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$NETE Aptito Restaurant POS will Exhibit at the 2017 Florida Restaurant & Lodging Show

Special promotions will be available during the event

MIAMI, FL–(Oct 5, 2017) – Net Element, Inc. (NASDAQ: NETE) (“Net Element” or the “Company”), a global financial technology and value-added solutions group that supports electronic payments acceptance in an omni-channel environment spanning across point-of-sale (POS), e-commerce and mobile devices, today announces that its Aptito subsidiary will exhibit at the 2017 Florida Restaurant & Lodging Show which will take place on October 11-13, 2017 at the Orange County Convention Center in Orlando, Florida.

This premier 3-day event encompasses everything merchants need to master with the emerging trends, amp up profits, energize their business and engage customers in unique and memorable ways. Attendees will join 8,000+ of their peers at the Florida Restaurant & Lodging Show, where they will have access to the latest menu trends, state-of-the-art design and décor, the best in business education and 450 of the leading vendors and purveyors dedicated to serving the restaurant and food service community — all under one roof.

The event also provides Aptito increased exposure as it unveils its most comprehensive Restaurant POS placement program to the market. Through this innovative program, businesses in any stage of development can qualify to receive cutting-edge point-of-sale solutions.

As a special promotion, Aptito will offer the following incentives to merchants during the event:

  • Show Special bundle $99 per month — includes iPad POS system, printer and cash drawer
  • 5 Free Mobile licenses
  • Defer payments for 3 months

Visit our booth to learn more.

“We are very excited to showcase our Aptito POS solution and kick off our North America road show to present our solution to merchants across the United States. Our simple all inclusive EMV POS offering and comprehensive features are sure to streamline operations at any restaurant,” commented Vlad Sadovskiy, President of Integrated Payments for Net Element.

About Net Element
Net Element, Inc. (NASDAQ: NETE) operates a payments-as-a-service transactional and value-added services platform for small to medium enterprise (“SME”) in the US and selected emerging markets. In the US it aims to grow transactional revenue by innovating SME productivity services such as its cloud based, restaurant and retail point-of-sale solution Aptito. Internationally, Net Element’s strategy is to leverage its omni-channel platform to deliver flexible offerings to emerging markets with diverse banking, regulatory and demographic conditions such as UAE, Kazakhstan, Kyrgyzstan and Azerbaijan where initiatives have been recently launched. Net Element was named in 2016 by South Florida Business Journal as one of the fastest growing technology companies. Further information is available at www.netelement.com.

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. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, whether Net Element can secure any additional financing and if such additional financing will be adequate to meet the Company’s objectives. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Net Element and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: (i) Net Element’s ability (or inability) to obtain additional financing in sufficient amounts or on acceptable terms when needed; (ii) Net Element’s ability to maintain existing, and secure additional, contracts with users of its payment processing services; (iii) Net Element’s ability to successfully expand in existing markets and enter new markets; (iv) Net Element’s ability to successfully manage and integrate any acquisitions of businesses, solutions or technologies; (v) unanticipated operating costs, transaction costs and actual or contingent liabilities; (vi) the ability to attract and retain qualified employees and key personnel; (vii) adverse effects of increased competition on Net Element’s business; (viii) changes in government licensing and regulation that may adversely affect Net Element’s business; (ix) the risk that changes in consumer behavior could adversely affect Net Element’s business; (x) Net Element’s ability to protect its intellectual property; (xi) local, industry and general business and economic conditions; (xii) adverse effects of potentially deteriorating U.S.-Russia relations, including, without limitation, over a conflict related to Ukraine, including a risk of further U.S. government sanctions or other legal restrictions on U.S. businesses doing business in Russia. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K and the subsequently filed quarterly reports on Form 10-Q and current reports on Form 8-K filed by Net Element with the Securities and Exchange Commission. Net Element anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Net Element assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.

Contact:
Net Element, Inc.
media@netelement.com
+1 (786) 923-0502

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$STLHF The Global Scramble for Lithium

October 5, 2017

NetworkNewsWire Editorial Coverage: Lithium stocks have rocketed over the last 12 months propelled by the unabated demand for lithium-ion (Li-ion) batteries. The world’s largest lithium producer, Albemarle Corp. (ALB), has delivered a 77% return over the last year. During the same period Sociedad Quimica y Minera de Chile (SQM) surged 150% and FMC Corp. (FMC) is up 95%. All three major producers trade near all-time highs but cracks are beginning to show. Respected investment bank, Baird, just downgraded Albemarle to neutral, stating that near-term execution is already priced into ALB’s stock and the shares are fully valued at current levels (http://nnw.fm/a9WRJ). Despite continued massive upside in the lithium market, the big three lithium producers may now be over-crowded and already reached full value. To profitably exploit market imbalance and burgeoning demand, rotation to prospective junior lithium miners like Standard Lithium Ltd. (TSXV: SLL) (FRA: S5L) (OTCQX: STLHF) and Nemaska Lithium Inc. (NMX-CA) may be imminent.

Demand for lithium is certain to surge as vehicles become greener and electricity becomes cleaner. Indicative of its importance, Goldman Sachs has identified lithium as “the new gasoline.” Worldwide sales of lithium salts are currently only about $1 billion a year, but the element has become a crucial component of Li-ion batteries that now power everything from electric cars to power tools to smart phones. Lithium demand has been projected to grow over 300% within the next eight years. However, with evermore electric utility companies expanding solar power capacity requiring high-density Li-ion energy storage, lithium demand could soar exponentially. As example, Duke Energy recently halted a proposed nuclear power plant in Florida and instead plans a $6 billion solar and battery infrastructure investment (http://nnw.fm/gp4RD). The unrelenting demand for rechargeable batteries and high-density energy storage has created an escalating dependence on lithium which has sparked a global search for new lithium fields.

Standard Lithium Ltd. (TSXV: SLL) (FRA: S5L) (OTCQX: STLHF) is in the thick of the hunt for new lithium sources. The company is intensely focused on further exploration and the immediate development of its Bristol Dry Lake, Brine Project located in the Mojave region of California. With the signing of its mineral lease agreement with National Chloride Corporation of America — a Permitted Brine Producer — for the exploration of lithium, Standard Lithium’s Bristol Lake project now encompasses approximately 25,000 acres of placer mineral claims and private property. The company’s geophysics team recently concluded a comprehensive gravity survey over the entire basin, and initial interpretation of the data indicates that the basin is deep and expansive.  Historical drilling and sampling to total depths of approximately 500 feet has produced brine samples with lithium values over 100 mg/L for the entire drilled interval.

For nearly 100 years National Chloride and others have surfaced mined the area to produce chloride for various industrial applications. Subsequently, the area has excellent mining infrastructure, which addresses the primary challenges in cost effective lithium mining and production – location, access and infrastructure. Standard Lithium’s location already has easy road and rail access, abundant electricity and water sources, and is permitted for extensive brine extraction and processing activities.  There is electric power and water on the property with a major paved road on the western edge and a rail siding nearby.

The strategic relationship with National Chloride, allows Standard Lithium immediate access to conduct exploration brine sampling and extraction, evaporation and processing activities, and enable a fast-tracked project development schedule. The project is in a friendly, clean energy development jurisdiction with proven near surface brines which provide for efficient geophysical exploration drilling programs. The company anticipates selective lithium recovery through a combination of membrane, chemical precipitation and solvent extraction. With a market cap of only $62 million, successful strategy execution could easily propel Standard Lithium to new heights as a significant low cost domestic producer of battery grade lithium materials.

To exceed objectives and market expectations, Standard Lithium has established a world class Scientific Advisory Council of lithium extraction scientists and process engineers that are in charge of the lithium extraction process testing work (http://nnw.fm/NmC1U). As Robert Mintak, CEO of Standard Lithium stated, “Standard Lithium has a very clear focus…we have the ideal team with a blend of experience, knowledge, technical agility and pragmatic problem-solving abilities, to develop optimal process solutions for Standard Lithium’s world-class assets.” There’s little doubt of Standard Lithium’s intent to produce low cost domestic lithium and capitalize on the immense global market imbalance.

The demand for Li-ion batteries will likely explode as grids modernize to handle the massive influx of mainstream electric vehicles, battery devices and ever more electric utilities that require more high-density energy storage systems. Investors need direct or indirect exposure to lithium and/or lithium batteries to profit from this energy revolution.

Another prospective junior miner, Nemaska Lithium (TSX: NMX-CA), is an exploration stage lithium miner focused on supplying the essential element to the battery industry through exploration and development of hard rock lithium mining and the processing of spodumene (lithium aluminum silicate) into lithium compounds. The company has yet to produce lithium and claims a proprietary process to produce lithium hydroxide and lithium carbonate for which patents have been filed. For the three months ended in March 2017, unaudited financial statements show a net operating loss of over $2 million for Nemaska, and, in a testament to escalating lithium demand, the company carries a lofty $430+ million market capitalization.

Of the three major lithium producers, Albemarle Corp. (ALB) is the largest and derives nearly 39% of its total revenue from lithium sales. Long a global leader in the specialty chemical business, Albemarle’s lithium business segment mines lithium and converts it into different forms along the value chain, like lithium carbonate and lithium hydroxide, or value-added specialties like butyl lithium and lithium aluminum hydride. With its acquisition of Rockwood Holdings in 2015, the company now controls one of the only operating lithium brines in North America and operates another lithium brine in Chile. ALB also holds a 49% share in Talison Lithium in Australia and is expanding production there in 2019 under a joint venture. Given Baird’s recent downgrade of the stock to neutral “with little opportunity seen for near-term upside” investors looking to deploy capital in the lithium market may want to consider other options at this time.

Sociedad Quimica y Minera S.A. (SQM) is part of the global scramble to secure supplies of lithium to feed battery producers and other end-users. Headquartered in Chile, SQM produces over 45,000 tons of lithium carbonate equivalent per year. With hints of shadowy connections, recent revelations show a Chinese state-controlled firm may bid for part of a controlling stake in SQM in conjunction with China’s attempts to secure continuous supplies of this vital raw material (http://nnw.fm/XKkK4). SQM plans to expand lithium carbonate capacity in Chile to 63,000 metric tons by 2018. Shares of SQM surged to all-time highs in 2017 and are now a frothy $56 per share. The company is inconsistent in paying dividends that yield around 3% and carries a hefty 42+ PE ratio.

FMC Corp. (FMC) owns and operates a 17,000+ tons per year lithium brine facility in Argentina, where political upheaval has sparked rampant inflation and social discord. FMC is a large diversified multinational chemical company servicing global agricultural, consumer and industrial markets, and lithium represents only a small fraction of company revenues. The company operates in three business segments: FMC Agricultural Solutions, FMC Health and Nutrition and FMC Lithium. FMC’s shares trade near all-time highs with a PE ratio over 56. Looking to boost lithium revenues, FMC plans to increase lithium hydroxide capacity to 30,000 metric tons per year by the end of 2019. As with most established lithium producers, shares of FMC trended much higher in 2017.

Investment risk in these three chemical conglomerates is mitigated since overall performance is tied to other chemicals and metals. However, each of these lithium behemoths are trading near all-time highs, may be crowded and fully valued, and don’t provide the pure play direct exposure to the lithium market that a junior mining company may offer.

In spite of its downgrade of ALB, Baird stated that it “continue(s) to believe lithium is in a multiyear growth cycle.” It’s estimated that in just eight years over 785,000 metric tons per year of lithium carbonate equivalent will be needed to meet global demand (http://nnw.fm/riS7f) compared to 227,000 tons of supply this year. Many other analysts are even more bullish expecting greater demand, larger lithium deficits and further price increases for this essential element. New sources of lithium are necessary to meet the insatiable demand. For the foreseeable future, well positioned lithium investors should be richly rewarded.

For more information on Standard Lithium please visit: Standard Lithium Ltd. (TSXV: SLL) (FRA: S5L) (OTCQX: STLHF)

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$BNFT Streamlines Health Savings Accounts and COBRA Administration with New Solutions

Developed in partnership with customers, software-enabled services simplify management of critical benefits for employers and the employees they support

CHARLESTON, S.C., Oct. 4, 2017  — Benefitfocus, Inc. (NASDAQ: BNFT), a leading provider of cloud-based benefits management software, today unveiled Benefitfocus Consumer-Directed Healthcare Accounts and Benefitfocus COBRA Administration. The addition of these new solutions to the Benefitfocus Platform will provide employers, brokers and employees a single partner to support communication, enrollment and administration of these critical benefits. Employers representing more than 31,000 employees spanning the retail, banking, education and manufacturing industries have already signed on to take advantage of the new capabilities.

“By streamlining the experience on the Benefitfocus Platform we can help employers increase employee participation in critical benefits like Health Savings Accounts and better manage the compliance risk of processes like COBRA administration,” said Benefitfocus Co-Founder and CEO Shawn Jenkins. “A common theme from our employer, insurance carrier and broker partners has been a desire to simplify benefits communication, enrollment, administration and services with a single partner. With the addition of these new solutions we are positioned to help them achieve that goal.”

Benefitfocus Consumer-Directed Healthcare Accounts
As health care premiums and deductibles have increased for employees, so has the importance of Consumer-Directed Healthcare Accounts, and Health Savings Accounts in particular. Benefitfocus Consumer-Directed Healthcare Accounts improve the experience for participating employers and their employees through:

  • A simplified experience. Employees can now enroll in, open and manage accounts on the same platform with a single password. No additional steps are required to activate new accounts.
  • Mobile by design. Through the Benefitfocus mobile application, submitting an expense for reimbursement is as easy as taking a picture. Expenses are processed immediately and account balances are updated instantly.
  • A single platform. Benefits leaders can monitor plan participation and employee contribution trends with the powerful reporting capabilities built within BENEFITFOCUS® Marketplace.

Benefitfocus COBRA Administration
Benefitfocus COBRA Administration simplifies compliance with the highly-regulated requirements of COBRA, easing the burden of a complicated, time consuming process. As part of Benefitfocus Marketplace, customers benefit from:

  • Process automation. Changes in employee eligibility within Benefitfocus Marketplace trigger required COBRA communications. No manual data entry into third-party systems is necessary.
  • Continuous synchronization. Third-party systems typically rely on weekly file transfers, which can result in systems becoming out of sync. Benefitfocus COBRA Administration processes files daily, reducing compliance risk for employers.

Interested employers, brokers and insurance carriers can learn more about the new solutions here or visit Benefitfocus at booth 1324 at the HR Technology Conference, October 10-13 in Las Vegas, by scheduling a meeting here.

About Benefitfocus
Benefitfocus (NASDAQ: BNFT) provides a leading cloud-based benefits management platform that simplifies how organizations and individuals shop for, enroll in, manage and exchange benefits. Every day leading employers, insurance companies and the consumers they serve rely on our platform to manage, scale and exchange benefits data seamlessly. In an increasingly complex benefits landscape, we bring order to chaos so our clients and their employees have access to better information, make better decisions and lead better lives. Learn more at www.benefitfocus.comLinkedIn and Twitter.

Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the need to innovate and provide useful products and services; changes in government regulations; our ability to compete effectively; the immature and volatile nature of the market for our products and services and other factors that could impact our anticipated growth; management of growth; fluctuations in our financial results; general economic risks; reliance on key personnel; our ability to maintain our culture and recruit and retain qualified personnel; privacy, security and other risks associated with our business; and the other risk factors set forth from time to time in our SEC filings, copies of which are available free of charge within the Investor Relations section of the Benefitfocus website at http://investor.benefitfocus.com/sec.cfm or upon request from our investor relations department. Benefitfocus assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

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$ONTX to Host Key Opinion Leader Meeting on Novel Approaches to Pediatric RASopathies

NEWTOWN, Pa., Oct. 04, 2017  — Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), today announced that it will host a Key Opinion Leader (KOL) breakfast meeting on the topic of Novel Approaches to the Diagnosis and Treatment of RASopathies.  The event and live webcast will take place on Wednesday, October 11, from 8:00 AM-9:30 AM Eastern Time, in New York City.

The meeting will feature presentations by KOLs, Bruce D. Gelb, M.D. (Mount Sinai, New York), and Elliot Stieglitz, M.D. (University of California San Francisco), who will discuss new diagnostic and research developments for pediatric patients with RASopathies, which are related genetic syndromes usually caused by mutations that alter the Ras subfamily and mitogen activated protein kinases that control signal transduction.

Onconova’s management team, including Steven Fruchtman, M.D., the Chief Medical Officer, will also provide an update on rigosertib, a small molecule inhibitor of Ras signaling pathways (Saikumar et al, Cell, 2016) that is planned to be studied in pediatric patients with Rasopathies complicated by the development of Ras associated cancers.  Currently, rigosertib, the Company’s lead product candidate, is being evaluated in a global Phase 3 trial (INSPIRE) for higher risk-MDS patients after failure of therapy with hypomethylating agents.

A Q&A session with the featured experts and management will follow the presentations.

This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay will be accessible here.

KOL Biographical Information:

Bruce D. Gelb, M.D., is the Director and Gogel Family Professor of the Mindich Child Health and Development Institute at the Icahn School of Medicine at Mount Sinai. He is Professor of Pediatrics and of Genetics and Genomic Sciences. Dr. Gelb completed a pediatric residency and pediatric cardiology fellowship at Babies Hospital of Columbia-Presbyterian Medical Center and Texas Children’s Hospital at the Baylor College of Medicine, respectively. He joined the faculty at Mount Sinai in 1991 following his fellowship and has remained there since. Dr. Gelb developed and now oversees an extensive program in genomics/gene discovery for congenital heart disease. He has received the E. Mead Johnson Award from the Society for Pediatric Research, and the Norman J. Siegel New Member Outstanding Science Award from the American Pediatric Society. Dr. Gelb was elected to the American Society of Clinical Investigation and the National Academy of Medicine (formerly, the Institute of Medicine). He is the President-Elect for the American Pediatric Society, President for the International Pediatric Research Foundation and a Board Member for the American Society of Human Genetics. In addition to his research, Dr. Gelb co-directs the Cardiovascular Genetics Program at Mount Sinai.

Elliot Stieglitz, M.D., is an assistant professor at the University of California San Francisco (UCSF) in the division of Pediatric Hematology & Oncology. His research focuses on improving outcomes for children diagnosed with myeloid malignancies, particularly those with juvenile myelomonocytic leukemia (JMML), an aggressive hematologic malignancy of childhood. As his primary clinical focus, Dr. Stieglitz is study chair for ADVL1512, a phase II clinical trial sponsored by the Children’s Oncology Group (COG) that will evaluate the safety of trametinib in children with relapsed JMML. This trial has recently been approved by the COG and is expected to enroll patients by the end of 2017. His primary laboratory focus is elucidating the mechanism of mutant SETBP1-mediated leukemogenesis, which is associated with the most aggressive form of JMML and is the subject of a K08 award.

About Onconova Therapeutics, Inc.
Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS). Rigosertib, Onconova’s lead candidate, is a proprietary Phase 3 small molecule agent, which the Company believes blocks cellular signaling by targeting RAS effector pathways.  Using a proprietary chemistry platform, Onconova has created a pipeline of targeted agents designed to work against specific cellular pathways that are important in cancer cells, while causing minimal damage to normal cells. Onconova has three product candidates in the clinical stage and several pre-clinical programs. Advanced clinical trials with the Company’s lead compound, rigosertib, are aimed at what the Company believes are unmet medical needs of patients with MDS. For more information, please visit http://www.onconova.com.

About IV Rigosertib
The intravenous form of rigosertib has been employed in Phase 1, 2, and 3 clinical trials involving more than 800 patients, and is currently being evaluated in the randomized Phase 3 international INSPIRE trial for patients with higher-risk MDS, after failure of hypomethylating agent, or HMA, therapy. This formulation is intended for patients with advanced disease, provides long duration of exposure, and ensures dosing under a controlled setting.

About Oral Rigosertib
The oral form of rigosertib was developed to provide more convenient dosing for use where the duration of treatment may extend to multiple years. This dosage form also supports many combination therapy modalities. To date, 368 patients have been treated with the oral formulation of rigosertib.  Initial studies with single-agent oral rigosertib were conducted in hematological malignancies, lower-risk MDS, and solid tumors. Combination therapy of oral rigosertib with azacitidine and chemoradiotherapy has also been explored. Currently, oral rigosertib is being developed as a combination therapy together with azacitidine for patients with higher-risk MDS who require HMA therapy.  A Phase 2 trial of the combination therapy has been fully enrolled and the preliminary results were presented in 2016. An expansion of this trial is currently enrolling patients at multiple sites in US, Europe and Australia. This novel combination therapy is the subject of an issued US patent with earliest expiration in 2028.

Forward Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to future events or Onconova Therapeutics, Inc.’s future operations, clinical development of Onconova’s product candidates and presentation of data with respect thereto, regulatory approvals, expectations regarding the sufficiency of Onconova’s cash and other resources to fund operating expenses and capital expenditures, Onconova’s anticipated milestones and future expectations and plans and prospects. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including Onconova’s ability to continue as a going concern, the need for additional financing and current plans and future needs to scale back operations if adequate financing is not obtained, the success and timing of Onconova’s clinical trials and regulatory approval of protocols, and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q.

Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

CONTACT:

General Contact
http://www.onconova.com/contact/

Investor Relations Contact
Katja Buhrer, MBS Value Partners on behalf of Onconova Therapeutics
Katja.Buhrer@mbsvalue.com / (212) 661-7004

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$STRM Expands Relationship With Existing Audit Services Client via eValuator™

Company Executes on Strategy to Add Technology to Audit Services Clients

ATLANTA, Oct. 4, 2017 — Streamline Health Solutions, Inc. (NASDAQ: STRM), provider of integrated solutions, technology-enabled services and analytics supporting revenue cycle optimization for healthcare enterprises, today announced the sale of eValuator, its new cloud-based automated pre-bill code auditing technology, to one of their existing West Coast-based clients.  The Company began its relationship with the hospital system in late 2016  when it chose Streamline Health to handle its audit services needs.

With eValuator, Streamline Health is leading an industry movement to improve healthcare providers’ financial performance by moving mid-to-late revenue cycle interventions upstream, optimizing coding accuracy for every patient encounter prior to bill submission.  By improving coding accuracy before billing, providers can reduce revenue leakage, mitigate overbill risk, and reduce denials and days in A/R. This enables providers to turn unpredictable revenue cycles into dynamic revenue streams.

“We really appreciate the relationship we’ve developed with this client by handling their traditional post-bill audits.  As our relationship grew, we showed them how they could further improve their coding accuracy and coder training by using eValuator for automated analysis of all cases prior to billing,” stated David Sides, President and Chief Executive Officer, Streamline Health.  “It’s great to work with innovative healthcare providers that are truly committed to the health of the communities they serve and constantly looking for ways to improve overall financial performance as it funds their mission.  With eValuator, our code auditing technology can help them further improve their financial performance by reviewing all coded patient records before they are billed.”

About Streamline Health
Streamline Health Solutions, Inc. (NASDAQ: STRM) is a healthcare industry leader in capturing, aggregating, and translating enterprise data into knowledge­ – producing actionable insights that support revenue cycle optimization for healthcare enterprises.   We deliver integrated solutions, technology-enabled services and analytics that enable providers to drive reimbursement in a value-based world. We share a common calling and commitment to advance the quality of life and the quality of healthcare – for society, our clients, the communities they serve, and the individual patient. For more information, please visit our website at www.streamlinehealth.net.

Disclosure Regarding Client Relationships
This announcement may contain statements regarding the availability and sale of solution offerings from Streamline Health Solutions, Inc.  Readers should understand that inherent risks in contractual relationships, such as changes in duration, scope or volume and similar unanticipated events, may come into play, and readers are cautioned to consider such factors in any reliance on these statements.

Company Contact:
Randy Salisbury
SVP, Chief Marketing Officer
(404) 229-4242
randy.salisbury@streamlinehealth.net

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$RGSE & $DOW Exclusive License Agreement to Commercialize POWERHOUSE™ Solar Shingle

RGS Energy Will Host a Conference Call Today at 2:15 p.m. MT

DENVER, Colo., Oct. 04, 2017 — RGS Energy (NASDAQ:RGSE) has entered into an exclusive domestic and international license agreement with The Dow Chemical Company for the POWERHOUSE™ solar shingles system, an innovative and aesthetically pleasing solar shingle system developed by Dow that has been deployed on more than 1,000 homes. See images of the solar shingles and additional information about POWERHOUSE™ solar shingles at RGSPOWERHOUSE.com.

RGS will lead all commercial activities for the product, including supply chain management, marketing, sales, installation and warranty.

Starting in 2008, Dow began research and development of solar shingles designed to be integrated directly into a roof. The first and second generation products, POWERHOUSE™ 1.0 and 2.0 solar shingles, were based on CIGS (copper indium gallium selenide) technology, and were deployed in more than 1,000 solar installations across 18 states.

To make the product more economic to homeowners, beginning in 2015, Dow began development of POWERHOUSE™ 3.0 solar shingles which uses traditional silicon solar cells rather than CIGS technology. This shift significantly reduced the cost, while improving panel efficiency. Dow holds numerous patents covering the POWERHOUSE™ 3.0 solar shingles technology, all of which are now exclusively licensed to RGS.

RGS and Dow anticipate UL product certification during the first quarter of 2018 and are taking pre-orders in advance of final written certification.  RGS plans to begin sales and installation of POWERHOUSE™ 3.0 solar shingles immediately thereafter.

Market Potential

The POWERHOUSE™ product is well-suited for homeowners needing to replace their roofs. With a typical asphalt roof lasting 20 to 25 years, RGS estimates that annually there are approximately 5 million homes needing new roofs in the United States. Approximately 80 percent of homes in the U.S. are asphalt roofs. POWERHOUSE™ 3.0 solar shingles was designed to blend in perfectly with asphalt roofs and includes a low profile making the solar array less conspicuous as compared to traditional solar panels.

For homeowners needing a new roof, RGS believes that POWERHOUSE™ 3.0 solar shingles are aesthetically more pleasing than a traditional solar array, and also will be more economic to homeowners.

New home builders will continue to be a target segment for the POWERHOUSE™ 3.0 solar shingles, as the market demand for building integrated photovoltaic (BIPV) products is increasing. In fact, some cities have mandated solar for new home builds.

Outside of the U.S., the exclusive license allows RGS to market the product internationally. According to BBC Research, the global market for BIPV will grow at a 12.2% CAGR from $2.5 billion in 2016 to $4.3 billion by 2021.

RGS anticipates a materially lower cost of customer acquisition than its traditional solar business achieved by (i) expanding upon the network of authorized local roofers utilized by Dow for lead generation and installation and (ii) direct sales of POWERHOUSE™ solar shingles to new home builders to be installed in their new communities.

Management Commentary

“This enhanced POWERHOUSE™ 3.0 system comes at an opportune time,” said Dennis Lacey, CEO of RGS Energy. “At an increasing rate, goals and targets are being set for renewable energy. Some localities are mandating solar for new build homes. Customers also increasingly want their solar installations to be an aesthetic and technical improvement integrated with a home renovation, rather than a hefty module that is bolted onto their rooftop. POWERHOUSE™ 3.0 solar shingles fulfills this need. We have been the POWERHOUSE™ solar shingles official warranty service provider since 2015. Given this familiarity with Dow and POWERHOUSE™ solar shingles, we are in a unique position to commercialize POWERHOUSE™ 3.0 solar shingles.”

“We are very pleased to partner with RGS Energy for the commercialization of our POWERHOUSE™ 3.0 product,” said Kirk Thompson, Business Director of Dow Solar. “We believe that RGS is well positioned to optimize the market potential for POWERHOUSE™ 3.0 solar shingles system. The design of POWERHOUSE™ 3.0 solar shingles addresses the critical requirements of customers and installers and achieves a price point that will be very competitive.”

Manufacturing Supply Chain, Sales and Installation Partners

The patented POWERHOUSE™ 3.0 product includes a base assembly and electrical connector into which a solar laminate is inserted. RGS expects the base assembly and electrical connector will continue to be made by U.S.-based companies. To ensure the commercial feasibility of the product, RGS expects the solar laminate will be manufactured overseas.

RGS plans to expand its call center and digital marketing program to aggressively market the product using media that is well suited to demonstrate the ease of installation and aesthetic value of the product, such as television.

POWERHOUSE™ 3.0 solar shingle system was designed to enhance its appeal to roofing companies. The new product works with traditional roofing products, making installation simple and efficient. RGS plans to utilize and expand the regional roofing companies used for installation of the earlier generations of POWERHOUSE™ product, as well as enter new jurisdictions beyond the initial 18 where the earlier generations were installed.

The commercialization of POWERHOUSE™ 3.0 solar shingles is expected to generate jobs in the United States.

Conference Call and Webcast Details

RGS will host a conference call today at 2:15 p.m. Mountain time to discuss the new agreement.

Participants will include RGS Energy CEO, Dennis Lacey, and Business Director of Dow Solar, Kirk Thompson.

Date: Wednesday, October 4, 2017
Time: 4:15 p.m. Eastern time (2:15 p.m. Mountain time)
Toll-free dial-in number: 1-800-263-8506
International dial-in number: 1-719-457-2689
Conference ID: 8654305
Webcast: http://public.viavid.com/index.php?id=126573

The conference call will be webcast live and available for replay via the investor relations section of the company’s website at investors.rgsenergy.com.

Please call the conference telephone number five minutes prior to the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact CMA at 1-949-432-7566.

A replay of the call will be available after 7:15 p.m. Eastern time on the same day through October 11, 2017.

Toll-free replay number: 1-844-512-2921
International replay number: 1-412-317-6671
Replay ID: 8654305

More information about the POWERHOUSE™ 3.0 product will be available at RGSPOWERHOUSE.com.

About RGS Energy 

RGS Energy (NASDAQ:RGSE) is a residential and small business commercial solar company since 1978 which has installed more than 25,000 solar power systems. RGS Energy makes it very convenient for customers to save on their energy bill by providing turnkey solar solutions – from system design, construction planning, customer financing assistance, installation, to interconnection and warranty.

For more information, visit RGSEnergy.com, on Facebook at www.facebook.com/rgsenergy and on Twitter at www.twitter.com/rgsenergy. Information on such websites is not incorporated by reference into this press release.

RGS Energy is the Company’s registered trade name. The Company files periodic and other reports with the Securities and Exchange Commission under its official name “Real Goods Solar, Inc.”

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, including statements regarding the RGS Energy’s results of operations and financial positions, and RGS Energy’s business and financial strategies.  Forward-looking statements are neither historical facts nor assurances of future performance.  Instead, they provide our current beliefs, expectations, assumptions, forecasts, and hypothetical constructs about future events, and include statements regarding our future results of operations and financial position, business strategy, budgets, projected costs, plans and objectives of management for future operations.  The words “expect,” “intend,” “plan,” “future,” “believe,” “may,” “will,” “estimate” and similar expressions as they relate to RGS Energy or Dow are intended to identify such forward-looking statements.

Forward-looking statements should not be read as a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved, if at all.  Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Therefore, RGS Energy cautions you against relying on any of these forward-looking statements.

Key risks and uncertainties that may cause a change in any forward-looking statement or that could cause our actual results and financial condition to differ materially from those indicated in the forward- looking statements include: the ability to successfully commercialize POWERHOUSE 3.0 to homeowners and new home builders; the ability to obtain requisite certification of POWERHOUSE 3.0; the adequacy of and access to necessary capital to commercialize POWERHOUSE 3.0; the satisfaction of other conditions to the license agreement; RGS Energy’s ability to manage supply chain in order to have production levels and pricing of the Powerhouse shingles to be competitive; the ability of RGS Energy to successfully expand its operations and employees and realize profitable revenue growth from the sale and installation of POWERHOUSE 3.0, and to the extent, anticipated; the potential impact of the announcement with employees, suppliers, customers and competitors; changes in general economic, business and political conditions, including tariffs on imported solar cells and changes in the financial markets; significant competition that RGSE faces; compliance with extensive government regulation.

You should read the section entitled “Risk Factors” in our 2016 Annual Report on Form 10-K, as amended, and in our Quarterly Report on Form 10-Q/A for the quarter ended June 30, 2017, each of which has been filed with the Securities and Exchange Commission, which identify certain of these and additional risks and uncertainties. Any forward-looking statements made by us in this press release speak only as of the date of this press release. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We do not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

™ Trademark of The Dow Chemical Company, used under license.

RGS Energy’s Investor Relations Contact

Ron Both
Managing Partner, CMA
Tel 1-949-432-7566
RGSE@cma.team

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$IGC Prepares a Liquid Delivery Formulation of IGC-AD1 for Alzheimer’s

Readies Line of Medical Dispensary Products Targeting Enhanced Mitochondrial Function in AD patients

BETHESDA, Md., Oct. 04, 2017 — India Globalization Capital, Inc. (NYSE-MKT:IGC) provides an update on compelling in vitro data compiled from genetically engineered cell lines within an Alzheimer’s Disease (AD) model, showing that at varying concentrations of IGC-AD1 mitochondrial function is enhanced between 30% and 60%.

“Based on our analysis of this and other previously announced compelling data, we are readying IGC-AD1 in a liquid formulation that will not cause inebriation. The initial commercialization will be through licensed medical cannabis dispensaries,” stated IGC’s CEO, Ram Mukunda.

Mitochondrial dysfunction is thought to be at the apex of the AD pyramid, which is believed to trigger a cascade leading to AD. Studies have indicated that overproduction of Aβ disturbs the dynamics of mitochondrial fusion/fission, among others, and alters mitochondrial function. It is theorized that age related mitochondrial dysfunction leads to two types of legions found in the brains of AD patients: senile plaques composed of amyloid beta proteins and neurofibrillary tangles (NFTs) composed of tau protein.

The summary in vitro data indicates that exposure over 36 hours to IGC-AD1 with a dosage between 2.5nM and 25nM concentration improved mitochondrial function between 30% and 60%, in the presence of FCCP, at the basal. Dr. Chuanhai Cao, IGC’s Senior Advisor and Associate Professor of Pharmaceutical Sciences at USF’s College of Pharmacy conducted the studies.

About Alzheimer’s Disease

Alzheimer’s Disease (AD) is a form of dementia. It is known as America’s most expensive disease, with an estimated cost to the U.S. economy of $236 billion. AD currently affects more than 5.3 million Americans and over 65% of AD patients are women. Over the next 20 years, the number of those afflicted with the disease is expected to double. The forecast is staggering, considering that to date, no effective cure has been found.

About IGC
IGC is engaged in the development of cannabis based combination therapies to treat Alzheimer’s, pain, nausea, eating disorders, several end points of Parkinson’s, and epilepsy in dogs and cats. IGC has assembled a portfolio of patent filings and four lead product candidates addressing these conditions. The company is based in Maryland, USA.

For more information please visit www.igcinc.us
Follow us on Twitter @IGCIR and Facebook.com/IGCIR/

Forward-looking Statements
Please see forward looking statements as discussed in detail in IGC’s Form 10K for fiscal year ended March 31, 2017, and in other reports filed with the U.S. Securities and Exchange Commission.

Contact:
Claudia Grimaldi
301-983-0998

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The Green Organic Dutchman (TSX: TGOD) (OTC: TGODF)

The Green Organic Dutchman (TSX: TGOD) (OTC: TGODF), whose principal location is in Hamilton, Ontario, produces farm grown, organic, pesticide-free medical cannabis in small batches using all natural, organic craft growing principles. TGOD is licensed under the Access to Cannabis for Medical Purposes Regulations (ACMPR) to cultivate medical cannabis. The company carries out its principal activities producing cannabis pursuant to the provisions of the ACMPR and the Controlled Drugs and Substances Act (Canada).

Committed to becoming the global leader in delivering organic cannabis solutions that enhance people’s lives, TGOD consistently adheres to the highest levels of excellence. Its world-class management team includes a proven group of leaders with outstanding executive and operational experience specific to consumer packaged goods, consumer products, cannabis and finance industries.

TGOD is positioned as one of the highest quality and most cost efficient cannabis producers in Canada by leveraging innovative technology and low-cost power solutions. It holds one of the largest land packages under a single ACMPR license in Canada, providing future cannabis Agri-park style development and opportunities for joint ventures, licensing and distribution partners. Its industry leading alliance partners include Eaton, Ledcor Group and Hamilton Utilities Corp.

Eaton is the second largest power management company in the world and promises to supply innovative and cost effective power solutions to meet TGOD’s growing demands. Construction management is supplied by Ledcor, Canada’s second largest multidisciplinary construction company and a pioneer in the Green Building Industry. An alliance with Hamilton Utilities Corp allows TGOD to reduce its power costs from $0.13 per kWh to less than $0.05 per kWh. Greenhouse design is provided by Larssen Greenhouse, whose 25-plus years of experience in building some of the most modern and sophisticated greenhouses in the industry will provide TGOD with state of the art, climate-controlled hybrid greenhouse solutions.

Canada is quickly becoming a hub for cannabis investors with over $1.3 billion raised by Canadian companies to date. There are 58 licensed producers to service a population of 36 million and only two organic producers. TGOD, which holds licenses in Ontario and Quebec, is strategically located in both provinces that together claim 22 million Canadians as residents. Another estimated 57 million people live next door in six U.S. bordering states.

The Canadian cannabis market currently has a massive supply demand gap, which makes TGOD’s expansion plans even more important to investors. These plans include a combined build-out capacity of 970,000 square feet, allowing TGOD to produce 116,000 kg annually of organic cannabis. Upon completion, Phase One in Hamilton, Ontario, which is fully funded, will provide 150,000 square feet of growing capacity capable of producing up to 14,000 kg of cannabis or $112 million in revenue at $8 a gram.

The company’s Quebec expansion will be constructed on a recently secured 75-acre property near Montreal. This new property has a planned expansion of 820,000 square feet capable of producing 102,000 kg of organic cannabis. The first phase of this expansion is underway and construction is expected to be completed by the end of 2018. Quebec’s first phase will consist of 220,000 square feet capable of producing 22,000 kg of cannabis. Two additional expansion phases will add 250,000 square feet (26,000 kg of cannabis) and 350,000 square feet (54,000 kg of cannabis). Power costs remain exceptionally low for both facilities with access to all other needed utilities available and close by.

TGOD also plans to gain a share of the burgeoning cannabis oils market which by Q1 2017 accounted for 49 percent of all cannabis sold in Canada under the ACMPR, up from only 27% in Q2 2016. TGOD has ordered a purpose-built extraction laboratory with an estimated commission in Q4 of 2017. This is a commercial-scale CO2 extraction unit capable of processing up to 12,000 kg of raw material per year and producing approximately $170 million worth of organic cannabis oils. Raw cannabis oil provides a significant downstream manufacturing opportunity into several potential recreational market verticals including edibles, beverages, topicals and concentrates.

Data from the Canadian ACMPR Market Trends report indicates a rising number of consumers will continue to seek out healthier, less conspicuous ways to consume cannabis, ensuring sales of organic cannabis oil products remain brisk. Organic cannabis products demand a significant premium compared to non-organic products and the demand keeps growing.

Plans to take the company public are underway with an initial public offering (IPO) slated for January 2018. In November, the company raised $13 million in equity financing and in March closed a $27 million non-brokered private placement. Another $20 million is currently being raised before the IPO in January, which will be utilized for expansion plans.

TGOD is uniquely positioned between the medical and recreational cannabis industry since Canada is scheduled to legalize cannabis for all adults in mid-2018. As of August 2017, TGOD has 2,400 shareholders. Established in 2012, TGOD’s motto, “Making Life Better,” can be seen in its strategic partnerships, top quality management team, and dedication to organic farming and principles.

Investment Considerations

  • Nearly 1 million sq. ft. expansion underway to produce 116,000 KG annually
  • Proven management team with vast experience in relevant fields
  • One of the largest land packages under a single ACMPR license in Canada
  • Well positioned to capitalize on rapid growth with industry leading alliance partners


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$BIOP Announces Special Cash Dividend

CASTLE ROCK, Colo., Oct. 3, 2017  — Bioptix, Inc (NASDAQ: BIOP) (the “Company”), announced today that its Board of Directors has authorized a special dividend of approximately $1.00 per common share (including common share equivalents) in cash, payable on or about October 18, 2017 to shareholders of record as of October 13, 2017.

Michael Beeghley, the Company’s Chairman and Chief Executive Officer, commented, “This special dividend is a positive step to return value to all Bioptix shareholders. We continue to explore options for delivering additional value to shareholders with our streamlined overhead and cash position.”

The exact dividend total amount is subject to final calculation. Shareholders do not need to take any action to receive the dividend. Shares held in street name should receive the dividend by credit to their brokerage accounts and shares held by shareholders of record will receive a check. Equity Stock Transfer has been appointed paying agent for administration of the dividend and any questions should be directed to them at 212.575.5757 or info@equitystock.com.

About Bioptix
The Company holds an exclusive license from the University of Washington in St. Louis (“UW”) focusing on animal healthcare and owns important intellectual property rights related to veterinary products and has granted a license relating to single chain reproductive hormone technology for use in non-human mammals which is under active development by the licensee (bovine rFSH).  The Company had been involved in developing blood-based testing for diagnosis and treatment of acute appendicitis until a negative response from the FDA in 2015.  The Company acquired BiOptix Diagnostics, Inc in 2016 and following a decision in 2017 to exit that business has been reviewing possible strategic alternatives for that business, including a possible sale.  The Company has been reviewing other strategic alternatives, including shifting its focus to new technologies in unrelated markets.

Safe Harbor
The information provided in this press release may include forward-looking statements relating to future events or the future financial performance of the Company. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipates,” “plans,” “expects,” “intends,” “will,” “potential,” “hope” and similar expressions are intended to identify forward-looking statements.  These forward-looking statements are based upon current expectations of the Company and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release relating to the Company may be found in the Company’s periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled “Risk Factors” in its annual report on Form 10-K for the fiscal year ended December 31, 2016, as amended and supplemented from time to time and the Company’s Quarter Reports on Form 10-Q and other filings submitted by the Company to the SEC, copies of which may be obtained from the SEC’s website at www.sec.gov. The parties do not undertake any obligation to update forward-looking statements contained in this press release. 

Media Contacts
Karen Chase or Travis Kruse
Russo Partners, LLC
(646) 942-5627
(212) 845-4272
karen.chase@russopartnersllc.com
travis.kruse@russopartnersllc.com

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$KOOL Allowance for U.S. Patent Application, Novel Method of Cell Separation

RANCHO CORDOVA, Calif., Oct. 03, 2017 – Cesca Therapeutics Inc. (NASDAQ:KOOL), a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance regarding the company’s pending application for a patent covering its proprietary method for separating rare, therapeutically critical target cells from blood, bone marrow, leukapheresis product, and other cell sources, while maintaining the viability of the cells under asceptic conditions. This advanced cell separation technology, known as Buoyancy-Activated Cell Separation, or BACS, is key to the ongoing development of Cesca’s CAR-TXpress™ platform.

When issued, this will be Cesca’s second patent in a series relating to its X-BACS technology. On July 28, 2017, Cesca announced that SynGen, Inc., which the company acquired on July 10, 2017, had been awarded a U.S. patent (No. 9,695,394, or the ‘394 patent) covering the X-BACS apparatus. The ‘394 patent also allows for the automated isolation of cells with low density surface antigens, which was previously a major cellular manufacturing challenge.

“This Notice of Allowance further strengthens our intellectual property position as we advance development of our novel CAR-TXpress™ solution for the automated manufacture of CAR-T cells,” said Chris Xu, Cesca’s chief executive officer. “CAR-T represents the future of cancer treatment, yet we believe speed, cost and consistency will likely emerge as significant industry challenges. With the X-BACS technology embedded in CAR-TXpress, manufacturers will be able to improve the yield and consistency of CAR-T cells in less time and at a lower cost. We look forward to partnering with some of the most innovative biopharmaceutical companies in the field to enhance the commercial viability of these ground-breaking treatments.”

“We are pleased that the USPTO continues to recognize the unique attributes of the X-BACS technology,” said Philip Coelho, chief technology officer of ThermoGenesis and co-inventor of the allowed patent. “In clinical trials, CAR-T immunotherapies continue to show unprecedented results where currently available treatments have failed, but the delivery of CAR-T represents a significant departure from legacy biopharmaceutical business models. We are eager to leverage X-BACS to make these expensive and time-consuming treatments more broadly available to patients in need.”

The X-BACS technology employs microscopic bubbles to isolate a specific cell type from a complex mixture of cells, such as blood. These microbubbles bear antibodies on their surface, enabling them to bind specifically to a single desired target cell type. When coated with microbubbles, the target cells float to the top of the host liquid, while non-target cells sink to the bottom – a process that can be accelerated by centrifugation. Subsequent collection of the floating target cell layer and release of the cells from their microbubbles provides a highly-purified preparation of just the cells of interest, with high recovery efficiency while retaining cell viability.

About Cesca Therapeutics Inc.
Cesca is a leading regenerative medicine company that develops, commercializes and markets a range of automated technologies for cell-based therapeutics. Its device division, ThermoGenesis, provides a full suite of solutions for automated clinical biobanking, point-of-care applications, and automation for immuno-oncology. Cesca is also leveraging its proprietary AutoXpress® technology platform to develop autologous stem cell-based therapies that address significant unmet needs in the vascular, cardiology and orthopedic markets.

Forward-Looking Statement
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. A more complete description of risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics’ forward-looking statements is set forth under the caption “Risk Factors” in Cesca Therapeutics’ annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.

Company Contact: Cesca Therapeutics Inc.
Wendy Samford
Cesca Therapeutics Inc.
916-858-5191
ir@cescatherapeutics.com

Investor Contact:
Rx Communications
Paula Schwartz
917-322-2216
pschwartz@rxir.com

 

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$CTMX & Amgen Announce Strategic Collaboration In Immuno-Oncology

Companies to Jointly Develop T-Cell Engaging Bispecific Probody

THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Oct. 3, 2017 — Amgen (NASDAQ:AMGN) and CytomX Therapeutics, Inc., (NASDAQ:CTMX) today announced that the companies have entered into a strategic collaboration in immuno-oncology. The companies will co-develop a CytomX Probody™ T-cell engaging bispecific against the Epidermal Growth Factor Receptor (EGFR), a highly validated oncology target expressed on multiple human cancer types. Probody T-cell engaging bispecifics are antibody constructs capable of directing cytotoxic T-cells in tumor microenvironments. In preclinical studies, CytomX’s Probody versions of EGFRxCD3 bispecific therapeutics induced tumor regressions and increased the therapeutic window for this high potential cancer target.

“Our collaboration with CytomX leverages Amgen’s development leadership in bispecifics and expands our immuno-oncology capabilities with an additional and complementary bispecific technology,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “EGFR is a particularly compelling target on which to employ the CytomX Probody platform given its potential to localize activity within tumors while limiting potential toxicity.”

“Probody-based T-cell engaging bispecific antibodies offer significant potential in treating cancers by employing localized therapeutic activity within tumor tissue,” said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. “Through this collaboration, we are positioned to combine Amgen’s industry-leading expertise in leveraging bispecifics to activate a patient’s immune-system with CytomX’s ability to design potent new therapies that exploit unique conditions in the tumor microenvironment. Development of Probody-based T-cell engaging bispecifics further validates the broad applicability of the Probody platform in addressing unmet needs in oncology.”

Under the terms of the agreement, Amgen and CytomX will co-develop a Probody T-cell engaging bispecific against EGFRxCD3 with CytomX leading early development. Amgen will lead later development and commercialization with global late-stage development costs shared between the two companies. Amgen will make an upfront payment of $40 million and purchase $20 million of CytomX common stock. CytomX will be eligible to receive up to $455 million in development, regulatory and commercial milestones for the EGFR program. Amgen will lead global commercial activities with CytomX able to opt into a profit share in the U.S. and receive tiered, double-digit royalties on net product sales outside of the U.S.

Amgen will also receive exclusive worldwide rights to develop and commercialize up to three additional, undisclosed targets. Should Amgen ultimately pursue all of these targets, CytomX will be eligible to receive up to $950 million in additional upfront and milestone payments and high single-digit to mid-double digit royalty payments on any resulting products. CytomX will also receive the rights from Amgen to an undisclosed preclinical T-cell engaging bispecific program; Amgen is eligible to receive milestones and royalty payments on any resulting products from this CytomX program.

Conference Call / Webcast Information
CytomX will host a teleconference today at 5 p.m. ET to discuss the strategic collaboration. Sean McCarthy, D.Phil., president and chief executive officer at CytomX and Debanjan Ray, chief financial officer at CytomX, will lead the teleconference. Interested parties may access the live audio webcast of the teleconference through the Investor and News page of CytomX’s website at http://ir.cytomx.com or by dialing (877) 809-6037 and using the passcode 94163867. A replay will be available on the CytomX website or by dialing (855) 859-2056 and using the passcode 94163867.  The replay will be available from October 3, 2017, at 8:00 p.m. ET until October 10, 2017, at 8:00 p.m. ET.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

About CytomX Therapeutics
CytomX Therapeutics is a clinical-stage biopharmaceutical company with a deep and differentiated oncology pipeline of investigational Probody™ therapeutics. Probody therapeutics are designed to exploit unique conditions of the tumor microenvironment to more effectively localize antibody binding and activity while limiting activity in healthy tissues. The Company’s pipeline includes proprietary cancer immunotherapies against clinically-validated targets, such as PD-L1, and first-in-class Probody drug conjugates against highly attractive targets, such as CD166 and CD71, which are considered to be inaccessible to conventional antibody drug conjugates due to their presence on healthy tissue. In addition to its wholly owned programs, CytomX has strategic collaborations with AbbVie, Bristol-Myers Squibb Company, Pfizer Inc., MD Anderson Cancer Center and ImmunoGen, Inc. For more information, visit www.cytomx.com or follow us on Twitter.

CytomX Therapeutics Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential safety and efficacy of products and to CytomX’s ability and the ability of its collaborative partners to develop and advance product candidates into and successfully complete clinical trials. The process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties. Collaborations with partners may not result in products, and milestone payments and royalties may not be received. Applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, collaborations, and other risks identified under the heading “Risk Factors” included in CytomX’s Quarterly Report on Form 10-Q filed with the SEC on August 7, 2017. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project.  Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. We are increasingly dependent on information technology systems, infrastructure and data security. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Kristen Neese, 805-313-8267 (media)
Arvind Sood, 805-447-1060 (investors)

CONTACT: Cytomx Media Contact:
Spectrum
Amir Khan
akhan@spectrumscience.com
212-899-9730

CytomX Investor Contact:
Trout Group
Pete Rahmer
prahmer@troutgroup.com
646-378-2973

Tuesday, October 3rd, 2017 Uncategorized Comments Off on $CTMX & Amgen Announce Strategic Collaboration In Immuno-Oncology

$MTBC Signs New talkEHR Customers in 42 States During First Month of Rollout

SOMERSET, N.J., Oct. 03, 2017 — MTBC (NASDAQ:MTBC) (NASDAQ:MTBCP), a leading provider of mHealth and cloud-based clinical and practice management solutions, today announced the successful full launch of its next-generation, voice-enabled electronic health records (EHR) solution, talkEHR™.

“The response from physicians during the first 30 days of our full rollout is overwhelming and confirms our belief in the market opportunity for a free, voice and AI driven EHR such as talkEHR,” said Karl Johnson, MTBC SVP Sales and Marketing. He continued, “We’re very pleased to have already signed new talkEHR clients representing 30 unique specialties, spanning across 42 states plus Guam and Puerto Rico.  talkEHR is a phenomenal addition to our fully integrated, industry leading, cloud-based and mobile platform and we expect it to play an important role as we continue to expand our customer base.”

talkEHR – MTBC’s next generation SaaS EHR solution – is designed to utilize natural language processing and artificial intelligence to automate key components of patient charting and reduce manual tasks and errors. It is an all-in-one, easy-to-use and easy-to-implement clinical platform that also includes value added solutions such as electronic claims submission, electronic prescriptions, appointment scheduling, automated patient reminders and quality incentive support.

talkEHR is being offered completely free of cost to all US healthcare providers.  talkEHR users can also upgrade to a full-service package that includes end-to-end medical billing for 2.95% of a physician’s collections.

Healthcare providers interested in learning more can visit www.talkEHR.com.

About MTBC

MTBC is a healthcare information technology company that provides a fully integrated suite of proprietary web-based solutions, together with related business services, to healthcare providers throughout the United States. Our integrated Software-as-a-Service (SaaS) platform helps our customers increase revenues, streamline workflows and make better business and clinical decisions, while reducing administrative burdens and operating costs. MTBC’s common stock trades on the NASDAQ Capital Market under the ticker symbol “MTBC,” and its Series A Preferred Stock trades on the NASDAQ Capital Market under the ticker symbol “MTBCP.”

For additional information, please visit our website at www.mtbc.com.

Follow MTBC on TWITTER, LINKEDIN and FACEBOOK.

talkEHR™ is a trademark of MTBC.

Forward-Looking Statements
This press release contains various forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended. These statements relate to anticipated future events, future results of operations or future financial performance. In some cases, you can identify forward-looking statements by terminology such as “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “goals”, “intend”, “likely”, “may”, “plan”, “potential”, “predict”, “project”, “will” or the negative of these terms or other similar terms and phrases.

Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. Forward-looking statements in this press release include, without limitation, statements reflecting management’s expectations for future financial performance and operating expenditures, expected growth, profitability and business outlook, increased sales and marketing expenses, and the expected results from the integration of our acquisitions.

Forward-looking statements are only current predictions and are subject to known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements. These factors include, but are not limited to, the company’s ability to manage growth; integrate acquisitions; effectively migrate and keep newly acquired customers and other important risks and uncertainties referenced and discussed under the heading titled “Risk Factors” in the Company’s filings with the Securities and Exchange Commission. Although we believe that the expectations reflected in the forward-looking statements contained in this press release are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

The statements in this press release are made as of the date of this press release, even if subsequently made available by the Company on its website or otherwise. The Company does not assume any obligations to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made.

SOURCE MTBC

Company and Investor Contact:
Bill Korn
Chief Financial Officer
Medical Transcription Billing, Corp.
bkorn@mtbc.com
(732) 873-5133
Tuesday, October 3rd, 2017 Uncategorized Comments Off on $MTBC Signs New talkEHR Customers in 42 States During First Month of Rollout

$CLSN Clinical Data from OVATION Study at AACR Conference on Ovarian Cancer

100% Disease Control; 86% Objective Response Rate and 86% R0 & R1 Surgical Resection Rate in All Patients Treated in Four Dose-Escalating Cohorts

Clear Evidence of Biological Activity Including Dose Dependent Increases in Inflammatory Cytokines (IL-12 and IFN-g), Decreases in VEGF Levels and No Dose Limiting Toxicities

Expert Advisory Board Endorses Randomized Phase II in Newly Diagnosed Stage III and IV Ovarian Cancer

LAWRENCEVILLE, N.J., Oct. 03, 2017 — Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced final clinical and translational research data from its OVATION Study, a Phase Ib dose escalating clinical trial combining GEN-1, the Company’s DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced Stage III/IV ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery.  GEN-1 is an IL-12 DNA plasmid vector formulated as a nanoparticle in a non-viral delivery system to cause the sustained local production and secretion of the Interleukin-12 (IL-12) protein loco-regionally to the tumor site.   

The Company updated the translational data from the OVATION Study in a poster presentation at the American Association of Cancer Research (AACR) Special Conference entitled “Addressing Critical Questions in Ovarian Cancer Research and Treatment” at the Wyndham Grand Pittsburgh Downtown in Pittsburgh, PA.  The poster entitled “Immunological changes following intraperitoneal administration of a formulated IL-12 plasmid in combination with neoadjuvant chemotherapy in newly diagnosed advanced ovarian cancer patients,” was presented by Dr. Khursheed Anwer, Celsion’s executive vice president and chief scientific officer in a poster session on Monday, October 2, 2017 from 6:00 PM to 8:30 PM.

The Company also held an Advisory Board Meeting on September 27, 2017 with the clinical investigators and scientific experts including those from Roswell Park Cancer Institute, Vanderbilt University Medical School, and M.D. Anderson Cancer Center to review and finalize clinical, translational research and safety data from the OVATION Study in order to determine the next steps forward for this exciting new immunotherapy.  With the endorsement and recommendations from the Advisory Board, the Company expects to file a next phase protocol with FDA later this year.

Translational Research Data

Key translational research findings from all evaluable patients are consistent with the earlier reports from partial analysis of the data and are summarized below:

  • The intraperitoneal treatment of GEN-1 in conjunction with neoadjuvant chemotherapy resulted in dose dependent increases in IL-12 and Interferon-gamma (IFN-g) levels that were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients’ systemic circulation. These and other post-treatment changes including decreases in VEGF levels in peritoneal fluid are consistent with an IL-12 based immune mechanism.
  • Consistent with the previous partial reports, the effects observed in the IHC analysis were pronounced decreases in the density of immunosuppressive T-cell signals (Foxp3, PD-1, PDL-1, IDO-1) and increases in CD8+ cells in the tumor microenvironment.
  • The ratio of CD8+ cells to immunosuppressive cells was increased in approximately 75% of patients suggesting an overall shift in the tumor microenvironment from immunosuppressive to pro-immune stimulatory following treatment with GEN-1.  An increase in CD8+ to immunosuppressive T-cell populations is a leading indicator and believed to be a good predictor of improved overall survival.
  • Analysis of peritoneal fluid by cell sorting, not reported before, shows treatment-related decrease in the percentage of immunosuppressive T-cell (Foxp3+), which is consistent with the reduction of Foxp3+ T-cells in the primary tumor tissue, and a shift in tumor naïve CD8+ cell population to more efficient tumor killing memory effector CD8+ cells.

These translational research findings demonstrate that GEN-1 in ovarian cancer patients is biologically active and creates a shift in the primary tumor and in the surrounding tumor environment in the peritoneal cavity that promotes a pro-immune T-cell population dynamic and conversion of tumor naïve T-cell into cytotoxic effector T-cells in the tumor microenvironment.

“These distinct immunological changes in the local disease environment are likely to translate into clinical benefit and warrant the continued development of our GEN-1 IL-12 immunotherapy as a potential adjuvant, in both first and second-line ovarian cancer,” said Dr. Kunle Odunsi, Deputy Director, Chair of Gynecologic Oncology and Center for Immunotherapy Executive Director at Roswell Park Cancer Institute. “Furthermore, pro-immune changes in the tumor microenvironment appear to support research combining GEN-1 with other exciting immuno-oncology therapies including adaptive T-cell and check point inhibitors.”

Clinical Data

Celsion also reported highly encouraging clinical data from the first fourteen patients who have completed treatment in the OVATION Study.  GEN-1 plus standard chemotherapy produced positive clinical results, with no dose limiting toxicities and promising dose dependent efficacy signals which correlate well with successful surgical outcomes as summarized below:

  • Of the fourteen patients treated in the entire study, two (2) patients demonstrated a complete response, ten (10) patients demonstrated a partial response and two (2) patients demonstrated stable disease, as measured by RECIST criteria. This translates to a 100% disease control rate (“DCR”) and an 86% objective response rate (“ORR”).  Of the five patients treated in the highest dose cohort, there was a 100% objective response rate with one (1) complete response and four (4) partial responses.
  • Fourteen patients had successful resections of their tumors, with nine (9) patients (64%) having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed.   Seven out of eight (87%) patients in the highest two dose cohorts experienced a R0 surgical resection. All five patients treated at the highest dose cohort experienced a R0 surgical resection.
  • All patients experienced a clinically significant decrease in their CA-125 protein levels as of their most recent study visit. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells.
  • Of the eight patients who have received GEN-1 treatment over one year ago (cohort 1 – 3) and are being followed; only two patients’ cancer has progressed.  This compares favorably to the historical median progression free survival (PFS) of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer that undergo neoadjuvant chemotherapy followed by interval debulking surgery.  Of the remaining six patients who have been on the study for over one year, their average PFS as of September 30, 2017 is 18 months with the longest progression-free patient at 24 months.

“We have completed enrollment of our Phase Ib OVATION Study in newly diagnosed ovarian cancer patients to determine GEN-1’s clinical and biological activity in combination with standard chemotherapy.  The remarkable surgical outcomes for all patients completing the prescribed eight weekly treatments of GEN-1 reinforce our belief in the promise of GEN-1’s ability to work safely and effectively in advanced ovarian cancer,” said Dr. Nicholas Borys, Celsion’s senior vice president and chief medical officer. “The Advisory Board Meetings held in late September 2017 with our clinical investigators and scientific experts in immuno-oncology provided an important endorsement of our development program for this innovative immunotherapy for first line ovarian cancer.”

The poster presentation will be available on Celsion’s website under “News & Investors – Scientific Presentations.

OVATION Study Design

The Phase Ib trial was designed to evaluate weekly intraperitoneal dosing of GEN-1 in combination with neoadjuvant chemotherapy, the standard of care for patients newly diagnosed with ovarian cancer. Concurrently with neoadjuvant chemotherapy, enrolled patients will receive escalating weekly doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and 79mg/m² weekly for 8 treatments in total, with interval debulking surgery to follow. The regimen will primarily be evaluated for its safety and tolerability.

About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer, and recently completed a Phase Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer.

About Celsion Corporation

Celsion is a fully-integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. The Company’s lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer.  The pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers.  Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies. For more information on Celsion, visit our website: http://www.celsion.com. (CLSN-G1 CLSN-OV)

Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995.  Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time, and risk of failure of conducting clinical trials; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in Celsion’s periodic reports and prospectuses filed with the Securities and Exchange Commission.  Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

Celsion Investor Contact

Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com

Tuesday, October 3rd, 2017 Uncategorized Comments Off on $CLSN Clinical Data from OVATION Study at AACR Conference on Ovarian Cancer

$ABUS to Receive $116 Million Strategic Investment from Roivant Sciences

Cash to Provide Significant Support for Arbutus to Fund HBV R&D Pipeline
Roivant to Support Accelerating Development of Arbutus’ HBV Pipeline and Maximizing the Value of Arbutus’ LNP Assets

VANCOUVER, British Columbia and WARMINSTER, Pa., Oct. 02, 2017 — Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading hepatitis B virus (HBV) therapeutic solutions company, today announced that it has signed a share purchase agreement with Roivant Sciences for the sale of convertible preferred shares (“Preferred Shares”) for gross proceeds of $116.4 million. Arbutus intends to use the proceeds to further develop and advance its clinical and preclinical HBV pipeline programs.

“We are pleased to receive this strategic investment from Roivant, Arbutus’ largest existing shareholder and a company known for its innovative approach to drug development,” said Dr. Mark J. Murray, President and CEO of Arbutus. “This financing meaningfully extends Arbutus’ operating runway to enable the generation of important clinical data for multiple pipeline programs. I look forward to leveraging Roivant’s infrastructure and capabilities to complement Arbutus and to accelerate our mission of developing a curative therapy for HBV.”

“I am pleased with the progress that Arbutus has made over the past two years, but I believe that the company’s most exciting days are ahead of it,” said Vivek Ramaswamy, Founder and CEO of Roivant and Chairman of Arbutus. “HBV is one of the most devastating diseases impacting patients globally, and a cure remains elusive. Roivant is proud to support Arbutus in taking on this bold mission through an expanded relationship. We look forward to providing strategic and operational support to Arbutus, while also maximizing the value of Arbutus’ other assets, including through potential additional investment where required.”

Following the close of this transaction, Roivant and Arbutus intend to explore working together to leverage Roivant’s infrastructure to accelerate more efficient development of Arbutus’ HBV drug pipeline. Arbutus also anticipates working with Roivant to expand its geographic footprint in HBV drug development and to maximize the value of Arbutus’ non-HBV assets, including Arbutus’ LNP and GalNAc platforms for the delivery of novel therapeutic modalities including RNA interference, mRNA, and gene editing technologies.

Roivant’s investment will take the form of preferred shares which will be convertible into common shares at a conversion price of $7.13 per share (a 15% premium to the closing stock price on September 29, 2017). The preferred shares plus an amount equal to 8.75% per annum compounded annually will be subject to mandatory conversion into common shares on the fourth anniversary of the closing date. Roivant has agreed to a four year lock-up period for this investment and its existing holdings in Arbutus. The initial investment of $50.0 million is expected to close shortly, and the remaining amount of $66.4 million is expected to close promptly upon satisfaction of customary closing conditions including regulatory and shareholder approvals, as applicable, under applicable Canadian securities law.

Please refer to the Company’s Form 8-K to be filed with the Securities and Exchange Commission for further details of the terms of the convertible preferred shares.

About Chronic Hepatitis B
Chronic Hepatitis B (cHBV) is a serious infection of the liver caused by the hepatitis B virus (HBV) and is considered a major global health problem. cHBV infection can cause chronic liver disease, which increases a patient’s risk of death from liver cirrhosis and liver cancer. Estimates from the Centers for Disease Control and Prevention (CDC) indicate that up to 350 million people globally may be chronically infected with HBV. According to the World Health Organization (WHO), more than 780,000 people die every year due to HBV. Most currently available therapies aim to suppress viral replication but do not lead to a cure in the overwhelming majority of patients.

Advisors
MTS Securities, LLC is serving financial advisor for the Special Committee of the Board of Directors of Arbutus. Arbutus’ Canadian legal advisor is Farris, Vaughan, Wills & Murphy LLP, with Dorsey & Whitney LLP as Arbutus’ US legal advisor. Roivant’s Canadian legal advisor is Lawson Lundell LLP, with White & Case LLP as Roivant’s US legal advisor.

About Arbutus Biopharma
Arbutus Biopharma Corporation is a biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic HBV infection. Arbutus is headquartered in Vancouver, BC, and has facilities in Warminster, PA. For more information, please visit www.arbutusbio.com.

About Roivant Sciences
Roivant is dedicated to transformative innovation in healthcare. Roivant focuses on realizing the full potential of promising biomedical research by developing and commercializing novel therapies across diverse therapeutic areas. Roivant partners with innovative biopharmaceutical companies and academic institutions to ensure that important medicines are rapidly developed and delivered to patients.

Roivant advances its drug pipelines through wholly- or majority-owned subsidiary companies, including Axovant (neurology), Myovant (women’s health and endocrine diseases), Dermavant (dermatology), Enzyvant (rare diseases), and Urovant (urology). Roivant also pursues its mission by incubating and launching innovative healthcare companies operating outside of traditional biopharmaceutical development. Roivant’s long-range mission is to reduce the time and cost of developing and delivering new medicines for patients. For more information, please visit www.roivant.com.

THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER TO SELL OR THE SOLICITATION OF AN OFFER TO BUY ANY SECURITY. THE PREFERRED SHARES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR APPLICABLE STATE SECURITIES LAWS AND MAY NOT BE OFFERED OR SOLD IN THE UNITED STATES OR ANY STATE THEREOF ABSENT REGISTRATION UNDER THE SECURITIES ACT AND APPLICABLE STATE SECURITIES LAWS OR AN APPLICABLE EXEMPTION FROM REGISTRATION REQUIREMENTS.

Proxy Statement Information

IN CONNECTION WITH THE TRANSACTION, ARBUTUS BIOPHARMA CORPORATION WILL FILE A PROXY STATEMENT AND OTHER DOCUMENTS WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (SEC). INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ THE DEFINITIVE PROXY STATEMENT WHEN IT BECOMES AVAILABLE BECAUSE IT WILL CONTAIN IMPORTANT INFORMATION REGARDING THE TRANSACTION.

A definitive proxy statement will be sent or made available to stockholders of Arbutus Biopharma Corporation seeking their approval of the transaction as described above. Investors and security holders may obtain a free copy of the definitive proxy statement (when available) and other documents filed by Arbutus Biopharma Corporation with the SEC at the SEC’s website, www.sec.gov. The definitive proxy statement (when available) and such other documents relating to Arbutus Biopharma Corporation may also be obtained free of charge by directing a request to Artbutus Biopharma Corporation, Investor Relations,  100 – 8900 Glenlyon Parkway, Burnaby, British Columbia, Canada V5J 5J8, Telephone: 604.419.3200 or from Arbutus Biopharma Corporation’s website, www.arbutus.com.

Arbutus Biopharma Corporation, Roivant Sciences Ltd. and their respective directors and executive officers may, under the rules of the SEC, be deemed to be “participants” in the solicitation of proxies in connection with the proposed transaction. Information concerning the interests of the persons who may be “participants” in the solicitation will be set forth in the proxy statement when it becomes available.

Forward-Looking Statements and Information
This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements in this press release include statements about the $120 strategic investment from Roivant; Arbutus’ operating runway to fund HBV R&D pipeline (including genereation of clinical data for multiple Arbutus pipeline progrants); the acceperation of developing a curative therapy for HBV; Roivant support to accelerate development of Arbutus’ pipeline and maximizing value of Arbutus’ non-HBV assets (including Arbutus’ LNP and GalNAc platforms); additional Roivant investments; shareholder approval for the Roivant investment; closing of the Roivant investment; and discovering, developing and commercializing a cure for patients suffering from chronic HBV infection.

With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: meeting the conditions to close the Roivant investment (including shareholder approval); cash runway requirements to fund the HBV R&D pipeline; continued Roivant support; the effectiveness and timeliness of preclinical and clinical trials, and the usefulness of the data; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.

Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: the Roivant investment may not close on the terms and timing currently anticipated, or at all; the proceeds of the Roivant investment may not be sufficient to fund Arbutus’ programs, or may not result in the advancement of Arbutu’s programs; Arbutus’ shareholders may not approve the Roivant investment; anticipated pre-clinical and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; and market shifts may require a change in strategic focus.

A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K and Arbutus’ continuous disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

Contact Information

Investors
Adam Cutler
Senior Vice President, Corporate Affairs
Phone: 604-419-3200
Email: acutler@arbutusbio.com

Tiffany Tolmie
Manager, Investor Relations
Phone: 604-419-3200
Email: ttolmie@arbutusbio.com

Media
David Schull
Russo Partners
Phone: 858-717-2310
Email: david.schull@russopartnersllc.com

Monday, October 2nd, 2017 Uncategorized Comments Off on $ABUS to Receive $116 Million Strategic Investment from Roivant Sciences

$RIGL Provides Update on FDA Review of Fostamatinib for ITP

SOUTH SAN FRANCISCO, Calif., Oct. 2, 2017  — Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that during the company’s mid-cycle meeting with the U.S. Food and Drug Administration (FDA) the FDA indicated that, at this point, it is not planning to hold an Oncology Drugs Advisory Committee (ODAC) meeting to discuss the New Drug Application (NDA) for fostamatinib in patients with chronic or persistent immune thrombocytopenia (ITP).  Additionally, the FDA indicated that it anticipates meeting the Prescription Drug User Fee Act (PDUFA) action date for the application review, which is April 17, 2018. In an earlier communication, the FDA had conditionally approved the proprietary name TavalisseTM.

“Since we submitted our NDA this spring, we have worked collaboratively with the FDA to answer routine questions as they arise,” said Anne-Marie Duliege, MD, executive vice president and chief medical officer of Rigel. “Our positive interactions with the FDA, including their customary biomedical monitoring (BIMO) inspections at our facilities and clinical sites, are in-line with our expectations and have progressed well. We will continue to work closely with the agency and remain committed to bringing fostamatinib to patients with ITP who are in need of new treatment options.”

About ITP
In patients with ITP, the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing.  Common symptoms of ITP are excessive bruising and bleeding.  People suffering with chronic ITP may live with increased risk of severe bleeding events that can result in serious medical complication, or even death.  Currently approved therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients derive a benefit from existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematological disorders, cancer and rare diseases. Rigel’s pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company’s current clinical programs include clinical trials of fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in a number of indications. Rigel has submitted and the FDA has accepted for review, an NDA for fostamatinib in patients with chronic or persistent immune thrombocytopenia (ITP). In addition, Rigel has product candidates in development with partners BerGenBio AS, Daiichi Sankyo and Aclaris Therapeutics.

Forward Looking Statements
This release contains forward-looking statements relating to, among other things, the FDA’s indication that it is not planning to hold an ODAC meeting to discuss the NDA for fostamatinib in patients with chronic or persistent ITP, the timing of the FDA’s application review of our NDA submission and Rigel’s belief that fostamatinib may be an attractive alternative for patients with ITP.  Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “planned,” “will,” “may,” “expect,” “hope” and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel’s 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, the FDA may later decide to hold an ODAC meeting; delays in the FDA’s review of the submitted NDA by the PDUFA action date; the FDA may interpret Rigel’s findings differently, which could result in the FDA not approving any submitted NDA; the availability of resources to develop Rigel’s product candidates; Rigel’s need for additional capital in the future to sufficiently fund Rigel’s operations and research; the uncertain timing of completion of and the success of clinical studies; market competition, risks associated with and Rigel’s dependence on Rigel’s corporate partnerships; as well as other risks detailed from time to time in Rigel’s reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2017. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

Contact: Raul Rodriguez
Phone: 650.624.1302
Email: invrel@rigel.com

Media Contact: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@inventivhealth.com

Monday, October 2nd, 2017 Uncategorized Comments Off on $RIGL Provides Update on FDA Review of Fostamatinib for ITP

$VICL Announces Antifungal VL-2397 Eligible for Limited Use Indication Approval by FDA

Vical plans to initiate Phase 2 trial of VL-2397 for the treatment of invasive aspergillosis in 4Q 2017

Management to host conference call on October 3rd at 12:00 pm ET to discuss the Phase 2 trial design

SAN DIEGO, Oct. 02, 2017  — Vical Incorporated (Nasdaq:VICL) today announced that the U.S. Food and Drug Administration (FDA) has advised that Vical’s investigational antifungal VL‑2397 would be eligible for a Limited Use Indication (LUI) approval assuming a successful outcome of a single Phase 2 trial carried out in accordance with a protocol and statistical analysis plan consistent with the Agency’s advice. The final determination whether the drug is approvable will be made by FDA after review of all relevant data.

The LUI is a provision of the Limited Population Pathway (LPP) established under the 21st Century Cures Act of 2016. Vical plans to initiate a single Phase 2 trial for the treatment of invasive aspergillosis (IA) in acute leukemia patients and allogeneic hematopoietic cell transplant (HCT) recipients in the fourth quarter of 2017.

“The LPP will allow Vical to develop and commercialize VL-2397 on a potentially accelerated basis for a limited use indication,” said Vijay Samant, Vical’s President and CEO. “New antifungals with novel mechanisms of action are needed to address the urgent need in IA, particularly in patients who are intolerant to existing drugs and in patients infected by azole-resistant strains.”

Dr. Haran Schlamm, MD, Vical’s infectious disease consultant and former Pfizer Senior Medical Director responsible for Pfizer’s antifungal portfolio also commented, “The preclinical and clinical data to date for VL-2397 supports the profile of an ideal antifungal agent which must be fast acting, have minimal drug interactions, and a low risk for toxicity.”

The global Phase 2 trial will be a non-inferiority study comparing VL-2397 to standard of care treatment for IA. Approximately 200 acute leukemia patients and recipients of allogeneic HCT will be enrolled and randomized 2:1. The primary endpoint will be all-cause mortality (ACM) at 4 weeks with a key secondary endpoint of ACM at 6 weeks. Achieving LUI approval is contingent upon successfully meeting both endpoints.

In addition to interactions with the FDA, Vical has worked extensively with the Mycoses Study Group Education and Research Consortium (MSGERC) on the Phase 2 study design and preparations. MSGERC provides scientific and medical thought leadership for evidence-based medicine in the diagnoses, prevention, treatment and maintenance of patients at risk for or afflicted with invasive fungal infections.

Vical will conduct a conference call and webcast tomorrow, October 3, at noon Eastern Time, to discuss this announcement. The call and webcast are open on a listen-only basis to any interested parties. To listen to the conference call, dial in approximately ten minutes before the scheduled call to (913)312-1496 (preferred), or (888)417-2254 (toll-free), and reference confirmation code 9759530. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719)457-0820 (preferred) or (888)203-1112 (toll-free) and enter replay passcode 9759530. The webcast will also be available live and archived through the events page at www.vical.com. For further information, contact Vical’s Investor Relations department by phone at (858)646-1127 or by e-mail at ir@vical.com.

About the Limited Population Pathway
The LPP is designed to streamline development programs for certain antimicrobial agents intended to treat specific groups of patients who are not well addressed by available therapies for their serious or life-threatening infections. Under this pathway, the drug can be used to treat only the limited population for which it is approved while additional trials are conducted to establish safety and effectiveness for broader indications. Standards for a new drug application must be met for LUI approval.  In the case of VL‑2397, the limited population approval would be for patients for whom alternative regimens are not available to treat their invasive aspergillosis. A Phase 3 trial would be required to support full approval of VL-2397 for the treatment of IA in a broader population.

About VL-2397
VL-2397 is Vical’s novel antifungal compound that was licensed from Astellas Pharma in 2015. VL-2397 was isolated from a leaf litter fungus collected in a Malaysian national park and represents the first agent in a potentially new class of antifungal drugs. The FDA has granted Vical Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designations for VL-2397 in the treatment of invasive aspergillosis.

About Invasive Aspergillosis
Invasive aspergillosis is a life-threatening infection that typically affects immunocompromised patients, including those with acute leukemia and recipients of allogeneic HCT or lung transplants. Infection typically starts in the lungs and rapidly disseminates to other tissues. More than 200,000 cases of IA are diagnosed annually worldwide.

About Vical
Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented DNA delivery technologies and other therapeutic approaches. Additional information on Vical is available at www.vical.com.

Forward-Looking Statements
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include anticipated developments in clinical programs, including the plans, timing of initiation, and enrollment for clinical trials. Risks and uncertainties include whether Vical or others will continue development of  VL-2397; the risk that the FDA does not grant LUI approval of VL-2397 following the results of Vical’s planned Phase 2 clinical trial; whether Vical  will be able to obtain regulatory allowances or guidance necessary to proceed with proposed clinical trials or implement anticipated clinical trial designs; whether on-going or planned clinical trials will be initiated or completed on the timelines Vical currently expects; whether any product candidates will be shown to be safe and efficacious in clinical trials; the fact that results from the planned Phase 2 clinical trial of VL-2397 may be inconsistent with the results from prior preclinical studies and clinical trials; whether Vical will have access to sufficient capital to fund its planned development activities; whether Vical will seek or gain approval to market any product candidates; and additional risks set forth in the Company’s filings with the Securities and Exchange Commission. These forward-looking statements represent the Company’s judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.

Contact:
Andrew Hopkins
(858) 646-1127
Website:  www.vical.com
Monday, October 2nd, 2017 Uncategorized Comments Off on $VICL Announces Antifungal VL-2397 Eligible for Limited Use Indication Approval by FDA

$ATEC Accelerates Business Transformation w/ Spine-Experienced Leadership Appointments

  • Patrick Miles to lead company as Executive Chairman
  • Quentin Blackford appointed to Board of Directors
  • Miles and Blackford to make equity investments totaling more than $3.5 million

CARLSBAD, Calif., Oct. 02, 2017 — Alphatec Holdings, Inc. (Nasdaq:ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, announced that Patrick Miles has been appointed as Executive Chairman and Quentin Blackford as a member of the Board, effective today.  Miles will lead the organization, and Terry Rich, Alphatec‘s Chief Executive Officer, will continue in his role, reporting to Miles. In conjunction with these appointments, Miles and Blackford are personally investing in Alphatec common stock in an aggregate amount in excess of $3.5 million.

“Today’s announcement marks continued execution of our vision to reposition Alphatec as the most respected, fastest-growing company in U.S. spine,” said Mr. Rich. “Pat and Quentin have decades of industry experience and well-deserved reputations that speak for themselves. Their personal financial commitments are a powerful testament to their personal commitments to increase shareholder value; a conviction that has been expressed by our entire leadership team.”

Rich continued, “Pat is a globally recognized spine visionary and a proven driver of market-share expansion.  His passionate belief that our most important business is in the operating room aligns absolutely with the Alphatec value system, and positions him extraordinarily well to lead the organization. I have great confidence that Pat’s influence on daily operations, product development decisions, and surgeon engagement will accelerate the business transformation that we are driving. I look forward to partnering with him to advance Alphatec’s growth trajectory by executing our mission to improve patient lives.”

Miles brings a wealth of orthopedics and innovation expertise, with over 25 years of industry experience, and as a named inventor on close to 100 industry patents. In his capacity as Executive Chairman, he will be fully engaged, focusing primarily on further defining and implementing Alphatec’s strategic initiatives, expanding and fortifying the Company’s relationships with surgeon customers, and leading Alphatec’s new technology development.  Miles joins Alphatec following a 17-year tenure at NuVasive, Inc., where he was a central figure in the company’s expansion from a start-up business to a global spine corporation with close to $1 billion in revenues.  He most recently served as NuVasive’s Vice Chairman; prior to that, he was its President and Chief Operating Officer, and President of Global Products and Services.  Before joining NuVasive, Mr. Miles held sales and marketing roles with Medtronic Sofamor Danek and Smith & Nephew.

“I am thrilled to work closely with Terry once again to reposition Alphatec as the next great growth story in spine. Together, we share roughly 50 years of spine and orthopedics expertise – a level unrivaled in spine leadership – which will guide us in determining how best to serve this market.  I look forward to driving toward improved surgical outcomes and market share expansion,” said Miles. “Alphatec has a broad and impressive product portfolio, improving surgeon engagement, and great access to hospitals; all of which position the Company exceptionally well to take market share in today’s environment. This is a high-caliber team driving an important mission, and I feel incredibly lucky to be a part of it.”

Blackford joins the Alphatec Board of Directors with 17 years of experience in the medical device industry.  He is currently Executive Vice President and Chief Financial Officer of DexCom, Inc. Prior to joining Dexcom, Blackford was Executive Vice President, Chief Financial Officer, Head of Strategy and Corporate Integrity for NuVasive.  In that role, he led the Finance, Strategy and Corporate Development, Compliance and Regulatory functions. Before joining NuVasive in 2009, Mr. Blackford held various leadership roles with Zimmer Holdings, Inc., including Director of Finance and Controller for Zimmer Dental.

“Alphatec has assembled an exceptional team of spine industry leaders who are already transforming the business.  I am excited to help shape the Company’s strategic direction as Alphatec evolves into a leading spine player,” said Blackford.

In connection with these appointments, Mortimer Berkowitz III, Alphatec’s Chairman since December 2016, will transition into the role of Lead Director. In addition, Stephen O’Neil has resigned from his position as a member of the Company’s Board of Directors, effective immediately.  Mr. Rich will also remain a key member of the Alphatec Board.

Mr. Berkowitz, said, “I would like to thank Steve for his 12 years of dedicated service to Alphatec, and for being a trusted colleague and counselor. I also enthusiastically welcome Pat and Quentin to the Alphatec family, and thank Terry for his efforts in bringing them aboard. They share the optimism and the vision that we have for the future of this Company, and I look forward to serving with them in the Lead Director role.”

Inducement Award
As an inducement to accepting employment with the Company, and in accordance with applicable NASDAQ listing requirements, the Board of Directors has also approved an award to Mr. Miles of 1,000,000 restricted stock units (RSUs).

The RSUs will be granted following registration of the common stock underlying the RSUs and will vest in equal annual installments on each of the first three anniversaries of Mr. Miles’ date of employment if he remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs will fully vest upon a change in control of Alphatec.

The Board approved an amendment to Alphatec’s 2016 Employment Inducement Award Plan to increase the shares reserved for issuance thereunder by 1 million shares, effective October 2, 2017.

Equity Investments in Alphatec Common Shares
Mr. Miles has agreed to purchase 1.3 million shares of common stock and Mr. Blackford has agreed to purchase at least 220,000 shares of common stock and up to 440,000 shares of common stock, all at a purchase price of $2.26 per share (the consolidated closing bid price of Alphatec common shares on September 29, 2017), for gross proceeds to the Company of between $3.5 million and $4 million. The share purchases are expected to close on or before January 1, 2018. In connection with his purchase of Alphatec common stock, at the closing, Mr. Miles will also receive a five-year warrant to purchase up to 1.3 million shares of common stock at a purchase price of $5.00 per share which, if exercised, will generate additional gross proceeds to the Company of $6.6 million.

About Alphatec Holdings, Inc.
Alphatec Holdings, Inc., through its wholly owned subsidiary Alphatec Spine, Inc., is a medical device company that designs, develops, and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities, and trauma. The Company’s mission is to improve lives by providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. The Company markets its products in the U.S. via independent sales agents and a direct sales force.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The Company cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include the references to the Company’s strategy in significantly repositioning the Alphatec brand and turning the Company into a growth organization.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  the uncertainty of success in developing new products or products currently in the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and current reports, filed with the Securities and Exchange Commission. Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

Investor/Media Contact:
Zack Kubow
The Ruth Group
(646) 536-7000
alphatec@theruthgroup.com

Company Contact:
Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.
(760) 431-9286
Investorrelations@alphatecspine.com

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$ECYT Exclusive Worldwide License, Phase 3-Ready PSMA-Targeted Prostate Cancer Therapy

– Transformational Transaction Provides Endocyte with the Most Advanced Targeted Radioligand Therapy in Development for Prostate Cancer, Addressing a Greater than $1 Billion Market Opportunity –

–  High Response Rates Demonstrated in Late Stage Prostate Cancer Patients in Clinical Data Presented at Recent European Society for Medical Oncology –

–  Endocyte to Focus Resources on Phase 3 Registration Trial Planned to Initiate in First Half 2018 –

– Investigator Initiated Trials Intended to Support Registration and Provide Ongoing Data Assessments –

– Conference Call Today at 8:30 a.m. EDT –

WEST LAFAYETTE, Ind., Oct. 02, 2017  — Endocyte, Inc. (NASDAQ Global Market:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment,  today announced the completion of an exclusive worldwide license of PSMA-617 from ABX GmbH. Endocyte intends to move quickly into Phase 3 development of 177Lu-PSMA-617, a radioligand therapeutic (RLT) that targets the prostate-specific membrane antigen (PSMA), present in approximately 80% of patients with metastatic castration-resistant prostate cancer (mCRPC).

177Lu-PSMA-617 delivers the short-range beta-emitting radioactive isotope lutetium (177Lu) selectively to tumor cells while by-passing non-PSMA-expressing healthy cells with encouraging efficacy and safety results. As highlighted in roughly 20 peer reviewed publications of studies in the post-chemotherapy compassionate use setting, 177Lu-PSMA-617 has consistently demonstrated a PSA response (defined as greater than 50% decline from baseline) in 40% to 60% of patients, and a RECIST response rate in soft tissue disease of between 40% and 50%.

“This transaction is transformational to Endocyte, accelerating our path to commercialization. 177Lu-PSMA-617 has the potential to be the first-in-class RLT to address both bone and soft tissue disease, and it is profoundly important to the many patients suffering from mCRPC,” said Mike Sherman, president and CEO of Endocyte. “Our experience with PSMA targeting and companion imaging development, in addition to our relationships with distinguished prostate cancer investigators from around the world, uniquely position Endocyte to lead this therapy to registration. We intend to seek regulatory approval to initiate a Phase 3 registration trial of 177Lu-PSMA-617 in early 2018. By focusing the company’s resources on the execution of this program, we project trial completion as early as 2020.”

Mr. Sherman continued, “Endocyte remains strongly committed to careful expense management and maintaining a strong balance sheet. With the exception of a very targeted effort to generate proof-of-concept data for our CAR T-cell program, we will focus our resources on the development of 177Lu-PSMA-617. We will explore out-licensing opportunities for all other development programs.”

“Despite advances in the last decade that slow the progression of prostate cancer, once metastasized it is nearly always lethal, leading to 300,000 worldwide deaths annually. 177Lu-PSMA-617 has demonstrated the most compelling activity of any drug currently in development for these post-chemotherapy patients,” said Alison Armour, chief medical officer.

PSMA-617 was developed at DKFZ (German Cancer Research Center) and University Hospital Heidelberg and exclusively licensed to ABX GmbH in Germany for early clinical development. As a result of the enthusiasm of physician investigators and patients, the investigational therapy has been evaluated in hundreds of patients through both compassionate use studies and prospective trials.

“The data generated thus far have created significant enthusiasm for 177Lu-PSMA-617. PSMA is a promising target in prostate cancer and radioligand therapy may be the best application for this target,” said Michael Morris, MD, associate professor, Genitourinary Oncology, Memorial Sloan Kettering Cancer Center. “Particularly where disease has become resistant to current therapies, there is a tremendous need for new approaches and I look forward to working with Endocyte to investigate this innovative, first-in-class therapy for prostate cancer patients.”

Clinical Data Presented at European Society for Medical Oncology (ESMO)

Dr. Michael Hofman of the Peter MacCallum Cancer Center in Melbourne, Australia presented the results of an open-label, single-arm, non-randomized pilot study of 177Lu-PSMA-617 in September 2017, at the European Society for Medical Oncology (ESMO) Congress. Thirty mCRPC patients were treated with up to four cycles of 4-8 GBq. Primary endpoints included safety and efficacy as defined by PSA response, quality of life, and imaging response.

The results showed a remarkable 57% PSA response rate (>50% reduction) and 71% interim response rate in soft tissue lesions (as measured by RECIST criteria) in patients who had previously failed such conventional therapies as docetaxel, cabazitaxel, enzalutamide and abiraterone. Median overall survival was 12.7 months. The drug was well-tolerated, with a low rate of adverse effects and no renal toxicity. Significantly improved quality of life scores and reduction in pain scores were recorded in 37% and 43% of patients, respectively. This trial has subsequently been expanded to 50 subjects from the original 30, with updated results expected to be presented in 2018.

Transaction Terms

Under the terms of the agreement, Endocyte has exclusive worldwide rights to develop and commercialize PSMA-617. Endocyte has made an upfront payment of $12 million to ABX. In addition, Endocyte issued 2 million shares of Endocyte common stock to ABX and issued a warrant for the purchase of up to 4 million additional shares of Endocyte common stock. ABX is eligible for regulatory and commercial milestones of up to $160 million, and tiered royalties beginning in the mid-teens.

Conference Call

Endocyte management will host a conference call today at 8:30 a.m. EDT.
U.S. and Canadian participants:  (877) 845-0711
International:                               (760) 298-5081

A live, listen-only webcast of the conference call may also be accessed by visiting the Investors & News section of the Endocyte website, www.endocyte.com.

The webcast will be recorded and available on the company’s website for 90 days following the call.

Website Information

Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the “Investors & News” section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the “Investors & News” section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.

About Endocyte

Endocyte is a biopharmaceutical company and leader in developing targeted therapies for the treatment of cancer. Endocyte uses drug conjugation technology to create novel therapeutics and companion imaging agents for personalized targeted therapies. The company’s agents actively target receptors that are over-expressed on diseased cells relative to healthy cells, such as prostate specific membrane antigen (PSMA) in prostate cancer. This targeted approach is designed to safely enable the delivery of highly potent drug payloads. The companion imaging agents are designed to identify patients whose disease over-expresses the target of the therapy and who are therefore more likely to benefit from treatment. For additional information, please visit Endocyte’s website at www.endocyte.com.

Forward Looking Statements

Certain of the statements made in this press release are forward looking, such as those, among others, relating to future spending, future cash balances, the timing of initiation and completion of clinical trials, estimates of the potential market opportunity for the company’s product candidates, and the company’s future development plans including those relating to the completion of pre-clinical development in preparation for possible future clinical trials. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the company or independent investigators may experience delays in the initiation of completion of clinical trials (whether caused by competition, adverse events, patient enrollment rates, shortage of clinical trial materials, regulatory issues or other factors); risks that data from prior clinical trials may not be indicative of subsequent clinical trial results; risks related to the safety and efficacy of the company’s product candidates; risks that early stage pre-clinical data may not be indicative of subsequent data when expanded to additional pre-clinical models or to subsequent clinical data; risks that evolving competitive activity and intellectual property landscape may impair the company’s ability to capture value for the technology; risks that expectations and estimates turn out to be incorrect, including estimates of the potential markets for the company’s product candidates, estimates of the capacity of manufacturing and other facilities required to support its product candidates, projected cash needs, and expected future revenues, operations, expenditures and cash position. More information about the risks and uncertainties faced by Endocyte, Inc. is contained in the company’s periodic reports filed with the Securities and Exchange Commission. Endocyte, Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Stephanie Ascher, Stern Investor Relations, Inc., (212) 362-1200, stephanie@sternir.com

Media Contact:
David Schull, Russo Partners, LLC., (212) 845-4271, david.schull@russopartnersllc.com

Monday, October 2nd, 2017 Uncategorized Comments Off on $ECYT Exclusive Worldwide License, Phase 3-Ready PSMA-Targeted Prostate Cancer Therapy

$CIIX Appoints Skin Care Veteran, Shanghai Beauty Influencer, Fannie Tang as Marketing Director

SAN GABRIEL, California, October 2, 2017  —

ChineseInvestors.com, Inc. (OTCQB: CIIX) (“CIIX” or the “Company”), the premier financial information website for Chinese-speaking investors, today announces that it has appointed Skin Care Industry veteran and Shanghai beauty influencer, Fannie (Chun Fang) Tang as Marketing Director of its wholly-owned foreign enterprise, CBD Biotechnology Co., Ltd. effective immediately. Ms. Tang will report directly to CBD Biotechnology’s CEO, Summer Yun, and will be responsible for developing and implementing branding strategies for CBD Biotechnology’s CBD Magic Hemp Series skin care line in China. With over 20 years’ experience in the industry, Tang was highlighted in the book entitled Shanghai Beauty 26 as a leading influencer in Shanghai’s beauty culture. Ms. Tang served as the CEO of L.D. Waxson Group’s China Division until it was acquired in 2012 by India’s third largest software services provider, Wipro Limited, for $144 million. L.D. Waxson, a leading skin care company with manufacturing facilities in China and Malaysia, and a strong footprint in Singapore, Malaysia, China, Taiwan, Hong Kong and Thailand, reported revenues of approximately $68m prior to its acquisition in 2012. It’s portfolio of brands included the skin care lines Bioessence and Ginvera, and Ebene, a popular healthcare brand.

“With over twenty years of marketing and branding experience in the skin care and cosmetics industry, I believe CBD Biotechnology is extremely fortunate to be working with Ms. Tang,” says Yun. “Ms. Tang’s concept of ‘Beauty Derives from Nature and Creation’ aligns with CBD Biotechnology’s vision to develop an innovative, natural skin care band. Moreover, Ms. Tang has proven success in the industry in this region. Through her efforts, we are confident that CBD Biotechnology will position itself to become a leader in China’s skin care industry.”

In September 2017, CBD Biotechnology completed the filing process with the China Food & Drug Administration for its first three products in the CBD Magic Hemp Series line, namely the CBDBIO TECH Brightening and Refreshing Moisturizer, the CBDBIO TECH Perfecting Shield Primer, and the CBDBIO TECH Peptide Collagen Solution, which are expected to be formally launched this month. The CBD Magic Hemp Series skin care line will be marketed through multiple sales channels, including online sales, app sales, and third party distribution relationships with online celebrities and market influencers.

“China can be a complex business culture to navigate,” says ChineseInvestors.com, Inc.’s CEO Warren Wang. “As such, a company’s management and leadership team is critical to its success. Ms. Tang is a proven marketing leader and beauty influencer in China. With Ms. Tang’s expertise and a breakthrough hemp-infused skin care line, I believe we have the key elements for success in this market.”

“I am honored to serve as the Marketing Director of CBD Biotechnology,” says Tang. “Hemp extract, otherwise known as cannabidiol or CBD, is a powerful antioxidant and anti-inflammatory agent making it a perfect ingredient for skin care products. CBD Biotechnology will be among the first skin care companies in China to infuse its products with natural hemp extract making it a pioneer in this segment of the skin care industry. I believe CBD Biotechnology has a unique opportunity to take the lead in the Chinese market with its innovative skin care line.”

About ChineseInvestors.com (OTCQB: CIIX)

Founded in 1999, ChineseInvestors.com endeavors to be an innovative company providing: (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) advertising and public relation related support services; and (c) retail, online sales and direct sales of non-industrial hemp-based products and other health related products.

For more information visit ChineseInvestors.com

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Forward-Looking Statements

This 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. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.

Contact:
ChineseInvestors.com, Inc.
227 W. Valley Blvd, #208 A
San Gabriel, CA 91776

Investor Relations:
Alan Klitenic
+1-214-636-2548

Corporate Communications:
NetworkNewsWire (NNW)
New York
+1-212-418-1217 Office
Editor@NetworkNewsWire.com

http://www.NetworkNewsWire.com

Monday, October 2nd, 2017 Uncategorized Comments Off on $CIIX Appoints Skin Care Veteran, Shanghai Beauty Influencer, Fannie Tang as Marketing Director

$MOBL Wins CyberSecurity Breakthrough Award, Application Security Solution of the Year

MOUNTAIN VIEW, Calif., Sept. 29, 2017 — MobileIron (NASDAQ:MOBL), the security backbone for the multi-cloud enterprise, today announced that MobileIron Access has been selected as winner of the Mobile Security “Application Security Solution of the Year” award from CyberSecurity Breakthrough, an independent organization that recognizes the top companies, technologies, and products in the global information security market today.

There are a variety of security risks that exist between devices and apps and the services to which they connect. For example:

  • Jailbroken device: An employee uses Office 365 mobile app to access business data from a jailbroken device. Business data is now on a hacked device.
  • Unauthorized Mac or PC: An employee syncs Google Drive files to a personal computer. Business data is now on an unsecured device.
  • Unauthorized cloud app: A salesperson downloads one of the dozens of apps that use APIs to connect to the salesforce.com cloud service. Business data is now in an unsecured mobile app.

The critical link between the mobile app and the cloud service, MobileIron Access solves these security risks by acting as a gate on the authentication path between the user and the cloud data. With MobileIron Access, only trusted users on trusted devices using trusted applications can get to that data. Untrusted users, apps, and devices are blocked.

“We believe we are the first to solve this problem and are proud to see MobileIron Access recognized by CyberSecurity Breakthrough,” said Barry Mainz, President and CEO, MobileIron. “Identity solutions and cloud gateways alone are insufficient because they lack visibility and control over the security posture of mobile devices and apps. MobileIron Access is the next generation of cloud security and lets our customers confidently expand their use of cloud services.”

The mission of the CyberSecurity Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of information security categories, including Cloud Security, Threat Detection, Risk Management, Fraud Prevention, Mobile Security, Email Security and many more. This year’s program attracted more than 2,000 nominations from over 12 different countries throughout the world. All nominations were evaluated by an independent panel of experts within the information security industry.

About MobileIron
MobileIron provides the secure foundation for companies around the world to transform into Mobile First organizations. For more information, please visit www.mobileiron.com.

About CyberSecurity Breakthrough
The CyberSecurity Breakthrough Awards program is devoted to honoring excellence in information security and cybersecurity technology companies, products and people. The CyberSecurity Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough information security companies and products in categories including Cloud Security, Threat Detection, Risk Management, Fraud Prevention, Mobile Security, Web and Email Security, UTM, Firewall and more. For more information visit www.CyberSecurityBreakthrough.com.

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$TNXP Presented at the 2nd Annual Cohen Veterans Care Summit in Washington, D.C.

NEW YORK, Sept. 29, 2017 — Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a company developing innovative pharmaceutical and biological products to address major public health challenges, announced today that Seth Lederman, M.D., president and chief executive officer of Tonix, presented at the 2nd Annual Cohen Veterans Care Summit that took place September 27-28, 2017, in Washington, D.C. During the Coalition to Heal Invisible Wounds Panel session of the Summit, Dr. Lederman addressed policy approaches for greater incentives to develop new medicines, with a focus on small molecule medicines, for the treatment of mental health disorders. Tonix is in Phase 3 development of Tonmya®*, a U.S. Food and Drug Administration (FDA)-designated Breakthrough Therapy for the treatment of PTSD.

“At Tonix, we believe in the potential for new medicines to address the psychiatric disorders that contribute to a wide range of challenges faced by society, including problems linked to inadequate treatment options for posttraumatic stress disorder,” commented Seth Lederman, president and chief executive officer of Tonix. “We are proud to be an active participant in discussions of public policy approaches in support of broader efforts to develop improved pharmacotherapies in areas of deep need, which is particularly evident for psychiatric conditions.”

*Tonmya has been conditionally accepted by the U.S. Food and Drug Administration (FDA) as the proposed trade name for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for PTSD. TNX-102 SL is an investigational new drug and has not been approved for any indication.

About the Cohen Veterans Care Summit

The Cohen Veterans Care Summit is the pre-eminent convening event for private and public sector leadership to gather and advance the Veterans Brain Health research agenda and clinical care delivery model. The Summit is jointly hosted by Cohen Veterans Bioscience and Cohen Veterans Network to advance the state of PTSD and Traumatic Brain Injury (TBI) care today and tomorrow.

About Tonmya and the Phase 3 HONOR Study

Tonmya is a patented sublingual transmucosal formulation of cyclobenzaprine that is in Phase 3 development. PTSD is a serious condition characterized by chronic disability, inadequate treatment options, especially for military-related PTSD, and an overall high utilization of healthcare services that contributes to significant economic burdens. In a Phase 2 study, Tonmya 5.6 mg (2 x 2.8 mg tablets), was found to be effective in treating military-related PTSD, which formed the basis of the Breakthrough Therapy designation granted by the FDA. Tonix is currently conducting a Phase 3 trial of Tonmya in military-related PTSD in the United States, the HONOR study, which is a multi-site 12-week randomized, double-blind, placebo-controlled trial evaluating the efficacy of Tonmya 5.6 mg in participants with military-related PTSD. This two-arm, adaptive-design trial is targeting enrollment of up to approximately 550 participants. An unblinded interim analysis will be conducted once the study has accumulated efficacy results from approximately 275 randomized participants. In a recent Cross-Disciplinary Breakthrough Therapy meeting, the FDA confirmed that (i) a single-study new drug application (NDA) approval could be possible if the topline data from the HONOR study are statistically very persuasive, and (ii) an additional abuse assessment study is not required for the NDA filing. Additional details of the HONOR study are available at www.thehonorstudy.com or https://clinicaltrials.gov/ct2/show/NCT03062540. The U.S. Patent and Trademark Office has issued a patent (U.S. Patent No. 9,636,408) protecting the composition and manufacture of the unique Tonmya formulation. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary Tonmya composition. This patent is expected to provide Tonmya, upon NDA approval, with U.S. market exclusivity until 2034.

About Tonix Pharmaceuticals Holding Corp.

Tonix is developing innovative pharmaceutical and biological products to address major public health challenges. In addition to Tonmya for PTSD, Tonix is developing TNX-601 (tianeptine oxalate), a clinical candidate at pre-IND (Investigational New Drug) application stage, designed as a daytime treatment for PTSD and TNX-801, a live synthetic version of horsepox virus, at the pre-IND application stage, to be developed as a potential smallpox-preventing vaccine.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the Securities and Exchange Commission (the “SEC”) on April 13, 2017, and future periodic reports filed with the SEC on or after the date hereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.

Contacts

Jessica Morris (investors)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(212) 980-9159

Russo Partners (media)
Rich Allan
rich.allan@russopartnersllc.com
(646) 942-5588

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$TRXC Reports Progress on Senhance FDA Submission

RESEARCH TRIANGLE PARK, N.C.

– Files additional information response with FDA
– Continues to expect 510(k) clearance in 2017

TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced the Company has filed its response to the Food and Drug Administration’s (“FDA”) Additional Information (“AI”) request related to the Company’s Senhance Surgical Robotic System 510(k) submission.

“We are very pleased to have submitted our AI response ahead of schedule, demonstrating our team’s effectiveness and our ongoing collaboration with the FDA,” said Todd M. Pope, President and Chief Executive Officer of TransEnterix. “The submission of our response is a key step towards achieving 510(k) clearance for the Senhance, which we continue to expect in 2017.”

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The Company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The Company also developed the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has been granted a CE Mark but is not currently available for sale in the United States. For more information, visit the TransEnterix website at www.transenterix.com.

Forward-Looking Statements

This press release includes statements relating to our second quarter 2017 results, the Senhance™ Surgical Robotic System and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations, including, whether the Senhance 510(k) will achieve clearance in 2017, if at all. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2016, which was filed on March 6, 2017, and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

 

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1-443-213-0501
invest@transenterix.com
or
Media Contact:
(For EU) Conrad Harrington, +44 (0)20 3178 8914
or
(For US) Hannah Dunning, +1-415-618-8750
TransEnterix-SVC@sardverb.com

Friday, September 29th, 2017 Uncategorized Comments Off on $TRXC Reports Progress on Senhance FDA Submission

$ZGNX Positive Top-line Results Phase 3 Clinical of ZX008 in Dravet Syndrome

Primary Endpoint Achieved – Statistically Significant Convulsive Seizure Reduction for ZX008 versus Placebo for Adjunctive Treatment of Seizures

ZX008 Also Demonstrated Statistical Significance in All Key Secondary Endpoints

Zogenix to Host Conference Call Today at 8:30 AM Eastern Time/5:30 AM Pacific Time

EMERYVILLE, Calif., Sept. 29, 2017 — Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, today reported positive top-line results from its first Phase 3 trial (Study 1) for its investigational drug, ZX008 (low-dose fenfluramine hydrochloride), for the treatment of Dravet syndrome. The trial met its primary objective of demonstrating that ZX008, at a dose of 0.8 mg/kg/day, is superior to placebo as adjunctive therapy in the treatment of Dravet syndrome in children and young adults based on change in the frequency of convulsive seizures between the 6-week baseline observation period and the 14-week treatment period (p<0.001).  ZX008 0.8 mg/kg/day also demonstrated statistically significant improvements versus placebo in all key secondary measures, including the proportion of patients with clinically meaningful reductions in seizure frequency and longest seizure-free interval. The same analyses comparing a 0.2 mg/kg/day ZX008 dose versus placebo also demonstrated statistically significant improvement compared with placebo.

“Dravet syndrome is a rare, but catastrophic form of epilepsy that can be devastating for patients and their families,” said Joseph Sullivan M.D., director of the Pediatric Epilepsy Center in UCSF Benioff Children’s Hospital San Francisco, and Principal Investigator of Study 1 in the U.S. “These results are truly exciting and demonstrate, in a large multicenter controlled trial, the impressive efficacy of low-dose fenfluramine for patients with Dravet syndrome. If approved, ZX008 could play an important role in treating this devastating condition.”

The randomized, double blind, placebo controlled, Phase 3 study enrolled 119 patients across sites in the United States, Canada, Europe, and Australia. The median age of patients was 8 years (range, 2-18 years). Following a six-week baseline observation period, patients were randomized to one of three treatment groups: ZX008 0.8 mg/kg/day (30 mg maximum daily dose; n=40), ZX008 0.2 mg/kg/day (n=39) and placebo (n=40) in which ZX008 or placebo was added to current regimens of antiepileptic drugs. Patients were titrated to their target dose over two weeks and then remained at that fixed dose for 12 weeks. The mean baseline convulsive seizure frequency across the study groups was approximately 40 seizures per month.

The primary efficacy measure was a comparison of the change in mean monthly convulsive seizure frequency between ZX008 0.8 mg/kg/day and placebo during the 14-week treatment period compared with the 6-week baseline observation period. Patients taking ZX008 0.8 mg/kg/day achieved a 63.9% reduction in mean monthly convulsive seizures compared to placebo (p<0.001). The median percent reduction in monthly convulsive seizure frequency was 72.4% among ZX008 0.8 mg/kg/day patients compared to 17.4% in placebo patients.

A key secondary endpoint was the same analysis for a comparison of ZX008 0.2 mg/kg/day and placebo. Patients taking ZX008 0.2 mg/kg/day achieved a reduction in mean monthly convulsive seizures of 33.7% compared to placebo (p=0.019). Collectively, these top-line data suggest a dose-response relationship for ZX008 in the adjunctive treatment of convulsive seizures in Dravet syndrome.

Additional key secondary objectives of the study were to compare 0.8 mg/kg/day and 0.2 mg/kg/day ZX008 (independently) with placebo in terms of (1) the proportion of patients who achieved ≥50% reductions in monthly convulsive seizures and (2) the median of the longest convulsive seizure-free interval. These results are shown in the following table. The proportion of patients who achieved ≥75% seizure reductions, a secondary efficacy measure, is also presented.

ZX008 0.8
mg/kg/day
(N=40)
ZX008 0.2
mg/kg/day
(N=39)
Placebo
(N=40)
Patients with ≥50%
reduction in monthly
convulsive seizures
70.0%
(p<0.001)
41.0%
(p=0.001)
7.5 %
Patients with ≥75%
reduction in monthly
convulsive seizures
45.0%
(p=0.001)
20.5%
(p=0.033)
2.5 %
Longest seizure-free
interval (median)
20.5 days
(p<0.001)
14 days
(p=0.011)
9 days

ZX008 was generally well-tolerated in this study with the adverse events consistent with the known safety profile of fenfluramine. The incidence of treatment emergent adverse events was higher in the treatment groups as compared to the placebo group, with 95% (n=38) of patients in the 0.8mg/kg/day group and 94.9% (n=37) of patients in the 0.2 mg/kg/day group experiencing at least one treatment emergent adverse event compared to 65.0% (n=26) of patients in the placebo group. The incidence of serious adverse events was similar in all three groups with 12.5% (n=5) of patients in the 0.8 mg/kg/day group and 10.3% (n=4) of patients in the 0.2 mg/kg/day group experiencing at least one treatment emergent serious adverse event compared to 10.0% (n=4) of patients in the placebo group. Five patients in the 0.8 mg/kg/day group had an adverse event leading to study discontinuation compared to none in the other treatment groups. Prospective cardiac safety monitoring throughout the study demonstrated no clinical or echocardiographic evidence of cardiac valvulopathy or pulmonary hypertension.

“On behalf of everyone at Zogenix, I would like to extend my sincere appreciation to the patients, families and investigators involved in this study. We are extremely pleased with the top-line efficacy and safety results from Study 1 which reinforce the potential of ZX008 to be an important new treatment for seizure control in children with Dravet syndrome.  We look forward to presenting further data in future publications and at medical conferences,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix.  “We expect top-line results from our second pivotal Phase 3 trial, Study 1504, which is nearing full enrollment, in the first half of 2018. We remain on track to submit applications for regulatory approvals in the U.S. and Europe in the second half of 2018.”

ZX008 is designated as an orphan drug in both the U.S. and Europe, and has received Fast Track designation in the U.S. for the treatment of Dravet syndrome.

Conference Call Details
Friday, September 29 @ 8:30 AM Eastern Time/5:30 AM Pacific Time
Toll Free: 888-455-2265
International: 719-457-2627
Conference ID: 7770264
Webcast: http://public.viavid.com/index.php?id=126480
Audio Replays, available through October 13, 2017:
Domestic: 844-512-2921
International: 412-317-6671
Replay PIN: 7770264

About Zogenix

Zogenix (Nasdaq:ZGNX) is focused on developing therapies for patients with rare central nervous system (CNS) conditions that have limited or no treatment options but face a critical need. For more information, visit www.zogenix.com.

About the ZX008 Dravet Syndrome Global Development Program

Study 1 is a prospective merged analysis of two identical double-blind, placebo-controlled studies, ZX008-1501 (US/Canada) and ZX008-1502 (Europe/Australia), designed to enroll approximately 40 patients per treatment group and includes patients from sites in the United States, Canada, Europe, and Australia.  A total of 119 patients were randomized into one of two dose groups of ZX008, 0.2 and 0.8 milligrams per kilogram per day, or placebo.  After a six-week baseline period, randomized subjects were titrated to their target dose over two weeks, and then held to that fixed dose for 12 weeks of maintenance treatment. The primary objective of the study was to demonstrate that ZX008 at the high dose is superior to placebo in controlling seizures based on the change in the frequency of convulsive seizures between baseline and the combined titration and maintenance periods.  The percent of patients who achieve equal or greater than a 50% reduction in convulsive seizures, and measurement of the longest seizure-free interval, were key secondary endpoints.  Patients who complete Study 1 are eligible to enter a long-term, open-label extension study.

Zogenix is conducting a second double-blind, randomized, two-arm pivotal Phase 3 trial, Study 1504, in which all patients will be taking stiripentol, valproate and clobazam as part of their baseline standard care.  In February 2017, the Company announced the initiation of the safety and efficacy portion of Study 1504, which compares a single dose of ZX008 versus placebo across the titration and 12-week maintenance periods.  Study 1504 will enroll 40 patients per treatment group.

Forward Looking Statements

Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. These forward-looking statements include statements regarding ZX008’s potential as a treatment for seizures associated with Dravet syndrome; the timing of topline results from Study 1504; and regulatory submission timelines for ZX008. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix’s business, including, without limitation: the top-line data Zogenix has reported is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such top-line data may not accurately reflect the complete results of the trial, and the FDA may not agree with Zogenix’s interpretation of such results; the uncertainties associated with the clinical development and regulatory approval of product candidates such as ZX008, including potential delays in the enrollment and completion of clinical trials; the potential that earlier clinical trials and studies may not be predictive of future results; Zogenix’s reliance on third parties to conduct its clinical trials, enroll patients, manufacture its preclinical and clinical drug supplies; unexpected adverse side effects or inadequate therapeutic efficacy of ZX008 that could limit approval and/or commercialization, or that could result in recalls or product liability claims; Zogenix’s ability to fully comply with numerous federal, state and local laws and regulatory requirements, as well as rules and regulations outside the United States, that apply to its product development activities; and other risks described in Zogenix’s prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

CONTACT:

Investors:
Andrew McDonald
Founding Partner, LifeSci Advisors LLC
646-597-6987 | Andrew@lifesciadvisors.com

Media:
David Polk
Senior Media Relations Strategist, INC Research/inVentivHealth
310-309-1029 | david.polk@inventivhealth.com

University of California, San Francisco:
Suzanne Leigh
Senior Public Information Representative, Strategic Communications & University Relations
415-476-2993   Cell: 415-680-5133   Suzanne.Leigh@ucsf.edu

Friday, September 29th, 2017 Uncategorized Comments Off on $ZGNX Positive Top-line Results Phase 3 Clinical of ZX008 in Dravet Syndrome

$CIIX NetworkNewsWire Publication on Investment Opportunities in the Cannabis Industry

NEW YORK, NY–(Sep 29, 2017) –  NetworkNewsWire (“NNW”), a multifaceted financial news and publishing company, today announces the publication of an editorial featuring ChineseInvestors.com, Inc. (OTCQB: CIIX), a client of NNW recognizing unprecedented opportunities in the U.S. cannabis industry and laying the groundwork to capitalize on growing demand for cannabidiol (CBD)-based nutrition and health products.

The publication is titled, “Cannabis Companies Demonstrate the Diverse Nature of the Global Marijuana Market.” It discusses various public companies across multiple sectors that are getting their share of the profitable marijuana market.

To view the full publication, visit: https://www.networknewswire.com/cannabis-companies-demonstrate-diverse-nature-global-marijuana-market/

ChineseInvestors.com, Inc. (CIIX) is staking its position in the market with several product lines, including hemp-infused skin care products. Cannabis is known to have anti-inflammatory and antioxidant properties. The company noted the benefits in this area in an August 2017 press release (http://nnw.fm/z9WPp). They include improvements to skin complexion, thanks to the omega-3 and omega-6 fatty acids present in hemp seed oil. The fatty acids help keep skin moist and stimulate collagen production, helping skin to become firmer. In fact, the human endocannabinoid system includes cannabinoid receptors in the skin.

“Fully aware of the demand for medical cannabis, CIIX has worked to improve the user experience as well. It has developed an investing process, known as the ChineseInvestors Method, and introduced various web-based tools to disseminate market information to investors. That puts investors on the front lines of China’s $30 billion per year skin care product industry.

“The company also developed and launched a Chinese-language social media app, approved for download via the Apple App Store. It enables users to view, discuss, and write reviews on cannabis strains and marijuana dispensaries. People can use the application’s maps to find retailers, view business summary reports and see product recommendations.”

About ChineseInvestors.com

Founded in 1999, ChineseInvestors.com endeavors to be an innovative company providing: (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) advertising and public relation related support services; and (c) retail and online sales of hemp-based products and other health related products. For more information visit www.ChineseInvestors.com.

About NetworkNewsWire

NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

For more information please visit https://www.NetworkNewsWire.com

Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer

Forward-Looking Statements

This 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. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.

NNW Contact:
NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Email Contact

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$SPPI Poziotinib Data in Lung Cancer Presented at 18th IASLC World Conference

HENDERSON, Nev.

Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology Company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced the release of an abstract from a clinical study evaluating poziotinib in EGFR Exon 20 Mutant Non-Small Cell Lung Cancer (NSCLC) by scientists from The University of Texas MD Anderson Cancer Center, the sponsor of the trial. This abstract contains limited data as of the submission deadline of June 21, 2017. Additional data from their clinical experience and the ongoing Phase 2 study will be released in an oral presentation at the 18th International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer in Yokohama, Japan, October 15-18, 2017.

Wednesday, October 18th, 2017:

Abstract # Type Title First Author/Presenting Author Time
10369 Oral The Preclinical and Clinical Activity of Poziotinib, a Potent, Selective Inhibitor of EGFR Exon 20 Mutant NSCLC Elamin, Heymach 11:00 AM-11:10 AM JST

Abstract #10369: The Preclinical and Clinical Activity of Poziotinib, a Potent, Selective Inhibitor of EGFR Exon 20 Mutant NSCLC

Background

Approximately 10% of EGFR mutant NSCLCs have an insertion/mutation in exon 20 of EGFR resulting in primary resistance to currently available tyrosine kinase inhibitors (TKIs). We previously reported that the structural features of poziotinib could potentially enable it to circumvent the steric hindrance induced by exon 20 mutations. Here we further characterize the preclinical activity of poziotinib and report on initial clinical activity of poziotinib in patients EGFR exon 20 mutations from an ongoing phase II study.

Methods

We evaluated poziotinib activity in vitro using human NSCLC cell lines and the BAF3 model as well as several patient-derived xenograft (PDX) models and genetically engineered mouse models (GEMMs) of exon 20 insertion. We launched a phase 2 investigator-initiated trial of poziotinib in patients with metastatic NSCLC with EGFR exon 20 insertions (NCT03066206).

Results: In vitro poziotinib was approximately 100x more potent than osimertinib and 40x more potent than afatinib against a common panel of EGFR exon 20 insertions. Furthermore, it had ~65-fold greater potency against common exon 20 insertions compared with EGFR T790M mutations; 3rd generation inhibitors osimertinib, EGF816, and rociletinib were all significantly less potent for exon 20 mutations/insertions compared with T790M. in vivo poziotinib led to >85% reduction in tumor burden in GEM models of EGFR exon 20 insertion (D770insNPG) NSCLC and the PDX model LU0387 (H773insNPH).

To date, 8 platinum-refractory patients with EGFR exon 20 insertion mutation metastatic NSCLC have been enrolled in the clinical trial and treated with poziotinib at a dose of 16 mg PO daily. Two patients have reached the first interval-imaging time point (at 8 weeks of therapy per protocol). Both patients exhibited dramatic partial response, with one patient reporting improvement in dyspnea and cough at one week of therapy. In this early stage of the study, one case of grade 3 paronchycia was observed. One additional platinum- and erlotinib-refractory patient with EGFR exon 20 insertion was treated with poziotinib on compassionate basis. The patient achieved partial response after three weeks of treatment.

Conclusion: Poziotinib has selective activity against EGFR exon 20 mutations and potent activity in cell lines, PDX, and GEM models. Three platinum-refractory patients with EGFR exon 20 mutations have been treated thus far and are evaluable for response; all three had partial responses at the time of the initial scan. Updated data from the ongoing phase 2 clinical trial of poziotinib will be presented at the meeting.

About Poziotinib

Poziotinib is a novel, oral pan-HER inhibitor that irreversibly blocks signaling through the Epidermal Growth Factor Receptor (EGFR, HER) Family of tyrosine-kinase receptors, including HER1 (erbB1; EGFR), HER2 (erbB2), and HER4 (erbB4), and importantly, also HER receptor mutations; this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. Spectrum received exclusive license to develop, manufacture and commercialize worldwide excluding Korea and China from Hanmi Pharmaceuticals.

About the WCLC

The World Conference on Lung Cancer (WCLC) is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting over 6,000 researchers, physicians and specialists from more than 100 countries. The goal is to disseminate the latest scientific achievements; increase awareness, collaboration and understanding of lung cancer; and to help participants implement the latest developments across the globe. Organized under the theme of “Synergy to Conquer Lung Cancer,” the conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit http://wclc2017.iaslc.org/.

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in Hematology and Oncology. Spectrum currently markets six hematology/oncology drugs, and has an advanced stage pipeline that has the potential to transform the Company. Spectrum’s strong track record for in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.

Forward-looking statement — This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management’s current beliefs and expectations. These statements include, but are not limited to, statements that relate to Spectrum’s business and its future, including certain company milestones, Spectrum’s ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, the timing and results of FDA decisions, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Spectrum’s existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company’s reports filed with the Securities and Exchange Commission. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

SPECTRUM PHARMACEUTICALS, INC.® is a registered trademarks of Spectrum Pharmaceuticals, Inc and its affiliate. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.

© 2017 Spectrum Pharmaceuticals, Inc. All Rights Reserved

Spectrum Pharmaceuticals, Inc.
Shiv Kapoor
Vice President, Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com

Thursday, September 28th, 2017 Uncategorized Comments Off on $SPPI Poziotinib Data in Lung Cancer Presented at 18th IASLC World Conference

$AEHR Receives Follow-on Orders for FOX-XP™ Test and Burn-in Solution

FREMONT, Calif., Sept. 28, 2017 — Aehr Test Systems (NASDAQ:AEHR), a worldwide supplier of semiconductor test and burn-in equipment, today announced that it has received follow-on orders totaling $2.7 million from a subcontractor of its initial lead FOX-XPTM Test and Burn-in System customer. The orders include a partially populated FOX-XP system, multiple DiePak® Carriers for their next generation devices and multiple FOX DiePak Loader/Unloaders to increase their current production capacity.

Gayn Erickson, President and CEO of Aehr Test Systems, commented, “We are excited to receive these additional follow-on orders from this large multinational customer for their production test/burn-in requirements. The new orders build on an existing device test/burn-in implementation at this customer now moving into volume production, which continues to expand our production presence for multiple generations of devices.

“The FOX-XP system’s unique capability to deliver thousands of test resources to each DiePak Carrier loaded in the FOX-XP system makes it appropriate for volume test/burn-in production of high power small footprint devices such as those being produced by this customer. In addition, the system is capable of heating or cooling devices while in test/burn-in using a proprietary design, which can handle up to 2 kW of heat energy per DiePak Carrier to ensure that each device’s desired junction temperature is maintained very accurately. Another advantage of the FOX-XP system design is the integrated autoloader option, which handles device loading/unloading of the DiePak Carrier in high volume production.

“We believe that the FOX-XP system’s capabilities and our cost-effectiveness for high volume singulated device test/burn-in differentiate Aehr Test from the competition and enable us to address our customer’s current and next generation devices requirements.”

The FOX-XP system, available with multiple WaferPakTM Contactors (full wafer test) or multiple DiePak Carriers (singulated die/module test) configurations, is capable of functional test and burn-in/cycling of integrated optical devices, 2D and 3D sensors, magnetic sensors, flash memories, microcontrollers, and other leading-edge ICs in either wafer form, before they are assembled into single or multi-die stacked packages, or in singulated die or module form.

A single FOX-XP test system may be configured with up to 18 Blades of wafer test resources, enabling up to 18 wafers to be tested simultaneously handling 1 kW each, or 9 wafers or DiePak Carriers at up to 2 kW each. Each Blade may be configured with up to eight Channel Modules of test resources. These Channel Modules may be: Universal Channel Channel Modules (UCCMs), High Current Channel Modules (HCCMs), or High Voltage Channel Modules (HVCMs) to supply device stimulus to test/burn-in/cycle die or modules. The footprint of the 18-wafer test system is similar to the footprint of typical semiconductor Automatic Test Equipment (ATE) that can only test one wafer at a time.

The FOX-XP system’s FOX WaferPak Contactor provides a cost-effective solution for making full wafer electrical die contact in a multi-wafer environment and may contain up to tens of thousands of probes to contact all die simultaneously on wafers and substrates up to 300mm. The DiePak® Carrier provides a cost-effective solution for making both thermal and electrical singulated die/module test contact in a multi-DiePak Carrier environment and may contain up to thousands of contacts to test/burn-in 100’s of devices on a single DiePak Carrier. Other key components of a FOX-XP test cell are the FOX WaferPak Aligner, which provides fully automatic alignment of the customer’s wafers to the WaferPak Contactor, and the FOX DiePak Loader/Unloader, which enables fully automatic handling of device exchanges with the DiePak Carriers.

About Aehr Test Systems
Headquartered in Fremont, California, Aehr Test Systems is a worldwide provider of test systems for burning-in and testing logic, optical 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, incremental capacity needs, and new opportunities for Aehr Test products in package, wafer level, and singulated die/module level test.  Aehr Test has developed and introduced several innovative products, including the ABTSTM and FOX-PTM families of test and burn-in systems, the FOX WaferPak Aligner, the FOX DiePak Loader/Unloader, the FOX WaferPak Contactor, and the FOX DiePak® Carrier.  The ABTS system is used in production and qualification testing of packaged parts for lower power and higher power logic devices as well as all common types of memory devices. The FOX-XPTM system is a full wafer contact and singulated die/module 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, systems-on-a-chip, and integrated optical devices.  The WaferPak Contactor contains a unique full wafer probe card capable of testing wafers up to 300mm that enables IC manufacturers to perform test and burn-in of full wafers on Aehr Test FOX systems.  The DiePak Carrier is a reusable, temporary package that enables IC manufacturers to perform cost-effective final test and burn-in of both bare die and modules. For more information, please visit Aehr Test System’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 Aligners, DiePak Loader/Unloaders, WaferPak Contactors and DiePak Carriers 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.

Contacts:

Aehr Test Systems  
Carl Buck
V.P. of Marketing
(510) 623-9400 x381
cbuck@aehr.com

MKR Group Inc.
Todd Kehrli or Jim Byers
Analyst/Investor Contact
(323) 468-2300
aehr@mkr-group.com

Thursday, September 28th, 2017 Uncategorized Comments Off on $AEHR Receives Follow-on Orders for FOX-XP™ Test and Burn-in Solution

$EXA to be Acquired by Dassault Systèmes

  • Transaction valued at approximately $400 million or $24.25 per share
  • Proven Technology and Industrialized Solutions Will Be Available to Customers in All Industries

BURLINGTON, Mass., Sept. 28, 2017 — Exa® Corporation (NASDAQ:EXA), a global innovator in simulation software for product engineering, today announced that its Board of Directors has unanimously agreed to be acquired by Dassault Systèmes in a transaction valued at approximately $400 million or $24.25 per share.

Headquartered in Paris, France and Boston, Massachusetts, Dassault Systèmes (www.3ds.com) provides business and people with virtual universes to imagine sustainable innovations.  Its world-leading solutions transform the way products are designed, produced, and supported.  Dassault Systèmes’ collaborative solutions foster social innovation, expanding possibilities for the virtual world to improve the real world.  The group brings value to over 220,000 customers of all sizes, in all industries, in more than 140 countries.

With the addition of Exa, Dassault Systèmes’ 3DEXPERIENCE platform will provide customers with a proven portfolio of Lattice Boltzmann fluid simulation technologies, fully industrialized solutions and over 350 highly experienced simulation professionals.

Simulation of fluid flow, such as the cooling of an engine or the lift of a wing, is a necessary component of simulating the physical behavior of products, nature and life. For the many situations where fluid flow conditions change rapidly, simulation of dynamically variable flows is critical to accurate assessments of a product and its behavior in its environment. For these applications, the combination of Exa’s accuracy and timeliness provides results that are superior to those of alternative CFD methods.

“Exa’s unique Lattice Boltzmann simulation technology combined with our extensive professional and industry expertise has enabled us to deliver significant value to the leading companies in the global transportation and other flow-based product industries,” said Stephen Remondi, President and Chief Executive Officer of Exa. “We can solve the most challenging fluids problems faster and more accurately than traditional methods for aerodynamics, aeroacoustics, thermal management and other fluids-related applications. The combination of Exa with Dassault Systèmes’ 3DEXPERIENCE platform will provide Exa with the critical mass of manpower and technology required to accelerate the delivery of our shared vision of driving the value of digital engineering knowledge, enabling everyone in the value chain to access the power of simulation for critical business decisions.”

“Both Dassault Systèmes and Exa believe in the value of an integrated focus on science and industry. It is a critical part of our commitment to delivering 3DEXPERIENCE universes that harmonize products, nature and life. Simulation of dynamic fluid flow is an important part of our multiphysics and multiscale simulation strategy,” said Bernard Charlès, Vice Chairman and CEO, Dassault Systèmes. “With Exa’s valuable application knowledge in transportation and mobility and other industry verticals, we will accelerate our delivery of industry solution experiences to benefit our existing and future customers.”

Benefits of the transaction

  • Enhanced Customer Value. The complementary strengths and combined expertise of both companies enables the delivery of the power of digital engineering throughout the value chain, leading to dramatic increases in engineering and manufacturing productivity.
  • Improved Collaboration. Combining the two companies will greatly enhance collaboration with customers, and facilitate the ability to offer integrated solutions and simplify both commercial and technical interactions.
  • Accelerated Delivery of a Shared Vision. As one company, Exa and Dassault Systèmes will continue to deliver innovative new 3D technologies for design, engineering, CAD, modeling, simulation, and data and process management.

Under the terms of the merger agreement, a subsidiary of Dassault Systèmes will commence a  tender offer within the next 10 business days to acquire all of the issued and outstanding shares of Exa common stock for a price of $24.25 per share payable in cash upon completion of the offer. This represents a fully diluted equity value for Exa of approximately $400 million.

Completion of the transaction is subject to customary closing conditions, including required regulatory approvals. The acquisition is expected to close in the fourth quarter of 2017, subject to the satisfaction of customary closing conditions.

Today’s Conference Call Information

Today, Thursday, September 28, 2017, Dassault Systèmes will host a conference call at 11:30 AM New York time/ 4:30 PM London time/ 5:30 PM Paris time. The conference call will be available via the Internet by accessing http://www.3ds.com/investors/. Please go to the website at least 15 minutes prior to the webcast or conference call to register, download and install any necessary audio software. The webcast and conference call will be archived for one year.

Stifel, Nicolaus & Company, Inc. acted as financial advisor and Foley Hoag LLP as legal counsel to Exa in connection with the transaction.

About Exa Corporation

Exa (NASDAQ:EXA) (www.exa.com) Corporation’s visualization and simulation software helps designers and engineers produce better vehicles and equipment. As a design evolves, Exa accurately predicts the performance of that design while providing actionable insight to optimize the performance of the product. With Exa, the need for costly physical prototypes and expensive late-stage changes is reduced.

Now, designers and engineers are freed from the risk of producing compromised products that do not meet market and regulatory requirements. Some of the most successful product companies in the world use Exa, including BMW, Delphi, Denso, Fiat Chrysler, Ford, Hino, Honda, Hyundai, Jaguar Land Rover, Kenworth, Komatsu, MAN, Nissan, Peterbilt, Peugeot, Renault, Scania, Toyota, Volkswagen and Volvo Trucks.

Founded in 1991, the company is headquartered at 55 Network Drive, Burlington, MA, USA 01803. Tel: 1.781.564.0200; Fax: 1.781.564.0299; Email: info@exa.com; URL: www.exa.com; (NASDAQ:EXA)

Important Additional Information Will Be Filed with the Securities and Exchange Commission

The tender offer to be commenced by a subsidiary of Dassault Systèmes for shares of common stock of Exa has not yet commenced, and this press release is neither an offer to purchase nor a solicitation of an offer to sell shares of Exa. At the time the tender offer is commenced, Dassault Systèmes will file with the Securities and Exchange Commission (“SEC”) and mail to Exa’s stockholders a Tender Offer Statement and Exa will file with the SEC and mail to its stockholders a Tender Offer Solicitation/Recommendation Statement in connection with the transaction. These documents will contain important information about Dassault Systèmes, Exa, the transaction and other related matters. Investors and security holders are urged to read each of these documents carefully when they are available. Investors and security holders will be able to obtain free copies of the Tender Offer Statement, the Tender Offer Solicitation / Recommendation Statement and other documents filed with the SEC by Dassault Systèmes and Exa through the website maintained by the SEC at www.sec.gov. In addition, investors and security holders will be able to obtain free copies of these documents  by writing to Exa Corporation, 55 Network Drive, Burlington, Massachusetts 01803, [attention: Investor Relations].

Cautionary Statement Regarding Forward-Looking Statements

Forward-looking statements made herein with respect to the tender offer and related transactions, including, for example, the timing of the completion of the tender offer and the subsequent merger contemplated by the agreement and plan of merger between Exa and Dassault Systèmes, which we refer to as the merger agreement, or the potential benefits of the tender offer and the merger, reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, the actual outcome of this transaction may differ materially from Exa’s expectations.

The following factors, among others, could cause actual plans and results to differ materially from those described in forward-looking statements. Such factors include, but are not limited to, the effect of the announcement of the tender offer and related transactions on the Exa’s business relationships, operating results and business generally; the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement, and the risk that the merger agreement may be terminated in circumstances that require Exa to pay a termination fee; the outcome of any legal proceedings that may be instituted against Exa or its board of directors related to the transactions contemplated by the merger agreement, including the tender offer and the merger; uncertainties as to the number of Exa stockholders who may tender their stock in the tender offer; the failure to satisfy other conditions to consummation of the tender offer or the merger, including the receipt of regulatory approvals related to the merger (and any conditions, limitations or restrictions placed on these approvals); risks that the tender offer and related transactions disrupt current plans and operations and the potential difficulties in employee retention as a result of the proposed transactions; the effects of local and national economic, credit and capital market conditions on the economy in general, and other risks and uncertainties; and those risks and uncertainties discussed from time to time in Exa’s other reports and other public filings with the SEC.

Additional information concerning these and other factors that may impact the Exa’s expectations and projections can be found in its periodic filings with the SEC, including its Annual Report on Form 10-K for the year ended January 31, 2017. Exa’s SEC filings are available publicly on the SEC’s website at www.sec.gov, on Exa’s website (www.exa.com) under the heading “Company–Investor Relations” or upon request by writing to Exa at Exa Corporation, 55 Network Drive, Burlington, Massachusetts 01803, attention: Investor Relations. Exa disclaims any obligation or undertaking to update or revise the forward-looking statements contained herein, whether as a result of new information, future events or otherwise.

For inquiries, please contact:
Garo Toomajanian, ICR Incorporated, Tel: +1 617-956-6728
E-mail: Garo.Toomajanian@icrinc.com
Suresh Sundaram, Exa Corporation, Tel: +1 617-388-6841
E-mail: suresh@exa.com

Thursday, September 28th, 2017 Uncategorized Comments Off on $EXA to be Acquired by Dassault Systèmes

$ZYNE Positive Top Line Results in ZYN002 Open Label Phase 2

ZYN002 successfully met the primary endpoint and showed clinically meaningful improvements

Zynerba to host conference call and webcast today, September 28 at 8:30 am ET

DEVON, Pa., Sept. 28, 2017 — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to developing and commercializing innovative pharmaceutically-produced transdermal cannabinoid treatments, today announced positive top line results from an open label exploratory Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) clinical trial evaluating ZYN002 cannabidiol (CBD) gel in pediatric and adolescent patients with Fragile X syndrome (FXS). The study successfully met its primary endpoint, achieving a 46% improvement (p<0.0001) in the total score of Anxiety, Depression, and Mood Scale (ADAMS) at week twelve compared to baseline. ZYN002 also achieved clinically meaningful improvements in all measures of the Aberrant Behavior Checklist for Fragile X (ABC-FXS), which address the key symptoms of FXS including social avoidance, temper tantrums, repetitive movements, and hyperactivity.

“The data from the FAB-C trial are very exciting and demonstrate that ZYN002 may have a profound effect on improving many of the most disabling symptoms of Fragile X, such as anxiety and difficult behaviors,” said Steven Siegel, MD, PhD Professor and Chair, Psychiatry and Behavior Sciences, Keck School of Medicine of USC. “Fragile X is a challenging genetic autism spectrum disorder, with complex symptomatology that significantly impacts patients and their families. Many children with Fragile X and their families struggle with the lack of approved drugs to safely treat their symptoms. This study suggests that ZYN002 is ready for the next phase of development, and I believe that this drug holds great promise as a potential treatment for these very difficult-to-treat symptoms.”

With these data, Zynerba anticipates that it will meet with the U.S. Food and Drug Administration (FDA) in the first half of 2018 with the goal of moving quickly into a pivotal Phase 2/3 program in pediatric and adolescent patients with FXS in 2018. The FDA has granted Zynerba Orphan Drug designation for the use of CBD as treatment of patients with FXS. Orphan Drug designation is granted to novel drugs that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S., and provides benefits including a seven-year period of U.S. marketing exclusivity upon marketing approval for the designated indication and may provide a rapid path to market authorization.

“We are thrilled with the positive clinical results of ZYN002 in the FAB-C trial; it is a major step forward for the hundreds of thousands of patients worldwide with Fragile X who currently have no approved therapeutic options to treat their symptoms,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “The clinically meaningful improvements in Fragile X symptoms and the excellent tolerability seen in the FAB-C trial are compelling. These data will allow us to discuss the pathway to approval in a meeting with the FDA, which we expect to take place during the first half of 2018. I want to thank the patients, families, physicians, study coordinators, and the Zynerba team for their support of this important study.”

“The symptoms of Fragile X can be overwhelming to a patient and caregiver, so I’m very enthusiastic about the responses to ZYN002 that we saw during this study,” said Honey Heussler, FRACP, Associate Professor at Children’s Health Queensland, Medical Director Child Development and lead investigator in the FAB-C study. “These data are extremely promising, particularly the improvements in anxiety, social avoidance, and irritability as measured by scales including ADAMS, ABC-FXS, and PARS-R. Tolerability is essential in these patients, so I’m very pleased to see that ZYN002 was well tolerated in Fragile X patients.”

Study Design
Twenty patients (3:1 males) aged 6 to 17 years of age (mean = 10.7) with Fragile X as confirmed by molecular documentation of FMR1 full mutation were enrolled in the open label FAB-C study. ZYN002 was added on to other medications being administered. The first six weeks of the study were designed to titrate dosing in patients. Dosing was initiated at 50 mg daily and could be increased to 250 mg daily. Weeks 7 through 12 of the study was a maintenance period where patients were treated at the dose established at week six. At the completion of the study, patients could enter an open label extension study for up to 12 months.

Top-line data: Primary endpoint
The primary endpoint for the trial was the change in the total score of the Anxiety, Depression, and Mood Scale (ADAMS) from baseline to week 12. The ADAMS is a 28-item scale designed to assess general anxiety, social avoidance, compulsive behavior, manic/hyperactive behavior, and depressed mood. It has been validated in patients with FXS.

Results for the primary endpoint are summarized as follows:

Baseline Week 12 Change in Score % improvement p Value
ADAMS: Total Score 33.4 18.1 -14.1 45.81 % <0.0001

 

The subscales of ADAMS are as follows:

Baseline Week 12 Change in Score % Improvement p Value
ADAMS:  General Anxiety Subscale 10.0 4.6 -4.8 54.00 % <0.0001
ADAMS:  Social Avoidance Subscale 10.2 4.8 -5.1 52.94 % 0.0002
ADAMS: Compulsive Behavior Subscale 2.8 1.4 -1.2 50.00 % 0.0262
ADAMS: Manic / Hyperactive Behavior Subscale 9.4 6.1 -2.7 35.11 % 0.0003
ADAMS: Depressed Mood Subscale 2.8 2.0 -0.9 28.57 % 0.1417

 

Top-line data: Secondary endpoints
The Company evaluated multiple secondary endpoints including the Aberrant Behavior Checklist – FXS Specific (ABC-FXS), a Clinical Global Impression of Improvement (CGI-I), the Pediatric Anxiety Rating Scale (PARS-R), Visual Analog Scales for Anxiety, Hyperactivity and Tantrum/Mood Lability, the Vineland Adaptive Behavior III, a Quality of Sleep measurement and the Pediatric Quality of Life (PedsQL™). The results of the secondary endpoints reinforce the results demonstrated in the ADAMS.

Results from the ABC-FXS are summarized as follows:

Baseline Week 12 Change in Score  % improvement p Value
ABC: Irritability – “Has Temper Tantrums” 18.2 10.6 -7.1 41.76 % 0.0096
ABC: Hyperactivity – “Disrupts Group Activities” 14.5 9.7 -4.1 33.10 % 0.0194
ABC: Socially Unresponsive/Lethargic –  “Does Not Pay Attention” 8.7 4.1 -5.1 52.87 % 0.0034
ABC: Social Avoidance – “Seeks Isolation” 5.1 2.3 -2.8 54.90 % 0.0005
ABC: Stereotypy –  “Repetitive Movements” 7.9 3.2 -4.9 59.49 % 0.0006
ABC: Inappropriate Speech – “Repeats Words or Phrases” 6.1 3.5 -2.4 42.62 % 0.0018

 

Safety data
ZYN002 was shown to be very well tolerated, and the safety profile was consistent with previously released data from clinical trials. Two patients discontinued due to worsening of pre-existing eczema. Four other patients experienced an adverse event. No adverse events were considered severe. No patient experienced drug-related GI events during the 12-week treatment period, and no THC was detected in the plasma. Thirteen of the 18 patients who completed the study have enrolled in the open label extension.

Conference call information
Zynerba management will host a live conference call and webcast today at 8:30 am Eastern Time to discuss the results of this clinical trial. The call can be accessed by dialing (866) 573-0180 (U.S. and Canada) or (430) 775-1345 (international) and referencing conference ID 90858811. To access the live webcast or the replay, visit the investor page of the Company’s website at http://ir.zynerba.com/. The webcast will be recorded and available on the Company’s website for 30 days.

About Fragile X syndrome
Fragile X syndrome is an autism spectrum disorder affecting 1 in 4,000 males and 1 in 8,000 females. It is the most common inherited intellectual disability in males and a significant cause of intellectual disability in females. It is caused by a mutation in the Fragile X Mental Retardation gene located on the X chromosome and leads to dysregulation of the endocannabinoid pathway including the reduction in endogenous cannabinoids (2-AG and anandamide). The disorder negatively affects synaptic function, plasticity and neuronal connections, and results in a spectrum of intellectual disabilities, social anxiety and memory problems. In the US, there are about 71,000 patients suffering with FXS.

About Our Technology
Cannabinoids are a class of chemical compounds found in the Cannabis plant. The two primary cannabinoids contained in Cannabis are cannabidiol, or CBD, and ∆9-tetrahydrocannabinol, or THC. Clinical and preclinical data support the potential for CBD in treating epilepsy, arthritis and Fragile X Syndrome, and THC has positive effects on treating pain. Zynerba is developing therapeutic medicines that utilize innovative transdermal technologies that, if successful, may allow for sustained and controlled delivery of therapeutic levels of CBD and THC. Transdermal delivery of cannabinoids may have benefits over oral dosing because it allows the drug to be absorbed through the skin directly into the bloodstream. This avoids first-pass liver metabolism, potentially enabling lower dosage levels of active pharmaceutical ingredients with a higher bioavailability and improved safety profile. Transdermal delivery also avoids the gastrointestinal tract, lessening the opportunity for GI related adverse events and the potential degradation of CBD by gastric acid into THC, which may be associated with unwanted psychoactive effects. Using an established chemical pharmaceutical process for manufacturing, Zynerba replicates the CBD and THC found in the Cannabis plant. We believe that this will allow us to meet stringent global regulatory agencies’ standards while ensuring that we can efficiently supply the amount of product required to meet the demand of the large markets that we are targeting.

About ZYN002
Zynerba’s ZYN002 CBD gel is the first and only pharmaceutically-produced CBD formulated as a patent-protected permeation-enhanced gel and is being studied in children with Fragile X Syndrome, osteoarthritis and in adult epilepsy patients with focal seizures. ZYN002 is a clear, permeation-enhanced gel that is designed to provide controlled drug delivery transdermally with once- or twice-daily dosing.

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is dedicated to improving the lives of people with severe health conditions where there is a high unmet medical need by developing and commercializing pharmaceutically-produced transdermal cannabinoid medicines designed to meet the rigorous efficacy and safety standards established by global regulatory agencies. Through the discovery and development of these life-changing medicines, Zynerba seeks to improve the lives of patients battling severe, chronic health conditions including epilepsy, Fragile X syndrome, osteoarthritis, fibromyalgia and peripheral neuropathic pain. Learn more at www.zynerba.com and follow the Company on Twitter at @ZynerbaPharma.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. For example, there can be no guarantee that the Company will obtain approval for ZYN002 or ZYN001 from the U.S. Food and Drug Administration (FDA) or foreign regulatory authorities; even if ZYN002 or ZYN001 are approved, the Company may not be able to obtain the label claims that it is seeking from the FDA. In addition, the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the success, cost and timing of the Company’s product development activities, studies and clinical trials; the success of competing products that are or become available; the Company’s ability to commercialize its product candidates; the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates; and the Company’s expectations regarding its ability to obtain and adequately maintain sufficient intellectual property protection for its product candidates. This list is not exhaustive and these and other risks are described in the Company’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Zynerba Contacts
Jim Fickenscher, CFO and VP Corporate Development
484.581.7483
fickenscherj@zynerba.com

Will Roberts, VP Investor Relations and Corporate Communications
484.581.7489
robertsw@zynerba.com

Media contact
Theresa Dolge
Tonic Life Communications
Office: 215-928-2748
Theresa.Dolge@toniclc.com

Thursday, September 28th, 2017 Uncategorized Comments Off on $ZYNE Positive Top Line Results in ZYN002 Open Label Phase 2

$AMMA Acquires Victory Fighting Championship

NEW YORK

Heartland mixed martial arts leader becomes top acquisition to date

Alliance MMA, Inc. (“Alliance MMA” or the “Company”) (NASDAQ:AMMA), the only publicly-traded mixed martial arts (MMA) company, unifying elite regional promotions and aspiring MMA champions, announced today it has acquired the assets of Victory Fighting Championship. VFC produces events in Nebraska, Kansas, Iowa, South Dakota and forthcoming shows in Dallas/Ft. Worth – the nation’s 5th largest media market.

On April 14, Yuri Villefort (10-5), right, defeated Kassius Holdorf (10-4), left, for the Victory FC Welterweight title at VFC 56 in Omaha, Nebraska. (Photo Credit: Victory FC / Alliance MMA)

Headquartered in Omaha, Nebraska, VFC has produced more than 60 live MMA events since its founding in 2002. The Midwest’s MMA leader also has global distribution, being broadcast exclusively on UFC FIGHT PASS – the Ultimate Fighting Championship’s OTT digital streaming platform which reaches subscribers in more than 155 countries.1

Operated by owner and CEO Ryan Stoddard, VFC has served as the launching pad for former UFC lightweight champion Benson Henderson, as well as UFC standouts Jake Ellenberger, Tecia Torres, Travis Browne, Chris Camozzi, Spencer Fisher, Josh Neer, and many others.

“With this acquisition, we are taking leaps toward achieving goals on multiple fronts,” said Paul Danner, Chief Executive Officer of Alliance MMA. “VFC’s organizational footprint, in terms of scale and distribution on UFC FIGHT PASS, provides an incredible opportunity for Alliance MMA to produce content – including live content – that fans want to see.

“In addition, as we continue to pursue a presence in all the right geographies, we will build upon VFC’s rock-solid foundation. Under the leadership of Ryan Stoddard, whose vision of expansion aligns with ours, we feel VFC’s unique brand of entertainment and proven quality can best translate to several new cities in the near future.”

“We at Victory are excited to join Alliance MMA, which promises to strengthen our promotion in many ways including access to an expanded slate of superlative venues,” said Ryan Stoddard, General Manager of Victory Fighting Championship. “I believe in the ascendant business model of Alliance MMA and felt this offered the most rewarding outcome both for our promotion and for fighters interested to climb the ladder to get to the majors.”

VFC joins Alliance MMA’s growing umbrella of regional promotions, operating in 13 of the top 30 Nielsen Designated Market Areas (DMA), including each of the top five. With the goal of unifying elite regional promotions and fostering the development of aspiring MMA champions, Alliance MMA also promotes MMA events through New Jersey-based Cage Fury Fighting Championship (CFFC), Washington-based Combat Games MMA (COGA), Illinois-based Hoosier Fight Club (HFC), Tennessee-based V3Fights, Maryland-based Shogun Fights, Ohio-based Iron Tiger Fight Series, Florida-based Fight Time Promotions, Georgia-based National Fighting Championship (NatFight), and Southern California-based SoCa Fights.

About Alliance MMA, Inc.

Alliance MMA (NASDAQ: AMMA) is a professional mixed martial arts (MMA) company that brings together the best regional productions. Alliance MMA’s mission is to identify and cultivate the next generation of fighters and champions for the Ultimate Fighting Championship (UFC) and other premier MMA promotions.

With some of the world’s leading MMA promotions under the Alliance MMA umbrella, the organization aims eventually to host in excess of 125 events per year, showcasing more than 1,000 fighters. Alliance MMA is also dedicated to generating live original sports media content, attracting an international fan base, and securing major brand sponsorship revenue for live MMA events, digital media, and Alliance MMA fighters.

MMA is the world’s fastest-growing sport with worldwide fans of approximately 300 million according to sports marketing research firm Repucom. MMA is a full contact sport that allows a wide range of fighting techniques, including striking and grappling from various martial arts and disciplines including Boxing, Wrestling, Brazilian Jiu Jitsu, Karate, and Muay Thai. Professional MMA fights are legal and regulated by state athletic commissions in all 50 states.

Alliance MMA, Inc. was incorporated in 2015 for the purpose of acquiring businesses that engage in the promotion of mixed martial arts (MMA) events. In 2016, the company completed an initial public offering that culminated in a listing on the NASDAQ stock exchange. Alliance MMA is the only mixed martial arts promotion company that is publicly-traded.

For more information, visit www.alliancemma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws. These statements relate to anticipated future events, future results of operations or future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “might,” “will,” “should,” “intends,” “expects,” “plans,” “goals,” “projects,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” or “continue” or the negative of these terms or other comparable terminology. Actual results may differ materially from historical results or those indicated by these forward-looking statements as a result of a variety of factors including, but not limited to, those discussed under the heading “Risk Factors” in our registration statement on Form S-1 (Registration No. 333-213166) declared effective by the Securities and Exchange Commission on September 2, 2016. Alliance MMA encourages you to review other factors that may affect its future results in Alliance MMA’s registration statement and in its other filings with the Securities and Exchange Commission.

Footnotes:
1. http://www.ufc.com/news/ufc-fight-pass-incivta-deal

 

Alliance MMA, Inc.
Media:
Matt Cassidy, 484-340-2871
mcassidy@alliancemma.com
or
Investors:
James Platek, 212-739-7825
jplatek@alliancemma.com

Thursday, September 28th, 2017 Uncategorized Comments Off on $AMMA Acquires Victory Fighting Championship

$CIIX Again Names Paul Dickman as CFO, Pursues Exploding $7.2 Billion Legal Cannabis Market

September 28, 2017

  • CIIX is pursuing the $7.2 billion legal cannabis market with hemp-based cannabidiol (CBD) products; CIIX showed a 76% year-over-year operating revenues gain in FY2017
  • Dickman previously served as CFO from 2010-2016; Warren Wang, CIIX’s CEO, said Dickman will “build an infrastructure that supports long-term growth”
  • CIIX has plans to launch a hemp-based line of skin care products in China by year-end 2017 and is already marketing a line of hemp-infused cannabidiol products, “OptHemp,” through its U.S. subsidiary

ChineseInvestors.com, Inc. (OTCQB: CIIX) announced in an 8K SEC filing (http://nnw.fm/UA4wB) that Paul Dickman has returned as its chief financial officer, effective September 25, 2017. He served earlier as CFO of the company from July 2010 through October 2016. In his new position, he remains on the company’s board of directors and, as CFO, will now also be responsible for leading CIIX’s financial operations as well as instituting the company’s financial plan and strategies.

CIIX is aggressively pursuing the $7.2 billion legal cannabis market (http://nnw.fm/S17sa) with hemp-based cannabidiol (CBD) products targeted at the global Chinese-speaking community. By the end of 2017, it plans to market a hemp-infused skin care line in China through its CBD Biotechnology Co., Ltd. subsidiary. It is already marketing its OptHemp line of hemp oil-based products through its U.S. subsidiary, ChineseHempOil.com, Inc.

CIIX’s goal is to become the primary Chinese publicly traded company offering real-time financial information on its website. It conducts research & development on cannabidiol, as well as providing global retail distribution to the Chinese-speaking community. It has an online store based in the free trade zone of Shanghai, China, and plans to open a brick-and-mortar unit in San Gabriel, California. It markets hemp-based, legalized cannabidiol and other health products as well as planning the debut of a subscription website which will have the latest news on cryptocurrencies, such as bitcoin.

CIIX’s year-over-year operating revenues grew by 76% in FY2017. The consumer market for hemp-derived cannabidiol products is projected to grow at a 55% compound annual growth rate (CAGR) from $170 million in 2016 to $1 billion within three years (http://nnw.fm/oApL5). Consilium Global Research projects that CIIX sales will reach $14.8 million by FY2020, skyrocketing at a CAGR of nearly 100% (http://nnw.fm/73IRz). It also projects that the global CBD industry will reach $2.1 billion in consumer sales by 2020, propelled by a CAGR of about 80%.

“We are incredibly fortunate that Paul has agreed to return as our Chief Financial Officer,” Warren Wang, founder and CEO of CIIX, stated in a news release. “We look forward to his contributions in the financial and contractual management of the Company’s growth. Moreover, Paul shares our passion for excellence, innovation and entrepreneurial thinking. I am confident that Paul will serve effectively as our CFO just as he did in the past, helping us to build an infrastructure that supports long-term growth.”

For more information, visit the company’s website at www.ChineseInvestors.com

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Thursday, September 28th, 2017 Uncategorized Comments Off on $CIIX Again Names Paul Dickman as CFO, Pursues Exploding $7.2 Billion Legal Cannabis Market