Archive for June, 2017

$FSC is Engaged in Strategic Discussions

GREENWICH, CT, June 30, 2017  — Fifth Street Asset Management, Inc. (NASDAQ:FSAM) (“FSAM”) is in discussions regarding a potential sale transaction regarding its BDC investment advisory business, which includes the management of Fifth Street Finance Corp. (NASDAQ:FSC) and Fifth Street Senior Floating Rate Corp. (NASDAQ:FSFR).

No definitive agreement has been reached and there can be no assurance that any transaction will result from these discussions.  FSAM does not intend to comment further at this time and any additional statements will be made if and when appropriate.

About Fifth Street Asset Management Inc.

Fifth Street Asset Management Inc. (NASDAQ:FSAM) is a nationally recognized credit-focused asset manager. The firm has approximately $5 billion of assets under management across two publicly-traded business development companies, Fifth Street Finance Corp. (NASDAQ:FSC) and Fifth Street Senior Floating Rate Corp. (NASDAQ:FSFR), as well as multiple private investment vehicles. The Fifth Street platform provides innovative and customized financing solutions to small and mid-sized businesses across the capital structure through complementary investment vehicles and co-investment capabilities. With a nearly 20-year track record focused on disciplined credit investing across multiple economic cycles, Fifth Street is led by a seasoned management team that has issued billions of dollars in public equity, private capital and public debt securities. Fifth Street’s national origination strategy, proven track record and established platform have allowed the firm to surpass $10 billion of loan commitments since inception. For more information, please visit fsam.fifthstreetfinance.com.

Forward-Looking Statements

This press release may contain, and certain oral statements made by our representatives from time to time may contain, forward-looking statements, because they relate to future events or our future performance or financial condition. Forward-looking statements may include the potential for a transaction, statements as to the fees charged by FSAM to FSC and FSFR, FSAM’s future operating results, dividends by FSAM and business prospects of FSAM.  Words such as “believes,” “expects,” “seeks,” “plans,” “should,” “estimates,” “project,” and “intend” indicate forward-looking statements, although not all forward-looking statements include these words. These forward-looking statements involve risks and uncertainties. Actual results could differ materially from those implied or expressed in these forward-looking statements for any reason.  Such factors are identified from time to time in FSAM’s filings with the Securities and Exchange Commission and include changes in the economy, the financial markets and future changes in laws or regulations, competitive conditions in the business development company space and conditions in FSAM’s operating areas.  FSAM undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

CONTACT:

Investor Contact: 
Robyn Friedman, Executive Director, Head of Investor Relations
(203) 681-3720 
ir-fsam@fifthstreetfinance.com

Media Contact:
James Golden / Aura Reinhard / Andrew Squire 
Joele Frank Wilkinson Brimmer Katcher
(212) 355-4449
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$PPSI Announces New Contract for Liquid-Filled Network Transformers

Estimated Annualized Revenue of Up to $2 Million

FORT LEE, N.J., June 30, 2017  — Pioneer Power Solutions, Inc. (Nasdaq: PPSI) (“Pioneer” or the “Company”), a company engaged in the manufacture, sale and service of electrical transmission, distribution and on-site power generation equipment, today announced it has signed a contract with a large electric utility provider to supply its liquid-filled network transformers. The Company expects the 30-month contract, which became effective June 26, 2017, to generate annualized revenues of up to $2 million through 2019. First shipments are expected to begin in the fourth quarter of 2017.

Nathan Mazurek, Pioneer’s Chairman and Chief Executive Officer, said, “This agreement adds a new, large utility to our customer list. Pioneer continues to benefit from increasing demand for electricity, as well as increased infrastructure spending. This new customer and incremental order is an encouraging win for us, demonstrating our growing presence among major utilities and bolstering our optimism as we look into 2018 and beyond.”

The technologically advanced network transformers will be manufactured by the Company’s Pioneer Transformers Ltd. division, a North American leader in the manufacturing of liquid-filled distribution, small power and specialty transformers, including subway and vault-type network transformers designed to withstand harsh environments. These transformers are typically used by utilities and municipal power authorities in secondary grid applications to ensure reliability of service, enabling electrical grids to continue to withstand major storms or other events. Pioneer has been in the liquid-filled transformer business for over 50 years.

About Pioneer Power Solutions, Inc.

Pioneer Power Solutions, Inc. manufactures, sells and services a broad range of specialty electrical transmission, distribution and on-site power generation equipment for applications in the utility, industrial, commercial and backup power markets. The Company’s principal products and services include custom-engineered electrical transformers, low and medium voltage switchgear and engine-generator sets and controls, complemented by a national field-service organization to maintain and repair power generation assets. Pioneer is headquartered in Fort Lee, New Jersey and operates from 12 additional locations in the U.S., Canada and Mexico for manufacturing, centralized distribution, engineering, sales, service and administration. To learn more about Pioneer, please visit its website at www.pioneerpowersolutions.com.

Safe Harbor Statement:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the Company’s ability to expand its business through strategic acquisitions, (ii) the fact that many of the Company’s competitors are better established and have significantly greater resources, and may subsidize their competitive offerings, (iii) the Company’s dependence on a few large customers for a material portion of its sales, (iv) the potential loss or departure of key personnel (v) the fact that fluctuations between the U.S. dollar and the Canadian dollar will impact the Company’s results, (vi) market acceptance of existing and new products, (vii) the Company’s dependence on a distributor agreement with Generac Power Systems through which its Critical Power segment derives a significant portion of its revenues, (viii) restrictive loan covenants or the Company’s ability to repay or refinance debt under its credit facilities that could limit the Company’s future financing options and liquidity position and may limit the Company’s ability to grow its business, (ix) general economic and market conditions, (x) unanticipated increases in raw material prices or disruptions in supply, (xi) the fact that the Company’s Chairman controls a majority of the Company’s combined voting power, and may have, or may develop in the future, interests that may diverge from yours, (xii) reported material weaknesses in the Company’s internal control over financial reporting, and (xiii) the fact that future sales of large blocks of the Company’s common stock may adversely impact the Company’s stock price. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual and Quarterly Reports on Form 10-K and Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Contact:
Brett Maas, Managing Partner
Hayden IR
(646) 536-7331
brett@haydenir.com

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$DXR Holds Annual Meeting, Provides Business Growth Update and Strategic Plan

NEW YORK, NY–(Jun 29, 2017) – Daxor Corporation, (NYSE MKT: DXR) an investment company with medical instrumentation and biotechnology operations, held its annual meeting on June 27th in New York City, where it briefed investors on its progress in growing its medical technology operating company supplying the Daxor BVA-100 blood volume analysis device.

At the meeting, President and CEO Michael Feldschuh briefed shareholders, stating, “We have seen important and dramatic results for patients through the use of our device, notably the 89% lower 30-day mortality and 52% lower 30-day readmissions versus benchmarks reported in acute heart failure at ACC 2016.” The referenced study of 250 patients was presented by Drs John Strobeck and Wayne Miller and highlights the potential impact of individualized care guided by blood volume analysis on outcomes for the estimated 1 million heart failure patients hospitalized each year in the U.S. as well as on the forecasted growth in the resource utilization burden.

Daxor also announced that its device is being incorporated into an upcoming multicenter international clinical trial by a major pharmaceutical company that is slated to start this summer. The inclusion of Daxor’s technology in that trial, as well as confidential pending enquiries from other drug makers regarding the use of the device were cited during the meeting as strong indications of the value of the technology and rising recognition of the importance of understanding the volume effects of drugs in patient populations.

A BVA-100 device was announced as having been acquired on June 26th by the Uniformed Services University of Health Sciences. Feldschuh stated that the company is working closely with “a number of Department of Defense research groups” on optimizing the role of blood volume analysis, entailing the placement of several devices, as the armed forces focuses on improving the care of soldiers through precision medicine and individualized care. In a similar vein, efforts at obtaining government grants for further development of Daxor’s technology are in the works, and the company is working toward its next generation technology to improve the speed and usability of its device.

Further research and development of the company’s growing patent portfolio was also discussed in the meeting. In addition to patents received last year for total body albumin measurements, provisional patents the company has recently filed as well as several patents currently being devised were also mentioned as priority initiatives at the company.

Progress in driving utilization of the device at the base of over 55 hospitals where the company has placed devices was discussed, as well as progress in reducing costs associated with each unit sold by over 50% over the past 18 months, were cited during discussion of improvements in the sales process.

Shareholders asked questions regarding the philosophy of the company toward further partnerships and mergers. Management cited strategic alliances as a priority for the company as it builds its assets, both in the field via the growth of the install base and in the intellectual property and know-how that make Daxor a leader in the field of blood volume measurement and its successful application to improve patient care.

Feldschuh closed out his opening remarks by stating, “Healthcare is moving toward individualized care, and results/reimbursement matter in this value-conscious environment. Our time for this test has come as crucial elements align and come together with our renewed focus and strategy.”

Daxor’s device is widely considered the gold standard of blood volume measurement and the is only device capable of delivering direct, 98% accurate volume and red blood cell status via a swift (under 90 minutes), non-invasive test in the clinical setting.

Daxor Corporation manufactures and markets the BVA-100 Blood Volume Analyzer, which is used in conjunction with Volumex, Daxor’s single-use diagnostic kit. For more information regarding BVA and the Daxor BVA-100, visit Daxor’s website at www.Daxor.com.

Daxor contact information:
Soren Thompson
Vice President Business Development
212-330-8502
sthompson@daxor.com

Lisa Quartley
Senior Vice President, Marketing and Commercial Development
212-330-8518
lquartley@daxor.com

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$NXE Announces Additional US$110 Million Financing with CEF Holdings

VANCOUVER, June 30, 2017 – NexGen Energy Ltd. (“NexGen” or the “Company“) (TSX:NXE, NYSE MKT:NXE) is pleased to announce that it has entered into a binding term sheet with CEF Holdings Limited (“CEF“) for a second financing package totalling US$110 million, comprising:

(a) US$50 million of common shares of NexGen (the “Placement Shares“); and
(b) US$60 million aggregate principal amount of unsecured convertible debentures (the “New Debentures“).

The US$50 million placement will result in the issuance of approximately 24.1 million Placement Shares at a price of C$2.70 (US$2.07 at an exchange rate of 1.3060) per Placement Share representing the 20-day VWAP of the Company’s common shares (the “Common Shares“). The New Debentures will be convertible at the holder’s option into Common Shares at a conversion price (the “Conversion Price“) of C$3.52 (US$2.69 at an exchange rate of 1.3060), equal to a 30% premium to the 20-day VWAP of the Common Shares. The “20-day VWAP” was calculated as the volume weighted average trading price of the Common Shares on the Toronto Stock Exchange (the “TSX“) for the 20 trading days ending on the day prior to the date of execution of the binding term sheet, converted into US$ using the C$-US$ daily average rate of exchange published by the Bank of Canada for each relevant date.

In connection with the financing, the Company and CEF have also agreed to extend the maturity date of the existing US$60 million aggregate principal amount of unsecured convertible debentures (the “Existing Debentures“) to match the maturity date of the New Debentures as well as certain other non-financial amendments including the strategic alignment provisions described below.

Leigh Curyer, Chief Executive Officer of NexGen commented: “We are thrilled to build on the partnership between NexGen and CEF, which formally commenced just 12 months ago with the initial investment of US$60 million. This financing represents a very strong alignment between NexGen and CEF and funds the Company to expedite the optimal development of Arrow.”

“Our investment today builds on the shared long-term vision and close strategic partnership with NexGen,” said CEF’s Chief Executive Officer, Warren Gilman.  “NexGen continues to deliver on all its objectives as it develops Arrow.  We are excited at the opportunity to support the Company in its goal of maximizing shareholder value by optimizing the development of Arrow which is proving to be one of the best mineral assets we’ve encountered.”

The Existing Debentures, Placement Shares and New Debentures are expected to be held by CEF (Capital Markets) Limited, a wholly-owned subsidiary of CEF (as to US$20 million principal amount of Existing Debentures, US$25 million of the Placement Shares and US$20 million principal amount of New Debentures); and holding companies (the “Li Investor“) of which each of Messrs. Li Ka Shing and his son Victor Li are entitled to exercise, or control the exercise of, one-third or more of the voting power at general meetings (as to the balance of Existing Debentures, Placement Shares and New Debentures).  CEF (Capital Markets) Limited and the Li Investor are collectively referred to below as the “Investors”.

The Terms

The New Debentures will carry a 7.5% coupon (the “Interest“) over a 5-year term.  The New Debentures will be convertible at the holder’s option into Common Shares at the Conversion Price of C$3.52 (US$2.69 at an exchange rate of 1.3060), equal to a 30% premium to the 20-day VWAP ending on the day prior to the date of execution of the binding term sheet.

The Company will be entitled, on or after the third anniversary of the date of the issuance of the New Debentures, at any time that the 20-day VWAP exceeds 130% of the Conversion Price, to redeem the New Debentures at par plus accrued and unpaid Interest.

Two-thirds of the Interest (equal to 5% per annum) is payable in cash. One-third of the Interest (equal to 2.5% per annum) is payable in Common Shares issuable at a price equal to the 20-day VWAP on either the TSX or NYSE MKT (whichever has the greatest trading volume of Common Shares) ending on the day prior to the date such Interest payment is due.

Strategic Alignment Provisions

In consideration for the increased investment in NexGen, the Company and the Investors will enter into an investor rights agreement (the “Investor Rights Agreement“). The Investor Rights Agreement will provide for the following:

(a) For so long as they hold at least 10% of the Common Shares (on a partially diluted basis), the Investors will agree (i) not to tender or agree to tender (or convert) the New Debentures or the Existing Debentures or any Common Shares they hold to an unsolicited takeover bid, (ii) to exercise the votes attached to all Common Shares they hold in respect of any change of control transaction, and deposit or tender such Common Shares, in accordance with the recommendation of the Company’s Board of Directors (the “Board“), (iii) to withhold votes in respect of any Common Shares they hold in respect of the election of individuals to the Board who are not nominees of management, and (iv) in respect of non-change of control matters, not to exercise the votes attached to any Common Shares they hold contrary to the recommendation of the Board;
(b) For so long as they hold at least 10% of the Common Shares (on a partially diluted basis), the Investors will agree to a standstill whereby they will, among other things, not acquire any securities of the Company or solicit proxies or otherwise attempt to influence the conduct of security holders of the Company;
(c) For so long as they hold at least 10% of the Common Shares (on a partially diluted basis), the Investors will be subject to restrictions on disposition applicable to any Common Shares they hold, consisting of giving prior notice to the Company of any proposed disposition of more than 0.5% of the number of Common Shares then outstanding and either: (i) disposing of such Common Shares to specific willing investors identified by the Company within a 7-day period; or (ii) disposing of such Common Shares either through a broad distribution on the public markets or in a private transaction or block trade to anyone other than specific investors identified by the Comany within the 7-day period; and
(d) For so long as they hold at least 15% of the Common Shares (on a partially diluted basis), the Investors will have the right to nominate one director to the Board.

Use of Proceeds

Including the proceeds from this financing, NexGen will have cash reserves of approximately C$200 million. Proceeds from the financing will be used to fund the continuing exploration and development of the Company’s SW2 properties (which includes the Rook 1 project) and for general corporate purposes.

Approval

The financing is subject to the satisfaction of customary closing conditions, including regulatory approval, the completion of definitive documentation, there being no material adverse change in the business of the Company, or a major event of national or international consequence that disrupts the financial markets or the business, operations or affairs of the Company.

Advisors

TD Securities Inc. is acting as financial advisor and lead placement agent to NexGen and CIBC World Markets Inc. is acting as financial advisor to CEF.

This news release shall not constitute an offer to sell or a solicitation of any offer to buy any securities, nor shall there be any sale of any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. The securities referenced herein have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act“), and such securities may not be offered or sold within the United States absent registration under the U.S. Securities Act or an applicable exemption from the registration requirements thereunder.

Early Warning Disclosure

This portion of the news release is issued pursuant to National Instrument 62-103 – The Early Warning System and Related Take-Over Bid and Insider Reporting Issues (“NI 62-103“) of the Canadian Securities Administrators, which also requires an early warning report to be filed with the applicable securities regulators containing additional information with respect to the foregoing matters.  A copy of the early warning report of the Li Investor will be available on NexGen’s issuer profile on SEDAR at www.sedar.com.

Following completion of this financing, the Li Investor will hold: (a) an aggregate of 13,903,461 Common Shares, representing approximately 4.2% of the issued and outstanding Common Shares; (b) US$40 million aggregate principal amount of Existing Debentures; and (c) US$40 million aggregate principal amount of New Debentures.  For the Placement Shares that partially gave rise to the early warning reporting requirements, the Li Investor paid C$2.70 per share and C$32.597 million in aggregate. Immediately before this financing, the Li Investor holds 1,250,735 Common Shares, representing approximately 0.4% of the issued and outstanding Common Shares as well as US$40 million aggregate principal amount of the Existing Debenture. The Li Investor does not have any present intention to acquire ownership of, or control over, additional securities of NexGen, other than pursuant to the terms of the New Debentures and Existing Debentures and the placement fee owing in connection with this financing which will be paid in Common Shares at closing. It is the intention of the Li Investor to evaluate its investment in NexGen on a continuing basis and such holdings may be increased or decreased in the future, subject to the strategic alignment provisions. For the purposes of NI62-103 the head office address of the Li Investor is East Asia Chambers, P.O. Box 901, Road Town, Torotola, British Virgin Islands and the head office address of the Company is 3150 – 1021 West Hastings Street, Vancouver BC Canada V6E 0C3.

About CEF Holdings Limited

CEF Holdings Limited is owned 50% by CK Hutchison Holdings Ltd. and 50% by the Canadian Imperial Bank of Commerce (“CIBC“). CK Hutchison Holdings is the publicly-listed flagship company of the CK Hutchison Group of companies, the Hong Kong based multi-national conglomerate with the combined market cap of the Group in excess of US$100 billion. CIBC is a leading North American financial institution with operations around the world. CEF is an investor in significant resource assets on a global basis.

About NexGen

NexGen is a British Columbia corporation with a focus on the acquisition, exploration and development of Canadian uranium projects. NexGen has a highly experienced team of uranium industry professionals with a successful track record in the discovery of uranium deposits and in developing projects through discovery to production.

NexGen owns a portfolio of prospective uranium exploration assets in the Athabasca Basin, Saskatchewan, Canada, including a 100% interest in Rook I, location of the Arrow Discovery in February 2014 and Bow Discovery in March 2015 and the Harpoon discovery in August 2016. The Arrow deposit’s updated mineral resource estimate with an effective date of December 20, 2016 was released in March 2017, and comprised 179.5 M lbs U3O8 contained in 1.18 M tonnes grading 6.88% U3O8 in the indicated mineral resource category and an additional 122.1 M lbs U3O8 contained in 4.25 M tonnes grading 1.30% U3O8 in the inferred mineral resource category.

All scientific and technical information in this news release has been prepared by or reviewed and approved by Mr. Garrett Ainsworth, P.Geo., Vice President – Exploration & Development for NexGen. Mr. Ainsworth is a qualified person for the purposes of National Instrument 43-101 – Standards of Disclosure for Mineral Projects (“NI 43-101“) of the Canadian Securities Administrators, and has verified the sampling, analytical, and test data underlying the information or opinions contained herein by reviewing original data certificates and monitoring all of the data collection protocols. For details of the Rook I Project including the quality assurance program and quality control measures applied and key assumptions, parameters and methods used to estimate the mineral resource set forth herein please refer to the technical report entitled “Technical Report on the Rook 1 Property, Saskatchewan, Canada” dated effective March 31, 2017 (the “Rook 1 Technical Report“) prepared by Mark B. Mathisen and David A. Ross, each of whom is a “qualified person” under NI 43-101. The Rook I Technical Report is available on NexGen’s issuer profile on SEDAR at www.sedar.com.

U.S. investors are advised that while the terms “indicated resources” and “inferred resources” are recognized and required by Canadian regulations, the U.S. Securities and Exchange Commission does not recognize these terms. U.S. investors are cautioned not to assume that any part or all of the material in these categories will ever be converted into mineral reserves.

Forward-Looking Information

The information contained herein contains “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of applicable Canadian securities legislation. “Forward-looking information” includes, but is not limited to, statements with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, including, without limitation, the completion of the proposed financing, the use of proceeds from the financing described in this news release, and the receipt of all required regulatory approvals, including of the TSX and the NYSE MKT. Generally, but not always, forward-looking information and statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes” or the negative connotation thereof or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved” or the negative connotation thereof.

Forward-looking information and statements are based on the then current expectations, beliefs, assumptions, estimates and forecasts about NexGen’s business and the industry and markets in which it operates. Forward-looking information and statements are made based upon numerous assumptions, including among others, that the proposed transaction will be completed, the results of planned exploration activities are as anticipated, the price of uranium, the cost of planned exploration activities, that financing will be available if and when needed and on reasonable terms, that third party contractors, equipment, supplies and governmental and other approvals required to conduct NexGen’s planned exploration activities will be available on reasonable terms and in a timely manner and that general business and economic conditions will not change in a material adverse manner. Although the assumptions made by the Company in providing forward looking information or making forward looking statements are considered reasonable by management at the time, there can be no assurance that such assumptions will prove to be accurate.

Forward-looking information and statements also involve known and unknown risks and uncertainties and other factors, which may cause actual results, performances and achievements of NexGen to differ materially from any projections of results, performances and achievements of NexGen expressed or implied by such forward-looking information or statements, including, among others, negative operating cash flow and dependence on third party financing, uncertainty of the availability of additional financing, the risk that pending assay results will not confirm previously announced preliminary results, imprecision of mineral resource estimates, the appeal of alternate sources of energy and sustained low uranium prices, aboriginal title and consultation issues, exploration risks, reliance upon key management and other personnel, deficiencies in the Company’s title to its properties, uninsurable risks, failure to manage conflicts of interest, failure to obtain or maintain required permits and licenses, changes in laws, regulations and policy, competition for resources and financing, specific risks relating to the negotiation and execution of the definitive agreements for the financing, the use of proceeds from the financing, the satisfaction of each party’s obligations in accordance with the terms of the definitive agreements for the financing; failure to receive any required regulatory approvals (including stock exchange) or other approvals, and other factors discussed or referred to in the Company’s Annual Information Form dated March 31, 2017 under “Risk Factors“.

Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in the forward-looking information or implied by forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended.

There can be no assurance that forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking statements or information. The Company undertakes no obligation to update or reissue forward-looking information as a result of new information or events except as required by applicable securities laws.

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$IPCI FDA Advisory Committee Meeting for Rexista

TORONTO, June 30, 2017 — Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:IPCI) (“Intellipharmaceutics” or the “Company”), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (“FDA”) has been scheduled for July 26, 2017 to review the Company’s New Drug Application (“NDA”) for RexistaTM abuse-deterrent oxycodone hydrochloride extended release tablets.

The Company’s NDA submission for RexistaTM was accepted for review by the FDA on February 2, 2017.  The FDA set a target action date under the Prescription Drug User Fee Act (“PDUFA”) of September 25, 2017.  RexistaTM is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.  The submission is supported by pivotal pharmacokinetic studies that demonstrated that RexistaTM is bioequivalent to OxyContin® (oxycodone hydrochloride extended release). The submission also includes abuse-deterrent studies conducted to support abuse-deterrent label claims, having reference to the FDA’s “Abuse-Deterrent Opioids — Evaluation and Labeling” guidance published in April 2015.

The CEO of Intellipharmaceutics, Dr. Isa Odidi, said, “We are very pleased with the progress made towards our goal of securing FDA approval of our RexistaTM NDA candidate.  We look forward to sharing our data and discussing Rexista™ with the members of the Advisory Committees, and in continuing to work closely with the FDA through the review process.”

The abuse-deterrent properties incorporated into RexistaTM are designed to make the product unlikable and discourage or make it more difficult to manipulate for the purpose of abuse or misuse.  If approved, RexistaTM may be the only abuse-deterrent oxycodone product with properties that may provide early warning of drug abuse if the product is manipulated or abused. The Company previously announced the results of a food effect study which showed that RexistaTM can be administered with or without a meal (i.e., no food effect), providing another point of differentiation from currently marketed oral oxycodone extended release products.

There can be no assurance that we will not be required to conduct further studies for RexistaTM, that the FDA will ultimately approve the NDA for the sale of RexistaTM in the U.S. market, or that it will ever be successfully commercialized.

More About RexistaTM

Our RexistaTM (abuse deterrent oxycodone hydrochloride extended release tablets) NDA product candidate is intended as an abuse and alcohol-deterrent controlled-release oral formulation of oxycodone hydrochloride for the relief of pain. The RexistaTM long-acting formulation of oxycodone is intended to present a significant barrier to tampering when subjected to various forms of physical and chemical manipulation commonly used by abusers. It is also designed to prevent dose dumping when inadvertently co-administered with alcohol. Dose dumping is the rapid release of an active ingredient from a controlled-release drug into the blood stream that can result in increased toxicity, side effects, and a loss of efficacy. Dose dumping can result by consuming the drug through crushing, taking with alcohol, extracting with other beverages, vaporizing or injecting. In addition, when crushed or pulverized and hydrated, the proposed extended release formulation is designed to coagulate instantaneously and entrap the drug in a viscous hydrogel, which is intended to prevent syringing, injecting and snorting. Our RexistaTM formulation is difficult to abuse through the application of heat or an open flame, making it difficult to inhale the active ingredient from burning. Our RexistaTM formulation contains a blue dye that is emitted once the tablet is tampered with or crushed, and may act as a deterrent to a user who attempts to abuse it orally or via the intra-nasal route.

About Intellipharmaceutics

Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company’s patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products (some of which have received FDA approval) and product candidates in various stages of development, including Abbreviated New Drug Applications (“ANDAs”) filed with the FDA (and one Abbreviated New Drug Submission filed with Health Canada) in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.

Intellipharmaceutics also has NDA 505(b)(2) specialty drug product candidates in its development pipeline. These include Rexista, an abuse deterrent oxycodone based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin™ XR (pregabalin extended-release capsules). Our current development effort is increasingly directed towards improved difficult-to-develop controlled-release drugs which follow an NDA 505(b)(2) regulatory pathway. The Company has increased its research and development emphasis towards new product development, facilitated by the 505(b)(2) regulatory pathway, by advancing the product development program for both Rexista and Regabatin™. The 505(b)(2) pathway (which relies in part upon the approving agency’s findings for a previously approved drug) both accelerates development timelines and reduces costs in comparison to NDAs for new chemical entities. An advantage of our strategy for development of NDA 505(b)(2) drugs is that our product candidates can, if approved for sale by the FDA, potentially enjoy an exclusivity period which may provide for greater commercial opportunity relative to the generic ANDA route.

Cautionary Statement Regarding Forward-Looking Information

Certain statements in this document constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and/or “forward-looking information” under the Securities Act (Ontario). These statements include, without limitation, statements expressed or implied regarding our plans, goals and milestones, status of developments or expenditures relating to our business, plans to fund our current activities, statements concerning our partnering activities, health regulatory submissions, strategy, future operations, future financial position, future sales, revenues and profitability, projected costs and market penetration. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “expects”, “plans”, “plans to”, “anticipates”, “believes”, “estimates”, “predicts”, “confident”, “prospects”, “potential”, “continue”, “intends”, “look forward”, “could”, or the negative of such terms or other comparable terminology. We made a number of assumptions in the preparation of our forward-looking statements. You should not place undue reliance on our forward-looking statements, which are subject to a multitude of known and unknown risks and uncertainties that could cause actual results, future circumstances or events to differ materially from those stated in or implied by the forward-looking statements. Risks, uncertainties and other factors that could affect our actual results include, but are not limited to, the effects of general economic conditions, securing and maintaining corporate alliances, our estimates regarding our capital requirements and the effect of capital market conditions and other factors, including the current status of our product development programs, on capital availability, the estimated proceeds (and the expected use of any proceeds) we may receive from any offering of our securities,  the potential dilutive effects of  any future financing, our ability to maintain compliance with the continued listing requirements of the principal markets on which our securities are traded, our programs regarding research, development and commercialization of our product candidates, the timing of such programs, the timing, costs and uncertainties regarding obtaining regulatory approvals to market our product candidates and the difficulty in predicting the timing and results of any product launches, the timing and amount of profit-share payments from our commercial partners, and the timing and amount of any available investment tax credits the actual or perceived benefits to users of our drug delivery technologies, products and product candidates as compared to others, our ability to establish and maintain valid and enforceable intellectual property rights in our drug delivery technologies, products and product candidates, the scope of protection provided by intellectual property for our drug delivery technologies, products and product candidates, the actual size of the potential markets for any of our products and product candidates compared to our market estimates, our selection and licensing of products and product candidates, our ability to attract distributors and/or commercial partners with the ability to fund patent litigation and with acceptable product development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts, sources of revenues and anticipated revenues, including contributions from distributors and commercial partners, product sales, license agreements and other collaborative efforts for the development and commercialization of product candidates, our ability to create an effective direct sales and marketing infrastructure for products we elect to market and sell directly, the rate and degree of market acceptance of our products, delays in product approvals that may be caused by changing regulatory requirements, the difficulty in predicting the timing of regulatory approval and launch of competitive products, the difficulty in predicting the impact of competitive products on volume, pricing, rebates and other allowances, the inability to forecast wholesaler demand and/or wholesaler buying patterns, the seasonal fluctuation in the numbers of prescriptions written for our Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules, which may produce substantial fluctuations in revenues, the timing and amount of insurance reimbursement regarding our products, changes in laws and regulations affecting the conditions required by the FDA for approval, testing and labeling of drugs including abuse or overdose deterrent properties, and changes affecting how opioids are regulated and prescribed by physicians, changes in laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products, changes in U.S. federal income tax laws currently being considered, including, but not limited to, the U.S. changing the method by which foreign income is taxed and resulting changes to the passive foreign investment company laws and regulations which may impact our shareholders, the success and pricing of other competing therapies that may become available, our ability to retain and hire qualified employees, the availability and pricing of third-party sourced products and materials, challenges related to the development, commercialization, technology transfer, scale-up, and/or process validation of manufacturing processes for our products or product candidates, the manufacturing capacity of third-party manufacturers that we may use for our products, potential product liability risks, the recoverability of the cost of any pre-launch inventory should a planned product launch encounter a denial or delay of approval by regulatory bodies, a delay in commercialization, or other potential issues, the successful compliance with FDA, Health Canada and other governmental regulations applicable to us and our third party manufacturers’ facilities, products and/or businesses, our reliance on commercial partners, and any future commercial partners, to market and commercialize our products and, if approved, our product candidates, difficulties, delays, or changes in the FDA approval process or test criteria for ANDAs and NDAs challenges in securing final FDA approval for our product candidates, including RexistaTM in particular, if a patent infringement suit is filed against us, with respect to any particular product candidates (such as in the case of RexistaTM), which could delay the FDA’s final approval of such product candidates, healthcare reform measures that could hinder or prevent the commercial success of our products and product candidates, the FDA may not approve requested product labeling for our product candidate(s) having abuse-deterrent properties targeting common forms of abuse (oral, intra-nasal and intravenous), risks associated with cyber-security and the potential for vulnerability of our digital information or the digital information of a current and/or future drug development or commercialization partner of ours, and risks arising from the ability and willingness of our third-party commercialization partners to provide documentation that may be required to support information on revenues earned by us from those commercialization partners. Additional risks and uncertainties relating to us and our business can be found in the “Risk Factors” section of our latest annual information form, our latest Form 20-F, and our latest Form F-3 (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada and the U.S. which are available on www.sedar.com and www.sec.gov. The forward-looking statements reflect our current views with respect to future events, and are based on what we believe are reasonable assumptions as of the date of this document, and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Trademarks used herein are the property of their respective holders.

Unless the context otherwise requires, all references to “we,” “us,” “our,” “Intellipharmaceutics,” and the “Company” refer to Intellipharmaceutics International Inc. and its subsidiaries.

Company Contact:
Intellipharmaceutics International Inc.
Domenic Della Penna
Chief Financial Officer
416-798-3001 ext. 106
investors@intellipharmaceutics.com

Investor Contact:
ProActive Capital
Kirin Smith
646-863-6519
ksmith@proactivecapital.com
Friday, June 30th, 2017 Uncategorized Comments Off on $IPCI FDA Advisory Committee Meeting for Rexista

$IMNP Provides Update to Proposed Pint Pharma Transaction

NEW YORK, June 29, 2017 — Immune Pharmaceuticals Inc. (NASDAQ: IMNP) (the “Company”) announced today that its oncology subsidiary, Cytovia Inc. (“Cytovia”) has reached substantial agreement on the material terms of a licensing and commercialization agreement of Ceplene® in Latin America with Pint Pharma S.A. (“Pint”), a private specialty pharmaceutical company with extensive experience in the pharmaceutical sector throughout Latin America.  As previously announced by us on April 20, 2017, the Company had entered into a letter of intent with Pint, which provided that the parties would use their best efforts to reach agreement regarding the terms of an exclusive license which would provide Pint the rights to commercialize Ceplene® throughout Latin America, including Argentina, Brazil, Chile, Colombia and Mexico within 60 days. The parties currently anticipate that they will execute a definitive licensing agreement within the next five to seven business days.

The parties have agreed that Pint will be responsible for the registration and commercialization of Ceplene® in Latin American countries, and that Pint will base its registration application on the existing European marketing authorization for Ceplene®. Commercialization activities include registration, pricing and reimbursement, and sales and marketing activities. The definitive agreements will provide for sales based milestones as well as product supply pricing schedules, which will provide appropriate economics to our subsidiary, Cytovia.

In addition, the parties have agreed to enter into a definitive agreement related to Pint’s commitment to invest $4 million into Cytovia at terms similar to other investors in the same financing round and upon satisfaction of certain conditions precedent. Dr. Massimo Radaelli, Executive Chairman of Pint, will join the board of directors of Cytovia following completion of the investment.

Dr. Daniel Teper commented, “I am pleased to confirm the substantial progress made in this regard and look forward to a partnership with Pint for Latin America markets, which follows our acquisition of the remainder of worldwide Ceplene® rights from Mylan. Our strategic plan is to commercialize Ceplene® in combination with low dose IL-2 in all markets that accept the European registration dossier as a basis for approval.  We also plan to pursue approval of Ceplene® in the United States based on the previously announced global overall survival study, REMAIN”.

“We are very excited about the partnership with Immune and its subsidiary, Cytovia, an emerging global bio-pharmaceutical company focused on the development of immuno-oncology drugs. Providing Ceplene® to patients with Acute Myeloid Leukemia (AML) in the Latin America region is an important milestone and expands Pint’s robust oncology pipeline”, added David Munoz, CEO of Pint.

Currently, Ceplene® is the only drug approved in 30 European countries and Israel for the maintenance of first remission in Acute Myeloid Leukemia (AML). It is administered in combination with interleukin-2 (IL-2). Given the significant unmet need (~10,000 newly diagnosed AML patients a year in Latin America) and no alternative drugs in the remission setting, Pint and Cytovia strongly believe in the importance of launching the combination of Ceplene® and IL-2 in Latin American countries.

About Ceplene®

Ceplene® (histamine dihydrochloride) is administered in conjunction with low dose interleukin-2 (IL-2), for maintenance of first remission in patients with Acute Myeloid Leukemia (AML). It has been shown in clinical studies to prevent leukemic relapses in AML patients in first remission and prolong leukemia-free survival, while maintaining good quality of life during treatment.  Ceplene® acts by enhancing the immunostimulatory effect of IL-2 and countering reactive oxygen species-induced dysfunction and apoptosis of T and NK cells, thereby inducing immune-mediated killing of leukemic cells, providing a strong rationale for this combination therapy. A recent Phase IV study presented at the meeting of the American Association for Cancer Research in 2016 confirmed the safety and efficacy of Ceplene® in the international study that supported European approval.

About Acute Myeloid Leukemia (AML)

AML patients receive intensive induction treatment with chemotherapeutic drugs at diagnosis and typically become free of detectable leukemia, achieving “complete remission.” However, within 1-2 years, the majority (75-80%) of adult patients will experience a relapse of leukemia, with a survival prognosis of 33% in younger patients and 15-20% in patients over 60 years of age. According to the American Cancer Society, there will be approximately 21,380 new cases of AML and 10,590 deaths from AML in the US in 2017. The prognosis following first remission is poor and there are no other effective remission therapies currently available. AML represents an orphan condition with high unmet need.

Forward-Looking Statements

This news release, and any oral statements made with respect to the information contained in this news release, may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal” or the negative of those words or other comparable words to be uncertain and forward-looking. Such forward-looking statements include statements that express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. Forward-looking statements include, among others, statements regarding the Company’s ability to reduce expenses, capitalize on strategic alternatives, develop its assets, and generate value for shareholders. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements.

There can be no assurance that the Company will ever successfully complete its corporate restructuring, or that the Company will be able to reduce expenses, capitalize on strategic alternatives, develop its assets, and generate value for shareholders. In addition, among other risks, there can be no guarantee that the Pint licensing and commercialization agreement or the concomitant investment by Pint will be completed, or if it is completed, that it will close within the anticipated time period or that the expected benefits of these agreements will be realized. Factors that may cause actual results or developments to differ materially include, but are not limited to: the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern; the risks associated with our ability to continue to meet our obligations under our existing debt agreements; the risk that ongoing or future clinical trials will not be successful; the risk that our compounds under development will not receive regulatory approval or achieve significant commercial success; the risk that we will not be able to find a partner to help conduct future trials or commercialize our product candidates on attractive terms, on a timely basis or at all; the risk that our product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later-stage clinical trials; the risk that we will not obtain approval to market any of our product candidates; the risks associated with dependence upon key personnel; the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; and risks associated with our ability to protect our intellectual property. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and our other filings with the U.S. Securities and Exchange Commission.

You are urged to carefully review and consider the disclosures found in our filings, which are available at www.sec.gov or at www.immunepharma.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors. We expressly disclaim any obligation to publicly update any forward-looking statements contained herein (including those relating to the corporate reorganization and exploration of strategic alternatives), whether as a result of new information, future events or otherwise, except as required by law.

Thursday, June 29th, 2017 Uncategorized Comments Off on $IMNP Provides Update to Proposed Pint Pharma Transaction

$TROV Announces Manufacturing Agreement with NerPharMa

SAN DIEGO, June 29, 2017  — Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, today announced it has executed a supplier agreement with NerPharMa, S.r.l., a pharmaceutical manufacturing company and a subsidiary of Nerviano Medical Sciences S.r.l., in Milan, Italy, to manufacture drug product for PCM-075. The agreement covers the clinical and commercial supply of PCM-075 for Trovagene, and includes both Active Pharmaceutical Ingredients (API) and GMP (Good Manufacturing Process) production of capsules.

NerPharMa has previously supplied drug product for PCM-075 in a completed phase 1 study conducted by Nerviano Medical Sciences.  NerPharMa has an established manufacturing process scaled for producing PCM-075 for future clinical studies and commercial use.  Under the terms of the agreement, Trovagene directs NerPharMa to produce GMP-grade PCM-075 drug substance for use in Trovagene’s Phase 1b/2 clinical program and for other related clinical and commercial activities. Trovagene is developing PCM-075, a polo-like kinase 1 (PLK1) inhibitor, and plans to initiate a Phase 1b/2 clinical trial in patients with acute myeloid leukemia (AML).

“This contract represents a significant step forward for the development of PCM-075,” said Bill Welch, Chief Executive Officer of Trovagene. “We are excited to have a manufacturer of NerPharMa’s caliber and experience producing GMP supply of PCM-075 bulk product and finished capsules. The availability of validated API and the ability to immediately initiate capsule production enables a cost-effective and accelerated start-up of our Phase 1b/2 clinical program.”

NerPharMa’s GMP manufacturing facility is approved by both the Italian Medicines Agency (AIFA), the national authority responsible for drug regulation in Italy, and the U.S. Food and Drug Administration (FDA) for the production of PCM-075.

“We are pleased to be working with Trovagene to manufacture and provide finished product for their investigational and commercial needs,” said Angelo Colombo, CEO of NerPharMa.

About PCM-075

PCM-075 is a highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in several different hematologic malignancies, as well as solid tumors such as breast, prostate, ovarian, lung, gastric and colon cancers. PCM-075 is orally bioavailable and has been explored in an initial Phase 1, open-label, dose-escalation safety study in patients with advanced metastatic solid tumor cancers. In this study, PCM-075 demonstrated an acceptable safety profile, as well as anti-tumor activity. Trovagene plans to initiate clinical trials of PCM-075 in AML, since it has significant advantages over prior PLK1 inhibitors evaluated in this indication, including a higher selectivity, greater potency, oral bioavailability and shorter half-life.

About Nerviano Medical Sciences (NMS)

Nerviano Medical Sciences, part of the NMS Group, is the largest pharmaceutical research and development facility in Italy and one of the largest oncology-focused, integrated discovery and development companies in Europe.

About Trovagene, Inc.

Trovagene is a precision medicine biotechnology company developing oncology therapeutics for improved cancer care by leveraging its proprietary Precision Cancer Monitoring® (PCM) technology in tumor genomics.  Trovagene has broad intellectual property and proprietary technology to measure circulating tumor DNA (ctDNA) in urine and blood to identify and quantify clinically actionable markers for predicting response to cancer therapies.  Trovagene offers its PCM technology at its CLIA/CAP – accredited laboratory and plans to continue to vertically integrate its PCM technology with precision cancer therapeutics.  For more information, please visit https://www.trovagene.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 words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Trovagene’s expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene’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, our need for additional financing; our ability to continue as a going concern; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations.  There are no guarantees that any of our technology or products will be utilized or prove to be commercially successful, or that Trovagene’s strategy to design its liquid biopsy tests to report on clinically actionable cancer genes will ultimately be successful or result in better reimbursement outcomes.  Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful.  Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2016, and other periodic reports filed with the Securities and Exchange Commission.  While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties.  Unlisted factors may present significant additional obstacles to the realization of forward-looking statements.  Forward-looking statements included herein are made as of the date hereof, and Trovagene does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Trovagene Contact:

Vicki Kelemen
VP, Corporate Communications
858-952-7652
vkelemen@trovagene.com

Thursday, June 29th, 2017 Uncategorized Comments Off on $TROV Announces Manufacturing Agreement with NerPharMa

$EIGR Announces Sale of Non-Strategic Assets to Theragene Pharmaceuticals

PALO ALTO, Calif. and SAN DIEGO, June 29, 2017  — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), announced today an agreement to sell to Theragene Pharmaceuticals, Inc., a private biotechnology company, a non-strategic asset, Mydicar® (rAAV1-SERCA2a).  Financial terms of the agreement include a total upfront of $3.1 million in payments from Theragene to Eiger, comprised of $240,000 in upfront cash and expense reimbursement in addition to $2.85 million in Theragene common stock, plus pre-specified clinical and regulatory milestones totaling $15 million, royalties on net sales, and sublicensing and milestone fees.  Theragene has committed to repurchase $1.35 million of the common stock paid to Eiger upon the closing of a financing raise of $4 million or more.  Additional financial terms are not being disclosed.

“We are delighted to have successfully monetized a non-strategic asset at favorable terms with the potential to generate additional monetary value to Eiger over time,” said David Cory, President and CEO of Eiger.  “Building on the significant progress we made in 2017 across our Phase 2 programs, over the coming months we anticipate achieving numerous important value-driving milestones as we continue to advance our proprietary pipeline of therapeutically differentiated product candidates for the treatment of orphan diseases.  We wish Theragene well in their efforts to develop and commercialize Mydicar, and look forward to participating in their potential success.”

“We are excited for the opportunity to advance the clinical development of Mydicar,” said Jon Berglin, CEO of Theragene.  “We firmly believe in the potential of this gene therapy to improve the lives of those with heart disease.  Our gene therapy expertise and strong relationships with the original developers of Mydicar will allow us the best opportunity to successfully and efficiently advance this therapy.”

About Mydicar®
Mydicar® is a novel breakthrough cardiovascular gene therapy product that utilizes rAAV1 (recombinant adeno-associated virus 1) to deliver SERCA2a (sarcoplasmic reticulum Ca2+-ATPase protein) to cardiac myocytes.  SERCA2a is crucial to the normal function of cardiac myocytes.  Preclinical, Phase 1b, and Phase 2a studies have demonstrated safety and efficacy.  Studies were conducted by Celladon Corporation which later merged with Eiger in March 2016.   Although the Phase 2b study design endpoints were not met, safety was proven and overall analysis indicated a trend in favor of therapy.  Further development is indicated.

About Theragene Pharmaceuticals, Inc.
Theragene is a biopharmaceutical company developing cutting-edge science for the treatment of debilitating diseases.  The Company’s diverse portfolio consists of preclinical and clinical oncology and cardiology platforms utilizing next generation gene therapy and immunotherapy methods.

About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to developing and commercializing novel products for the treatment of rare diseases.  The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is identified, and for which an effective therapy is urgently needed.

Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties.  All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements.  These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will” and other words and terms of similar meaning.  Examples of such statements include, but are not limited to, whether Mydicar can be successfully developed and commercialized to generate payments from the Theragene purchase agreement, whether or not pegylated interferon lambda-1a or lonafarnib or ubenimex or exendin 9-39 may be further developed and approved, and whether promising earlier clinical study results will be repeated in larger, later clinical studies, statements relating to the availability of cash for Eiger’s future operations, Eiger’s ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized.  Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the “Risk Factors” sections in the Quarterly Report on Form 10-Q for the three-month period ended March 31, 2017 and other periodic reports filed with the SEC by Eiger.  Eiger does not assume any obligation to update any forward-looking statements, except as required by law.

Investors: Ingrid Choong, PhD., Eiger BioPharmaceuticals, Inc., 650-619-6115,
ichoong@eigerbio.com

Investors: Jon Berglin, CEO, Theragene Pharmaceuticals, Inc., 858-876-4920, Investor@theragenepharma.com

Thursday, June 29th, 2017 Uncategorized Comments Off on $EIGR Announces Sale of Non-Strategic Assets to Theragene Pharmaceuticals

$OBSV Announces Presentations Related to its Assisted Reproductive Technology

ObsEva SA / ObsEva Announces Presentations Related to its Assisted Reproductive Technology (ART) and Pre-term labor (PTL) Development Programs at ESHRE 2017 Annual Meeting . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

Phase 2 nolasiban previously reported data supports potential for meaningfully increasing live birth rates in ART

Non-clinical results of OBE022 for PTL demonstrate both monotherapy/combination potential

Geneva, Switzerland and Boston, MA – 29 June 2017 – ObsEva SA (Nasdaq: OBSV), a Swiss biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today announced it will make presentations at the European Society of Human Reproduction and Embryology (ESHRE) 2017 Annual Meeting, taking place July 2-5 in Geneva, Switzerland. These presentations will include the following:

  • Previously reported post-hoc analysis from the dose-ranging, placebo-controlled, randomized, double-blind, Phase 2 clinical trial (IMPLANT) assessed pregnancy and live birth rates after single oral administration of a novel oxytocin antagonist, nolasiban, prior to embryo transfer (ET). The findings will be presented in an oral presentation (O-024) on Monday July 3rd, 2017 by Professor Herman Tournaye, Principal Investigator at one of the participating clinics, the Centre for Reproductive Medicine at the University of Brussels in Belgium.
    “The results indicate a potential absolute increase of about 10 percent, or greater compared to placebo in pregnancy and live birth rates after administration of a single oral dose of nolasiban before ET. If confirmed in larger prospective trials, this finding has important potential for improving live birth rates following in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI).” concluded Professor Herman Tournaye.
  • Non-clinical pharmacology data showing the activity of PGF2alpha (FP) receptor antagonist, OBE022, on the inhibition of both PGF2alpha- and oxytocin-induced contractions of human pregnant myometrium strips in vitro (Poster presentation P-692, Tuesday July 4th, 2017).
  • In vitro data showing the additive effect of OBE022 on the inhibition of oxytocin-induced contractions of human pregnant myometrium strips when combined with atosiban or nifedipine (Oral presentation O-119, Tuesday July 4th, 2017).

“We are pleased to have the opportunity to present to the medical community, these two sets of data from the development programs of two of our product candidates, nolasiban and OBE022.” said Ernest Loumaye, MD, PhD, OBGYN, CEO and Co-Founder of ObsEva.

“The results of the IMPLANT study with nolasiban, previously reported, show a potential absolute improvement of about 10 percent, or greater in live birth rate in women undergoing assisted reproduction for infertility. This magnitude of improvement, if replicated in our ongoing, 760 patients, Phase 3, IMPLANT-2 clinical trial that we began in March of 2017, could have a significant impact on patients undergoing IVF as currently only about one out of three patients will go home with a baby after an embryo transfer.

The pharmacology data presented for OBE022 are also important as they not only indicate the potential of our compound to treat preterm labor as monotherapy but also displays additive effects with currently available treatments that have limited efficacy. We are utilizing these key data to design the Phase 2 program for OBE022 in pregnant women with preterm labor, which is scheduled to begin later this year.”

About Assisted Reproductive Technology

Infertility affects about 10 percent of reproductive-aged couples, with approximately 1.6 million ART treatments (including IVF and ICSI) performed worldwide each year.

While the success of ART depends on multiple factors such as embryo quality and ET procedure, a successful pregnancy ultimately hinges on the receptivity of the uterus to accept embryo implantation. Uterine contractions at the time of ET, as well as suboptimal thickness of the uterine wall and blood flow to the uterus, may impair the implantation of the embryo.

About Nolasiban

Nolasiban (previously known as OBE001), is an oral oxytocin receptor antagonist with the potential to decrease uterine contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation, all of which may increase the chance of successful pregnancy and live-birth among patients undergoing ART. ObsEva licensed nolasiban from Merck-Serono in 2013 and retains worldwide commercial rights.

About Preterm Labor

Preterm labor, defined as the birthing process starting prior to 37 weeks of gestation, is a serious condition characterized by uterine contractions, cervical dilation and rupture of the fetal membranes that can lead to preterm birth. According to a study published in the Lancet in 2012, approximately 15 million babies were born before 37 weeks of gestation in 2010, accounting for 11.1% of all live births worldwide. Over 1 million children under the age of five died in 2013 worldwide due to preterm birth complications, and many infants who survive preterm birth are at greater risk for cerebral palsy, delays in development, hearing and vision issues, and often face a lifetime of disability. The rates of preterm births are rising in almost all countries with reliable data for preterm birth, and are associated with an immense financial impact to the global healthcare system.

To date, only treatments with limited efficacy or restrictive safety issues are available to treat preterm labor. In the United States, recommended first-line tocolytic treatments (medications that inhibit labor) include beta-adrenergic receptor agonists, calcium channel blockers, or NSAIDs, which are used for short-term prolongation of pregnancy (up to 48 hours) to allow for the administration of antenatal steroids (e.g. betamethasone). Magnesium sulfate, used for fetal neuroprotection can also be used (up to 48 hours) to inhibit acute preterm labor. Approved tocolytic treatments in Europe include beta-adrenergic agonists, which carry severe maternal cardiovascular risks, and intravenous infusions of atosiban (an oxytocin receptor antagonist).

While prostaglandin inhibitors (NSAIDs) have been shown to be effective for inhibiting preterm labor, use of such drugs is limited, due to the threat of serious and sometimes life-threatening side effects in the fetus. Such side effects may include kidney function impairment, premature constriction of the blood vessel connecting the pulmonary artery and the descending aorta in a developing fetus, and higher risk of thrombosis of the intestinal arteries (a condition called necrotizing enterocolitis).

About OBE022 and PGF2alpha

ObsEva is developing OBE022, a potential first-in-class, once daily, oral and selective prostaglandin F2alpha receptor antagonist, which is designed to control preterm labor by reducing inflammation, decreasing uterine contractions, preventing cervical changes and fetal membrane rupture without causing the potentially serious side effects to the fetus seen with non-specific prostaglandin inhibitors (NSAIDs). PGF2alpha is believed to induce contractions of the myometrium and also upregulate enzymes causing cervix dilation and membrane rupture. In nonclinical studies, ObsEva has observed that OBE022 markedly reduces spontaneous and induced uterine contractions in pregnant rats without causing the fetal side effects seen with prostaglandin inhibitors such as indomethacin. ObsEva licensed OBE022 from Merck-Serono in 2015 and retains worldwide commercial rights.

About ObsEva

ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving ART outcomes. ObsEva is listed on The NASDAQ Global Select Market and is trading under the ticker symbol “OBSV”. For more information, please visit www.ObsEva.com.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan,” “potential,” “will,” and similar expressions, and are based on ObsEva’s current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and related interactions with regulatory bodies, ObsEva’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2016, and other filings ObsEva makes with the SEC from time to time. These documents are available on the Investors page of ObsEva’s website at http://www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

###

Media Contact:
Liz Bryan
Spectrum Science
lbryan@spectrumscience.com
+ 1 202-955-6222 x2526

Company Contact:
CEO Office Contact
Delphine Renaud
delphine.renaud@obseva.ch
+41 22-552-1550

Investor Contact
Mario Corso
Senior Director, Investor Relations
mario.corso@obseva.com
+1 781-366-5726

Thursday, June 29th, 2017 Uncategorized Comments Off on $OBSV Announces Presentations Related to its Assisted Reproductive Technology

$CHFS Aquadex FlexFlow® Aquapheresis System Receives FDA IDE Approval

EDEN PRAIRIE, Minn., June 29, 2017  — CHF Solutions, Inc., (fka Sunshine Heart, Inc.) (NASDAQ:CHFS) announced today that researchers in the Stanford University School of Medicine’s Department of Pediatrics have received FDA Investigational Device Exemption (IDE) approval to conduct a clinical study to evaluate the safety and effectiveness of CHF Solutions’ Aquadex FlexFlow Aquapheresis System for diuretic-resistant fluid overload in children with acute decompensated heart failure. The randomized multi-center, non-blinded clinical study will assess up to 45 children and young adults ages 6 months to 21 years with heart failure and diuretic-resistant fluid overload.  Heart failure is the leading cause of death in children with cardiomyopathy and congenital heart disease.

The study seeks to determine whether Aquapheresis therapy is associated with greater weight loss and a non-inferior rate of renal dysfunction compared to optimal medical therapy. In addition, the impact on heart failure symptoms using a novel pediatric heart failure symptoms score developed by the investigators, adverse outcomes and the need for medical management will be evaluated as secondary endpoints. The study is being led by Stanford’s Christopher Almond, Associate Professor of Pediatrics (Cardiology), and David Kwiatkowski, Clinical Assistant Professor of Pediatrics (Cardiology).

“We are pleased that the researchers have received FDA approval to proceed with this IDE study,” said John Erb, Chairman and CEO of CHF Solutions. “Given the limitations of patient unresponsiveness to diuretic therapies over time, our solution represents a potentially transformative future standard of care. We look forward to the clinical data results and to continuing our efforts to provide patients with additional treatment options for the treatment of heart failure,” Mr. Erb concluded.

About CHF Solutions

CHF Solutions, Inc. (NASDAQ:CHFS) is an early-stage medical device company focused on commercializing the Aquadex FlexFlow Aquapheresis System. The Aquadex FlexFlow Aquapheresis System, is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. All treatments must be administered by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.  The company’s objective is to improve the quality of life for patients with heart failure and related conditions. CHF Solutions is a Delaware corporation headquartered in Minneapolis with wholly owned subsidiaries in Australia and Ireland. The company has been listed on the NASDAQ Capital Market since February 2012.

Forward-Looking Statements

Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements the potential for Aquapheresis therapy to be a transformative standard of care for the treatment of fluid overload in heart failure patients and our efforts to evolve ultrafiltration as such, and the receipt of future clinical results.   Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, sources of funding for the approved clinical study, the timing and results of the approved clinical study, those risk associated with our ability to execute on our recently announced strategic realignment, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. CHF Solutions does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

For further information, please contact:

Claudia Napal Drayton	
Chief Financial Officer	
CHF Solutions Inc. 	
T: +1-952-345-4205

Investor Relations:
CHF Solutions, Inc.
ir@chf-solutions.com

-or-

Bret Shapiro
Managing Partner
CORE IR
516 222 2560
brets@coreir.com
www.coreir.com
Thursday, June 29th, 2017 Uncategorized Comments Off on $CHFS Aquadex FlexFlow® Aquapheresis System Receives FDA IDE Approval

$GEMP Top-Line Data from COBALT-1 Phase 2b in HoFH

Gemcabene achieves primary endpoint for LDL cholesterol in phase 2b HoFH trial

Company to host conference call at 4:30 pm ET today

LIVONIA, Mich., June 28, 2017  — Gemphire Therapeutics Inc. (NASDAQ:GEMP) today announced top-line data on the LDL-C primary endpoint from the completed open label Phase 2b COBALT-1 trial.  COBALT-1 evaluated gemcabene in homozygous familial hypercholesterolemia (HoFH) patients who are on stable maximally tolerated lipid-lowering therapies to assess the efficacy, safety, and tolerability of multiple rising doses of gemcabene.

COBALT-1 enrolled patients clinically or genetically diagnosed as HoFH, who were on a variety of background therapies including the highest doses of statins and/or ezetimibe and/or PCSK9 inhibitors.  These therapeutic classes represent the current initial drug therapies for HoFH.  Eight subjects (5 male and 3 female, all Caucasian, average age 53 years) on previously prescribed therapy (which included statins, ezetimibe, evolocumab, cholestyramine, and omega-3 fatty acids) were enrolled from sites in the US, Canada and Israel. Patients were sequentially administered oral gemcabene once daily (dosage escalating from 300 mg to 600 mg and then 900 mg every 4 weeks) for a total duration of 12 weeks.

The mean baseline LDL-C was 351 mg/dL (range from 138-623 mg/dL).  Gemcabene 300 mg lowered LDL-C by a mean of 25% (p=0.0063; range -55% to +1%), gemcabene 600 mg lowered LDL-C by a mean of 30% (p=0.0047; range -51% to +2%), and gemcabene 900 mg lowered LDL-C by a mean of 29% (p=0.0035; range -54% to +6%).  The complete data for COBALT-1 will be submitted to a cardiovascular conference for presentation, as well as for publication in a peer reviewed journal.

Adverse events (AEs) were mild to moderate in intensity across all doses of gemcabene and consistent with previously reported AEs. There were no serious AEs or withdrawals due to AEs in the COBALT-1 study.

“We are excited by these results from our COBALT-1 Phase 2b trial in HoFH patients,” said Steven Gullans, Ph.D., Interim CEO of Gemphire Therapeutics. “Gemcabene’s mean LDL-C reductions compare favorably with the LDL-C reductions, generally 15-25%, observed for approved therapies to treat HoFH patients and are consistent with the LDL-C reductions seen in our prior hypercholesterolemia trials.  These data continue to support gemcabene’s complementary mechanism of action, which is additive to existing lipid lowering therapies.”

COBALT-1 was designed to evaluate the LDL-C lowering efficacy of gemcabene in up to 8 patients with either genetic confirmation or a clinical presentation of HoFH on a stable low-fat, low cholesterol diet in combination with a pre-existing, regulatory-approved, lipid-lowering therapy for at least 4 weeks prior to treatment.  Patients were excluded if they were undergoing apheresis or taking mipomersen or lomitapide.  All enrolled patients were further evaluated for known DNA mutations causing HoFH.  The primary endpoint for each dose of gemcabene (300, 600 and 900 mg) was mean percent change in LDL-C from baseline at 4, 8, and 12 weeks respectively.  Secondary endpoints include mean percent change from baseline in hsCRP, apoB, non-HDL-C, TG, VLDL-C and total cholesterol.  Safety was being assessed by AE monitoring, clinical laboratory assessments, electrocardiograms, physical examinations and vital signs.

“These data announced today continue to demonstrate the additive lipid lowering efficacy of gemcabene that has been demonstrated in the extensive clinical program to date,” said Lee Golden, MD, CMO of Gemphire Therapeutics. “Gemcabene has a novel mechanism of action and demonstrates important additive lipid lowering to existing approved therapies for HoFH patients, who are the patient group with the most severe form of dyslipidemia.  As shown from this and other studies, HoFH patients continue to have elevated LDL-C and additional therapies are needed to help these patients.  We believe the lipid lowering observed in COBALT-1 should support discussions with the FDA to advance this program into Phase 3.”

Additional analyses of 6 subjects that met the more stringent European Atherosclerosis Society (EAS) Consensus Panel diagnosis of HoFH had a mean baseline LDL-C of 374 mg/dL (range 138 to 623 mg/dL). Gemcabene 300, 600 and 900 mg lowered LDL-C by a mean of 18% (p=0.0059; range -32% to +1%), 23% (p=0.0010; range -44% to +2%), and 21% (p=0.0019; range -33% to +6%), respectively, in such subjects. Three subjects known at enrollment to have ‘negative’ (<2%) LDL-receptor activity had a mean baseline LDL-C of 551 mg/dL (range 430 to 623 mg/dL) but still responded to gemcabene: 300 mg lowered LDL-C by a mean of 10% (range -30% to +1%), 600 mg lowered LDL-C by a mean of 15% (range -44% to +2%), and 900 mg lowered LDL-C by a mean of 12% (range -24% to +6%).

“The overall reductions in LDL-C, and in particular more than 20% in the subgroup that met the EAS Consensus Panel criteria of HoFH, are very encouraging and clinically relevant,” said Evan Stein, MD Director Emeritus of the Metabolic & Atherosclerosis Research Center, in Cincinnati, Ohio, USA. “Despite recently approved therapies there remains a need for additional safe and effective therapies for HoFH patients.  We believe these data suggest that gemcabene provides an effective, oral and complementary mechanism to reduce LDL-C for HoFH patients.”

“These data suggest that gemcabene can offer important additional add-on LDL-C reduction to approved therapies for HoFH patients,” said John Kastelein, MD, Professor of Medicine, Department of Vascular Medicine, Academic Medical Center/University of Amsterdam, The Netherlands.  “I am encouraged by these data in the most severe patients, who are completely deficient of LDL-R activity.  The data suggest that further evaluation of gemcabene is warranted in Familial Hypercholesterolemia per se.”

In 2014, gemcabene was granted Orphan Drug Designation for HoFH by the US FDA. Additional information on the COBALT-1 trial, including eligibility criteria and site locations, can be found at www.clinicaltrials.gov using the NCT Identifier NCT02722408.

In addition to these phase 2 results from COBALT-1 (Trial 19) reported here today, gemcabene is currently being evaluated for LDL-C lowering on top of high- and moderate intensity statins in heterozygous familial hypercholesterolemic (HeFH)/atherosclerotic cardiovascular disease (ASCVD) patients in ROYAL-1 (Trial 20) and for the reduction in triglyceride levels in a severe hypertriglyceridemia (SHTG) patient population in INGIGO-1 (Trial 21).

Conference Call and Webcast
Gemphire will further review the top-line data from the COBALT-1 Phase 2b clinical trial in HoFH patients in a conference call today at 4:30 pm ET. To participate, please dial (844) 494-0188 (domestic) or (425) 278-9114 (international) and reference conference ID 45939668. A webcast will be available simultaneously on the News & Events section of the Gemphire website for all interested parties and will be archived and available for 90 days.

About HoFH
HoFH is a rare genetic disease that is most commonly caused by a mutation in both alleles of the LDL receptor gene responsible for removing LDL from the blood. As a result of having defective or deficient LDL receptor function, HoFH patients exhibit severely high LDL-C levels, are at very high risk of experiencing premature cardiovascular events, such as a heart attack or stroke, and develop premature and progressive atherosclerosis. LDL-C levels in untreated HoFH patients are typically in the range of 500 mg/dL to 1,000 mg/dL, compared to a normal target range of 70 mg/dL to 100 mg/dL. Unless treated, most patients with HoFH do not survive beyond 30 years of age. There are approximately 300 to 2,000 HoFH patients in the United States and approximately 6,000 to 45,000 patients in the rest of the world, with a prevalence rate of about one in 160,000 to one in one million. Gemphire is proud to be a supporter of the FH Foundation (https://thefhfoundation.org).

Currently approved widely available treatments for patients with HoFH include statins, ezetimibe, other approved LDL-C lowering therapies (such as bile acid sequestrants), injectable PCSK9 inhibitor Repatha®, and in some countries novel drugs mipomersen (KYNAMRO®) or lomitapide (Juxtapid®) which both include boxed warnings for liver toxicity. HoFH patients usually also require LDL apheresis when available. Despite the availability of various treatments which combined may lower LDL-C 40-45%, many patients are still unable to achieve recommended LDL-C levels.

About Gemcabene
Gemphire’s product candidate, gemcabene (CI-1027), is a first-in-class, once-daily, oral therapy that may be suitable for patients who are unable to achieve normal levels of LDL-C or triglycerides with currently approved therapies, primarily statins.  Gemcabene’s mechanism of action enhances the clearance of very low-density lipoproteins (VLDLs) in the plasma and inhibition of the production of cholesterol and triglycerides in the liver.  The combined effect for these mechanisms has been clinically observed to result in a reduction of plasma VLDL-C, LDL-C, and triglycerides.  In addition, gemcabene has been shown to markedly lower C-reactive protein and improve insulin sensitization.  Gemcabene is liver-directed and reduces apoC-III mRNA and plasma levels.  Gemcabene also reduces acetyl-CoA carboxylase (ACC1) and CCR2/CCR5 receptor mRNA levels, which may have applications in non-alcoholic steatohepatitis (NASH)/non-alcoholic fatty liver disease (NAFLD).  Gemcabene has demonstrated proof of concept efficacy for NASH in the STAM™ model developed at SMC Laboratories in Tokyo, Japan. Gemcabene has been tested as monotherapy and in combination with statins and other drugs in 903 subjects across 19 Phase 1 and Phase 2 clinical trials and has demonstrated promising evidence of efficacy, safety and tolerability.

About Gemphire
Gemphire is a clinical-stage biopharmaceutical company that is committed to helping patients with cardiometabolic disorders, including dyslipidemia and NASH.  The Company is focused on providing new treatment options for cardiometabolic diseases through its complementary, convenient, cost-effective product candidate gemcabene as add-on to the standard of care especially statins that will benefit patients, physicians, and payors.  Gemphire has initiated 3 clinical trials for homozygous familial hypercholesterolemia (HoFH), heterozygous familial hypercholesterolemia (HeFH)/atherosclerotic cardiovascular disease (ASCVD), and severe hypertriglyceridemia (SHTG) under NCT02722408, NCT02634151, and NCT02944383, respectively with a fourth planned trial in NASH to initiate in second half of 2017.  Please visit www.gemphire.com for more information.

Forward Looking Statements
Any statements in this press release about Gemphire’s future expectations, plans and prospects, including statements about Gemphire’s financial prospects, future operations and sufficiency of funds for future operations, clinical development of Gemphire’s product candidate, expectations regarding future clinical trials and future expectations and plans and prospects for Gemphire, expectations regarding operating expenses and cash used in operations, and other statements containing the words “believes,” “anticipates,” “estimates,” “expects,” “intends,” “plans,” “predicts,” “projects,” “targets,” “may,” “potential,” “will,” “would,” “could,” “should,” “continue,” “scheduled” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.  Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the success and timing of Gemphire’s regulatory submissions and pre-clinical and clinical trials; regulatory requirements or developments; changes to Gemphire’s clinical trial designs and regulatory pathways; changes in Gemphire’s capital resource requirements; Gemphire’s ability to obtain additional financing; Gemphire’s ability to successfully market and distribute its product candidate, if approved; Gemphire’s ability to obtain and maintain its intellectual property protection; and other factors discussed in the “Risk Factors” section of Gemphire’s Annual Report on Form 10-K for the year ended December 31, 2016 and in other filings Gemphire makes with the SEC from time to time.  In addition, the forward-looking statements included in this press release represent Gemphire’s views as of the date hereof.  Gemphire anticipates that subsequent events and developments will cause Gemphire’s views to change.  However, while Gemphire may elect to update these forward-looking statements at some point in the future, Gemphire specifically disclaims any obligation to do so.  These forward-looking statements should not be relied upon as representing Gemphire’s views as of any date subsequent to the date hereof.

Contact:
Andrew McDonald, Ph.D.
LifeSci Advisors, LLC
(646) 597-6987

Jeff Mathiesen, CFO
Gemphire Therapeutics Inc.
(734) 245-1700
Wednesday, June 28th, 2017 Uncategorized Comments Off on $GEMP Top-Line Data from COBALT-1 Phase 2b in HoFH

$GBT Receives EMA PRIME Designation for GBT440 in SCD

– GBT440 is First Potential Treatment for SCD To Be Accepted for PRIME –

– PRIME Designation Allows for Frequent and Early Interactions with the Agency Aimed at Assisting Accelerated Evaluation and Approval –

SOUTH SAN FRANCISCO, Calif., June 28, 2017 — Global Blood Therapeutics, Inc. (GBT) (NASDAQ:GBT) today announced that the European Medicines Agency (EMA) has determined that GBT440 for the treatment of sickle cell disease is eligible for its Priority Medicines (PRIME) program. The PRIME program is a new regulatory mechanism that provides for early and proactive EMA support to medicine developers to help patients benefit as early as possible from innovative new products that have demonstrated the potential to significantly address an unmet medical need.

“Access to the EMA’s PRIME program is important not just for GBT, but for the entire SCD community, as this is the first eligibility granted to PRIME for a SCD therapy. It provides further recognition from a regulatory authority that SCD is a severely unmet medical need that requires attention,” said Ted W. Love, M.D., president and chief executive officer of GBT. “Additionally, it is external validation of the potential of GBT440 to address this need and bring a major therapeutic advantage to patients. We look forward to this enhanced collaboration with the EMA to further accelerate the development of GBT440 for patients in Europe.”

To be accepted for PRIME, a therapy must demonstrate the potential to benefit patients with unmet medical needs through early clinical data. The GBT440 acceptance was supported by data from the ongoing Phase 1/2 clinical trial (GBT440-001) evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of GBT440 in both healthy subjects and adults with SCD. Additionally, results from this trial, coupled with the well understood molecular pathophysiology of SCD and the mechanism of action of GBT440, support the scientific rationale that improvement in hemolysis and hemoglobin may be likely to translate into an improvement in patient symptoms and important disease modification.

About the Priority Medicines (PRIME) Initiative
PRIME is a program launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary program is based on enhanced interaction and early dialogue with developers of promising medicines, to optimize development plans and speed up evaluation so these medicines can reach patients earlier. Through PRIME, the EMA offers early and proactive support to medicine developers to optimize the generation of robust data on a medicine’s benefits and risks and enable accelerated assessment of medicines applications. The goal of the initiative is to help patients benefit as early as possible from therapies that may significantly improve their quality of life.

About Sickle Cell Disease (SCD) 
SCD is a lifelong inherited blood disorder caused by a genetic mutation in the beta-chain of hemoglobin, which leads to the formation of abnormal hemoglobin known as sickle hemoglobin (HbS). In its deoxygenated state, HbS has a propensity to polymerize, or bind together, forming long, rigid rods within a red blood cell (RBC). The polymer rods deform RBCs to assume a sickled shape and to become inflexible, which can cause blockage in capillaries and small blood vessels. Beginning in childhood, SCD patients suffer unpredictable and recurrent episodes or crises of severe pain due to blocked blood flow to organs, which often lead to psychosocial and physical disabilities. This blocked blood flow, combined with hemolytic anemia (the destruction of RBCs), can eventually lead to multi-organ damage and early death.

About GBT440 in Sickle Cell Disease
GBT440 is being developed as an oral, once-daily therapy for patients with SCD. GBT440 works by increasing hemoglobin’s affinity for oxygen. Since oxygenated sickle hemoglobin does not polymerize, GBT believes GBT440 blocks polymerization and the resultant sickling of red blood cells. With the potential to restore normal hemoglobin function and improve oxygen delivery, GBT believes that GBT440 may potentially modify the course of SCD. In recognition of the critical need for new SCD treatments, the U.S. Food and Drug Administration (FDA) has granted GBT440 both Fast Track and Orphan Drug designations for the treatment of patients with SCD, and the European Commission (EC) has designated GBT440 as an orphan medicinal product for the treatment of patients with SCD. GBT is currently evaluating GBT440 in the HOPE (Hemoglobin Oxygen Affinity Modulation to Inhibit HbS PolymErization) Study, a Phase 3 clinical trial in patients age 12 and older with SCD. Additionally, GBT440 is being studied in the ongoing Phase 1/2 GBT440-001 trial and in the ongoing HOPE-KIDS 1 Study, an open-label, single- and multiple-dose study in adolescents (age 12 to 17) with SCD designed to assess the safety, tolerability, pharmacokinetics and exploratory treatment effect of GBT440.

About Global Blood Therapeutics
Global Blood Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to discovering, developing and commercializing novel therapeutics to treat grievous blood-based disorders with significant unmet need. GBT is developing its lead product candidate, GBT440, as an oral, once-daily therapy for sickle cell disease. GBT is also investigating GBT440 for the treatment of hypoxemic pulmonary disorders in two ongoing Phase 2a studies in patients with idiopathic pulmonary fibrosis. To learn more, please visit www.globalbloodtx.com and follow the company on Twitter: @GBT_News.

Forward-Looking Statements 
Statements we make in this press release may include statements that are not historical facts and are considered forward-looking 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. We intend these forward-looking statements, including statements regarding the therapeutic potential and safety profile of GBT440, our ability to implement our clinical development plans for GBT440 in both SCD and hypoxemic pulmonary disorders, our ability to generate and report data from our ongoing studies of GBT440, regulatory review and actions relating to GBT440, and the timing of these events, to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. We can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved, and furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, the risks that our clinical and preclinical development activities may be delayed or terminated for a variety of reasons, that regulatory authorities may disagree with our clinical development plans or require additional studies or data to support further clinical investigation of our product candidates, and that drug-related adverse events may be observed in later stages of clinical development, along with those risks set forth in our Annual Report on Form 10-K for the fiscal year ended
 December 31, 2016 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, as well as discussions of potential risks, uncertainties and other important factors in our subsequent filings with the U.S. Securities and Exchange Commission. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Myesha Lacy (investors)
GBT
650-351-4730
investor@globalbloodtx.com

Julie Normart (media)
Pure Communications
415-946-1087
media@globalbloodtx.com
Wednesday, June 28th, 2017 Uncategorized Comments Off on $GBT Receives EMA PRIME Designation for GBT440 in SCD

$HTGM Diagnostics Launches its HTG EdgeSeq PATH Assay

TUCSON, Ariz., June 28, 2017 — HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments, reagents and services for molecular profiling applications, announced that it has launched its new HTG EdgeSeq PATH Assay for sale in the U.S. and Europe. The HTG EdgeSeq PATH Assay has been designed for retrospective gene expression profiling (GEP) to complement traditional immunohistochemistry (IHC) testing by allowing investigators to assess mRNA expression of large numbers of biomarkers when formalin-fixed, paraffin-embedded (FFPE) sample availability is limited. The assay is designed to detect up to 470 mRNA targets, typically assessed by IHC.

“We believe the trend toward smaller and less invasive biopsy methods, from which more and more information is needed, drives the market for our new HTG EdgeSeq PATH Assay,” stated TJ Johnson, President and Chief Executive Officer of HTG. “We expect this product to enable simple and cost effective retrospective studies, which, ultimately, could lead to new GEP-based diagnostic, prognostic and predictive classifiers in solid tumors and clinical IHC-replacement products, and an estimated $1.5 billion market opportunity.”

“We designed this assay to enable our customers to profile small tissue biopsies in a more comprehensive manner than conventional IHC permits, and we expect this additional GEP information to advance research that, in the end, will improve patient care,” stated Patrick Roche, Ph.D., HTG’s Senior Vice President, Research & Development.

About HTG:

Headquartered in Tucson, Arizona, the mission of HTG Molecular Diagnostics (HTG) is to empower precision medicine at the local level. In 2013 the company commercialized its first instrument platform and a portfolio of RNA assays that leveraged HTG’s original proprietary nuclease protection chemistry. Continuous improvement led to the 2014 launch of the company’s HTG EdgeSeq product line, which automates sample and targeted library preparation for next-generation sequencing. Additional information is available at www.htgmolecular.com.

Safe Harbor Statement:

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the market drivers for, and the expected  benefits and uses of, our new HTG EdgeSeq PATH Assay. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, 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, including, without limitation, the risk that we may not successfully commercialize the HTG EdgeSeq PATH Assay, the risks that the HTG EdgeSeq PATH Assay may not provide the anticipated benefits to our customers or that our customers may not use the HTG EdgeSeq PATH Assay to advance anticipated types of clinical research, risks associated with the process of developing and commercializing our products, our ability to achieve and sustain sufficient market acceptance, and the capabilities of our products to keep pace with rapidly changing technology and customer requirements. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission, including without limitation our Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. All forward-looking statements contained in this press release speak only as of the date on which they were made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contact:
Westwicke Partners
Jamar Ismail
Phone: 415-513-1282
Email: jamar.ismail@westwicke.com

TJ Johnson
President / CEO
HTG Molecular Diagnostics
Phone: 520-547-2827 x130
Email: tjjohnson@htgmolecular.com
Wednesday, June 28th, 2017 Uncategorized Comments Off on $HTGM Diagnostics Launches its HTG EdgeSeq PATH Assay

$ADOM to Ring the Nasdaq Closing Bell on Thursday July 6

LOS ANGELES, CA–(Jun 28, 2017) – Boustead Securities, LLC client ADOMANI, Inc. (NASDAQ: ADOM), a provider of advanced zero-emission electric and hybrid vehicles and replacement drivetrains, will be ringing The Nasdaq Stock Market Closing Bell on Thursday, July 6, 2017. In honor of the special occasion in which ADOM earned the distinction of being the first company to IPO on Nasdaq under Regulation A+, James L. Reynolds, ADOMANI President & CEO, alongside members of the Company’s leadership team, will conduct the historic event at the Nasdaq MarketSite in New York’s Times Square.

On June 15, 2017, ADOMANI, Inc. began trading on the NASDAQ Capital Market under the symbol “ADOM,” and currently ranks as the best-performing IPO for all of 2017. Dan McClory, Head of Equity Capital Markets at Boustead Securities, LLC, the Lead Underwriter in the ADOMANI IPO, stated “ADOMANI has made history by being the pioneering Reg A+ Initial Public Offering to list on NASDAQ,” he concluded.

Webcast:
A live stream of the Nasdaq Closing Bell will be available on July 6, 2017:
https://new.livestream.com/nasdaq/live or http://www.nasdaq.com/about/marketsitetowervideo.asx

About ADOMANI
ADOM is a provider of zero-emission electric and hybrid vehicles and replacement drivetrains that is focused on reducing the total cost of vehicle ownership. ADOM helps fleet operators unlock the benefits of green technology and address the challenges of traditional fuel price instability and local, state and federal environmental regulatory compliance. ADOM designs, manufactures and installs advanced zero-emission electric and hybrid drivetrain systems for use in new school buses and medium to heavy-duty commercial fleet vehicles. ADOM also designs, manufactures and installs unique and patented conversion kits to replace conventional drivetrain systems for diesel and gasoline powered vehicles, including buses, with zero-emission electric or hybrid drivetrain systems. In addition to benefitting our shareholders, we will also help improve the environment, and more importantly, improve the health of school children and citizens who live and work in and around traditional diesel and gasoline-fueled vehicles.

About Nasdaq
Nasdaq (NASDAQ: NDAQ) is a leading global provider of trading, clearing, exchange technology, listing, information and public company services. Through its diverse portfolio of solutions, Nasdaq enables customers to plan, optimize and execute their business vision with confidence, using proven technologies that provide transparency and insight for navigating today’s global capital markets. As the creator of the world’s first electronic stock market, its technology powers more than 89 marketplaces in 50 countries, and 1 in 10 of the world’s securities transactions. Nasdaq is home to 3,800 total listings with a market value of $11.0 trillion. To learn more, visit: http://business.nasdaq.com

About Boustead Securities, LLC
Boustead Securities, LLC (“Boustead”) is an investment banking firm that executes and advises on IPOs, mergers and acquisitions, capital raises and restructuring assignments in a wide array of industries, geographies and transactions, for a broad client base. Boustead’s core value proposition is the ability to create opportunity through innovative solutions and tenacious execution. With experienced professionals in the United States and around the world, Boustead’s team moves quickly and provides a broad spectrum of sophisticated financial advice and services. For more information, visit http://www.boustead1828.com/

Contact Information
Boustead Securities, LLC:
Dan McClory
Managing Director and Head of Equity Capital Markets
+1 (949) 502-4408
dan@boustead1828.com

Wednesday, June 28th, 2017 Uncategorized Comments Off on $ADOM to Ring the Nasdaq Closing Bell on Thursday July 6

$SRAX NetworkNewsBreaks: SRAX Announces New Tool to Extend Reach of Facebook Posts

Internet advertising company SRAX (NASDAQ: SRAX) this morning announced the launch of a new SRAX Social tool for digital marketers and content owners designed to create and promote posts that extend beyond their Facebook page communities. This release is noteworthy as, according to industry reporting, organic reach for businesses on Facebook fell more than 50 percent last year. “Organic reach for brand content on Facebook has rapidly declined leading to strong demand to boost content on the social network and beyond,” Chris Miglino, CEO and chairman of SRAX, stated in the news release. “The ability to boost posts directly from SRAX Social provides digital marketers and content owners a new tool to take advantage of the paid media opportunities on Facebook, while managing social media efforts, most importantly, data across social channels and campaigns, through one platform.” The new tool is the first of many planned monetization opportunities to be integrated into SRAX’s social media management platform, SRAX Social, which leverages programmatic technology and big data to share, schedule and automate social media content.

To view the full press release, visit: http://nnw.fm/K6Zl2

About SRAX

SRAX (NASDAQ: SRAX) is an advertising technology company providing the tools to automate digital marketers and content owners’ campaigns across digital channels. SRAX’s tools amplify performance and maximize profits for brands in the healthcare, CPG, automotive, wellness and lifestyle verticals through an omnichannel approach that integrates all aspects of the marketing experience into one platform. The company’s machine-learning technology identifies brands’ core consumers and their characteristics discovering new and measurable opportunities to target, reach and monetize audiences driving online and offline sales lift. For more information on how SRAX delivers a digital competitive advantage to surpass today’s marketing challenges, visit www.srax.com.

About NetworkNewsBreaks

NetworkNewsBreaks (NNB) provide a rapid summary of corporate news that caught the attention of NetworkNewsWire (NNW). NNB keeps you up-to-date on active US Public Companies complementary to NNW’s broader scope as a provider of news aggregation and syndication, enhanced press release services and a full array of social communication solutions. As a multifaceted financial news and 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.

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

NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Editor@NetworkNewsWire.com

Wednesday, June 28th, 2017 Uncategorized Comments Off on $SRAX NetworkNewsBreaks: SRAX Announces New Tool to Extend Reach of Facebook Posts

$OSUR to Drive Accelerated Adoption of OraQuick® HIV Self-Test

OraSure Technologies enters agreement with Bill & Melinda Gates Foundation to reduce price of rapid, point-of-care HIV self-test in 50 developing countries

BETHLEHEM, Pa., June 27, 2017 — OraSure Technologies, Inc. (NASDAQ:OSUR), a leader in point-of-care diagnostic tests and specimen collection devices, today announced a new agreement with the Bill & Melinda Gates Foundation that will enable OraSure to offer its OraQuick® HIV Self-Test at an affordable price in 50 developing countries with funding from the Gates Foundation.  The funding will consist of support payments tied to the volume of product sold by OraSure and reimbursement of certain related costs.

Under a four-year Charitable Support Agreement, OraSure will make its OraQuick® HIV Self-Test available for purchase in 50 developing countries located in Africa and Asia. These countries include Malawi, Zambia and Zimbabwe, where the Company has been providing tests for the “Self-Testing in Africa” or “STAR” Project implemented by Population Services International (“PSI”).

Through this agreement, funding from the Gates Foundation will enable non-governmental organizations in eligible countries that receive funding from government or public sector agencies and donors such as the Children’s Investment Fund Foundation (UK), the Global Fund, PEPFAR and UNITAID to access HIV self-testing at reduced pricing.  The funding from the Gates Foundation will be in an aggregate amount not to exceed $20 million over the four-year term or $6 million each year of the agreement.

“We are pleased to work with the Bill & Melinda Gates Foundation on this important initiative designed to support the rapid scale-up and adoption of the OraQuick® HIV Self-Test in the fight against HIV/AIDS,” said Douglas A. Michels, President and CEO of OraSure Technologies.  “We are witnessing the benefits of HIV self testing through the use of our product by PSI under the STAR Project.  The support payments provided by the Gates Foundation will help us expand our relationship with PSI and substantially accelerate the adoption of the OraQuick® HIV Self-Test in many more developing countries.”

“Diagnosing HIV quickly and accurately is critical to both improving treatment access and preventing new infections,” said Emilio Emini, Director of the HIV program at the Bill & Melinda Gates Foundation. “This initiative will allow for increased access to self-conducted HIV screening, resulting in a substantially improved ability to recognize and treat individuals living with HIV.”

The Gates Foundation is making this investment as part of its program-related investments (PRI) strategy, which aims to stimulate private sector-driven innovation, encourage market-driven efficiencies and attract external capital to priority global health and development initiatives that improve the lives of the world’s most vulnerable people.

The OraQuick® HIV Self-Test is a rapid, point-of-care test that allows an individual to detect antibodies to both HIV-1 and HIV-2 with an oral swab, with results in as little as 20 minutes.  It is the same test used in the Company’s OraQuick® In-Home HIV Test, the first and only FDA-approved in-home HIV test for consumers, except that the packaging and product instructions have been tailored for use by individuals in developing countries.

About OraSure Technologies

OraSure Technologies is a leader in the development, manufacture and distribution of point-of-care diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and HCV on the OraQuick® platform, oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications, and oral fluid laboratory tests for detecting various drugs of abuse. OraSure’s portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians’ offices, commercial and industrial entities and consumers. The Company’s products enable individuals to obtain critical health information at the point-of-care, thereby empowering them to make decisions to improve and protect their health.

For more information on OraSure Technologies, please visit www.orasure.com.

Important Information

This press release contains certain forward-looking statements, including with respect to expected revenues and earnings/loss per share. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to:  ability to market and sell products, whether through our internal, direct sales force or third parties; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the FDA or other regulators; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; impact of increased reliance on U.S. government contracts; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; impact of replacing distributors; inventory levels at distributors and other customers; ability of the Company to achieve its financial and strategic objectives and continue to increase its revenues, including the ability to expand international sales; ability to identify, complete, integrate and realize the full benefits of future acquisitions; impact of competitors, competing products and technology changes; impact of negative economic conditions, high unemployment levels and poor credit conditions; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of oral fluid testing or other products; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention (“CDC”) or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of our products; history of losses and ability to achieve sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of the Company’s stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital;  ability to meet financial covenants in credit agreements; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; and general political, business and economic conditions.  These and other factors are discussed more fully in the Company’s  Securities and Exchange Commission (“SEC”) filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2016, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.

Company contact:

Ronald H. Spair	
Chief Financial Officer	
610-882-1820	
Investorinfo@orasure.com
www.orasure.com

Shauna White
Corporate Marketing Manager
484-353-1575
media@orasure.com
www.orasure.com
Tuesday, June 27th, 2017 Uncategorized Comments Off on $OSUR to Drive Accelerated Adoption of OraQuick® HIV Self-Test

$SBBP Completes Target Enrollment Phase 3 SONICS Study Evaluating RECORLEV

DUBLIN, Ireland and TREVOSE, Pa., June 27, 2017  — Strongbridge Biopharma plc, (Nasdaq:SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that it has met its enrollment target of 90 patients in the Phase 3 SONICS study evaluating the safety and efficacy of RECORLEV (levoketoconazole), a next-generation cortisol synthesis inhibitor, for the treatment of endogenous Cushing’s syndrome. Based upon strong interest in the SONICS study at the end of screening, a small number of additional potential study participants remain in screening and will be allowed to enroll, if qualified.

“We would like to sincerely thank our investigators, their clinical teams, and, most importantly, all of the patients from many countries around the globe for their continued dedication and participation in the SONICS study,” said Fredric Cohen, M.D., chief medical officer of Strongbridge Biopharma. “We currently still have patients in screening for SONICS due to the high level of interest and demand in the study.  Although we have reached target enrollment, we are pleased to extend the study for a brief period to accommodate those in screening who qualify. This will enable us to report top-line results in the second quarter of 2018,” Dr. Cohen added.

“The need for a safe and effective, next-generation cortisol synthesis inhibitor, such as RECORLEV, in the treatment of Cushing’s syndrome is substantial. Through achieving target enrollment in the SONICS study, we are one step closer to better understanding the clinical value of RECORLEV and potentially bringing a new therapeutic treatment option to this community,” said Matthew Pauls, president and chief executive officer of Strongbridge Biopharma. “Because we strongly believe in the potential of RECORLEV to become a best-in-class therapy, and as previously announced, we have strengthened our Phase 3 development plan to include LOGICS, a nine-week, placebo-controlled study, which will complement the long-term SONICS study. We anticipate availability of top-line data from the LOGICS study in the third quarter of 2018,” Pauls added.

SONICS and LOGICS are multinational Phase 3 studies designed to evaluate the safety and efficacy of RECORLEV when used to treat endogenous Cushing’s syndrome. SONICS is a single-arm, open-label study conducted in three treatment phases. Patients titrate to a therapeutic dose in the first phase and are maintained at the therapeutic dose for six months in the second phase, the end of which marks the primary efficacy time point. A six-month extended evaluation is included for long-term safety evaluations. LOGICS uses a placebo-controlled, double-blind, randomized-withdrawal design. Approximately 35 patients with Cushing’s syndrome will be randomized in LOGICS, of which approximately one-half will have previously completed SONICS. Together, the SONICS and LOGICS studies will include the participation of approximately 100 clinical research sites in over 20 countries in North America, Europe and the Middle East.

For more information on the SONICS study, please visit ClinicalTrials.gov and reference identifier: NCT01838551.

About Endogenous Cushing’s Syndrome
Endogenous Cushing’s syndrome (CS) is a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure. Most people with CS have a variety of signs and symptoms – many of which, when they occur by themselves, are common and do not necessarily point to an underlying disease; this makes recognition of CS difficult. Common presenting symptoms include weight gain or obesity, fatigue, muscle weakness, headaches, mood or sleep disturbances, facial rounding or redness, excess body hair growth in women or baldness in men, thinned skin with stretch marks, easy bruising and other skin changes including acne, mood or sleep disturbances and irregular periods or loss of libido.  Patients are often found by their doctors to have new-onset or worsening of high blood pressure, abnormal levels of blood lipids, such as cholesterol, polycystic ovaries and abnormal blood glucose or diabetes. People with uncontrolled disease are seriously ill and have a 2- to 4-fold higher mortality rate than age- and gender-matched controls, mainly due to metabolic and cardiovascular complications. Treatment options for CS include surgery, radiation therapy, and medical treatment. Cushing’s syndrome most commonly affects adults ages 20-50 and is more prevalent in females, accounting for about 70 percent of all cases.

About Strongbridge Biopharma
Strongbridge Biopharma is a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Strongbridge’s first commercial product is KEVEYIS® (dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis. KEVEYIS has orphan drug exclusivity status in the U.S. through August 7, 2022. In addition to establishing this neuromuscular disease franchise, the Company has a clinical-stage pipeline of therapies for rare endocrine diseases. Strongbridge’s lead compounds include RECORLEV (levoketoconazole), a cortisol synthesis inhibitor currently being studied for the treatment of endogenous Cushing’s syndrome, and veldoreotide, a next-generation somatostatin analog being investigated for the treatment of acromegaly, with potential additional applications in Cushing’s syndrome and neuroendocrine tumors. Both RECORLEV and veldoreotide have received orphan designation from the U.S. Food and Drug Administration and the European Medicines Agency. For more information, visit www.strongbridgebio.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties.  All statements, other than statements of historical facts, contained in this press release, are forward-looking statements. These statements relate to future events and involve known and unknown risks, including, without limitation, uncertainties regarding Strongbridge’s strategy, plans, anticipated investment, status and results of clinical trials and objectives of management for future operations. The words “anticipate,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on current expectations, estimates, forecasts and projections and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. The forward-looking statements contained in this press release are made as of the date of this press release, and Strongbridge Biopharma does not assume any obligation to update any forward-looking statements except as required by applicable law.

Contacts:

Corporate and Media Relations
Elixir Health Public Relations
Lindsay Rocco
+1 862-596-1304
lrocco@elixirhealthpr.com

Investor Relations
U.S.:
The Trout Group
Marcy Nanus
+1 646-378-2927
mnanus@troutgroup.com

Europe:
First House
Mitra Hagen Negård
+47 21 04 62 19
strongbridgebio@firsthouse.no

USA
900 Northbrook Drive
Suite 200
Trevose, PA 19053
Tel. +1 610-254-9200
Fax. +1 215-355-7389
Tuesday, June 27th, 2017 Uncategorized Comments Off on $SBBP Completes Target Enrollment Phase 3 SONICS Study Evaluating RECORLEV

$ADMA Biologics Provides Corporate Timeline and Activities Update to Stockholders

RAMSEY, N.J. and BOCA RATON, Fla., June 27, 2017  — ADMA Biologics, Inc. (NASDAQ:ADMA), a late-stage biopharmaceutical company that develops, manufactures and commercializes specialty plasma-based biologics for the proposed treatment of immune deficiencies and prevention of certain infectious diseases, announced today that is has provided a corporate timeline and activities update to Stockholders.  The communication is provided below:

Dear Stockholders,

On behalf of the Board of Directors, management team and all employees of ADMA Biologics, Inc. (“we,” “us,” or the “Company”), I would like to thank you for your support with respect to our recent asset acquisition from Biotest Pharmaceuticals Corporation (the “Transaction”).  We believe this Transaction is transformative because having ownership of a vertically integrated biologics production plant is a rarity in our industry.

There are only a handful of these highly-specialized plasma fractionation plants in the world with approvals to market products in the U.S. and we believe that we are the only American-owned, headquartered and domiciled company with fractionation capacity.  We have seen that the M&A activity in the plasma products space, for both large and small vertically integrated facilities, has continued to yield attractive valuations.  Based on industry reports and the rising global demand for plasma and plasma derived biologics, we expect this trend to continue.  With the closing of the Transaction, we believe that our Company has a number of value creating milestones and inflection points in the near-term, including:

  • Remediation of the FDA Warning Letter of the acquired manufacturing facility;
  • Relaunch of BIVIGAM™ in the U.S.;
  • Refiling of the BLA for RI-002, and its anticipated subsequent approval;
  • Approval of our third plasma center; and
  • Extending our cash runway.

Now that we have control over our drug substance manufacturing, and with that the ability to have a direct communication with the U.S. Food and Drug Administration (the “FDA”) as an approved manufacturer of immune globulins, we believe ADMA Biologics is a more attractive Company than we were just a year ago.

We realize that many of you have questions regarding our Company’s near- and long-term goals and objectives.  Our goal is to evolve ADMA Biologics into a leading vertically integrated human protein plasma products and immune globulin manufacturer with an innovative and differentiated product portfolio that will address the unmet medical needs of patients with various forms of immune deficiencies.  We now have many of the assets in place to achieve this goal.  We believe a significant amount of value exists in this business model, and we have a clear strategic plan in place to unlock it.

Our top priority is to remediate the outstanding compliance issues identified at our acquired manufacturing facility and ensure that the status of the previously issued FDA Warning Letter is lifted and the objectionable status is eliminated.

As part of the Company’s preparations for closing the Transaction, we initiated discussions with the FDA’s Office of Compliance and Biologics Quality under the Center for Biologics Evaluation and Research with respect to our plans for achieving a successful remediation program.  In order to quickly and efficiently complete this objective, we have engaged a leading consulting firm with extensive experience in remediating compliance and inspection issues related to quality management systems, that manages a robust team of subject matter experts in plasma derived products and biologic drugs.  These consultants have been and continue to work side-by-side with our talented staff to develop and implement specific remediation strategies for each quality system in order to bring the facility into compliance with current Good Manufacturing Practices (“cGMP “).  Over the past four months (prior to closing of the Transaction), we worked with our advisors to identify all of the quality system functions within our manufacturing facility which required modifications, amendments and improvements.  We are now focused on implementing the appropriate changes and our consultants will assist, train and provide oversight of our plant manufacturing and testing activities as we advance towards GMP compliance.  Our goal with respect to this remediation project is to be “inspection ready” in approximately 6 months. While we cannot control the FDA’s inspection and meeting schedule, we are hopeful and optimistic that through our ongoing transparent dialogue with the FDA, we can achieve these target timelines.

Additionally, we remain committed to addressing the Complete Response Letter (“CRL”) received from the FDA for our patented lead product, RI-002.  As previously disclosed, we received the CRL because of existing compliance issues with certain of our vendors.  With our continuing focus on remediation on all aspects of our manufacturing and of our vendors activities, we believe that these vendors have addressed their specific issues directly with the FDA.  Now following the closing of the Transaction, and our team having operational control of the drug substance manufacturing, we anticipate that we will be in a position to refile the Biologics License Application (“BLA”) for RI-002 in the middle of 2018.

Concurrently, we are focused on relaunching Bivigam™(Immune Globulin Intravenous, Human),  and renewing sales and marketing efforts for Nabi-HB™ (Hepatitis B Immune Globulin, Human) which are products we acquired in the Transaction.  As reported in our proxy statement filed in connection with the Transaction, revenues of $76.5M were reported for calendar year 2016 from the Boca Facility, of which Bivigam™ represented approximately $50M of revenues during the same period.   However, as previously disclosed, the production of Bivigam™ was voluntarily halted by the prior ownership in order to conduct appropriate facility upgrades, renovations and improvements. We are pleased to report that these upgrades have now been completed and that we are in the process of final qualification with respect to these improvements.  With our continuing path towards compliance, we anticipate that our facility will be ready to begin manufacturing certain products for our Company and our clients in approximately 8 weeks.

While relaunch is important to our near-term success, we remain committed to maximizing our Company’s long-term success to becoming competitive in the market of specialty immune globulins.  To that end, over the past several months, we have been working with our consultant experts to optimize the manufacturing process for immune globulin products.  As you may recall, the previously issued Warning Letter for our manufacturing facility cited filter clogging during the manufacturing process for BIVIGAM™.  We are pleased to report that we have identified a number of possible sources for filter clogging and we are diligently working to prioritize and resolve these various possibilities. Our preliminary data suggests that optimization of the process has produced significant improvements in the filterability of the product.  We are hopeful that the institution of newly identified process controls, the setting of specific parameters for these processes during manufacturing combined with the tightening of our production specifications will bring our facility in line with FDA’s manufacturing expectations.  We believe that this is an important step in the overall remediation process to lift the FDA Warning Letter status.

We continue to grow revenue through the sale of source plasma to third party customers, as well as through the sale of our newly acquired hyperimmune globulin product for Hepatitis B, Nabi-HB™.  There is a broad population of patients who remain susceptible to potential Hepatitis B infection and ADMA is committed to increasing awareness and utilization of its Nabi-HB™ product to provide patients with the protection they need, as well as assist those patients who have failed conventional antiviral therapies and for whom the hyperimmune globulin may be the only available alternative.

Along with expending efforts to generate revenues for the business, ADMA management is exploring various financing options, which include potentially, refinancing its current senior debt facility, which if achieved on favorable terms, would be expected to allow ADMA to extend its current cash runway from the first quarter 2018, well into the second half of 2018 and perhaps further, depending on the timing and structuring of the loan facility.

Management is committed to the success of this acquisition and integration process.  Although there can be no assurances that we can achieve our goals on the timelines described, if at all, or that our current assumptions are accurate and do not require updating, we believe that hands-on oversight and operational management will be the single most important aspect to effect the corporate cultural changes at the Boca facility that are necessary to improve operational efficiency, accountability and redefine the focus of ADMA Biologics personnel on becoming a highly valuable company.  To this end, I will be moving to Boca Raton with my family in August 2017.

ADMA is committed to all of these activities because ultimately, there are patients who are counting on our Company and our products to improve medical outcomes and potentially save their lives.  All of this is possible because of our Stockholders.  We are grateful to you, for your continued patience and support while we work on integrating business operations and work to remediate the quality systems of our manufacturing facility. You have the ability to make a difference in the lives of so many people by investing in ADMA Biologics, and for this we deeply thank you for your confidence and support.

Sincerely,

Adam Grossman
President, CEO and Founder

About ADMA Biologics, Inc. (ADMA)
ADMA Biologics is a fully-integrated biopharmaceutical and specialty immunoglobulin manufacturing company that currently markets and develops specialty plasma-based biologics for the proposed treatment of immune deficiencies and prevention of certain infectious diseases.  ADMA’s mission is to develop and commercialize plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases. The target patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disease, or who may be immune-compromised for medical reasons. ADMA has received U.S. Patent 9,107,906 relating to certain aspects of its product candidate. ADMA has recently announced the closing of its acquisition of certain assets from Biotest Pharmaceuticals Corporation. For more information, please visit www.admabiologics.com.

Forward-Looking Statements
This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words “estimate,” “intend,” “target,” “will,” “is likely,” “would,” “may,” or in each case, their negative, or words or expressions of similar meaning. These forward-looking statements include, but are not limited to, statements concerning our ability to develop, manufacture, and commercialize specialty plasma-based biologics for the proposed treatment of immune deficiencies and the prevention of certain infectious diseases, the success of our work with our third party vendors and the U.S. Food and Drug Administration in furtherance of and progress towards an approval of our Biologics License Application for specialty plasma-based biologics and our ability and the ability of such third parties to respond adequately or in a timely manner to the issues raised by the FDA, our ability to successfully pursue commercialization and prelaunch activities, the timeframe within which we may receive approval from the FDA for specialty plasma-based biologics, if at all, the potential of our specialty plasma-based biologics to provide meaningful clinical improvement for patients living with PIDD or other indications and our ability to realize increased prices for plasma growth in the plasma collection industry. These forward-looking statements also involve risks and uncertainties concerning the expected benefits and synergies from our transaction with Biotest Pharmaceuticals, the anticipated combined businesses, operations, products and services, and liquidity, debt refinancing and/or repayment and capital return expectations, as well as ADMA’s ability to raise capital following closing of this transaction. Actual events or results may differ materially from those described in this document due to a number of important factors. These factors include, among others, the outcome of regulatory reviews with respect to the acquired assets, the ability of ADMA to successfully integrate the acquired therapy business, operations (including manufacturing and supply operations), sales and distribution channels, business and financial systems and infrastructures, research and development, technologies, products, services and employees;  and ADMA’s ability to manage the increased scale, complexity and globalization of its business, operations and employee base post-closing, among others. Forward-looking statements are subject to many risks and uncertainties that could cause our actual results and the timing of certain events to differ materially from any future results expressed or implied by the forward-looking statements, including those risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. Therefore, current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by ADMA or any other person that the objectives and plans of ADMA will be achieved in any specified time frame, if at all. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements.

CONTACT: Brian Lenz
Vice President and Chief Financial Officer |201-478-5552 | www.admabiologics.com
Tuesday, June 27th, 2017 Uncategorized Comments Off on $ADMA Biologics Provides Corporate Timeline and Activities Update to Stockholders

$APDN and Lily of the Desert to Prove Aloe vera Origin/Authenticity

Pilot study proves “Molecular SigNatures™” persist from the raw plant to the finished extracts and then to finished nutritional and personal care products. Inherent Aloe DNA does not suffice.

Applied DNA Sciences, Inc. (“Applied DNA,” “the company,” NASDAQ:APDN), has completed initial work under a funded contract with Lily of the Desert, a leading US-based producer of Aloe vera products, whose offerings include nutritional drinks, topical crèmes and gels. The pilot studies defined by the agreement are designed to demonstrate the feasibility of molecular tagging to create the industry’s first traceable and authenticated Aloe vera juices, from raw material to the manufacture of nutritional drinks and topical consumer products. Applied DNA and Lily of the Desert are working together to protect consumer supply lines, with Phase One expected to be completed within the next month.

Extracts of Aloe vera extracts represent a nearly $2 billion market, with a total mass of more than 60,000 metric tons and are expected to grow through 2026 at a compounded annual growth rate of 7.7% (Future Market Insights, 2016). The clinical utility of Aloe vera has been the subject of thousands of studies that document dermatologic and digestive impact. In a November report last year, Bloomberg stated there was no chemical evidence of Aloe vera in gels purported to contain the extract as a primary ingredient in products sold at Target, Walmart and CVS. A class action suit was filed in June of 2016 against CVS alleging there was no Aloe vera extract in their Aloe vera gels.

The challenge lies with traditional methods of verifying the content of Aloe vera in finished goods, which can be misleading in complex formulae – a problem that Applied DNA intends to resolve. Not only is Aloe vera difficult to chemically identify once processed into finished consumer products, but Applied DNA has demonstrated that manufacturing processes damage Aloe vera’s native DNA, making it impossible to rely solely on the traditional Bar Code of Life (BCOL) DNA for identification.

The solution lies in the laboratory and pilot manufacturing trials conducted by Applied DNA scientists in collaboration with Lily of the Desert. The stability and persistence of the Company’s Molecular SigNature tags have been demonstrated from raw material to nutritional supplements to fully-processed Aloe vera consumer products. With the capability to authenticate real Aloe vera juices throughout the supply chain based on a Molecular SigNatures, retailers and brands may support their label claims, and provide reassurance and certainty to consumers.

Dr. Glen Gillis, Vice President of Research and Chief Science Officer stated, “Proton NMR (Nuclear Magnetic Resonance), the current, accepted analytical technique for a detection of Aloe quality, has proven to be a powerful and accurate tool for detection of Aloe vera in many products. But as it is with any analytical technique, NMR is not without flaws. The application of ‘molecular tagging’ to Aloe vera, a new and cutting-edge technique used in tracking of the supply chain from source to shelf, will add to the industry another layer of protection for both branded products and end-user confidence.”

The same processes being employed in these pilot studies can be readily used to provide ingredient verification and supply chain security to other brands, using other natural extracts, who are seeking to reassure customers about the quality of their products. “Consumers are increasingly demanding transparency and they want to know the origins of the ingredients in the cosmetics they purchase. With our work in Aloe vera, they are getting even more than this. They are getting forensic proof of where the materials come from, giving them transparency with certainty,” said Dr. Barbara Brockway, Director of Personal Care at Applied DNA.

Dr. James A. Hayward, President and CEO of Applied DNA, said, “Since we have previously documented the ability of our Molecular SigNatures to authenticate Aloe vera, we look forward to receiving the results of this pilot study which, if successful, have the potential to open up new commercial markets for the Company. These tags function as the equivalent of molecular certificates embedded in the Aloe vera, documenting the extract content as the product is manufactured and travels through the supply chain. A wide array of markets, from food to supplements to pharmaceuticals to personal care, stand to benefit from the specific advantages of this method of verification, literally at the frontier of supply chain science.”

About Lily of the Desert

Lily of the Desert owns the organic Aloe vera farms and processing facilities for manufacturing the numerous unique aloe vera products that carry our brand name. This is rare amongst Aloe vera companies in the natural products industry. Our Aloe vera is grown and processed in the Rio Grande Valley of Texas and the desert of Mexico. Our corporate headquarters are in Denton, Texas. The Lily of the Desert brand of Aloe vera products is the leader of the Aloe vera category in the natural products industry, exceeding the next 6 competitors in total unit sales (ref. SPINS). As a company, Lily of the Desert has maintained our commitment in ‘Retaining the Quality that Nature Created’ by making aloe vera products our customers can be confident in buying.

About Applied DNA

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and DNA mass production for diagnostics and therapeutics.

We make life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. The proprietary DNA-based “CertainT™” platform can be used to identify, tag, test, and track products, to help assure authenticity, origin, traceability, sustainability and quality of products. SigNature® DNA describes the core technology ingredient that is at the heart of a family of uncopyable, security and authentication solutions such as SigNature® T and fiberTyping®, targeted toward textiles and apparel, BackTrac™ and DNAnet®, for anti-theft and loss prevention, and digitalDNA®, providing powerful track- and-trace. All provide a forensic chain of evidence, and can be used to prosecute perpetrators. Applied DNA Sciences is also engaged in the large-scale production of specific DNA sequences using the polymerase chain reaction.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward-Looking Statements

The statements made by APDN in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe APDN’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of APDN. Actual results could differ materially from those projected due to our short operating history, limited financial resources, limited market acceptance, market competition and various other factors detailed from time to time in APDN’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 6, 2016, and our subsequent quarterly reports on Form 10-Q filed on February 9, 2017, and May 11, 2017 which are available at www.sec.gov. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

 

Investor Relations:
LHAI
Sanjay Hurry, 212-838-3777
or
Media:
Dian Griesel Int’l
Susan Forman, 212-825-3210
or
Program:
Applied DNA
Dr. Barbara Brockway, +44 (0) 7484725053
web: www.adnas.com
twitter: @APDN

Tuesday, June 27th, 2017 Uncategorized Comments Off on $APDN and Lily of the Desert to Prove Aloe vera Origin/Authenticity

$MBRX Conference Call to Discuss New Discovery for Pancreatic Cancer

Call Scheduled for this Thursday, 6.29.17 at 4:30 PM ET

HOUSTON, TX–(June 27, 2017) – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that it will host a conference call on Thursday, June 29, 2017 at 4:30 PM ET to discuss the recent new discovery of a metabolic inhibitor with the potential to treat pancreatic cancer as well as to provide a business update.

Conference Call Information
The call can be accessed with the following dial-in information:

Participant dial in (toll free): 1-877-883-0383

Participant international dial in: 1-412-902-6506

Please ask to be joined into the Moleculin call. Participant Entry Number: 4675376

This conference call will be recorded and made available for replay as follows:

US Toll Free: 1-877-344-7529

International Toll: 1-412-317-0088

Canada Toll Free: 1-855-669-9658

Replay Access Code: 10109887

End Date: July 13, 2017

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

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, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential for its recent discovery to demonstrate potential for the treatment of pancreatic cancer. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech 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. Moleculin Biotech has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake 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.

Contacts

PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Tuesday, June 27th, 2017 Uncategorized Comments Off on $MBRX Conference Call to Discuss New Discovery for Pancreatic Cancer

$BOLC Global Mfg. Partnership Increases Throughput Capabilities for trutankless®

Agreement enables Bollente Companies to meet growing demand from its network of wholesale, homebuilder and installation partners

PHOENIX, June 27, 2017 — Bollente Companies, Inc. (OTCQB: BOLC) today announced that it has signed a manufacturing agreement with SINBON Electronics, a leading solution provider of electronic component integration design and manufacturing with a global presence in the U.S., Taiwan, China, Japan, the U.K., Germany, Hungary and the Czech Republic.

The agreement with SINBON will allow Bollente Companies to ramp up production of its award-winning trutankless line of electric tankless water heaters as it faces heavy demand from wholesalers like Ferguson, Hajoca, Hughes, Morrison and Winnelson, along with homebuilding and plumbing installation partners.

Since 1989, SINBON has provided solutions ranging from global materials sourcing and buying, product inquiries, sampling, manufacturing and after-sales service for the medical, automotive, green energy, industrial application and communications sectors. The company’s impressive client list includes household names like GE, Siemens, Honeywell, Porsche, Sony and Samsung. In addition, SINBON is committed to designing and developing environmentally friendly products and has adopted practices specified by ISO 14001 environmental management guidelines.

“We are excited to be a part of the trutankless transition from pioneering startup to a brand with global reach,” said Jesse Huang, Vice President of Sales at SINBON Electronics. “We seek partners with products that reflect long-term vision, innovative technology and excellence in design—all of which are evident in trutankless. We look forward to a long and successful partnership.”

Connect on social media:
www.houzz.com/pro/trutankless
www.facebook.com/trutankless
www.twitter.com/trutankless
www.youtube.com/trutankless

About trutankless:
Founded in 2010, trutankless, a division of Bollente Companies, Inc. (OTCQB: BOLC), was brought to life through the combined insight, ingenuity, and drive of industry professionals, engineers, and entrepreneurs. The objective was to create a line of electric tankless water heaters that far surpasses traditional tank water heaters in energy efficiency, output, dependability and environmental sustainability while overcoming the frustrating drawbacks of other tankless units on the market today.

The trutankless mission is to efficiently provide hot water on demand by combining smart engineering with forward-thinking technologies that save owners money, energy, and space. For more information, please visit www.trutankless.com or call 855-TO-BUY-TRU.

Forward-Looking Statement: The statements in this press release regarding any implied or perceived benefits from the release by trutankless of its line of electric tankless water heaters or added key strategic sales and distribution partners are forward-looking statements. Such statements involve risks and uncertainties, including, but not limited to, risks of the key strategic sales and distribution partners ability to sell our product, and effects of legal and administrative proceedings and governmental regulation, especially in a foreign country, future financial and operational results, competition, general economic conditions, and the ability to manage and continue growth.

Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual outcomes may vary materially from those indicated. Important factors that could cause actual results to differ materially from the forward-looking statements we make in this news release include the introduction of new technology, market conditions, and those set forth in reports or documents we file from time to time with the SEC. We undertake no obligation to revise or update such statements to reflect current events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Tuesday, June 27th, 2017 Uncategorized Comments Off on $BOLC Global Mfg. Partnership Increases Throughput Capabilities for trutankless®

$VOXX To Sell Its Hirschmann Car Communication Antenna And Tuner Business

HAUPPAUGE, N.Y., June 26, 2017  — VOXX International Corporation (NASDAQ: VOXX), a leading manufacturer and supplier of automotive, consumer electronics and accessories, and premium audio products worldwide, today announced that it has entered into a definitive agreement to sell Hirschmann Car Communication GmbH and its worldwide subsidiaries (“Hirschmann”) to a subsidiary of TE Connectivity Ltd. (NYSE: TEL).

Under the terms of the Stock Purchase Agreement, TE Connectivity (“TE”) will acquire Hirschmann for an enterprise value of 148.5 million Euro. Based on the Euro to US dollar conversion (1 Euro = $1.12), this equates to approximately $166.0 million. The final purchase price is subject to further net cash and working capital adjustments. VOXX International (Germany) GmbH is the selling entity in this transaction.

VOXX International Corporation will continue to operate in the Automotive industry and will retain its ongoing OEM business that is not part of this transaction through VOXXHirschmann Corporation. The Company will also continue its Automotive Aftermarket business through its proprietary brands and 3rd-party distribution agreements. The continuing operations include the Company’s market-leading rear-seat infotainment solutions, car security and remote start systems, remote start modules, app-based vehicle security solutions, keyless entry products and its newest innovation, the eFob, satellite radio products, and telematics, among others. Business lines that will be sold as part of this agreement, include Hirschmann’s antenna, smart antenna, multi-digital tuner and commercial asset tracking business, which incorporates various technologies and product lines. Under the terms of the agreement, VOXX International will phase out the VOXXHirschmann name over a period of two years.

Commenting on today’s announcement, Pat Lavelle, President and Chief Executive Officer of VOXX International Corporation stated, “I would like to thank the Hirschmann employees for their unwavering commitment to innovation and their positive contribution to VOXX International. The passion they have displayed in driving and developing technology-advanced products for OEM customers has been exceptional. We believe with the additional resources that TE Connectivity brings to Hirschmann, the business will have the ability to grow faster and garner a bigger share within their core product lines.”

Lavelle continued, “Over the past few years, we have won a considerable number of contracts from many of the most respected Automotive companies in the world, and the pipeline we have amassed has Hirschmann positioned very well in the future. While the business is growing, it would require significant working capital on our end and we believe now is the right time to sell. We also believe that TE is the right company to bring Hirschmann to the next level. Their ability to invest for growth, strong global presence and history of innovation makes this a win-win for all parties – for VOXX, TE Connectivity and the customers served.”

“The proposed acquisition of Hirschmann further expands our product portfolio and the integrated, highly engineered solutions we provide for connected and autonomous vehicles worldwide,” said Eric Kueppers, President of TE’s Global Automotive business. “Increasing data needs and new applications require active communications and increased connectivity within and outside the vehicle. Combining Hirschmann’s leading antenna technology with TE’s sensing and connecting capabilities allows us to expand our offerings, providing customers with value-add, holistic end-to-end data connectivity solutions.”

This transaction is subject to regulatory approval and customary closing conditions. The Company expects to provide more details around this transaction in its upcoming Fiscal 2018 first quarter results announcement and corresponding conference call, which will be held in mid-July 2017. Additionally, the expected close, subject to approvals, is anticipated to be on August 31, 2017.  Wells Fargo Securities is acting as exclusive financial advisor to VOXX International on the transaction.

ABOUT VOXX INTERNATIONAL CORPORATION

VOXX International Corporation (NASDAQ: VOXX) has grown into a worldwide leader in Automotive, Consumer Electronics, Consumer Accessories and Premium Audio.  Today, the Company has an extensive distribution network that includes power retailers, mass merchandisers, 12-volt specialists and most of the world’s leading automotive manufacturers.  The Company has an international footprint in Europe, Asia, Mexico and South America, and a growing portfolio, which now comprises over 30 trusted brands. Among the Company’s brands are Klipsch®, RCA®, Invision®, Jensen®, Audiovox®, Terk®, Acoustic Research®, Advent®, Code Alarm®, Car Connection®, 808®, AR for Her®, Prestige®, EyeLock, Jamo®, Energy®, Mirage®, Mac Audio®, Magnat®, Heco®, Schwaiger®, Oehlbach®, and Incaar™.  For additional information, please visit our Web site at www.voxxintl.com.

ABOUT HIRSCHMANN CAR COMMUNICATION

Hirschmann Car Communication is one of the world’s leading specialists in antenna, transmitter, receiver, M2M and telematics technologies, primarily for automobile communications and connectivity. The Company is a primary antenna provider to some of the world’s most notable auto manufacturers, and a leader in TV tuner applications in Europe, Middle East and Africa (EMEA). The Company operates in Europe, North America and China. Further information can be found at www.hirschmann-car.com.

ABOUT TE CONNECTIVITY

TE Connectivity (NYSE: TEL) is a $12 billion global technology leader. Our commitment to innovation enables advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. TE’s unmatched breadth of connectivity and sensor solutions, proven in the harshest of environments, helps build a safer, greener, smarter and more connected world. With 75,000 people – including more than 7,000 engineers – working alongside customers in nearly 150 countries, we help ensure that EVERY CONNECTION COUNTS – www.TE.com

Safe Harbor Statement

Except for historical information contained herein, statements made in this release that would constitute forward-looking statements may involve certain risks and uncertainties. All forward-looking statements made in this release are based on currently available information and the Company assumes no responsibility to update any such forward-looking statements. The following factors, among others, may cause actual results to differ materially from the results suggested in the forward-looking statements. The factors include, but are not limited to risks that may result from changes in the Company’s business operations; our ability to keep pace with technological advances; significant competition in the automotive, premium audio and consumer accessories businesses; our relationships with key suppliers and customers; quality and consumer acceptance of newly introduced products; market volatility; non-availability of product; excess inventory; price and product competition; new product introductions; foreign currency fluctuations and concerns regarding the European debt crisis; restrictive debt covenants; the possibility that the review of our prior filings by the SEC may result in changes to our financial statements; and the possibility that stockholders or regulatory authorities may initiate proceedings against VOXX International Corporation and/or our officers and directors as a result of any restatements. Risk factors associated with our business, including some of the facts set forth herein, are detailed in the Company’s Form 10-K for the fiscal year ended February 28, 2017.

Company Contact:
Glenn Wiener, President
GW Communications
Tel: 212-786-6011
Email: gwiener@GWCco.com

Monday, June 26th, 2017 Uncategorized Comments Off on $VOXX To Sell Its Hirschmann Car Communication Antenna And Tuner Business

$SELB Announces $50 Million Private Placement

WATERTOWN, Mass., June 26, 2017 — Selecta Biosciences, Inc. (NASDAQ:SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses, today announced that it has entered into definitive agreements to sell securities in a private placement that is expected to result in gross proceeds to the company of $50 million, before deducting placement agent and other offering expenses.

The company plans to use the proceeds from the financing primarily for ongoing clinical development of Selecta’s lead product candidate, SEL-212, for the treatment of chronic severe gout and to enable the company to bring additional product candidates into the clinic. Selecta expects the addition of these proceeds to its existing balance sheet will enable the company to fund its operating expenses and capital expenditure requirements into 2019. Stifel served as sole placement agent for the offering.

Certain new and existing institutional investors have agreed to purchase an aggregate of 2,750,000 shares of common stock at a price of $16.00 per share. Additionally, a member of the company’s Board of Directors has agreed to purchase, for an aggregate purchase price of approximately $6 million, 338,791 shares of common stock and warrants to purchase 79,130 shares of common stock at an exercise price of $17.71.  The closing of the offering is subject to certain conditions and is expected to occur on June 27, 2017.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws, and will be sold in a private placement pursuant to Regulation D of the Securities Act. The securities being issued in the private placement may not be offered or sold in the United States absent registration or pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws. The company has agreed to file a registration statement covering the resale of the securities acquired by the investors in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer or sale would be unlawful prior to the registration or qualification under the securities laws of such state.  Any offering of the securities under the resale registration statement will only be by means of a prospectus.

About Selecta Biosciences, Inc.
Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company that is focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses. Selecta plans to combine its tolerogenic Synthetic Vaccine Particles (SVP™) to a range of biologics for rare and serious diseases that require new treatment options. The company’s current proprietary pipeline includes SVP-enabled enzyme, oncology and gene therapies. SEL-212, the company’s lead candidate in Phase 2, is being developed to treat severe gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta’s clinical oncology candidate, LMB-100, is in a Phase 1 program targeting pancreatic cancer and mesothelioma. Its two proprietary gene therapy product candidates are being developed for rare inborn errors of metabolism and have the potential to enable repeat administration. The use of SVP is also being explored in the development of vaccines and treatments for allergies and autoimmune diseases. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com and follow @SelectaBio on Twitter.

Forward-Looking Statements
Any statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. (“the company”), including without limitation, statements relating to the closing of, the amount of any proceeds from, and the company’s use of any proceeds from, the private placement transaction, the company’s ability to unlock the full potential of biologic therapies, the company’s plan to apply its SVP platform to a range of biologics for rare and serious diseases, the potential of SEL-212 to treat severe gout patients and resolve their debilitating symptoms, the potential of the company’s two gene therapy product candidates to enable repeat administration, the potential treatment applications for products utilizing the SVP platform in areas such as gene therapy, oncology, allergies, autoimmune diseases and vaccines, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors discussed in the “Risk Factors” section of the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on May 11, 2017, and in other filings that the company makes with the SEC. In addition, any forward-looking statements included in this press release represent the company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The company specifically disclaims any obligation to update any forward-looking statements included in this press release.

 

Contact Information:

Jason Fredette
Selecta Biosciences, Inc.
617-231-8078
jfredette@selectabio.com
Monday, June 26th, 2017 Uncategorized Comments Off on $SELB Announces $50 Million Private Placement

$SVA Enters into Definitive Agreement for Going-Private Transaction

BEIJING, June 26, 2017  — Sinovac Biotech Ltd. (NASDAQ: SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that it has entered into a definitive amalgamation agreement (the “Amalgamation Agreement”) with Sinovac (Cayman) Limited (“Parent”) and Sinovac Amalgamation Sub Limited (“Amalgamation Sub”), a wholly owned subsidiary of Parent, pursuant to which Sinovac will be acquired by Parent in a transaction valued at approximately US$401.8 million.

Pursuant to the Amalgamation Agreement, Parent will acquire the Company for cash consideration equal to US$7.00 per common share of the Company (each, a “Share”).  This represents a premium of 32.1% and 30%, respectively, over the Company’s 30- and 60-trading day volume-weighted average price as quoted by NASDAQ prior to the Company’s announcement on February 1, 2016 that it had received a non-binding “going-private” proposal from Mr. Weidong Yin, the chairman, president and chief executive officer of the Company, and SAIF Partners IV L.P. (“SAIF”) and/or its affiliates to acquire all of the outstanding Shares not already owned by them.

The consideration to be paid to holders of Shares pursuant to the Amalgamation Agreement also represents an increase of approximately 13.3% from the original US$6.18 per Share offer price in the “going-private” proposal announced on February 1, 2016.

Immediately following the consummation of the transactions contemplated by the Amalgamation Agreement, Parent will be beneficially owned by a consortium (the “Buyer Consortium”) comprising Mr. Yin, SAIF, C-Bridge Healthcare Fund II, L.P. (“C-Bridge Capital”), Advantech Capital L.P. (“Advantech Capital”), Vivo Capital Fund VIII, L.P. and Vivo Capital Surplus Fund VIII, L.P. (together with Vivo Capital Fund VIII, L.P., “Vivo Capital”).  As of June 23, 2017, the members of the Buyer Consortium beneficially own in the aggregate approximately 29.5% of the issued and outstanding Shares.

Subject to the terms and conditions of the Amalgamation Agreement, at the effective time of the amalgamation, Amalgamation Sub will be amalgamated with and into the Company, with the Company continuing as the surviving corporation and a wholly owned subsidiary of Parent (the “Amalgamation”), and each of the Shares issued and outstanding immediately prior to the effective time of the Amalgamation will be canceled in consideration for the right to receive US$7.00 per Share in cash, without interest and net of any applicable withholding taxes, except for (i) 6,049,500 Shares held by Mr. Yin and 10,780,820 Shares held by SAIF (collectively, the “Rollover Shareholders”), (ii) Shares held by Parent, Parent’s affiliates, the Company or any of the Company’s subsidiaries, which Shares, in each case, will be canceled without payment of any consideration or distribution therefor and (iii) Shares owned by holders who have validly exercised and not effectively withdrawn or lost their rights to dissent from the Amalgamation in accordance with the provisions of Section 191 of the International Business Corporations Act, CAP. 222 of the Revised Laws of Antigua and Barbuda (as consolidated and revised) (the “IBCA”), which Shares will be canceled at the effective time of the Amalgamation for the right to receive the fair value of such Shares determined in accordance with the provisions of Section 191(4) or Section 195(2) of the IBCA, as applicable.

The Buyer Consortium intends to fund the Amalgamation through a combination of cash contributions from C-Bridge Capital, Advantech Capital and Vivo Capital or their respective affiliates pursuant to equity commitment letters.

The Company’s board of directors, acting upon the unanimous recommendation of the special committee formed by the board of directors (the “Special Committee”), unanimously approved the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation, and resolved to recommend that the Company’s shareholders authorize and approve the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation.  The Special Committee, which is composed solely of independent directors of the Company who are unaffiliated with Parent, Amalgamation Sub or any member of the Buyer Consortium or management of the Company, exclusively negotiated the terms of the Amalgamation Agreement with the Buyer Consortium with the assistance of its independent financial and legal advisors.

The Amalgamation, which is currently expected to close during the second half of 2017, is subject to customary closing conditions, including approval by an affirmative vote of holders of Shares representing at least two-thirds of the Shares present and voting in person or by proxy as a single class at a meeting of the Company’s shareholders, which will be convened to consider the authorization and approval of the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation, and the other closing conditions specified in the Amalgamation Agreement.  As of June 23, 2017, the Rollover Shareholders beneficially own in the aggregate approximately 29.5% of the issued and outstanding Shares.  Pursuant to a support agreement among the Rollover Shareholders, Parent and Sinovac Holding (Cayman) Limited, the sole shareholder of Parent, the Rollover Shareholders have agreed to vote all their Shares in favor of the authorization and approval of the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation.  If completed, the Amalgamation will result in the Company becoming a privately-held Company and the Shares will no longer be listed on NASDAQ.

Duff & Phelps LLC is serving as financial advisor to the Special Committee.  Weil, Gotshal & Manges LLP is serving as U.S. legal counsel to the Special Committee, Leslie-Ann Brissett Legal Services is serving as Antigua and Barbuda legal counsel to the Special Committee and Haiwen & Partners is serving as PRC legal counsel to the Special Committee.

Latham & Watkins LLP is serving as U.S. legal counsel to the Company and Delaney Law is serving as Antigua and Barbuda legal counsel to the Company.

Lazard is serving as financial advisor to the Buyer Consortium.  Kirkland & Ellis is serving as U.S. legal counsel to Mr. Yin and the Buyer Consortium and Roberts & Co is serving as Antigua and Barbuda legal counsel to the Buyer Consortium.  Skadden, Arps, Slate, Meagher & Flom LLP is serving as U.S. legal counsel to C-Bridge Capital and Advantech Capital.  Ropes & Gray LLP is serving as U.S. legal counsel to Vivo Capital.

Additional Information about the Transaction

The Company will furnish to the Securities and Exchange Commission (the “SEC”) a report on Form 6-K regarding the proposed transactions described in this announcement, which will include as an exhibit thereto the Amalgamation Agreement.  All parties desiring details regarding the transactions contemplated by the Amalgamation Agreement, including the Amalgamation, are urged to review these documents, which will be available at the SEC’s website (http://www.sec.gov).

In connection with the Amalgamation, the Company will prepare and mail a proxy statement to its shareholders. In addition, certain participants in the Amalgamation will prepare and mail to the Company’s shareholders a Schedule 13E-3 transaction statement that will include the proxy statement. These documents will be filed with or furnished to the SEC. INVESTORS AND SHAREHOLDERS ARE URGED TO READ CAREFULLY AND IN THEIR ENTIRETY THESE MATERIALS AND OTHER MATERIALS FILED WITH OR FURNISHED TO THE SEC WHEN THEY BECOME AVAILABLE, AS THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY, THE TRANSACTIONS CONTEMPLATED BY THE AMALGAMATION AGREEMENT AND RELATED MATTERS. In addition to receiving the proxy statement and Schedule 13E-3 transaction statement by mail, shareholders also will be able to obtain these documents, as well as other filings containing information about the Company, the Amalgamation and related matters, without charge, from the SEC’s website (http://www.sec.gov) or at the SEC’s public reference room at 100 F Street, NE, Room 1580, Washington, D.C. 20549.  In addition, these documents can be obtained, without charge, by contacting the Company at the following address and/or phone number:

Sinovac Biotech Ltd.
No. 39 Shangdi Xi Road
Haidian District, Beijing, People’s Republic of China
Phone:  +86-10-8279-9871

The Company and certain of its directors, executive officers and other members of management and employees may, under SEC rules, be deemed to be “participants” in the solicitation of proxies from shareholders with respect to the Amalgamation. Information regarding the persons or entities who may be considered “participants” in the solicitation of proxies will be set forth in the proxy statement and Schedule 13E-3 transaction statement relating to the Amalgamation when it is filed with the SEC. Additional information regarding the interests of such potential participants will be included in the proxy statement and Schedule 13E-3 transaction statement and the other relevant documents filed with the SEC when they become available.

This announcement is neither a solicitation of proxy, an offer to purchase nor a solicitation of an offer to sell any securities and it is not a substitute for any proxy statement or other filings that may be made with the SEC should the Amalgamation proceed.

Safe Harbor Statement

This announcement may include certain statements that are not descriptions of historical facts, but are forward-looking statements.  These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995.  These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements.  Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements.  Potential risks and uncertainties include, but are not limited to, uncertainties as to how the Company’s shareholders will vote at the meeting of shareholders, the possibility that competing offers will be made, the possibility that various closing conditions to the Amalgamation may not be satisfied or waived and other risks and uncertainties discussed in Sinovac’s filings with the SEC, as well as the Schedule 13E-3 transaction statement and the proxy statement to be filed by the Company in connection with the Amalgamation.  Sinovac does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

About Sinovac

Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases. Sinovac’s product portfolio includes vaccines against enterovirus71, or EV71, hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), and mumps. The EV71 vaccine, an innovative vaccine developed by Sinovac against hand foot and mouth disease caused by EV71, was commercialized in China in 2016. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. The Company is currently developing a number of new products including a Sabin-strain inactivated polio vaccine, pneumococcal polysaccharides vaccine, pneumococcal conjugate vaccine and varicella vaccine. Sinovac primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The Company has exported select vaccines to over 10 countries in Asia and South America.  For more information, please visit the Company’s website at www.sinovac.com.

Contact

Sinovac Biotech Ltd.
Helen Yang
Tel: +86-10-8279-9871
Fax: +86-10-6296-6910
Email: ir@sinovac.com

ICR Inc.
Bill Zima
U.S: 1-646-308-1707
Email: william.zima@icrinc.com

Monday, June 26th, 2017 Uncategorized Comments Off on $SVA Enters into Definitive Agreement for Going-Private Transaction

$CAR Avis Enters Into Partnership With Waymo

Collaboration Reinforces Avis Budget Group’s Position as Mobility Leader

PARSIPPANY, N.J., June 26, 2017  — Avis Budget Group, Inc. (NASDAQ:CAR) today announced that it has signed an agreement with Waymo, an Alphabet Inc. company, to offer fleet support and maintenance services for Waymo’s self-driving car program at Avis Car Rental and Budget Car Rental locations.

The collaboration is designed to support Waymo’s growing autonomous vehicle (AV) fleet and Waymo’s early rider program, a public trial of its self-driving cars in Phoenix, Arizona. Waymo recently announced that it is adding hundreds of Chrysler Pacifica minivans to build a 600-vehicle fleet. This partnership will allow Avis Budget Group to service Waymo’s growing number of cars on the road, ensuring Waymo’s self-driving vehicles are ready for riders around the clock.

Under the multi-year agreement, Avis Budget Group will enhance selected rental facilities to offer automotive services and secure parking for Waymo’s fleet. The services offered by Avis Budget Group include interior and exterior cleaning, oil changes, tire rotations, and the checking, ordering and installation of automotive parts, as well as other necessary fleet support and maintenance.

“With members of the public using our growing fleet of self-driving cars, our vehicles need standard maintenance and cleaning so they’re ready for our riders at any time of the day or night,” said John Krafcik, chief executive officer, Waymo. “Avis Budget Group is an ideal partner to provide fleet support and maintenance. With thousands of locations around the world, Avis Budget Group can help us bring our technology to more people, in more places.”

“We are excited to partner with Waymo, the self-driving technology leader that is changing the mobility landscape in a profoundly transformative and beneficial manner,” said Larry De Shon, president and chief executive officer, Avis Budget Group. “Not only does this partnership enable us to leverage our current capabilities and assets, but it also allows us to accelerate our knowledge and hands-on experience in an emerging area as Waymo-enabled self-driving cars become available in the marketplace.”

About Avis Budget Group
Avis Budget Group, Inc. is a leading global provider of mobility solutions, both through its Avis and Budget brands, which have more than 11,000 rental locations in approximately 180 countries around the world, and through its Zipcar brand, which is the world’s leading car sharing network, with more than one million members. Avis Budget Group operates most of its car rental offices in North America, Europe and Australia directly, and operates primarily through licensees in other parts of the world. Avis Budget Group has approximately 30,000 employees and is headquartered in Parsippany, N.J. More information is available at www.avisbudgetgroup.com.

About Waymo
Waymo is a self-driving technology company with a mission to make it safe and easy for people and things to move around. We’re determined to improve transportation for people around the world, building on software and sensor technology developed in Google’s labs since 2009. In October 2015, we achieved the world’s first fully self-driving trip on public roads, in a car without a steering wheel or pedals. We refine Waymo technology through one billion miles of simulation testing each year, and our cars have self-driven over three million miles on public roads across four U.S. cities.

Contacts:
Alice Pereira
Avis Budget Group
(973) 496-3916
PR@avisbudget.com

Waymo
press@waymo.com
Monday, June 26th, 2017 Uncategorized Comments Off on $CAR Avis Enters Into Partnership With Waymo