(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.

* 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.

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.

1. 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

Profiles powered by LD Micro – News Compliments of Accesswire

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

(EXPI) CEO Invited to Speak at Mendix World

(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

(OPCO) Sponsors 65th Annual BetterInvesting National Convention