:
| Advanced Semiconductor Engineering, Inc. | Siliconware Precision Industries Co., Ltd. |
| Iris Wu, Manager | Mike Ma, Spokesperson |
| irissh_wu@aseglobal.com | mikema@spil.com.tw |
| Tel: +886.2.6636.5678 | Tel: +886.4.2554.5527#5601 |
(MARA) to Present at the LD Micro Invitational
LOS ANGELES, CA / May 26, 2016 / Marathon Patent Group, Inc. (NASDAQ: MARA) (“Marathon”), a patent licensing and commercialization company, announced today that it will be presenting at the 6th annual LD Micro Invitational on Wednesday, June 8 at 10 AM PST / 1 PM EST. Doug Croxall, Marathon’s Chief Executive Officer, will be giving the presentation and meeting with investors.
The presentation will be webcast and will be available here: http://wsw.com/webcast/ldmicro10/mara
The conference will be held at the Luxe Sunset Bel Air Hotel and will feature 195 companies in the small / micro-cap space.
View Marathon Patent Group’s profile here: http://www.ldmicro.com/profile/MARA
Profiles powered by LD Micro – News Compliments of Accesswire
About Marathon Patent Group
Marathon is a patent licensing and commercialization company. The Company acquires patents from a wide-range of patent holders from individual inventors to Fortune 500 companies. Marathon’s strategy of acquiring patents that cover a wide-range of subject matter allows the Company to achieve diversity within its patent asset portfolio. Marathon generates revenue with its diversified portfolio through actively managed concurrent patent rights enforcement campaigns. This approach is expected to result in a long-term, diversified revenue stream. The Company’s commercialization division is focused on the full commercialization lifecycle which includes discovering opportunities, performing due diligence, providing capital, managing development, protecting and developing IP, assisting in execution of the business plan, and realizing shareholder value. To learn more about Marathon Patent Group, visit www.marathonpg.com.
About LD Micro
LD Micro was founded in 2006 with the sole purpose of being an independent resource in the microcap space. What started out as a newsletter highlighting unique companies has transformed into an event platform hosting several influential conferences annually (Invitational, Summit, and Main Event).
In 2015, LDM launched the first pure microcap index (the LDMi) to exclusively provide intraday information on the entire sector. LD will continue to provide valuable tools for the benefit of everyone in the small and microcap universe.
For those interested in attending, please contact David Scher at david@ldmicro.com or visit www.ldmicro.com for more information.
Contact:
Marathon Patent Group
Jason Assad
678-570-6791
Jason@marathonpg.com
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